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Regulation in the Herb Market: The Myth of the "Unregulated Industry"
ISSUE:
Page:
64

by R. William Soller, Ph.D., Senior Vice President and Director of Science and Technology1

Consumer Healthcare Products Association

Despite statements in the media about an "unregulated industry" 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."2 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 Congress’ 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, to ensure safe, beneficial, and quality dietary supplements are available for health promotion and maintenance and disease risk reduction, as intended by Congress in the passage of 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 difference—plus the relatively selective enforcement of existing laws for supplements by FDA and FTC—are the sources for the misconceptions surrounding the regulation of herbs and related dietary supplements. (See table, p. 67, Laws Regulating Herb and Dietary Supplements.)

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 esoteric—usually known only to those in industry and the regulators responsible for that industry—most persons in the media and conventional healthcare professions are not aware of the vast network of laws, regulations, and proposed regulations that deal specifically 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 (DSHEA). No other law has ever received as much direct grassroots advocacy, with the number of supportive letters to Congress topping 2 million.3 In passing DSHEA, Congress noted in the "findings" 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 create the right balance between 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.

Prior to 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 and/or claims that the product affected the structure or function of the body through a non-nutritive mechanism; 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 a 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 prior to 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, undoubtedly a result of a combination of factors. These include the following considerations: (1) dietary supplements have a very long history of safe use;2 (2) consumers usually use self-care products, such as dietary supplements, in a responsible manner;3 (3) most companies are meeting the legal requirements of DSHEA; (4) and importantly, the FDA and the Federal Trade Commission (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 supplements4 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 FTC’s "Dietary Supplements – An Advertising Guide for Industry":

The FTC’s approach to supplement advertising is best illustrated by its Enforcement Policy Statement on Food Advertising (Food Policy Statement). Although the Food Policy Statement does not specifically refer to supplements, 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 deference to an FDA determination of whether there is adequate support for a health claim. Furthermore, the FTC and the FDA will generally 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, 5

THE FDA6, 7 HAS THE POWER TO:

1. Stop any company from selling a dietary supplement that is toxic or unsanitary [see FDC Act, Section 402(a)];

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

3. Take action against dietary supplements that pose "a significant unreasonable risk of illness or injury" [see FDC Act, Section 402(f)];

4. Stop any company making a claim that a product cures or treats a disease [see FDC Act, Section 201(g)];

5. Stop a new dietary ingredient from being marketed if FDA does not receive enough safety data in advance [see FDC Act, Section 413];

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

The FTC8 has the power to:

1. Enforce laws outlawing "unfair or deceptive acts or practices"9 to ensure consumers get accurate information about dietary supplements, so they can make informed decisions about these products [see FTC Act, Section 5];

2. Challenge and stop advertising that is not adequately substantiated [see FTC’s Deception Policy Statement and Advertising Substantiation Policy Statement];

3. Investigate complaints or questionable trade practices; FTC can investigate either 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];

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

Since the passage of DSHEA in 1994, both 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 related to FDA’s 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 five years since the passage of DSHEA, the agency has issued 91 FR publications—66 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, p. 67, List of FDA 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 agency’s 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 ten-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 agency’s 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, both FDA and FTC maintain sentinel systems for complaints on product quality, safety, effectiveness, and labeling. FDA’s MedWatch program accepts adverse experience reports (AERs) associated with dietary supplement use (TEL: 1-800-FDA-1088, FAX 1-800-FDA- 0178; <www.fda.gov.medwatch/medwatch-online>). Medwatch "Safety Information Summaries" 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>). FDA’s Center for Food Safety and Applied Nutrition also maintains the Special Nutritional Adverse Events Monitoring System, which provides a on-line index of reports provided to the agency by health professionals and consumers on dietary supplements, infant formulas and medical foods <www.cfsan.fda.gov/~dms/aems>). FDA has currently placed further refinement of its adverse event monitoring systems as a top priority of the Center for Food Safety and Applied Nutrition’s (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 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" at <www.ftc.gov/bcp/conline/pubs/health/frdheal>; see FDA at <www.cfsan.fda.gov/~dms/supplmnt>).

In summary, dietary supplements are regulated by two sister agencies (FDA and FTC) which have 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/maintenance, nutrient content and disease risk reduction. DSHEA 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 a 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 Committee on Government Reform:12 "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."2 Similarly, Ms. Jodie Bernstein, Director of the FTC Bureau of Consumer Protection, recently provided her Bureau’s commitment to effective regulation of dietary supplements: "… 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 vulnerable consumer."12

References

1. R. William Soller received his doctorate in medical sciences from the Cornell University Graduate School of Medical Sciences, New York, New York. The Consumer Healthcare Products Association (CHPA), formerly known as the Nonprescription Drug Manufacturers Association (NDMA), is the 118-year-old trade organization representing the manufacturers and distributors of national and store brand dietary supplements and nonprescription medicines. CHPA’s membership includes over 200 companies involved in the manufacture and distribution of these self-care products and their affiliated services (e.g., raw material suppliers, research testing companies, contract manufacturing companies, advertising agencies, etc.).

2. Henney JE. Statement before the Committee on Government Reform U.S. House of Representatives. March 25, 1999.

3. Clay E. Personal communication. September 28, 1999.

4. Slaughter E. Assessing consumer use of dietary supplements. CHPA Annual Dietary Supplement Symposium. September 13-14, 1999.

5. Federal Trade Commission, Bureau of Consumer Protection: Dietary Supplements: An Advertising Guide for Industry. 1998. (see <www.ftc.gov>)

6. Taken from comments by Scott Bass, Esq. before Representative Dan Burton, Chairman of the House of Representatives Committee on Government Oversight, Oversight Hearing on the Dietary Supplement and Health Education Act of 1994. March 25, 1999.

7. McNamara S. FDA has adequate power and authority to protect the public from unsafe dietary supplements. HerbalGram. 38:25-27.

8. Bernstein JZ, Rusk MK. Comments of the staff of the Bureau of Consumer Protection of the Federal Trade Commission Statements made for dietary supplements before the Department of Health and Human Services Food and Drug Administration in the matter of regulations on statements made for dietary supplements concerning the effect of the product on the structure or function of the body. FDA Docket No. 98N-0044. August 27, 1998.

9. An unfair trade practice is one that: causes or is likely to cause substantial injury to consumers; is not reasonably avoidable by consumers themselves; and not outweighed by countervailing benefits to consumers or competition (see FTC’s Deception Policy Statement and Advertising Substantiation Policy Statement at <www.ftc.gov>).

10. Federal Trade Commission: Advertising Policy Statements and Guidance. <www.ftc.gov/bcp/guides/guides>.

11. Rusk M. Update on FTC activities relating to dietary supplements. Food Drug Law Institute Conference, Washington, D.C. November 9, 1999.

12. Bernstein J. The FTC and Dietary Supplements. FDLI Conference on Substantiating Claims for Dietary Supplement Advertising and Labeling, Washington, D.C. November 13, 1997.

FTC Policy Statements and Guidelines Affecting the Advertising of Dietary Supplements*

1. Advertising and Marketing on the Internet: The Rules of the Road

2. Frequently Asked Advertising Questions: A Guide for Small Business

3. Policy Statement Regarding Advertising Substantiation

4. Policy Statement on Deception

5. Guides Against Deceptive Pricing

6. Guide Concerning the Use of the Word "Free"

7. Guide Concerning the Use of Endorsements and Testimonials

8. Policy Statement on Unfairness

9. Dietary Supplements: An Advertising Guide for Industry

10. Staff Comment on Draft Report of the Commission on Dietary Supplements

11. Staff Comment on the Proposed Rule on Statements Made for Dietary Supplements

12. Enforcement Policy Statement on Food Advertising

FTC Actions Against Manufacturers of Dietary Supplements for Claims Made in Advertising

Since 1984 through November, 1999 the FTC has initiated 70 cases against supplement manufacturers challenging or seeking documentation for claims made in product advertising. For a complete listing see <www.ftc.gov>.

Laws Regulating Herbs and Dietary Supplements

Food, Drug, and Cosmetic Act (FD&C Act)

In 1938 the federal Food, Drug, and Cosmetic Act was passed by Congress, 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; and 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 prohibited the approval of any food additive shown to induce cancer in humans or animals, and the FDA published in the Federal Register the first list of substances Generally Recognized As Safe (GRAS). The list contained nearly 200 substances. (See FDA: Milestones in food and drug law: August, 1995. <www.fda.gov.com>)

Nutrition Labeling and Education Act of 1990 (NLEA)

The Nutrition Labeling and Education Act of 1990 requires packaged foods to bear nutrition labeling and health claims for foods to be consistent with terms defined by the Secretary of Health and Human Services (i.e., approved by FDA). The law preempts state requirements about food standards, nutrition labeling, 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 substances" was added to the term "dietary supplement." NLEA has been successful in raising consumer awareness and confidence about the role of nutrition in promoting health and reducing the risk of disease, and has brought structure to a field that in the 1980s had no regulatory framework. With this success and the growing interest in health maintenance promotion and disease risk reduction, NLEA served as a springboard to the Dietary Supplement and Health Education Act (DSHEA) of 1994, which established the legal basis for dietary supplements to become a core element of self care for the U.S. consumer.

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 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.) Enforcement authority for the FDA under the Food, Drug, and Cosmetic Act and of the FTC under the Federal Trade Commission Act remained unaltered and substantial.

Food and Drug Administration Modernization Act (FDAMA)

Before the Food and Drug Administration Modernization Act of 1997, 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, or 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.

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

Number Period of time

Total: 1962 – 1999 = 143 37 years

Subtotal: 6/62 – 11/81= 52 19.5 years

Subtotal: 12/81 – 5/93 = 0 11.5 years

Subtotal: 5/93 – 6/99= 91 6 years

[From: NEL-DS July-August 1999]

Explanation:

The 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 table shows that the FDA has had three eras of regulatory activity relating to dietary supplements—June 20, 1962, to November 21, 1981; November 22, 1981, to June 17, 1993; and June 18, 1993, to the present. In the first era, 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 of the middle era, FDA issued no such publications. In the third, current era of only six years, FDA has issued 91 publications. Compared to the first era, publications doubled in half the time, as measured by FDA’s publication activity in the Federal Register. For a complete list of these notices, please check the ABC website at <www.herbalgram.org/herbalgramarticle/sollerhg49regulation.html>.