I. Historical Background
It’s hard to remember, but dietary supplements were almost regulated out of existence before Congress passed the Dietary Supplement Health and Education Act (DSHEA) in October 1994. Since the early 1900s, when vitamins A and D were promoted as fish oil supplements, there has been confusion and disagreement about how to regulate dietary supplements. Antagonism between the FDA and what later became known as the dietary supple- ment industry continued during the 1970s as the FDA attempted to restrict the sale of high-potency vitamins and minerals. In the 1980s and early 1990s, the tension between the two camps continued, as the use of health claims on food labels proliferated and the industry challenged the FDA in court.
In 1992, Senator Orrin Hatch introduced the Health Freedom Act of 1992, which sought to rein in the FDA’s ability to use health claims as a basis for making supplements illegal. The gist of the bill was that supplements were neither drugs nor food additives, and the gray area in which they existed needed some fair parameters and definitions. While the Health Freedom Act did not pass, Senator
Hatch was able to persuade Congress to agree to the Dietary Supplement Act of 1992, which bought some much-needed time to address thedietary supplement issue. The FDA commissioner at the time had created a committee to write a report about how dietary sup- plements should be regulated, which was initially prepared in secret. Under pressure from the industry, FDA published the report – Proposed Rules for Food Labeling: General Requirements for Nutritional Labeling for Dietary Supplements of Vitamins, Min- erals, Herbs or other Similar Nutritional Substance – in the Federal Register in 1993. FDA’s intentions were clear – it planned on regulating most supplements as drugs.
In response, the supplement industry spearheaded one of the United States’ largest and most successful grassroots efforts. Consumers lobbied and wrote letters (this was pre-Internet and pre-social media) to Congress, resulting in more than 2.5 million letters in support of “health freedom,” and DSHEA was born.
President Bill Clinton signed DSHEA into law on October 25, 1994. DSHEA codified dietary supplements as a distinct subset of food, and clarified that “dietary ingredients” in supplements are not “food additives” but have a separate and distinct safety standard. This change was critical because, unlike food additives, dietary supplements normally don’t have to satisfy premarket notification requirements. As a result, manufacturers generally do not have to submit scientific evidence demonstrating safety prior to marketing a dietary supplement unless it contains a “new dietary ingredient.” New dietary ingredients are ingredients not marketed in the United States prior to DSHEA. Any manufacturer or distributor of a new dietary ingredient must submit to FDA a 75-day premarket notification containing safety data.
With DSHEA, Congress also restricted the type of information that can be placed on dietary supplement labels. Manufacturers may not make any claims that a supplement diagnoses, mitigates, cures, treats or prevents a specific disease or class of disease. Manufacturers of dietary supplements are permitted to make statements that claim a benefit related to a classical nutrient deficiency disease, but these statements must describe the prevalence of the disease in the United States and explain how the dietary supplement acts to main- tain the “structure or function” of the body affected by the disease. The statement must also be backed by substantiation (scientific evidence) for the claim that is truthful and not misleading. Finally, the supplement must contain a boldface disclaimer that the statement has not been evaluated by the FDA on its outer packaging. In short, under DSHEA FDA has broad statutory authority to regulate dietary supplements and to take enforcement action against unsafe or mislabeled products.
Despite this, there are still those who claim that dietary supplements are either unregulated or insuff iciently regulated and clamor for FDA preapproval – which would be a death knell for the industry. Those voices got signif icantly louder after reports that supplements containing ephedra caused nearly 150 deaths, including Major League Baseball player Steve Bechler and National Football League player Korey Stringer.1
III. The Ephedra Debacle
Ephedra was promoted for weight loss and athletic performance, and it soared in popularity after DSHEA was passed until it was associated with cardiovascular events and other adverse reactions. In February 2004, FDA issued a final rule declaring dietary supplements containing ephedrine alkaloids to be adulterated or illegal under DSHEA’s “significant or unreasonable” risk safety standard.
Manufacturers of products containing low levels of ephedrine alkaloids challenged FDA’s final regulation in federal court, arguing that there was no scientific proof of a significant or unreasonable risk of illness or injury at such levels. The district court granted summary judgment in favor of the manufacturer, holding that FDA’s use of a risk-benefit analysis was improper and that the FDA had failed to demonstrate that 10 mg doses of ephedrine alkaloids presented a significant or unrea- sonable risk of injury.2 Fourteen months later, the Tenth Circuit reversed the district court, holding that the FDA properly conducted a risk-benefit analysis and that the data submitted by the FDA suggested that ephedra posed an “unreasonable threat to the public’s health.”3
The ephedra debacle led to widespread criticism that DSHEA prevented the FDA from acting aggressively to protect consumers from unsafe dietary supplements. In response to this criticism, in 2006 Congress enacted the Dietary Supple- ment and Nonprescription Drug Consumer Protection Act (the “2006 Act”), which requires that a “responsible person” sub- mit to the FDA all reports of a “serious adverse event” associated with a dietary supplement.4 Notably, several years earlier, the American Herbal Products Associa- tion (AHPA), a national trade association consisting of herbal and botanical product companies, filed a Citizen Petition with the FDA (in March 2003), recommending that the agency impose a mandatory report- ing requirement on dietary supplement companies for all “serious adverse event” reports associated with the use of a dietary supplement. In any event, the supplement industry did not oppose the 2006 Act.
IV. The FTC’s Role In Regulating Dietary Supplement Advertising
The Federal Trade Commission (FTC) has broad authority to regulate dietary supplement advertising. With overlapping jurisdiction to regulate the labeling and advertising of foods, over-the-counter drugs, medical devices and cosmetics, FDA and FTC have worked out a memo- randum of understanding (MOU) pursuant to which FTC has primary responsibility for regulating food advertising and FDA for regulating food labeling.
To protect consumers from deceptive advertising, the FTC has extensive inves- tigative and law enforcement authority to prevent companies from engaging in unfair or deceptive practices. Among other things, the FTC may (1) request documents and information from a company through the use of voluntary “access letters”; (2) issue subpoenas and “civil investigative demands” requiring production of docu- mentary evidence for any matter under investigation; (3) seek and impose consent orders (through administrative or judicial proceedings in federal court) and (4) seek consumer redress (e.g., disgorgement of profits, refunds); and (5) seek temporary and permanent injunctions, which may include corrective advertising.
FTC administrative and judicial proceedings may be directed against companies and individuals. Endorsers, celebrities and spokespeople engaged in the promo- tion of dietary supplements may also be liable for violations of the FTC Act.
The dietary supplement industry con- tinues to be the focus of increased scrutiny by the FTC, with significant multimillion- dollar civil penalties, redress orders and disgorgement of profits sought in the federal district courts. Recent consent orders provide guidance with respect to the level of substantiation being sought by the FTC. For certain types of health-related claims, the FTC wants to see two adequate and well-controlled, product-specific clinical trials. When a company relies on third- party ingredient science to substantiate a health-related claim on a finished dietary supplement that has not been clinically tested, the burden will be on the com- pany to demonstrate that the studies were conducted on an essentially equivalent product.5
V. Conclusion – DSHEA Works (Albeit Sometimes Imperfectly)
To say that the dietary supplement industry has thrived since the passage of DSHEA is an understatement. Dietary supplement sales account for over $20 billion each year and continue to rise. It is estimated that 52 percent of consumers over 19 take dietary supplements.
Since the enactment of DSHEA, FDA has developed regulations and guid- ance documents to ensure that dietary supplements are safe and properly labeled. While there has not been consensus with the approach used to accomplish these ends, on balance the core elements of the regulatory framework envisioned by the authors of DSHEA are in place. Dietary supplements have a legal definition; there are comprehensive requirements in place for advertising claims that ensure that consumers have access to truthful and non-misleading information; and there is strong legal authority to remove unsafe products from the market, cease deceptive advertising and provide redress to consum- ers when appropriate. All of the forego- ing demonstrate that far from being the “Wild West” of an unregulated industry, the dietary supplement industry is in fact heavily regulated. Regardless of the challenges that face DSHEA going forward, the dietary supplement industry isn’t going anywhere and will continue to defend its right to provide helpful and safe products to the American public.
1. Reilley Michelle Dunne, Note, How Much Regulation Can We Swallow? The Ban on Ephedra and How It May Affect Your Access to Dietary Supplements, 31 J. LEGIS. 351, 351-52 (2004-2005).
2. Nutraceutical Corp. v. Crawford, 364 F.Supp. 2d 1310, 1319, 1321 (D. Utah 2005).
3. Nutraceutical Corp. v. Crawford, 459 F.3d 1033, 1043 (10th Cir. 2006).
4. Dietary Supplement and Nonprescription Drug Con- sumer Protection Act, Pub. L. No. 109-462, 120 Stat. 3469 (2006)(codified as amended at 21 U.S.C. § 371).
5. Federal Trade Commission Decisions, Findings, Opin- ions and Orders, January 1, 2011 to June 30, 2011: Vol- ume 151. Available at: www.ftc.gov/os/decisions/docs/ volume151.pdf
This article appeared in the June 2014 issue of The Metropolitan Corporate Counsel. The views and opinions expressed in this article are those of the author and do not necessarily reflect those of Sills Cummis & Gross P.C. Copyright © 2014 Sills Cummis & Gross P.C. All rights reserved