FDA Regulation of Dietary Supplements

FDA Regulation of Dietary Supplements

Elizabeth S. Westfall

Introduction

In 1994, as policymakers were debating the merits of health care reform, another health care debate, as divisive and passionate as that of health care reform, was heating up to a boil: the regulation of dietary supplements. While discussion of health care reform revolved around issues concerning the proper role of government in providing health insurance to Americans, the undercurrent of the dietary supplement debate centered on personal control over one's own fitness and health, without any governmental interference.

The dietary supplement industry and supplement consumers represent a potent, political force. Almost half of all Americans regularly consume dietary supplements,[1]which include, among other substances, vitamins, minerals, herbs, and amino acids. In the U.S., there are about six hundred supplement manufacturers whose annual sales exceed $4 billion annually.[2]Although many other U.S. industries dwarf the supplement industry, supplement manufacturers have long been successful in bringing about tremendous political pressure through their grassroot activities. During the 1970's, when FDA issued regulations which would have allowed vitamins or minerals to be a maximum of 150% of the U.S. Recommended Daily Allowance (RDA)[3]and announced that high potency Vitamin A and D would be considered prescription drugs,[4]the supplement industry drummed up their grassroots, flooded Capital Hill with mail, and succeeded in gaining the enactment of the Vitamin-Mineral Amendments, better known as the Proxmire Amendments.[5]

Recently, a similar supplement maelstrom struck Congressional offices over the issue of the proper regulatory framework for dietary supplements. After the enactment of the 1990 Nutritional Labeling and Education Act (NLEA),[6]perceived regulatory threats to supplement consumers autonomy and freedom ignited a political firestorm in Washington and beyond. With industry funding a $2.5 million public relations campaign,[7]Congressional offices were beseiged by angry supplement consumers. On the other side of the debate stood Center for Science in the Public Interest (CSPI), a non-profit consumer organization, which had strongly supported NLEA and was determined to thwart industry-backed legislation to regulate supplements.[8]On both poles and scattered in between, the FDA and key members of Congress, including Senators Orrin Hatch, Edward Kennedy, and Tom Harkin and Congressmen John Dingell, Henry Waxman, Bill Richardson, and Elton Gallegly, further fueled the debate about the proper regulatory framework for supplements. After four years of lobbying and intense legislative deliberations, Congress successfully enacted the Dietary Supplement Health and Education Act of 1994 (DSH&E Act) which was signed into law on October 25, 1 994.[9]

SCOPE AND INqUIRY OF THIS PAPER

This paper will discuss and analyze major provisions of the Dietary Supplement Health and Education Act of 1994 (DSH&E Act). Specifically, this paper will focus on political motivations behind certain provisions, reaction to and analysis of the DSH&E Act, and future implications and questions left unanswered by the Act. Part I will present a brief history of dietary supplement regulation and related legislation from passage of the NLEA to the enactment of the DSH&E Act. Part II will discuss and analyze in detail major provisions of the Act. Part III will conclude with a brief discussion of what issues lie ahead for dietary supplements, particularly in the area of health claims. [10]

I.Recent History of Dietary Supplement Regulation and Related Events

A.Nutrition Labeling and Education Act of 1990 and L-Tryptophan

Prior to passage of the NLEA, FDA permitted only manufacturers of drugs, but not conventional foods or dietary supplements, to label their products with claims concerning disease prevention, mitigation, treatment or cure.[11] In 1984, the Kellogg Company challenged this policy by labeling its AU-Bran cereal product with a health claim which included the statement "[ylou'll find no cereal has more fiber than Kellogg's All Bran" in conjunction with a statement about the National Cancer Institute's recommendation that eating high fiber foods, among other things, "may reduce your risk of some kinds of cancer".[12]A Congressional hearing revealed that FDA's failure to take action to prevent Kellogg's from making this health claim, coupled with FDA's 1987 proposed regulations to permit explicit health claims on food labels,[13]resulted in an abundance of false and misleading health claims in the marketplace.[14]Congressional disapproval of FDA's policy of permitting health claims on foods without requiring pre-market approval led, in part, to passage of the NLEA.[15]

Among other provisions, the NLEA updates and improves labeling requirements for food products, requires that claims about nutrients of foods are consistent, and provides for the approval of health claims for foods.[16]Most importantly, the NLEA allows FDA to permit food manufacturers to make health claims on food labels but requires that FDA promulgate regulations authorizing health claims if and only if FDA determines that there is "significant scientific agreement" to support such claims.[17]In conjunction with this provision, the NLEA exempts dietary supplements from the "significant scientific agreement" standard and leaves determination of the appropriate standard to the Secretary. Section 343(r)(5)(D) states, in pertinent part:

A ... claim [on the label or labeling concerning a disease or a health-related condition] made with respect to a dietary supplement of vitamins, minerals, herbs, or other similar nutritional substances ... shall be subject to a procedure and standard, respecting the validity of such claim, established by regulation of the Secretary.[18]

This provision, the first of a series of delays in determining the appropriate standard and procedure for the evaluation of health claims for supplements, signalled the beginning of the extended battle between the industry, the FDA, and Congress over this very issue.

During the period leading up to the enactment of the NLEA, another phenomenon occurred which would substantially shape the contours of the supplement debate. In 1989, an unknown illness later identified as eosinophilia-myalgia syndrome (EMS), appeared in New Mexico; soon thereafter, the illness was linked to use of contaminated L-tryptophan supplements.[19]As of 1993, at least 1,500 cases of EMS, included 38 deaths, were associated with L-tryptophan supplements.[20]Like other public health tragedies, the deaths and injuries from L-tryptophan prompted Congressional hearings and, more generally, stimulated Congressional interest in the regulation of dietary supplements.[21]

To supporters of regulation, EMS victims are emblematic of government's failure to regulate supplements; moreover, the L-tryptophan tragedy represents a powerful rebuttal to industry's claim that dietary supplements are universally safe. To many in the industry, on the other hand, the contaminated L-tryptophan is viewed as an aberration.

B.The Dvkstra Report and The Dietary Supplement Act of 1992

In response to the EMS outbreak, FDA Commissioner David Kessler convened a Dietary Supplement Task Force, composed of agency staff with expertise in issues concerning dietary supplements, whose mission was to examine issues surrounding dietary supplements and propose a regulatory framework for these products.[22]Among other issues, the Task Force considered means by which to ensure safety of dietary supplements; means of limiting the potential for fraudulent disease claims on labels and advertising; and steps necessary to ensure that the presence of dietary supplements on the market does not act as a disincentive to drug development. The Task Force stated that it sought to balance these goals with the desire of the public to have continued access to dietary supplements.[23]In May 1992, the Task Force submitted its report to the Commissioner[24]("the Dykstra Report") which recommended, among other things, that FDA: 1) revise the Generally Recognized as Safe (GRAS) regulations to establish safe levels of use for vitamins and mineral supplements; 2) regulate single amino acids and mixtures of amino acids as drugs; 3) regulate products other than vitamin, minerals, and amino acids (e.g. herbs) as food additives.[25]

Just as L-tryptophan became a unifying event for supporters of increased regulation of dietary supplements, the Dykstra Report became the call to arms for many in the supplement industry. Some in the industry viewed the Dykstra Report's most ominous recommendation, to regulate amino acids as drugs, as evidence of FDA's hostility towards supplements and a manifestation of the agency's unsubstantiated bias towards the supplement industry. The Report's recommendations served as the basis for some of the industry's more aggressive lobbying campaigns such as those instituted by the Nutritional Health Alliance (NHA), an association of health food stores and supplement makers, which advised supplement consumers to "write to Congress today or kiss your supplements good-bye!".[26]

The issue of the appropriate guidelines for FDA approval of health claims for dietary supplements continued to brew in 1992 and culminated that year with the enactment of the Dietary Supplement Act of 1992 (DSA). Anticipation that FDA would issue regulations relating to dietary supplements and health claims unfavorable to the industry may have been the impetus behind the DSA. Attached to the Prescription Drug User Fee Act of 1992, the DSA established a one year

Food and Drug Law - Final Exam 50421406057 moratorium prohibiting FDA from issuing regulations implementing the NLEA "with respect to dietary supplements of vitamins, minerals, herbs, or other similar nutritional substances", other than granting permission to make health claims.[27]In addition, the DSA barred FDA from making final "regulations that require the use of, or are based upon, recommended daily allowances of vitamins or minerals" for one year.[28]Finally, the DSA called for a report from the Secretary on enforcement priorities and practices,[29]a study by the General Accounting Office on FDA enforcement practices and costs and and benefits incurred in the regulation of supplements, and a study by the Office of Technology Assessment on regulatory frameworks used by other countries to regulate dietary supplements.[30]The DSA's provisions establishing a one year moratorium on certain regulation was set to expire on December 31, 1993; in addition, FDA was required to complete a new round of rulemaking the end of 1993 to implement the NLEA with respect to dietary supplements.[31]

C.Le2islation to Regulate Dietary Supplements in the 103d Congress: Let the Games Begin With a one year window of opportunity to enact legislation, industry and consumer lobbyists hit Congressional offices with a vengeance. What resulted were several bills providing for the regulation of suppelemtns, three of which were generally supported by industry (5. 784, introduced by Senator Hatch; H.R. 1709, introduced by Congressman Richardson; and H.R. 509, introduced by Congressman Gallegly)[32]and one of which resembled a legislative proposal floated by C5P1[33](H.R. 2329, introduced by Congresswoman Collins[34]).

Throughout 1993, lobbying intensified on all sides of the supplement issue. On the industry side, the Nutritional Health Alliance (NHA), the National Nutritional Foods Association (NNFA), the Council for Responsible Nutrition (CRN), a trade association of manufacturers of supplements, ingredients, and other nutritional products, the Utah Natural Products Alliance (representing eight major Utah-based supplement manufacturers) and others waged major public relations wars in support of 5. 784 and H.R. 1709 by drumming up supplement consumers and store owners and aggressively stating their case to Members and staff.[35]Supplement consumer groups, such as Citizens for Health and ACT-UP, the AIDS activist group, also contributed to the efforts to pass of 5. 784 and H.R. 1709.[36]Other consumer and health organizations, CSPI, as well as the American Association of Retired Persons (AARP), the American Cancer Society, and the American Heart Association, claimed 5. 784 and H.R. 1709 if passed would weaken FDA's ability to protect the public from fraudulent supplements, while allowing manufacturers to make scientifically unsupported claims.[37]

Meanwhile, in the early part of 1993, the FDA set up meetings with medical professionals, industry, and patient groups to explain its forthcoming regulatory proposal for supplements under the NLEA.[38]Organizations invited to the FDA briefings included the American Pharmaceutical Association, the Americans College of Physicians, American Nurses Association, and the Grocery Manufacturers Association.[39]In its information packet, the FDA responded to industry's call for "freedom of choice" of dietary supplements by asserting that "freedom of choice is not really free if it is based on false assumptions of safety or unproven label claims."[40]On June 18, 1993, FDA issued its Advance Notice of Proposed Rulemaking (ANPR) on the Regulation of Dietary Supplements which announced that the agency was reviewing its regulatory scheme for dietary supplements; on the same day, FDA issued a proposed rule to subject proposed health claims on dietary supplements to the same requirements applicable to other foods, in response to the NLEA and DSA.[41]

The second half of 1993 was marked by several Congressional hearings on the regulation of dietary supplements which focused in large part on the House and Senate bills, as well as FDA regulation of supplements under the NLEA.[42]The FDA Commissioner underscored that the agency supports "access to all dietary supplements that are safe and bear scientifically valid health claims" but emphasized that the dietary supplement industry is "essentially unregulated".[43]The supplement industry continued to express its criticisms of FDA regulation of supplements and its support for H.R. 1709 and 5. 784.[44] Finally, CSPI criticized the historical public health bias against supplements but reserved its harshest criticism for H.R. 1709, characterizing it as "not consistent with sound public health or consumer protection policy"[45]

Throughout the period of debate on H.R. 1709 and 5. 784, the issue of regulating health claims for supplements appeared to be the greatest barrier to compromise. Industiy views alone ranged tremendously: some espoused the view that manufacturers should be able to label their products with truthful, non-misleading claims without any pre-market approval or notification of the FDA; others favored pre-market notification of FDA of such claims;[46]still others did not object to NLEA's pre-market approval standard of "significant scientific agreement" in principle, but rather viewed FDA's interpretation of the NLEA as overly restrictive.[47]CSPI, in contrast, continued to espouse the view that health claims for food and supplements should both be subject to the "significant scientific agreement" standard and asserted that the alternative scheme under S. 784 would "allow supplement manufacturers to make health claims supported by a single, inconclusive study", thereby "preclud[ingl consumers from making an informed choice."[48]Given the divergent opinions - and strong emotions - underlying the debate over health claims, it seemed as though the players were drawing lines in the sand on the health claims issue. Other, more nuanced areas, like safety, had potential for plenty of wiggle room, but the polar views on health claims offered no such flexibility.

During the early months of 1994, several developments added to the growing pressure to resolve the supplement debate and pass legislation. First, industry, fearful of its July 1995 deadline to comply with FDA's dietary supplement regulations, renewed its commitment to passage of 5. 784 and H.R. 1709 and went into full combat mode.[49]Second, in anticipation of what was expected to be a time-consuming, divisive battle over health care reform, many in Congress were eager to bring closure to the supplement issue. In March, 1994, House Energy and Commerce Committee Chair Dingell, wrote a letter to Senate Labor and Human Resources Committee Chair Kennedy in which he referred to the current dietary supplement regulatory! legislative situation "unacceptable", requested assistance "to bring this matter to a close", and proposed initiating negotiations among key Members, including Congressman Wa.xman, Richardson, Moorhead, and Bliley and Senators Hatch and Kassenbaum.[50]Subsequently, Senator Hatch was able to get a commitment from Senate Labor and Human Resources Committee Chair Kennedy that 5. 784 would be marked up by the Senate Labor and Human Resources Committee by the end of April.[51]Finally, in an election year in which scores of Democrats feared losing their seats, there was tremendous political pressure to pass supplement legislation.

Before 5. 784 could reach the Senate floor for a vote, several issues raised by Senators during the Committee markup had to be resolved. Senator Harkin took the lead in working with Senator Hatch to reach an acceptable compromise. The final compromise, known as the HatchHarkin compromise dietary supplement bill, included a provision permitting dietary supplement manufacturers to make structure-function claims. In addition, the compromise contained a section designed to prohibit the marketing of unapproved drugs as dietary supplements. Finally, as with an earlier version of 5. 784, the compromise bill established a commission to study the issue of health claim for dietary supplements and report its findings to Congress in two years but subjected manufacturers to existing NLEA regulations during the interim.[52]The Hatch-Harkin version was passed in the Senate by unanimous consent on August 13, l994.[53]

Shortly thereafter, Congressmen Richardson and Gallegly sent a letter to Chairmen Dingell and Waxman, urging them to schedule a markup of H.R. 1709, which, by this time, had over 250 cosponsors.[54]Over the course of the following month and a half, Congressmen Waxman, Richardson, Bliley, and Dingell and Senators Hatch, Harkin, and Kennedy drafted a compromise bill which was largely based on the Senate-passed Hatch-Harkin bill but included several major changes;[55]the compromise bill: 1) permitted drug and biologic products that were previously marketed as dietary supplements to be reclassified as supplements; 2) required that manufacturers have substantiation for structure and function claims and that labels with such claims include a disclaimer', 3) added a section regarding the introduction of new dietary ingredients; 4) eliminated a provision in the Hatch-Harkin bill allowing manufacturers to appeal FDA warning letters in court, under certain conditions.[56]On October 7, 1994, the House passed the Waxman compromise by unanimous consent; a day later, the Senate passed the Waxman compromise. On October 25, 1994, President Clinton signed 5. 784 into law.[57]A year and a half after 5. 784 and H.R. 1709 had been introduced, with the aid of a $2.5 million industry public relations campaign,[58]the DSH&E Act was law.

II. THE DIETARY SUPPLEMENT HEALTH AND EDUCATION ACT OF 1994: REACTION. L~A~flA~ALX~IS

The Dietary Supplement Health and Education Act (DSH&E Act) was passed during the waning moments of the 103d Congress. When the smoke cleared, almost all interested parties claimed victory, at least to a certain extent. NNFA, for example, pronounced the Act to be "unequivocally, a major, major victory for consumers [and] the natural products industry".[59] Others, even more jubilant, stated that the Act "would keep our industry alive".[60]On the other side of the debate, consumer groups, such as CSPI, were surprisingly upbeat, calling the Act a "win-win for consumers', although expressing some reservations about the claims allowed under the Act.[61]Initially, only the FDA seemed genuinely despondent, one FDA official predicated that the Act's structure and function provision would become a loophole for a variety of unsubstantiated claims.[62]After several months of reflection, however, the reactions seem to have tempered. One influential industry attorney claims that the bill as enacted will bring about serious problems for the industry and the consumer.[63]

Given the bill's intensely conflictual drafting process and its sparse legislative history, the DSH&E Act leaves many questions unanswered. Most obviously, the Act fails to resolve the long standing dispute between FDA and the supplement industry concerning health claims. The following discussion of the DSH&E Act explores in detail its major provisions in an attempt to determine the Act's implications for the industry and consumers by examining the legislative history (hereinafter Statement of Agreement), various legal analyses of the bill, and FDA's draft implementation plan.[64]

5. 784. the DSH&E Act[65]

Section 3, D~iini1iQn~, may be broken down into three parts: 1) the basic definition of the term 'dietary supplement'; 2) the term 'dietary supplement' as it relates to new drugs; and 3) the exclusion from the definition of food additive. Section 3(a)(ff) defines 'dietary supplement' in an all-encompassing fashion to include: a "product...intended to supplement the diet that bears or contains one or more of the following dietary ingredients": a vitamin; mineral; herb or other botanical; amino acids; dietary substances for use by man to supplement the diet by increasing the total dietary intake; or a "concentrate, metabolite, constituent, extract, or combination of any of the above ingredients"; or, in general terms, a product which "is not represented for use as a conventional food or as a sole item of a meal or the diet" and "is labeled as a dietary supplement".[66]

The Act's broad definition represents a clear gain for the industry which pressed hard for an all-inclusive definition[67], perhaps with the primary intent of encompassing future product developments, but also to create a big tent for the purpose of unity within the industry and political strength. FDA reacted negatively to the provision and criticized the definition as "very broad"[68]; one FDA official had stated in 1993 that the term "dietary supplement" was "being used without discrimination to refer to a very diverse spectrum of products that pose widely varying concerns and that may not all be subject appropriately to the same regulatory approach.[69]FDA's comments most likely reflect the agency's safety concerns about particular amino acids and herbs and its desire to regulate these products more stringently than, say, multi-vitamins.[70]

Two interpretive issues are raised by the Act's definition of "dietary substnace". First, it is unclear how to draw the line between conventional foods and dietary supplements. Examples of such borderline products include vitamin/mineral drinks and powdered protein supplements.[71] Because the DSH&E Act includes provisions - such as the exclusion of supplements from the definition of food additives[72]- which are more favorable to supplements than to conventional food, manufacturers have an incentive to market borderline products as supplements. It is anticipated that FDA's short term implementation goals, which include developing a strategy to determine what types of products are encompassed in the definition of "dietary substance" and whether to draw the line based on food-use history,[73]will clarify the definition of "dietary substance."

A second, related problem in defining "dietary substance" is that the bill does not define the term "dietary". One analysis contends that FDA might determine that a substance that is not a vitamin, mineral, herb, or amino acid or concentrate, metabolite, constitutent, extract, or combination thereof lies outside the definition of "dietary substance."[74]This concern, if valid, threatens to circumscribe development of new dietary ingredients that seek to fall under the supplement classification; it may also lead to battles down the road between manufacturers and the FDA as to whether substances, such as melatonin or chemically-derived ephedrine, for example, fall within the "dietary substance" definition.[75]

The second part of the Act's definition of a dietary supplement, as it relates to new drugs, states that the term "dietary supplement" includes: an article approved as a new drug..., certified as an antibiotic..., or licensed as a biologic... and was prior to such approval, certification, or license, marketed as a dietary supplement or a food unless the Secretary has issued a regulation. ..finding that the article, when used as... a dietary supplement..., is unlawful under [the new safety requirements[76]][77] but does n~ include an article approved as a new drug, antibiotic, or biologic or "an article authorized for investigation as a new drug, antibiotic, or biological for which substantial clinical investigations have been instituted and for which the existence of such investigations has been made public" which was previously marketed as a dietary supplement or food, unless the Secretary issues a regulation finding that the article would be lawful.[78]

Determining whether a given substance falls within or out of the bill's definition of "dietary supplement" as it related to new drugs involves a two part analysis requiring a comparison of the date of first marketing the ingredient as a dietary supplement with the date of the drug approval, as well as a comparison of the dietary ingredient with the ingredients of the drug to determine whether they are or share the same article.[79]If the "article" is the same and the drug version was marketed before the supplement, the supplement does not fall under the bill's definition of "dietary supplement."[80]

The purpose of including this curious provision was to address the concerns of Senator Kennedy who feared that without such a provision, the Act would allow substances considered drugs and sold outside the U.S. to be marketed in the U.S. as supplements[81]and would allow drugs, such as Bristol-Myer Squibb's anti-cancer agent, Taxol, to be marketed as dietary supplements.[82]By offering pharmaceutical companies a level of protection from competition from supplement manufacturers who market natural products (often amino acids or herbs) intended to imitate prescription drugs[83], this provision also has the effect of encouraging drug manufacturers to direct their research to naturally occurring substances.

Although public reports of industry criticism of the Act's provision excluding new drugs from the definition of "dietary supplement" have not surfaced, the last sentence of this provision has been the source of considerable industry hand-wringing.[84]The last sentence reads: "[e]xcept for purposes of section 20 1(g) [the FD&C Act's definition of 'drug'], a dietary supplement shall be deemed to be a food within the meaning of this Act."[85]In contrast, 5. 784 as introduced included a provision specifically excluding dietary supplements from the drug definition.[86]If this last sentence is read in conjunction with the FD&C Act's definition of a drug,[87]the classification of drug as either a food or a drug appears to be circular. That is, except for the purposes of the drug definition, which provides that a substance (not a food) which affects the structure or function of the body is a drug, a supplement is a food.

Another possible interpretation involves reading the last sentence as referring only to the preceding provision concerning new drugs. Under this reading, the last sentence would mean that except for those supplements which, under the new drug provision, are excluded from the dietary supplement definition, dietary supplements are to be classified as food. However, the last sentence specifically refers to the FD&C Act's drug definition, § 20 1(g), not merely to the preceding new drug provision. Therefore, it is plausible that this last sentence may be applicable to a broader range of supplements than those exempted from the supplement definition under the new drug provision, although given the circular nature of this sentence when read in conjunction with §20 1(g), it is impossible to predict its effect with any certainty.

The third part of the definition section, excluding supplements from the definition of food additives,[88]was hailed as a major advance by the supplement industry[89], as well as having far-reaching implications for other industries, most notably food processors. One analysis commented that the food additive provision will be particularly helpful for dietary ingredients such calcium acetate, coenzyme QlO, evening primrose oil, black currant oil, boarage oil, linseed/flaxseed oil, chorella, magnesium orotate, and other orotate compounds.[90]Prior to enactment of the DSH&E Act, FDA had attempted to employ (with mixed success) the food additives provisions of the FD&C Act[91]to seize certain dietary supplements as adulterated under 21 USC § 342(a)(2)(C) for being food additives not recognized as safe.[92]One Court of Appeals recently characterized the FDA's approach as the follows: "The only justification for this Alice-in-Wonderland approach is to allow the FDA to make an end-run around the statutory scheme and shift to the processors the burden of proving the safety of a substance in all circumstances."[93]

By excluding dietary supplements from the definition of food additives, dietary supplements are no longer subject to § 409(c)(3)(A) of the FD&C Act,[94]otherwise known as the Delaney Clause.[95]This provision creates an anomaly in that the same ingredient when used in food would be subject to a different assessment if used in a dietary supplement.[96]One legal analysis concludes that while non-supplement foods remain subject to the Delaney Clause, if a product falling under the Act's definition of dietary supplements were found to be a carcinogen, "its safety would be determined without regard to the Delaney [C]lause, presumably on the basis of risk assessment and the exercise of scientific judgment."[97]In light of these dramatically different standards, manufacturers will be inclined to consider marketing products as dietary supplements, rather than conventional foods.[98]Compounding this tendency is another provision of the Act, §3(c), which further expands the definition of supplements into the realm of conventional foods.[99] Especially attractive candidates for such a change in marketing include food processed in a bar, liquid, or breakfast cereal form.[100]

In a larger sense, repeal of the Delaney Clause for dietary supplements signals a likely repeal of the Clause altogether. Certainly, the DSH&E Act provides an excellent basis for the food industry to argue that the lower standard for dietary supplement puts food at an unfair competitive disadvantage, thereby creatting leverage for the repeal of the Delaney Clause altogether.[101] To the extent that one would expect consumer groups to support the Delaney Clause, it was surprising that consumer groups did not appear to object to the DSH&E Act's provision exempting dietary supplements from the definition of a ood additive as the bill moved through the legislative process. In fact, CSPI's reaction to the final bill as passed criticized provisions covering structure and function claims, as well as the exemption from labeling of certain third-party materials, but not the exclusion of dietary supplements from the definition of food additives.[102]

In place of the powers afforded FDA by the FD&C Act's food additive provisions, the DSH&E Act includes Section 4, Safety of Dietary Supplements and Burden of Proof on FDA. This provision states that a dietary supplement is adulterated if, under its recommended or customary use: 1) it "presents a significant or unreasonable risk of illness or injury..."; 2) it "is a new dietary ingredient for which there is in adequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of injury or illness"; 3) the Secretary declares it "to pose an imminent hazard to public health or safety"; or 4) it bears or contains any poisonous or deleterious substances which may render it injurious to health. In addition, the Act specifies that the government will bear the burden of proof on each element to show that a supplement is adulterated and that courts shall decide any issue under this section on a de novo basis.[103]The burden of proof requirement prevents FDA from using rulemaking to determine adulteration. [104]

Some legal analysts for the industry claim that the new safety provisions will be disastrous for the industry,[105]whereas others characterize the provisions as "a much more coherent and rational mechanism for regulating the safety of dietary supplements than existing law".[106] Industry critics note that under 5. 784 as introduced, a dietary supplement would be considered adulterated if "the Secretary finds, after rulemaking, that the ingredient presents a substantial mid unreasonable risk of illness or injury"[107](emphasis added), whereas the version of the bill as enacted states that a supplement is adulterated if it "presents a significant or unreasonable risk of illness or injury"[108](emphasis added). Under the Act's "unreasonable risk" branch, the FDA presumably first would assess the usefulness of the supplement; accordingly, if FDA found that there were "no use" for the supplement, ~ risk would be deemed "unreasonable".[109]Under this analysis, products which might be threatened include primrose oil, black currant oil, and coenzyme Q1O.[110]Furthermore, critics claim, under the Act, the FDA could deem vitamins with high potencies "unuseful"; therefore, any perceived risk would enable FDA to claim that such vitamins were adulterated.[111]

A second industry criticism is that the Act's safety standards for a dietary supplement are more expansive than those of a food[112]which is deemed adulterated "[i]f it bears or contains any poisonous or deleterious substance which may render it injurious to health...".[113]In contrast, the analogous safety provisions of the DSH&E Act include the safety standard for food and additional standards for adulteration of supplements.[114]However, given the bill's all-encompassing definition of dietary supplements, FDA's justified concerns with the safety of certain supplements falling under this definition (particularly amino acids and some herbs),[115]and the strong consumer records of key Members who negotiated the bill, it is not surprising that the DSH&E Act included substantive safety provisions.

Industry defenders of the new safety standard argue that the regulatory scheme is much more rational than what was previously in place and emphasize safeguards in the Act which protect the industry from arbitrary and capricious FDA regulatory activity. In particular, supporters note that under the Act's safety provisions, FDA may not remove an existing product without proving in court that the product poses a "significant or unreasonable risk of illness or injury" under its recommended or customary use; similarly, the FDA may not prevent a manufacturer from introducing a new dietary ingredient onto the market without proving in court that there is not enough evidence to provide "reasonable assurance" that the ingredient does not present "a significant or unreasonable risk of illness or injury".[116]

FDA has noted that under the Act's safety provisions, the FDA always bears the burden of proving a supplement is safe and that the FDA is unable to shift this burden to manufacturers.[117] One agency official has stated that due to FDA's limited resources, this requirement will be a tremendous burden on FDA resources.[118]

Despite the potential for FDA abuse in evaluating "significant or unreasonable risk," the safety provisions represent an improvement over FDA's use of the FD&C Act's food additive provisions to attempt to regulate dietary supplements, which had been widely denounced by industry. Moreover, the procedural protection afforded the industry by the inclusion of requirements that the FDA bear the burden of proof in demonstrating the adulteration of a supplement and that the court decide issues on a de novo basis promise significant protections to the industry.

Section 5, Dietary Supplement Claims, which creates a labeling exception for dietary supplements, represents a gain for the industry by permitting manufacturers to distribute third-party literature at the point of sale, without triggering the NLEA restrictions on health claims[119] Section 5 adds a new section to the FD&C Act which provides that "[a] publication, including an article, a chapter in a book, or an official abstract of a peer-reviewed scientific publication that appears in an article.. .shall not be defined as labeling when used in connection with the sale of a dietary supplement", as long as it 1) "is not false or misleading"; 2) "does not promote a particular manufacturer or brand.."; 3) "is displayed or presented.. so as to present a balanced view of the available scientific information on a dietary supplement"; 4) "if displayed in an establishment, if physically separate from the dietary supplement"; and 5) "does not have appended to it any information by sticker..".[120]The DSH&E Act's legislative history adds that this section "does not apply to a summary of a publication other than an official abstract of a peer-reviewed scientific publication."[121]

This labeling exception, and its various qualifications and specifications, was the product of negotiation and ultimately compromise between Senators Hatch and Senators Kennedy and Harkin. The source of the "balanced view" requirement, as well as the non-promotional requirement, first appeared in Senator Kennedy's substitute bill which was defeated by the Senate Labor and Human Resources Committee.[122]Senator Kennedy explained the importance from a policy standpoint of restricting the use of third-party literature by noting that without limitations "companies would have no incentive to seek approval of health claims because they could use literature about their products like advertising."[123]Senator Harkin added his mark on this provision by crafting a compromise on third-party literature which permitted such literature, if it were "not false or misleading", did not promote a particular brand, and presented a "balanced view"; in addition, the compromise required that the burden of proof would fall on the government to establish that the literature was "false or misleading".[124]

With the exception of a few critics who are apprehensive of FDA's definition of "false and misleading", "balanced view", and "physically separate",[125]most of the industry favors the new labeling exception, although all have qualms about FDA's interpretation of the term "publication".[126]One analysis noted that the statutory language suggests that a manufacturer could: 1) "publish" a brochure itself and distribute it with the manufacturer's products and 2) distribute non-scientific articles such as those from the popular press and trade associations.[127] Despite the absence of statutory language explicitly restricting publications to third-party publications,[128]it has been cautioned that if FDA could show that a manufacturer itself created the publication, the FDA might argue that the publication did not actually fall within the DSH&E Act's definition of "publication", but rather that it was "labeling".[129]

Meanwhile, FDA appears to be comfortable with the DSH&E Act's exemption of third-party publications from the definition of labeling, although the agency has expressed reservations about the difficulty of enforcing the "balanced view" requirement.[130]One FDA official commented that requiring FDA to ensure that third-party literature is "balanced" "could put a unique regulatory burden on the agency." CSPI, in contrast to FDA, gave a more negative assessment of the exemption for third-party publications:

The final bill fails to prohibit dietary supplement manufacturers and retailers from distributing reprints of preliminary scientific studies discussing potential health benefits of supplements. The results of such studies are tentative and are meant to guide further research, not serve as the basis for health recommendations.[131]

The difference between CSPI's and FDA's reaction to the third-party publication labeling exemption may lie in the reasoning that by relenting on certain types of third-party publications, FDA may decrease the pressure for relaxed standards of the NLEA pre-market approval process for health claims, although at this time, industry has given no indication of backing down on its campaign to relax or even bypass the NLEA health claim standard. CSPI, in contrast, does not stand to gain anything by the third-party exemption, except, in its opinion, more confusing and conflicting health information in the marketplace which will prevent consumers about making informed choices about their health.

The central policy issue surrounding the exemption of third-party publications from the definition of labeling, or more generally of exempting any material from the definition of labeling, is how to strike an appropriate balance between permitting manufacturers to distribute information which reports emerging health research that is potentially beneficial to consumers - yet may also prove to be unfounded- while at the same time avoiding creating disincentives for manufacturers to seek FDA approval of health claims and avoiding flooding the market with confusing and misleading health information. Encouraging manufacturers to avoid the NLEA pre-market approval process is surely undesirable from a public health standpoint. Moreover, as raised by CSPI, it is not necessarily good policy to have consumers make decisions concerning their health care on the basis of preliminary studies. On the other hand, FDA's support, or at least acceptance, of certain restricted exemptions to the definition of labeling may assist in fostering a better relationship between industry and supplement consumers and the agency.

In short, the DSH&E Act's exemption of third-party publications from the definition of labeling, which includes strict restrictions, generally seems to strike an sensible balance between the aforementioned considerations, although the "balanced view" requirement may have to be abandoned, in light of the difficulties of its enforcement. One alternative would be expanding the use of disclaimers, such as "This statement has not been evaluated by the Food and Drug Administration", on third-party literature; however, one source close to the industry expressed vehement opposition to this disclaimer and stated that his foremost objection to the DSH&E Act was its requirement of a similar disclaimer to be used in conjunction with structure and function claims. [132]

Section 6, Statements of Nutritional Support, permits dietary supplements to be labeled with a structure and function claim[133]that: 1) "claims a benefit related to a classical nutrient deficiency disease and discloses the prevalence of such a disease in the United States"; 2) "describes the role of a nutrient or dietary ingredient intended to affect the structure or function in humans"; 3) "characterizes the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function"; or 4) "describes general well-being from consumption of a nutrient or dietary ingredient"[134]if "the manufacturer of the dietary supplement has substantiation that such statement is truthful and not misleading" and the statement contains the following disclaimer:

This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

The provision also explicitly prohibits statements that "claim to diagnose, mitigate, treat, cure, or prevent a specific disease or class of diseases". Finally, the provision requires that a manufacturer who proposes to make a structure or function claim "notify the Secretary no later than 30 days after the first marketing of the dietary supplement with such statement that such a statement is being made."[135]The Statement of Agreement states that section 6 of the Act "does not permit premarket approval or require pre- market review by the FDA of any statement permitted under that provision."[136]

Historically, certain types of structure or function claims have not been regulated as health claims.[137]Such claims include those which "describe the role of food in normal physiological process, such as the role of nutrients in normal metabolism."[138]Example of a structure and function claims are the statements "protein is essential for human growth, building tissue and maintaining adequate muscle" and "iron is part of the body's natural system to assure tissues receive sufficient oxygen".[139]Because these structure and function claims are not considered health claims, labeling products with such claims does not subject the claims to the drug definition of § 201(g).

FDA has indicated the existence of an overlap of between health claims and structure and funciton claims; some structure and function claims may in fact be "implied health claims" and that, conversely, some health claims may include claims concerning the function of nutrients on the body. In its January 6, 1993 final rule on food labeling, the FDA suggested that some types of structure and function claims are considered health claims by the agency and will be subject to NLEA requirements.[140]In particular, a claim such as "relating calcium to bone health" might be an "implied health claim" rather than a structure or function claim. In addition, FDA stated that health claims are characterized in part by their assertions about nutritive value, such as "value in sustaining human existence by such processes as promoting growth, replacing the loss of essential nutrients, or providing energy"[141]which sounds similar to definitions of structure and function claims.

Due to the overlap between what the FDA considers health claims and those that it considers structure and function claims, the effect of the DSH&E Act's structure and function provision will remain unclear, until FDA interprets the Act's terms under the structure and function provision. One of FDA's short term implementation goals under the Act is to consider publishing a notice defining several key terms of the structure and function provision including: "classical nutrient deficiency disease"; "structure and function" claims (versus § 201(g)(1)(B) claims); "documented mechanism" by which a nutrient or ingredient acts to maintain such structure or function; and limits for what constitutes the "general well-being" description.[142]

Both FDA and CSPI have revealed strong opposition to the Act's structure and function provisions. In fact, one FDA official described the provision as a "gigantic loophole" that will allow manufacturers to make unsubstantiated statements including "widespread immune system claims"; despite the provision's mandated disclaimer, the agency official argued, "what are people with compromised immune systems going to think?".[143]CSPI is equally despondent about the Act's structure and function provision: "The final bill ... fails to prohibit the industry from making so-called nutritional support claims such as 'Vitamin A is necessary for good vision'. Such claims may misleadingly imply that it is necessary to consume vitamin A supplements in order to maintain normal vision."[144] FDA's opposition to this provision suggests that the agency will attempt to define "structure and function" claims, so as to exclude as much as possible what FDA considers to be "implied health claims."

For the moment, different views as to the type of structure or function claims which falling under the Act's structure and function provision, as well as uncertainty as to the applicability of the substantiation and disclaimer requirements, have generated the range of industry response to the provision. There are two primary schools of thought within the industry. Some view the structure and function provision very favorably and describe the provision as "ground-breaking".[145] Others regard the provision as a step backwards from pre-DSH&E Act law for the industry.[146] According to the latter interpretation, prior to the bill's enactment, manufacturers could make certain structure and function claims without triggering FDA pre-market approval requirements. If FDA considered a claim to be false or misleading, the agency had to prove so in court.[147]Under the DSH&E Act, if the FDA considers a claim to be false or misleading, all the agency has to do is claim that the manufacturer does not have adequate substantiation that the claim is truthful and non-misleading.[148]This anlaysis seems to assume that the structure and function provision applies to all structure and function claims, including those which do not fall under the NLEA (i.e. are not implied health claims).

Another line of analysis concludes that the new obligations placed on manufacturers are, in fact, unenforceable and that the disclaimer section may technically apply to few types of structure and function claims.[149]The analysis is as follows: since the new provision 1) "does not make it a prohibited act to make a structure or function claim[] without complying with the FDA notification and [disclaimer] requirement" and 2) "simply exempts statements complying with those requirements from the NLEA", the FDA notification and disclaimer requirements apply only to structure and function claims which are considered health claims and thus subject to the NLEA pre-market approval requirements.[150]Therefore, since FDA has interpreted the NLEA to apply only to structure and function claims that imply a disease-related benefit, this provision would be applicable to only that particular category of structure and function claims; structure and function claims not implying a disease-related benefit would not be subject to the NLEA and therefore would not be obligated to display the disclaimer.[151]Supporters of the provision also note that the DSH&E allows for the first time "functional claims for dietary ingredients that do not qualify as 'nutrients' [e.g. the role of phyto-checmicals, herbal ingredients, and other non-DV dietary ingredients]...without creating problems under the health claims or drug definition, so long as the section 403(r)(6) procedures are followed."[152]

Since the structure and function provision, by its own terms, states that "[f]or the purposes of [403(r)O1)(B)]" which covers health claims, "a statement for a dietary supplement may be made if' the statement is a structure and function claim. This would seem to imply that the type of structure and function claims covered in the DSH&E Act's provision are those which make disease or health-related claims, that is, what is known as implied health claims. If this is the case, then the structure and function claims which are n~ implied health claims would not be covered by the Act's provision and therefore would not be subject to the substantiation or disclaimer requirements. Consequently, under this analysis, manufacturers would be permitted to make structure and function claims that are implied health claims (and thus previously subject to the premarket approval process under NLEA) if they had substantiation and included the disclaimer, a substantially lower standard than the NLEA approval process.

Section 7, Dietary Supplement Ingredient Labeling and Nutrition Information Labeling, provides that supplement is misbranded if it fails to: 1) list the name of each ingredient, 2) identify the product as a dietary supplement, 3) identify any part of the plant from which the ingredient is derived (in the case of herbs and botanicals), 4) conform to the specifications of an official compendium (if it is covered by an official compendium) or 5) meet quality, purity, or compositional specifications (if it is not covered by an official compendium). The provision also includes requirements for supplement listing on nutrition labeling.[153]

Creating a mechanism to address the safety of new dietary ingredients was one of the major sticking points during Congressional negotiations.[154]Section 8, New Dietary Ingredients. represents a compromise whereby dietary ingredients marketed in the United States before October 15, 1994 are essentially grandfathered, in terms of safety, whereas a supplement containing a "new dietary ingredient" (marketed after October 15, 1994) are deemed adulterated, unless it: 1) "contains only dietary ingredients which have been present in the food supply as an article used for food in a form in which the food has not been chemically altered or 2) "[t]here is a history of use or other evidence of safety establishing that the dietary ingredient....will reasonably be expected to be safe and ... [75 days before marketing] the manufacturer.. .provides the Secretary with information, including any citation to published articles, which is the basis on which the manufacturer or distributor has concluded that a dietary supplement containing such . .ingredient will reasonably be expected to be safe."[155]The Statement of Agreement adds that the term "chemically altered" does not include minor loss of volatile components, dehydration, lyophilization, milling, tincture, or solution in water, slurry, powder, or solid in suspension.[156]

Again, industry reaction has been mixed. Some claim that the industry might as well "forget about new products because the burden is going to be on the manufacturer to provide adequate information the the product does not present an "unreasonable risk."[157]One analysis noted that the new dietary ingredient provision will "destroy incentives for the discovery and introduction of new dietary ingredients."[158]

The new ingredient section does not require ingredients which have been present in the food supply as articles used for food which have not been chemically altered to provide FDA with a history or use or other safety evidence; accordingly, the pre-market requirements for new ingredients are limited in applicability to new ingredients which are not essentially food components.[159]Despite the potentially onerous submission to FDA required, the DSH&E Act "provides no basis for FDA to reject a submission, or require additional information."[160] However, under the DSH&E Act's safety provisions, if the FDA deemed the submission inadequate, the agency could block the introduction of a new dietary ingredient if it could prove in court that "there is inadequate information to provide reasonable assurance that such ingredient does not present a significant or unreasonable risk of illness or injury".[161]And as noted above, some in the industry have roundly criticized this safety standard.[162]

The central policy question concerning this provision is whether it makes sense to have grandfathered all pre-October 15, 1994 products and whether the scheme for new ingredients is workable. Comments made by the negotiating Congressmen during the drafting process reveal that the new ingredient provision was among the most contentious. Senator Kennedy's substitute offered at Committee markup required that manufacturers notify FDA before introduction of a new dietary supplement; notification would have required proof of a history of safe use, as well as the "basis on which the manufacturer or distributor has concluded that such dietary supplement is not adulterated under the proposed condition of use.[163]In addition, Senator Kennedy's substitute would have exempted from the notification requirements dietary supplements prior to May 1, 1994, unless the FDA were able to prove a reasonable possibility" that a given supplement were "injurious to health."[164]Manufacturers, on the other hand, who prior to the DSH&E Act had been able to determine themselves whether an ingredient was generally recognized as safe without notifying the FDA, wished to maintain the status quo.[165]

The final version, therefore, sought to accommodate both sides at once. Unfortunately, this endeavor was not entirely successful. For those who supported prenotification to FDA of the introduction of new dietary ingredients, the absence of any basis for FDA to reject a submission or demand further evidence of safety seriously weakens the purpose of the prenotification provision. In addition, the prenotification requirements only apply to new dietary ingredients which are not present in the food supply. For those who supported the status quo (manufacturers), the provision may act as a serious deterrent to new product development.[166]

One provision of the DSH&E Act which pleases all sides of the debate is section 9, requiring Good Manufacturing Practices (GMP).[167]CRN, NNFA, and American Herbal Products Association (AHPA) have all adopted guidelines for GMP's and will be meeting in February, 1995 to discuss developing one unified proposal to present to FDA.[168]FDA's CFSAN, meanwhile, intends to discuss with the Offices of General Counsel and Policy whether to initiate negotiated-rulemaking with industry on GMP's.[169]

The final major provisions of the DSH&E Act include section 11, withdrawing the June18, 1993 Federal Register notice of proposed rulemaking concerning dietary supplements; section12, establishing a Commission on Dietary Supplement Labels; and section 13, establishing an Office of Dietary Supplements within the National Institutes of Health (NIH). The mission of the Office of Dietary Supplements will be exploring the potential role of supplements in improving health and conducting and coordinating research within NIH relating to supplements.[170]

The Commission on Dietary Supplement Labels (Commission), created as an independent agency within the executive branch, will consist of seven members, appointed by the President, with expertise and experience in dietary supplements. The Commission is charged with conducting a study on and providing recommendations for the regulation of label claims and statements for dietary supplements which will be submitted to the President and Congress not more than two years after the date of the Act's enactment After the recommendations have been submitted, the Secretary of Health and Human Services is required to publish in the Federal Register a notice of any recommendation of the Commission in regulations and must include a notice of proposed rulemaking. Rulemaking is required to be completed no later than two years after the recommendations have been submitted.[171]During the four year interim, dietary supplements are bound by the regulations under the NLEA.

[II. FUTURE DIETARY SUPPLEMENT IssuEs

The DSH&E Act's provision to establish the Commission delays resolution of the politically charged and seemingly unsolvable issue of health claims. Despite the possibility that the Commission may recommend a scientific standard and procedure more favorable to the industry than that established for food under the NLEA and subsequent regulations, some in the industry are grumbling about the intervening four years during which supplements will be held to the NLEA.[172]Other industry analyses view the Commission more favorably as an "opportunity for there to be a truly unbiased review of the standards and procedures for making disease related claims". [173]

The question of health claims, which has been the preeminent concern of the dietary supplement debate, continues to perplex policymakers. From the outset, despite the mantra of manufacturers that they merely wished to provide "truthful and non-misleading" information to consumers, industry has not been able to articulate a sound policy rationale for regulating the health claims of dietary supplements any differently than the health claims of conventional foods. Some within the industry have argued that unlike conventional food manufacturers, whose products are purchased by consumers with or without health claims, dietary supplement manufacturers must rely on the appeal of perceived health benefits of dietary supplements to sell their products; however, the notion that the level of dependence on health claims in selling products should guide health policy is specious, at best. Others have asserted that "differential treatment [of supplements and conventional food] would recognize the special role that nutritional supplements play in maintaining good health." [174]While it is not entirely clear what is meant by "special role", this argument may rest on an assumption that supplements are indispensable to one's health, an assertion which is at the very least debatable.

If one assumes that the same standard should apply to conventional foods as dietary supplement, the next step is determining whether the FDA's interpretation of the NLEA's "significant scientific agreement" standard and the FDA's process of evaluating health claims could be improved to address both industry's criticisms of the FDA's standard and procedures and consumer groups' unwavering loyalty to the NLEA.

Several proposed recommendations should be adopted at once. One industiy group has suggested that Congress establish a time frame in which FDA must make decisions with respect to health claim applications.[175]The concept of imposing deadlines on FDA has been supported by consumer groups, as well.[176]Because there is general agreement that establishing a time frame would improve the health claim approval process, this suggestion should be adopted. Another suggestion by industry has been that FDA should presume "significant scientific agreement" to exist when "the claimed relationship has been recognized by a public health organization that is a credible source of information about diet and health" which should include at least the Center for Disease Control and the National Institute of Health.[177]This proposal appears to be a sensible means of responding to the frustration felt by industry when, as in the case of folic acid, one government agency (the Public Health Service) announced that by ingesting folic acid, pregnant women could reduce the likelihood of birth defects, yet FDA delayed approving this health claim for over a year.[178]Finally, the process of reviewing health claims could be improved by convening expert panels with experience with the dietary ingredient being evaluated.[179]In addition, some have suggested that other governmental agencies, such as the Public Health Service, assist in evaluating claim petitions.[180]Both the use of expert panels and the involvement of other agencies could result in increasing the number of claims approved. In addition, convening expert panels to evaluate claims might improve industry's perception of the process, while involving other agencies in the evaluation process would have the advantage of taking the political heat off of FDA. On the other hand, FDA might be displeased to lose its monopoly over this decision making process.

Another possible response to the health claim dilemma involves allowing manufacturers to use labeling to report the current state of science on the benefits of a particular dietary ingredient. While permitting manufacturers to include in labeling the current state of science on the benefits of a particular dietary ingredient would likely thrill industry, the FDA and consumer groups would probably vigorously oppose such a measure on a number of grounds. Developing uniform standards to reflect the "current state of science" would be as problematic to define and enforce as the DSH&E Act's "balanced view" standard. In addition, consumer groups might argue that such a proposal would lead to consumer confusion and information-overload, such groups might also maintain that it is not wise health policy to encourage consumers to make choices about their health based on initial research. On the other hand, since consumers are already bombarded by advertising and publications concerning the benefits of supplements, it may be wise policy to encourage information to be dispensed through highly regulated channels, such as labels and labeling, rather less regulated fora, such as advertising. In short, permitting labeling on the current state of science on the benefits of a particular ingredient might prove to reduce consumer reliance on advertising and publications but might also result in overwhelming consumers with information.

Now that the DSH&E Act has been signed into law, the final question to be answered is what lies ahead. NHA has indicated that its "top priority" during the 104th Congress is to "improve" the DSH&E Act.[181]One area of particular concern is the four year period of NLEA compliance, during the Commission on Dietary Supplement Label's deliberations and subsequent rulemaking process.[182]Since the House Subcommittee on Health and the Environment is expected to hold upcoming hearings concerning the FDA, any legislation following hearings might provide a vehicle for industry's tinkering with the DSH&E Act. Another area of expected activity is litigation by industry against FDA involving First Amendment challenges to FDA regulations on health claims.[183]Industry claims that FDA's prohibition on unapproved health claims is a prior restraint on speech. FDA, in turn, has responded that claims are not banned entirely but simply "prohibited under circumstances and in contexts where the claim would be misleading and confusing to consumers.."[184]Last, but not least, the recommendations of the CDSL, which will be forthcoming in about two years, will be eagerly anticipated by industry, consumer groups, FDA, and Congress alike.

[1] Dietary Supplement and Education Act, Pub. L. No. 103-417, § 2, 108 Stat. 4325, 4326 (1994).

[2] Id.

[3] 38 Fed. Reg. 20,708, at 20,717 (1973).

[4] I.d... at 20,723.

[5] Pub. L. No. 278, 90 Stat. 410 (1976). For a recent discussion of dietary supplement regulation and criticism of the industry, see Mark A. Kassel, From a History of Near Misses: The Future of Dietary Supplement Regulation, 238 Food and Drug L.J. 237, 249-264 (1994).

[6] Pub. L. No. 101-535, 104 Stat 2353 (1990) (codified as 21 U.S.C. §§ 343(q), 342(r)( 1992)).

[7] Philip J. Hilts, Bill Allowing Vitamin Claims Wins Approval, N.Y. Times, Oct. 8, 1994, at ALO.

[8] See Regulation of Dietary Supplements: Hearing Before the Subcomm. on Health and the Environment of the House Comm. on Energy and Commerce, 103rd Cong., 1st Sess. 296 (1993) [hereinafter House Hearing on Dietary SupplementsJ (statement of Bruce A. Silverglade, Director of Legal Affairs, Center for Science in the Public Interest, Washington, D.C.); Legislative Issues Related to the Regulation of Dietary Supplements: Hearing of the Senate Comm. on Labor and Human Resources, 103rd Cong., 1st Sess. 99-100 (1993) [hereinafter Senate Hearing on Dietary Supplements ](statement of Bruce A. Silvergiade).

[9] Pub. L. No. 103-417.

[10] This paper uses 'health claims" to mean "disease-prevention claims."

[11] H.R. Rep. No. 43, 100th Cong., 2d Sess. 2 (1988) (citing 21 CER 101.9(i)).

[12] i4~ at 2-3, n.9.

[13] 52 Fed. Reg. 28,843 (1987).

[14] FDA's Continuing Failure to Regulate Health Claims for Foods: Hearings Before theHuman Resources and Intergovernmental Relations Subcomm. of the House Comm. on Government Operations, 101st Cong., 1st Sess. 1-2 (1989) (opening statement of Chairman Weiss); for a general discussion of misleading and confusing health claims on food labels, see j~., at 10-18 (testimony of Bruce A. Silverglade, Director of Legal Affairs, CSPI).

[15] H.R. Rep. No. 101-538, 101st Cong., 2d Sess. 8-10 (1990).

[16] Pub. L. No. 101-535, 104 Stat 2353 (1990) (codified as 21 U.S.C. §§ 343(q), 342(r)( 1992)).

[17] 21 U.S.C. §§ 343(r)(3)(B)(i). The Secretary shall promulgate regulations authorizing f health claims] ... only if the Secretary determines, based on the totality of publicly available scientific evidence (including evidence from well-designedstudies conducted in a manner which is consistent with generally recognized scientific procedures and principles), that there is significant scientific agreement, among experts, qualified by scientific training and experience to evaluate such claims that the claim is supported by such evidence. Id..
The legislative history provides further guidance as to the content of the "significant scientific agreement" standard: "Under this standard, the Secretary must review all the scientific evidence available that is pertinent to a claim. In reviewing the studies, the Secretary may give greater weight to the studies that the Secretary finds more persuasive. The standard is intended to be a strong one .... The Bill requires that the Secretary have a high level of confidence that the claim is valid. However, the standard does not require a unanimous agreement among experts. Instead, the standard requires that there must be a significant agreement among experts, but it does not require that every expert in the field approve or agree with the claim." H.R. Rep. No. 101-538, supra note 15.

[18] 21 U.S.C. §§ 343(r)(5)(D) (1992).

[19] Carter Anne McGowan, Note, Learning the Hard Way: L-Tryptophan, the FDA, and the Regulation of Amino Acids, 3 Cornell J.L. & Pub. Pol'y 383, 383-4 (1994). At the time, L-tryptophan was widely used as treatment for insomnia, premenstrual syndrome, and depression. Id..

[20] 58 Fed. Reg. 33,690 (1993).

[21] See H.R. Doc. No. 25, 102d Cong., 1st Sess. (1991).

[22] 58 Fed. Reg. 33,690, 33,691 (1993).

[23] FDA, Dietary Supplements Task Force, Final Report. at 1-2 (1992).

[24] The report of the Task Force, known as the Dykstra Report (named after the Chair of the Task Force, Gary Dykstra), did not become available to the public until June, 1993. 58 Fed. Reg. 33690 (1993).

[25] FDA, Dietary Supplements Task Force, supra note 23, at 3.

[26] Dante E.A. Ramos, Vitamin Makers Try a Dose of Lobbying, 25 The Nat'l J. 1879 (1993). Throughout much of the legislative battle over supplements, CSPI and other organizations complained vociferously about the deceptive lobbying tactics of industry which, they claimed, were generating massive grassroots support with false information that FDA was going to ban, or make available only by prescription,dietary supplements. Li. In addition to consumer groups efforts to counter the industry's message, FDA continuously sought to reassure the public that the issue surrounding supplement regulation was not one of access, but rather, health claims. Irvin Molotsky,U.S. Issues Rules on Diet Supplement Labels, N.Y. Times, Dec. 30, 1993, at 15. The "health freedom"(access) slogans appeared to be based on several recommendations of the Dykstra Report concerning aminoacids; however, there is no evidence that FDA intended to ban or make available only on prescription vitamins and minerals which are the types of supplements consumed by the majority of supplement consumers. Today, it remains unclear what motivated consumers who responded to the industry's "health freedom" campaign.

[27] Pub. L. No. 102-571, 106 Stat. 441, § 202(a)(l)(1992).

[28] Pub. L. No. 102-571, § 203. The purpose of this provision was to halt FDA's proposed replacement of U.S. RDA's with Reference Daily Intakes (RDI's), which would have lowered recommended intake levels and adopted new units of measure for Vitamins A, D, andNiacin. Melinda Ledden Sidak, Dietary Supplements and Commercial Speech, 48 Food and Drug L.J. 441 (1993).

[29] Pub. L. No. 102-571. In 1992, the FDA raided analternative medicine clinic in Kent, Washington by sending police officers who, along with FDA officials, allegedly drew guns, kicked in the door, and ordered clinic employees to freeze. Sidak, supra note 28, at n. 16.

[30] Pub. L. No. 102-571, § 204-6.

[31] ~ § 202(a).

[32] 5. 784, 103d Cong., 1st Sess. (1993); H.R. 1709, 103d Cong., 1st Sess.; H.R. 509, 103d Cong., 1st Sess. (1993).

[33] CSPI's proposal included the following major provisions: 1) defines "dietarysupplements" as vitamins, minerals, herbs, amino acids or "other similar substances"; 2) dietary ingredients in use as of March 1, 1993 would be "deemed safe, provided manufacturers can adequatelydemonstrate through either scientific procedures or experience based on common usage, that the ingredients is safe under the conditions of its intended use"; and 3) requires that companies give FDA advancednotice of plans to market new dietary ingredient products that are already GRAS. Dietary Supplement Safety Would Be Reviewed by FDA under CSPI Legislative Proposal, F-D-C Rep. ("The Tan Sheet"), April 26, 1993.

[34] H.R. 2329, 103d Cong., 1st Sess. (1993).

[35] Benjamin Wittes, Health, Education, and Warfare, Legal Times, Oct. 3, 1994.

[36] Id.

[37] Id.

[38] FDA Building Support for Upcoming Dietary Supplement Proposal, F-D.C. Rep.("The Tan Sheet"), June 7, 1993. In January, 1993, the FDA had given the impression that health claims forsupplements should be subject to standards identical toconventional foods, 58 Fed. Reg. 2478, 2507-9 (1993).

[39] FDA Building Support for Upcoming Dietary Supplement Proposal, supra note 38.

[40] Id.

[41] 58 Fed. Reg. 33690 (1993); 58 Fed. Reg. 33700 (1993).

[42] Agriculture, Rural Development, Food and Drug Administration, and Related Agencies Appropriations for 1994. Dietary Supplements Before the Subcomm. on Agriculture, Rural Development, Food and Drug Administration, and Related Agencies of the House Comm. on Appropriations, 103d Cong., 1st Sess. (1993); House Hearing on Dietary Supplements, supra note 8. Senate Hearing on Dietary Supplements, supra note 8.

[43] House Hearing on Dietary Supplements, supra note 8, at 63 (statement of FDA Commissioner David Kessler).

[44] Li. at 2 18-229 (statement of J.B. Cordaro, President of CRN); U.s. at 232-6 (statement of Gerald Kessler, President of the NHA).

[45] Id.. at 277, 296 (statement of Bruce Silverglade, Director of Legal Affairs of CSPI).

[46] For an example of this proposal, see HR. 1709.

[47] For an example of the third industry view, see CRN's Congressional testimony. House Hearing on Dietary Supplements , supra note 8, at 225; Senate Hearing on Dietary Supplements, supra note 8, at 12-14.

[48] Senate Hearing on Dietary Supplements, supra note 8, at 97 (statement of BruceSilverglade, Director of Legal Affairs, CSPI).

[49] Supplement Regulations Cause Only Brief Pause in War, Food Labeling News, January 6, 1994; Hatch-Harkin Dietary Supplement Compromise Headed to Senate Floor, Harkin Says, F-D-C Rep. ("The Tan Sheet"), August 8, 1994.

[50] Rep. Din gell Calls Dietary Supplement Regulatory! Legislative Situation "Unacceptable", F-D-C Rep. ("The Tan Sheet"), March 28, 1994. At the time, Chairman Dingell probably anticipated playing a major role in the consideration of health care reform legislation.

[51] Id.. In fact, S. 784 was marked up on May 11 with the promise bySenator Hatch that "controversial issues could be discussed in greater detail" before the bill went to the floor for a vote.Dietary Supplement Substitute Bill Clears Senate Committee Markup, F-D-C Rep. ("The Tan Sheet"), May 16, 1994.

[52] Dietary Supplement Bill Would Allow Structure-Function Claims, Attorney Says, FD-C Rep. ("The Tan Sheet"), August 8, 1994.

[53] Hatch/Harkin Dietary Supplement Legislation Passes Senate by Unanimous Consent, supra note 49.

[54] Reps. Richardson and Gallegly Urge Waxman, Dingell to Mark-Up Dietary Supplement Bill, F-D-C Rep. ("The Tan Sheet"), August 22, 1994.

[55] The provisions of the final supplement bill as enacted will be discussed in great detail in section II.

[56] Dietary Supplement Bill Clears House Oct. 7, Senate Passage Appears Assured, F-DC Rep. ("The Tan Sheet"), Oct. 10, 1994.

[57] The President's press release contained a veiled criticism of FDA's handling of supplement regulation: '[I] n recent years, the regulatory scheme designed to promote the interests of consumers and a healthful supply of good food has been used instead of complicate choices consumers have made to advancetheir nutritional and dietary goals. With perhaps the best of intentions agencies of government...have paradoxically limited the information to make healthful choices...". Statement by the President, Office of the Press Secretary, The White House, October 26, 1994.

[58] Hilts, supra note 7. at AIO.

[59] Congress Passes Dietary Supplement Act, Shelves Health Claims, Food Labeling News, Oct. 13, 1994.

[60] Hilts, supra note 7, at AlO.

[61] Ld~; Congress Passes Dietary Supplement Act, Shelves Health Claims, supra note 59.

[62] FDA Fears Dietary Supplement Law's Structure/Function Clause Will be"Loophole" -- Zeller, F-D-C Rep. ("The Tan Sheet"), Oct. 31, 1994.

[63] Milton A. Bass, Memorandum: Dietary Supplement Bill (5. 784), October 10, 1994 (hereinafter Bass & UlIman Memo) at 1.

[64] Robert J. Guidos, Draft Implementation Plan for the Dietary Supplement Health and Education Act of 1994, Office of Legislative Affairs, FDA, Dec. 14, 1994 (hereinafter FDA Implementation Plan).

[65] Section 2, Ejadjn.g.~., lists a number of Congressional findings including the important role of dietary supplements in the health of Americans, the potentialsavings in health care expenditures from the use of supplements to prevent disease, and the contribution of thesupplement industry to the American economy. Pub. L. No. 103-417, § 2. Although Section 2 is merely window dressing in terms of its legal effect, it does serve an important as an symbolic vindication of values and beliefs in supplements held by supplement manufacturers and consumers.

[66] Pub. L. No. 103-417, § 3.

[67] Jonathan W. Emord, [Untitled Memorandum], October 13. 1994 (hereinafter Emord& Associates Memo) at 2.

[68] FDA's Zeller Lays Out Problems with Supplement Legislation, Food Labeling News, Sept. 29, 1994.

[69] Dietary Supplement Narrow Definition is "First Step" in Legislative Debate, FDA's Taylor, F-D-C Rep. ("The Tan Sheet"), Apr.5, 1993.

[70] FDA, Dietary Supplement Task Force, supra note 23. Interestingly, CSPI's legislative proposal more closely resembled the industry's by broadly defining "dietary supplement" as including herbs, amino acids, and "other similar nutritionalsubstance". Dietary Supplement Safety Would be Reviewed by FDA under CSPI Legislative Proposal, supra note 33.

[71] New Law Says Dietary Supplements are Not Food Additives, Food Chemical News, Oct. 31, 1994.

[72] Pub. L. No. 103-417, § 3(b).

[73] FDA Implementation Plan, supra note 64, at 7.

[74] Stephen H. McNamara, Memorandum, Oct. 11, 1994 (hereinafter Hyman, Phelps & McNainara Memo) at 2.

[75] Id.

[76] Pub. L. No. 103-417, § 4.

[77] Id..~. at § 3(a).

[78] Id.

[79] Memorandum: Dietary Supplement Health and Education Act of 1994, Covington & Burling, Oct. 12, 1994 (hereinafter Covington & Burling Memo) at 7.

[80] Ojj

[81] Dietary Supplement Substitute Bill Clears Senate Committee Markup, supra note 51.

[82] Hatch/Harkin Dietary Supplement Legislation Passes Senate by Unanimous Consent, supra note 49.

[83] Such as L-carnitine, which was approved as an orphan drug, and the dietary supplement version of the drug sold under the trade name Carnitor. Kassel, supra note 5, at 248.

[84] See Bass and UlIman Memo, supra note 63, at 3-4; Kirkpatrick W. Dilling, The New Dietary Supplement Legislation, Oct. 12, 1994 (hereinafter Dilling and Dilling Memo) at 3.

[85] Pub. L. No. 103-417, § 3(a).

[86] 5. 784.

[87] Sec. 201(g)(l)(C) of the FD&C Act provides that the term "drug" means: "articles(other than food) intended to affect the structure or any function of the body of man or other animals". 21 U.S.C. § 321.

[88] Pub. L. No. 103-417, § 3(b).

[89] Emord & Associates Memo, supra note 67, at 2.

[90] Hyman, Phelps & McNamara Memo, supra note 74, at 3.

[91] 21 U.S.C. § 321(s).

[92] U.S. v. Two Plastic Drums. More or Less of an Article of Food. Labeled in Park: Viponte Ltd Black Currant Oil Batch No. BOOSF 039. etc., 984 F.2d 814, 815 (7th Cir. 1993)(finding that encapsulated Black Currant Oil, with a single active ingredient, was not a "food additive"); U.S. v. 42/30 Tablet Bottles and 14-60 Capsule Bottles. More or Less. of an Article of Food. Labeled in Part: (Bottle) "Nature's Plus Coenzvme 010~ 779 F. Supp. 253, 254-5 (E.D.N.Y. 1991) (finding FDA's interpretation of CoQ1O and Germanium as food additives to be permissible). In addition, the industry sought relief in the courts from FDA's use of the food additive provisions. Di~1a.rx Supolement Coalition. Inc. v. Sullivan, 796 F.Supp. 441 (D. Or. 1991) (finding that manufacturers' action to declare their CoQlO products were "foods" and not "food additives" or were "generally recognized as safe" was not ripe for review).

[93] Two Plastic Drums at 819.

[94] 21 U.S.C. § 348.

[95] New Law Says Dietary Supplement Are Not Food Additives, supra note 71.

[96] Id.

[97] Edward Dunkelberger, Repeal of the Delaney Clause for Dietary Supplements, Oct. 28, 1994 (hereinafter Dunkelberger Memo) at 2.

[98] j4~. at 3.

[99] id.₁. Prior to the DSH&E Act, if a product s.innaJ.ai~.d. and ~aa~ ~ as a food, the product would not be classified as a supplement. § 411(c)(l)(B)(ii). Under § 3(c), the word "simulate" was deleted, thereby expanding the definition of dietary supplements. Dunkelberger Memo, at 3 n.5.

[100] Dunkelberger Memo, supra note 97, at 3 n.5.

[101] Delaney Repeal for Supplements of Note to Food Industry, Food Labeling News, Nov. 10, 1994.

[102] Congress Passes Dietary Supplement Act, Shelves Health Claims, supra note 59.

[103] Pub. L. No. 103-417, § 4.

[104] Covington & Burling Memo, supra note 79 at 3.

[105] Bass & UlIman Memo, supra note 63 at 1-2; Emord & Associates Memo, supra note67, at 4-5; Dilling and Dilling Memo, supra note 84, at I.

[106] Summary and Analysis of the Dietary Supplement Health and Education Act of1994, Wilmer, Cutler & Pickering, (hereinafter Wilmer, Cutler & Pickering Memo) at4.

[107] 5~ 784, § 4.

[108] Pub. L. No. 103-417, § 4.

[109] Bass & Uliman Memo, supra note 63, at 2. In fact, the FDA's Center for Food Safety and Applied Nutrition (CFSAN) will be determining the scientific criteria for meeting the bill's "significant or unreasonable risk of illness or injury" standard, perhaps based on "significant scientific agreement" or a sliding risk versus benefit scale. In addition, FDA intends to develop a list of botanical products "for which there is significant scientific agreement that these products present a significant or unreasonable risk" and initiate formal rulemaking. FDA Implementation Plan at 12.

[110] Bass & Ullman Memo, supra note 63, at 2. Id..

[111] Id.

[112] Id at 1.

[113] 21 U.S.C. § 342(a)(l).

[114] Pub. L. No. 103-417, § 4.

[115] House Hearing on Dietary Supplements, supra note 8, at 75-86 (statement of FDA Commissioner David Kessler). Specific herbals of concern to FDA include: germander, comfrey, chapparal, yohimbe. lobelia, jin bu huan, herbal products containing stephania and magnolia, ma huany, and willow bark. U...

[116] Wilmer, Cutler & Pickering Memo, supra note 106, at 4 (quoting language from §4 of the DSH&E Act). The NNFA also expressed support for the bill's requirement that FDA have the burden of proof that a dietary supplement is unsafe. Congress Passes Dietary Supplement Act, Shelves Health Claims, Food Labeling News, Oct. 13, 1994.

[117] New Law Says Dietary Supplements Are Not Food Additives, Food Chemical News, Oct. 31, 1994.

[118] Id_1.

[119] Wilmer, Cutler & Pickering Memo, supra note 106, at 5.

[120] Pub. L. No. 103-417, § 5.

[121] Statement of Agreement, §3.

[122] FDA Premarket Notification Mechanism for Supplements Proposed by Sen. Kennedy, F-D-C Rep. ("The Tan Sheet"), May 16, 1994.

[123] Id... (quoting Senator Kennedy at the Senate Labor and Human Resources Comm. markup of 5. 784).

[124] Hatch/Harkin Dietary Supplement Legislation Passes Senate By Unanimous Consent, supra note 49.

[125] Emord & Associates Memo, supra note 67, at 4; Bass & UlIman Memo, supra note63, at 4;

[126] Wilmer, Cutler & Pickering Memo, supra note 106, at 5; Hyman, Phelps & McNamara Memo, supra note 74 at 5-6.

[127] Wilmer, Cutler & Pickering Memo, supra note 106, at 5.

[128] Id.

[129] Hyman, Phelps & McNamara Memo, supra note 74, at 6. Much of the analysis of the labeling exemption will remain unresolved until FDA gives a clear sense of what it considers to be a "publication" for the purposes of the DSH&E Act. The FDA has indicated that FDA's Center for Food Safety and Applied Nutrition (CFSAN) will be considering drafting guidelines concerning the labeling exemption. FDA's Implementation Plan at 11.

[130] FDA's Zeller Lays Out Problems With Supplement Legislation, supra note 68.

[131] Congress Passes Dietary Supplement Act, Shelves Health Claims, supra note 59.

[132] Pub. L. No. 103-417, § 6.

[133] Also known as "statements of nutritional support". For the purposes of this paper, such statements will be referred to as "structure and function claims".

[134] This paper will refer collectively to #1-4 as "structure or function claims".

[135] Pub. L. No. 103-417, § 6.

[136] Statement of Agreement, § 4.

[137] Sarah E. Taylor. Memorandum re: "Structure or Function" Claims Potentially Regulated as Disease Prevention (Health) Claims Under the NL&E Act, Sept. 12, 1994 (hereinafter Taylor Memo), at 4.

[138] ID.

[139] Id.

[140] Id... at 4-5 (citing 58 Fed. Reg. 2665, 2670-1 (Jan. 6, 1993)).

[141] Id. at S (citing 21 C.F.R. § l0I.14(a)(3)).

[142] FDA Implementation Plan at 16.

[143] FDA Fears Dietary Supplement Law's Structure/Function Clause Will be a Loophole -- Zeller, supra note 62.

[144] Congress Passes Dietary Supplement Act. Shelves Health Claims, supra note 59.

[145] Id... (quoting NNFA).

[146] Bass & UlIman Memo, supra note 63, at 2-3; Emord & Associates Memo, supra note67 at 4-5; Dilling and Dilling Memo, supra note 84, at 2.

[147] Bass & UlIman Memo, supra note 63, at 4-5.

[148] Id... at 5.

[149] Covington & Burling Memo, supra note 79, at 8; Wilmer, Cutler & Pickering Memo, supra note 106, at 6.

[150] Wilmer, Cutler & Pickering Memo, supra note 106, at 6.

[151] Seel.d..

[152] Covington & Burling Memo, supra note 79, at 8.

[153] Pub. L. No. 103-417, § 7. Because § 7 of the DSH&E Act has produced minimal discussion and virtually no controversy, this paper will not provide any commentary on this section.

[154] Dietary Supplement Bill Negotiations Resume on Hill, Senate Mark-up Predicted for April, F-D-C Rep. ("The Tan Sheet"), Mar. 21, 1994.

[155] Pub. L. No. 103-417, § 8.

[156] Statement of Agreement, § 5.

[157] Bass & UlIman Memo, supra note 63, at 4.

[158] Emord & Associates Memo, supra note 67, at 5.

[159] Covington & Burling Memo, supra note 79. at 7.

[160] Id.

[161] ~ Wilmer, Cutler & PickeringMemo, supra note 106. at 8.

[162] Bass & UlIman Memo, supra note 63, at 1-2.

[163] FDA Premarket Notification Mechanism for Supplements Proposed by Sen. Kennedy, supra note 122.

[164] ID.

[165] Dietary Supplement Bill Would Allow Structure-Function Claims, Attorney Says, supra note 52.

[166] Bass & UlIman Memo, supra note 63,at 4.

[167] Dietary Supplement Safety Would Be Reviewed by FDA Under CSPI Legislative Proposal, supra note 33, (CSPI's legislative proposal included a OMP requirement); Hatch/Harkin Dietary Supplement Legislation Passes Senate by Unanimous Consent, F-D-C Rep. ("The Tan Sheet"), Aug. 22, 1994 (stating that Chairman Dingell suggesting including a GMP requirement, according to Senator Hatch); Dietary Supplement Health Claims Bound by NLEA for Two Years Under Senate Bill, F-D-C Rep. ("The Tan Sheet"), Aug. 22, 1994 (stating CRN and NNFA's work on voluntary GMP guidelines to be discussed with FDA).

[168] CRN News Supplement, Jan. 19, 1995, at 2.

[169] FDA Implementation Plan, supra note 64. at 4.

[170] Pub. L. No. 103-417, § 13.

[171] Pub. L. No. 103417, § 12.

[172] Bass & UlIman Memo, supra note 63, at 3; Emord & Associates Memo, supra note67, at 5; Dilling and Dilling Memo, supra note 84, at 4.

[173] Wilmer, Cutler & Pickering Memo, supra note 106, at 10.

[174] Sidak, supra note 28.

[175] House Hearing on Dietary Supplements, supra note 8, at 226 (statement of J.B. Cordaro).

[176] Senate Hearing on Dietary Supplements, supra note 8, at 135 (Mr. Silverglade). Senator Kennedy's failed substitute bill included a mechanism establishing time limits on FDA's response to health claim petitions. FDA Premarket Notification Mechanism For Supplements Proposed by Sen. Kennedy, F-D-C Rep. ("The Tan Sheet"), May 16, 1994.

[177] House Hearing on Dietary Supplements, supra note 8, at 227 (statement of J.B. Cordaro)

[178] lii.. at 225.

[179] Id... at 227.

[180] Senate Hearing on Dietary Supplements, supra note 8, at 135 (Mr. Silverglade). Mr. Silverglade commented prior to the passage of the NLEA, the FDA issued a proposed rule that would have established a Public Health Service committee to assist in evaluating claims for FDA approval. U..

[181] Dietary Supplement Law's Capitol Hill Champions Will Oversee Implementation, F-D-C Rept. ("The Tan Sheet"), Nov. 14, 1994.

[182] Id..

[183] Supplement Health Claims Issues Mulled in Court Cases, Food Labeling News, Nov. 17, 1994.

[184] Id..