HerbalEGram:

HerbalGram. 2000;49:64-7. American Botanical Council

Regulation in the Herb Market
The Myth of the "Unregulated Industry"
by R. William Soller, Ph.D.
Senior Vice President and Director of Science & Technology
Consumer Healthcare Products Association¹

Despite statements in the media about an "unregulated industry,î the herb and dietary supplement industry is actually characterized by a substantial level of laws, regulations, and proposed regulations on the federal level. "FDA has tools at its disposal to take enforcement actions against dietary supplements found to have safety, labeling, or other violations of the FD&C Act, as amended by DSHEA" This statement was made on March 25, 1999, by Food and Drug Administration Commissioner Jane E. Henney, M.D., before the House Committee on Government Reform. It is significant, given that it was made four-and-a-half years after the passage of the Dietary Supplement Health Education Act (DSHEA), over which time the media has decried Congressís intent and claimed dietary supplements are unregulated products.

This article explains the considerable enforcement authority that both the Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) have, and have displayed, since DSHEA became law, to ensure safe, beneficial, and quality dietary supplements are available for health promotion and maintenance and disease risk reduction, as intended by Congress in passing DSHEA. This article also demonstrates that, in contrast to assertions to the contrary usually made by persons unfamiliar with regulatory issues, the herb and dietary supplement industries are substantially regulated, but these regulations are significantly different from those in the pharmaceutical industry. This article suggests that this differenceóplus the relatively selective enforcement of existing laws for supplements by FDA and FTCóis the source for the misconceptions surrounding the regulation of herbs and related dietary supplements. (see Table 1)

One of the most persistent mantras in the mainstream media is the allegation that the herb and dietary supplement industry is "unregulated" While the inner workings of the legal and regulatory processes with respect to the manufacture, advertising, and promotion of any consumer product can be somewhat esotericóusually known only to those in industry and the regulators responsible for that industryómost persons in the media and conventional healthcare professions are not aware of the vast network of laws, regulations, and proposed regulations that deal with herbs and dietary supplements.

Much of the confusion surrounding the regulation of herbal products has arisen since the passage of the Dietary Supplement and Health Education Act of 1994. No other law has ever received as much direct grassroots advocacy, with the number of supportive letters to Congress topping 2 million². In passing DSHEA, Congress noted in the "findingsî section of the Act that "consumers should be empowered to make choices about preventive health care programs based on data from scientific studies of health benefits related to particular dietary supplements" The purpose of passing DSHEA, therefore, was to provide consumer access to products and truthful information about those products, while maintaining authority for FDA to take action against products that present safety problems or are improperly labeled.

Before DSHEA, dietary supplements (including vitamins and minerals) were regulated either as foods or as drugs, depending on their intended use. A product used primarily for its taste, aroma, or nutritive value was regulated as a food, whose ingredients were subject to the food additive provisions of the Food, Drug and Cosmetic Act (FD&C Act) and thus required the pre-marketing demonstration of safety. A product was regulated as a drug if the product made therapeutic (disease treatment/prevention) claims, claims that the product affected the structure or function of the body through a non-nutritive mechanism, or both; or there was other evidence that the intended use of the product was as a drug. A supplement marketed with such claims would have to meet the drug safety and efficacy requirements of the FD&C Act, including, in the great majority of cases, the extensive and expensive pre-market approval process known as the new drug application (NDA).

As a result of DSHEA, dietary ingredients used in dietary supplements do not require pre-market documentation of safety for submission to FDA unless they are new dietary ingredients (i.e., ingredients not sold before the passage of DSHEA in October 1994), subject to the notification requirement in Section 413(a)(2) of the FD&C Act. This has led critics of DSHEA to fear a "safety meltdown" Yet, such a meltdown has not occurred in the five years since the passage of DSHEA, probably as a result of a combination of factors. These include the following considerations: (1) dietary supplements have a very long history of safe use³; (2) consumers usually use self-care products, such as dietary supplements, in a responsible manner⁴; (3) most companies are meeting the legal requirements of DSHEA; and, importantly, (4) the FDA and the FTC have sufficient enforcement authority in this area and have engaged in the development of the new regulatory framework for dietary supplements.

The FDA and FTC work together under a long-standing agreement governing the division of responsibilities between the two agencies. As applied to dietary supplements,⁵ FDA has the primary responsibility for claims on the product labeling, including packaging, inserts, and other promotional materials distributed at the point of sale; FTC has primary responsibility for claims in advertising, including print and broadcast ads, infomercials, catalogs, websites, and similar direct marketing materials.

Because of their shared jurisdiction, the two agencies work together to ensure their enforcement efforts are consistent to the fullest extent feasible, as stated in FTCís "Dietary Supplements - An Advertising Guide for Industry:î

The FTC's approach to supplement advertising is best illustrated by its Enforcement Policy Statement on Food Advertising (Food Policy Statement).³ Although the Food Policy Statement does not refer to supplements per se, the principles underlying the FTC's regulation of health claims in food advertising are relevant to the agency's approach to health claims in supplement advertising. In general, the FTC gives great weight to an FDA determination of whether there is adequate support for a health claim. Furthermore, the FTC and the FDA will usually arrive at the same conclusion when evaluating unqualified health claims. As the Food Policy Statement notes, however, there may be certain limited instances when a carefully qualified health claim in advertising may be permissible under FTC law, in circumstances where it has not been authorized for labeling. However, supplement marketers are cautioned that the FTC will require both strong scientific support and careful presentation for such claims.⁴

The FDA^6,7 has the power to:

1. Stop any company from selling a dietary supplement that is toxic or unsanitary (see FD&C Act, Section 402(a));

2. Stop the sale of a dietary supplement that has false or unsubstantiated claims (see FD&C Act, Section 403(r)(6));

3. Take action against dietary supplements that pose "a significant unreasonable risk of illness or injuryî (see FD&C Act, Section 402(f));

4. Stop any company making a claim that a product cures or treats a disease (see FD&C Act, Section 201(g));

5. Stop a new dietary ingredient from being marketed if FDA does not receive enough safety data in advance (see FD&C Act, Section 413); and

6. Require dietary supplements to meet strict manufacturing requirements (Good Manufacturing Practices), including potency, cleanliness, and stability [see FD&C Act, Section 402(g)].

The FTC³ has the power to⁸:

1. Enforce laws outlawing "unfair or deceptive acts or practicesî⁹ to ensure consumers get accurate information about dietary supplements, so they can make informed decisions about these products (see Federal Trade Commission (FTC) Act, Section 5);

2. Challenge and stop advertising that is not adequately substantiated (see FTCís Deception Policy Statement and Advertising Substantiation Policy Statement);

3. Investigate complaints or questionable trade practices; FTC can investigate informally or formally, where it has strong compulsory investigative authority, including the power to require a respondent to produce documents, give testimony, or answer written questions [see FTC Act, Sections 6(a) and (b), and 9);

4. Following its own investigation, negotiate a consent order or proceed through an FTC adjudication resulting in a cease and desist order, which can be quite broad in its scope (see FTC Act, Section 5);

5. Seek preliminary and permanent injunctions to stop false advertisements or other violations of the FTC Act (see FTC Act, Sections 12 and 13) and

6. Seek civil penalties for violations of trade regulation rules see FTC Act, Section 5) or of cease and desist orders (see FTC Act, Section 5).

In the five years since the passage of DSHEA in 1994, FDA and FTC have been active in building the regulatory framework for dietary supplements. For example, over the past 37 years, FDA has published 143 proposed and final rules in the Federal Register (FR) relating to dietary supplements, excluding non-FR published compliance guides. In the 19-year period between 1962 and 1981, FDA issued 52 such publications, most of them related to FDAís attempt to regulate vitamins and minerals as drug products. From December 1981 to May 1993, FDA issued no documents pertaining to regulation of dietary supplements, but in the four-and-a-half years since the passage of DSHEA, the agency has issued 91 FR publicationsó66 percent of the total since 1962. These proposed and final rules cover such important enforcement topics as labeling, good manufacturing practices, development of a comprehensive regulatory strategy for dietary supplements, and issues relating to ingredient safety. (See Table 2 for a list of these FR notices.)

The FTC has also been active in defining the regulatory framework for advertising claims for dietary supplements. In 1998, FTC issued a guidance to industry on the agencyís expectations for truthful and non-misleading advertising of dietary supplements.⁴ This guidance is based on long-standing FTC policy in the areas of advertising substantiation, deceptive advertising, testimonials and endorsements, and enforcement policy. In addition, in the 10-year period preceding DSHEA, FTC settled about two dozen dietary supplement advertising cases. In less than half that period, from 1994 through 1999, post-DSHEA, FTC almost doubled the number of cases settled, most related to unsubstantiated health benefit claims. FTC has issued a number of guidances on the agencyís expectations for good business practices, and it is prudent for supplement marketers to ensure that they are familiar with basic FTC advertising principles.¹⁰

In addition, FDA and FTC maintain sentinel systems for complaints on product quality, safety, effectiveness, and labeling. FDAís MedWatch program accepts adverse experience reports (AERs) associated with dietary supplement use (1-800-FDA-1088, FDA. FAX 1-800-0178, <http://www.fda.gov/medWatch/>. Medwatch "Safety Information Summariesî on dietary supplement and drug products are published periodically on the MedWatch website (e.g., see Koo Sar and Gamma Butyrolactone at <www.fda.gov/medwatch/SAFETY/1999/safety99.htm#dietary>) FDAís Center for Food Safety and Applied Nutrition also maintains the Special Nutritional Adverse Events Monitoring System, which provides an on-line index of reports provided to the agency by health professionals and consumers on dietary supplements, infant formulas, and medical foods at <www.cfsan.fda.gov/~dms/aems.html>. FDA has recently made further refinement of its adverse event monitoring systems a top priority of the Center for Food Safety and Applied Nutritionís (CFSAN) program activity in 2000.

FTC maintains a consumer hotline (1-877-FTC-HELP, 9:00 am - 8:00 pm EST; or by toll, 202-326-2502), an online complaint form (www.ftc.gov/ftc/complaint), an internal database on complaints to track trends, and a system to share input to its sentinel systems with state attorneys general and other law enforcement agencies.¹¹ Both agencies also engage in a variety of educational activities to raise awareness among consumers about health issues, government regulations, and business practices (e.g., see FTC: "Fraudulent Health Claims: Don't Be Fooled,î at <www.ftc.gov/bcp/conline/pubs/health/frdheal.htm>; see FDA at <http://vm.cfsan.fda.gov/>).

In conclusion, dietary supplements are regulated by two sister agencies (FDA and FTC) with substantial enforcement powers to ensure the DSHEA-sanctioned availability of beneficial, safe, and quality dietary supplements making truthful and not misleading claims pertaining to health promotion and maintenance, nutrient content, and disease risk reduction. DHSEA has brought dietary supplements to the mainstream of American health, and both the public and the many companies seeking to compete fairly in conformance with DSHEA provisions need FDA and FTC to exert their authorized enforcement capabilities in a pro-active and reasonable manner. In this way, rogue companies will be put on notice, and the legitimate members of industry can prosper in a way that benefits the consumer, as intended by Congress in passing DSHEA.

Consumer trust will be the measure of the ultimate success or failure of the dietary supplement industry, as is true for every consumer product sector. That trust is built not only by a responsible industry but also by a government that has visible, effective, and reasonable enforcement programs for the regulated industry. It is appropriate, therefore, to close with two statements of commitment by top regulators overseeing government program activities on dietary supplements. FDA Commissioner Jane E. Henney, M.D., stated to the House Committee¹² on Government Reform: "Just as the Agency (i.e., the FDA) is committed to implementing DSHEA fully and ensuring consumers have access to dietary supplements, FDA also is committed to quickly removing unsafe products from the market or taking other timely actions to protect consumers"³ Similarly, Ms. Jodie Bernstein, Director of the FTC Bureau of Consumer Protection, recently provided her Bureauís commitment to effective regulation of dietary supplements: "Ö FTC must and will continue to maintain an enforcement presence here, giving priority to cases that present serious safety considerations or prey on the very sick and especially vulnerableconsumer"¹²

Table 1: Laws Regulating Herbs and Dietary Supplements

Food Drug and Cosmetic Act (FDC Act): In 1938 THE FEDERAL FOOD, DRUG, AND COSMETIC (FDC) ACT was passed by Congress, containing new provisions: extending control to cosmetics and therapeutic devices; requiring new drugs to be shown safe before marketing-starting a new system of drug regulation; eliminating the Sherley Amendment requirement to prove intent to defraud in drug misbranding cases; providing that safe tolerances be set for unavoidable poisonous substances; authorizing standards of identity, quality, and fill-of-container for foods; authorizing factory inspections; adding the remedy of court injunctions to the previous penalties of seizures and prosecutions.  In 1958 the FOOD ADDITIVES AMENDMENT was added, requiring manufacturers of new food additives to establish safety. The Delaney proviso prohibits the approval of any food additive shown to induce cancer in humans or animals, and FDA publishes in the Federal Register the first list of SUBSTANCES GENERALLY RECOGNIZED AS SAFE (GRAS). The list contains nearly 200 substances.  (see FDA:  Milestones in food and drug law: August, 1995. <www.fda.gov>)

Nutrition Labeling and Education Act of 1990 (NLEA):

1990 NUTRITION LABELING AND EDUCATION ACT requires all packaged foods to bear nutrition labeling and all health claims (i.e., disease risk reduction) for foods to be consistent with terms defined by the Secretary of Health and Human Services (i.e., preapproved by FDA). The law preempts state requirements about food standards, nutrition labeling, and health claims and, for the first time, authorizes some health claims for foods. The food ingredient information panel, serving sizes, and terms such as "low fat" and "light" are standardized. The phrase "herbs, or similar nutritional substancesî was added to the term "dietary supplement" DSHEA has been succcessful in raising consumer awareness and confidence about the role of nutrition in promoting health and reducing disease risk, thereby bringing structure to a field that had functioned in the 1980ís without a regulatory framework .  With this success and the growing interest in health maintance/promotion and disease risk reduction, NLEA served as an important springboard to the Dietary Supplement and health Education Act of 1994 (DSHEA), which established the framework for dietary supplements to become a core element of mainstream self care.

Dietary Supplement Health and Education Act of 1994 (DSHEA)

In 1994 DSHEA defined dietary supplements and dietary ingredients; established a new framework for assuring safety; outlined guidelines for literature displayed where supplements are sold; provided for use of claims and nutritional support statements; required ingredient and nutrition labeling; and granted FDA the authority to establish good manufacturing practice (GMP) regulations. The law also required formation of an executive level Commission on Dietary Supplement Labels and an Office of Dietary Supplements within the National Institutes of Health. (From:  FDA Center for Food Safety and Applied Nutrition Dietary Supplement Health and Education Act of 1994 Summary,  December 1, 1995. Importantly, enforcement authorities for the Food and Drug Admnistration under the Food, Drug, Cosmetic Act and that of the Federal Trade Commission under the Federal Trade Commission Act remained unaltered and substantial.

Food and Drug Administration Modernization Act (FDAMA)

Prior to the Food and Drug Administration Modernization Act of 1997 (FDAMA), companies could not use a health claim or nutrient content claim in food labeling unless the FDA published a regulation authorizing such a claim. Two new provisions of FDAMA now permit distributors and manufacturers to use such claims if they are based on current, published, authoritative statements from certain federal scientific bodies, as well as from the National Academy of Sciences. These provisions are intended to expedite the process by which the scientific basis for such claims is established, and they place dietary supplements on an equal footing with conventional foods.

Table 2: List of FDA Notices, Actions, and Proposed, Interim, or Final Rules Covering Dietary Supplements

[From:  NEL-DS July-August 1999]

FDA has issued a total of 143 notices, actions and proposed, interim and final rules covering dietary supplements over the last 37 years, from June 20, 1962 to June 18, 1999.  The total list demonstrates that the FDA has had three eras of regulatory activity relating to dietary supplementsóone from June 20, 1962 to November 21, 1981; another from November 22, 1981 to June 17, 1993; and a third from June 18, 1993 to the present time.  Of note is the fact that in the first era covering almost 20 years, FDA published in the Federal Register 52 notices, actions, and proposed, interim or final rules relating to dietary supplements.  In the eleven-and-a-half years comprising the middle era, FDA issued no such publications.  In the third current era covering six years, FDA has issued 91 such publications, which, compared to the first era, demonstrates a doubling in half of the time of FDAís regulatory program on dietary supplements, as measured by FDAís publication activity in the Federal Register (FR). 

The following is a listing of all FDA notices, actions and proposed, interim and final rules covering dietary supplements over the last 37 years, from June 20, 1962 to June 18, 1999.  The list demonstrates the FDA had three eras of regulatory activity relating to dietary supplements - one from June 20, 1962 to November 21, 1981; another from November 22, 1981 to June 17, 1993; and a third from June 18, 1993 to the present time.  Of note is the fact that in the first era covering almost 20 years, FDA published in the Federal Register 52 notices, actions, and proposed, interim or final rules relating to dietary supplements.  In the 11 ? years comprising the middle era, FDA issued no such publications.   In the third current era covering 6 years, FDA has issued 91 such publications, which compared to the first era demonstrates a doubling in half the time of FDAís regulatory program on dietary supplements, as measured by FDAís publication activity in the Federal Register.

1.        Dietary Supplement of Vitamins and Minerals, Proposal [27 FR 5815-18 (6/20/62)]  

2.        Status of Pteroylglutamic Acid (Folic Acid) in Foods for Special Dietary Use and as a Drug [29 FR 2557 (2/19/64)]  

3.        Vitamin D, Proposed Status as Special Dietary Food, Drug, Food Additive, and as Optional Ingredient in Standardized Foods [30 FR 11140-41 (8/28/65)]  

4.        Extension of Time for Filing Comments on Proposal Regarding Status of Vitamin D as Special Dietary Food, Drug, Food Additive, and as Optional Ingredient n Standardized Foods [30 FR 13456 (10/22/65)]  

5.        Dietary Supplements of Vitamins and Minerals, Proposed Definitions, Standards of Identity and Label Statements [31 FR 8525-27 (6/18/66)]  

6.        Dietary Supplements of Vitamins and Minerals, Order Staying Effective Date of Regulations; Amending Regulations; and Allowing Additional Time for Filing Objections [31 FR 15730-36 12/14/66)]  

7.        Dietary Supplements of Vitamins and Minerals, Correction of Order Staying Effective Date of Regulations; Amending Regulations; and Allowing Additional Time for Filing Objections [31 FR 16312 (12/21/66)]  

8.        Dietary Supplements of Vitamins and Minerals, Notice of Hearing and Prehearing Conference [33 FR 5268-69 (4/2/68)]  

9.        Dietary Supplements of Vitamins and Minerals, Notice of Appointment of Hearing Examiner [33 FR 6828 (5/4/68)]  

10.     Dietary Supplements of Vitamins and Minerals, Notice of Reconvening of Public Hearing [33 FR 8679 (6/13/68)]  

11.     Folic Acid Preparations for Therapeutic Use, Drug Efficacy Study Implementation [36 FR 6843-44 (4/9/71)] 

12.     Certain OTC Vitamin and Vitamin and/or Mineral Preparations, DESI, Action Deferred [37 FR 10461-65 (5/23/72)]  

13.     Certain OTC Hematinic Preparations, DESI, Action Deferred [37 FR 11278-81 (6/6/72)]   

14.     Certain OTC Multiple-Vitamin Preparation, Notice of Proposed Withdrawal of Approval of New Drug Applications [37 FR 18576 (9/13/72)]  

15.     Certain OTC Multiple-Vitamin Preparation, Notice of Withdrawal of Approval of New Drug Applications [37 FR 25249 (11/29/72)]  

16.     Vitamin A and Vitamin D, Proposed Statement of Policy [37 FR 26618-20 (12/14/72)]  

17.     Vitamin A and Vitamin D, Correction of Proposed Statement of Policy [38 FR 799 (1/4/73)]  

18.     Special Dietary Foods, Label Statements; Proposed Findings of Fact, Conclusions, and Tentative Order Following Public Hearing [38 FR 2143-50 (1/19/73)]  

19.     Dietary Supplements of Vitamins and Minerals; Definition, Identity, and Label Statements; Proposed Findings of Fact, Conclusions, and Tentative Order Following a Public Hearing [38 FR 2152-62 (1/19/73)]  

20.     Standard of Identity for Vitamin-Mineral Supplements; Notice of Opportunity for Exceptions and Comments [38 FR 2163 (1/19/73)]  

21.     Prospective Requirements for Manufacturers, Packers, and Distributors of Vitamin-Mineral Supplements; Request for Comments [38 FR 2163-64 (1/19/73)]  

22.     Dietary Supplements of Vitamins and Minerals; Definition, Identity, and Label Statements; Proposed Findings of Fact, Conclusions, and Tentative Order Following a Public Hearing; Extension of Time for Exceptions [38 FR 6396 (3/9/73)]  

23.     Special Dietary Foods, Label Statements; Findings of Fact, Conclusions, and Final Order [38 FR 20708-18 (8/2/73)]  

24.     Status of Vitamin A and Vitamin D [38 FR 20723-25 (8/2/73)]  

25.     Dietary Supplements of Vitamins and Minerals; Definition, Identity, and Label Statements; Findings of Fact, Conclusions, and Final Order [38 FR 20730-40 (8/2/73)]  

26.     Use of International Units for Vitamins A and D, Proposal [38 FR 20749 (8/2/73)]  

27.     Folic Acid Preparations for Therapeutic Use;  Amendment of Drug Efficacy Study Implementation Notice [38 FR 20750 (8/2/73)]  

28.     Special Dietary Foods, Label Statements; Correction of Findings of Fact, Conclusions, and Final Order [38 FR 27593 (10/5/73)]  

29.     Request for Data and Information on OTC Vitamin, Mineral and Hematinic Drug Products [38 FR 28581-83 (10/15/73)]  

30.     Dietary Supplements of Vitamins and Minerals; Correction of Findings of Fact, Conclusions, and Final Order [38 FR 28820 (10/17/73)]  

31.     Use of International Units for Vitamins A and D; Correction of Proposal [38 FR 28840 (10/17/73)]  

32.     Special Dietary Foods, Label Statements; Correction of Findings of Fact, Conclusions and Final Order [38 FR 29219 (10/23/73)]  

33.     Dietary Supplements of Vitamins and Minerals; Stay of Effective Date for Ordering New Labeling [38 FR 29577 (10/26/73)]  

34.     Use of International Units for Vitamins A and D [39 FR 5313 (2/12/74)]  

35.     Use of International Units for Vitamins A and D; Confirmation of Effective Date of Order [39 FR 20884 (6/14/74)]  

36.     Uniform Effective Date for New Food Labeling Regulations, Except those Governing Dietary Supplements of Vitamins and Minerals [39 FR 36501-02 (10/10/74)]  

37.     Extension of Uniform Effective Date for New Food Labeling Regulations, Except those Governing Dietary Supplements of Vitamins and Minerals [39 FR 40184-85 (11/14/74)]  

38.     Supplemental Request for Data and Information on OTC Vitamin, Mineral and Hematinic Drug Products [40 FR 10505 (3/6/75)]  

39.     Opportunity for Filing Applications for Additional Formulations of Dietary Supplements of Vitamins and Minerals; Preliminary Notice of Reopening of Hearing; Tentative Amendments to Final Orders [40 FR 23244-50 (5/28/75)]  

40.     Extension of Time for Filing Additional Formulation Applications of Dietary Supplements of Vitamins and Minerals [40 FR 29089 (7/10/75)]  

41.     Further Notice of Stay of Effective Date of Regulations Governing Dietary Supplements of Vitamins and Minerals [40 FR 34586-87 (8/18/75)]