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The Food and Drug Administration lately has been paying increased attention to dietary supplements. On the one hand, it has shown that it takes its enforcement responsibilities seriously. But at the same time, it is demonstrating that it can allow supplement manufacturers and marketers some leeway to make claims about their products that previous policy did not allow. It is important for lawyers to understand the FDA’s current stance in both of these areas. Over the past several years, the Dietary Supplement Health and Education Act of 1994 (DSHEA) has been widely criticized. In the main, this criticism grew out of the FDA’s time-consuming consideration of whether to ban one ingredient, ephedra, from supplements (which it finally did on Feb. 11, 2004). It also stemmed from the growing number of outlandish therapeutic claims to which there was no FDA enforcement response. Dietary supplement trade associations repeatedly called for FDA enforcement, but it was not until Sens. Orrin Hatch (R-Utah) and Tom Harkin (D-Iowa), DSHEA’s original Senate sponsors, obtained $500,000 earmarked for enforcement, that the FDA took action. Having called for fire on its own position, the dietary supplement industry has, for the most part, supported the FDA’s efforts. Through mid-2003, the FDA disclosed that it had brought three criminal actions against dietary supplement distributors. One was against a woman distributing products claiming cures for cancer, arthritis, and heart disease. Another was against a company and its officers for substituting low-priced ingredients for labeled, more-valuable, ingredients. The third was against counterfeiters of branded dietary supplements. Until disclosed in an FDA report, these actions had gone unnoticed within the industry. NEW FUNDING, NEW ENFORCEMENT With new funding for enforcement, however, the FDA has recently increased its efforts. In conjunction with the Federal Trade Commission, the FDA seized products at the headquarters of Seasilver USA Inc., a marketer of an aloe vera-based supplement. The agencies complained that the company promised to treat or cure over 650 diseases. The FDA seized more than $7 million in product, and the FTC obtained a court order appointing a receiver to operate the company. More than 600 employees and contractors were sent home. The company was not up and running again for five weeks. The FDA and the FTC took similarly strong regulatory action against the marketers of coral calcium. This was a product marketed largely through television infomercials hosted by Bob Barefoot. The claims made ranged from pain relief to weight loss. In another joint action, the FDA seized more than $2 million in product, and the FTC sought injunctions against various promoters and vendors. Barefoot has now entered into a consent decree, and the FTC has injunctions against others. The FTC action followed a complaint by a major dietary supplement trade association against the claims made for these products. The FDA also entered into a consent decree with a major dietary supplement manufacturer that resulted in the destruction of $2.7 million in product for which cancer claims had been made. The FDA also assisted the FTC in proceeding against Glen Braswell, whose marketing practices and claims were the subject of a Senate Special Committee on Aging hearing in 2001. Braswell is perhaps best known in Washington as someone who received one of President Bill Clinton’s last-minute pardons. Braswell’s dietary supplement marketing company sold a variety of products making prohibited therapeutic claims. Other recent FDA actions have included seizures and criminal investigations of sex stimulant “supplements” that were actually laced with counterfeit sildenafil or tadalafil, both prescription drug ingredients. The lesson here is that a relatively small amount of congressional funding can go a long way toward turning the “big engine that couldn’t” into the “big engine that can.” The FDA’s enforcement actions were long in coming, but welcomed by consumer groups and industry alike. Since DSHEA became law in 1994, there was concern in the industry that the FDA would not enforce the law and that a few bad actors might drive the industry into the ground. The low point came in 1996 when the owner of a company marking a street-drug knockoff, Herbal Ecstasy, claimed in a cover article in a national news magazine that whenever the FDA publicly criticized his product, sales went up. The FDA repeatedly tried to use its “bully pulpit” to warn consumers about ephedra-containing supplements, to little effect. Indeed, it was not until product liability insurance carriers refused ephedra coverage that manufacturers began to remove this ingredient from their products. As the FDA’s recent actions indicate, enforcement teeth can get similar results. ALLOWING MORE HEALTH CLAIMS In July 2003, while busy acting against unsafe and falsely promoted dietary supplements, the FDA planted a seed of hope for those makers of foods and supplements who long to make more health claims on their products’ labels. It came out with the Consumer Health Information for Better Nutrition initiative, which provided guidance on how to make “qualified” health claims for foods and dietary supplements. A “qualified” health claim is a claim that admits its own deficiencies. For example, a claim such as “Very limited and preliminary scientific research suggests that chocolate may reduce the risk of heart disease,” is a “qualified” claim because of words such as “very limited,” “preliminary,” “suggests,” and “may.” The idea behind a qualified claim is that, while it does not inspire much confidence in its being scientifically correct, it is sufficiently tentative to avoid being false. At its heart, the FDA is a scientific organization. For many years, it did not permit health claims unless the claims were supported by a thick stack of scientific data that would cause even the most skeptical scientist to salute. Now, the FDA says it will permit claims that are supported by only enough data to make them more likely than not to be true. Why has the FDA relaxed its scientific standards? Because it has been uncomfortably reminded by several courts that there is a First Amendment. Freedom of speech, at least in its current incarnation, includes the freedom to make health claims that are more likely than not to be true. As a result, the FDA now has published guidance on how to make these and various other health-related claims on food and dietary supplement labels: • Health claims. These are claims about how consumption of a substance may affect the risk of developing a disease — for example, “phytosterols may reduce the risk of heart disease as part of a diet low in saturated fat and cholesterol.” This type of claim requires prior FDA approval, and must be supported by “significant scientific agreement” — a high scientific standard. • Qualified health claims. These are similar to “health claims” except that the needed scientific support is weaker. When the FDA reviews these claims, it will rank the scientific support into three categories: (1) moderate-to-good, (2) low, and (3) extremely low. It will then require the claim to contain “qualifying” language to convey the level of scientific support. • Structure-function claims. These are claims about how consumption of a substance helps maintain the healthy structure or function of the body. Unlike health claims, these claims must not refer to disease and they do not require pre-approval by the FDA. Thus, for example, the statement “phytosterols may help maintain heart health” is a structure-function claim that does not require FDA pre-approval, whereas the statement “phytosterols may reduce the risk of heart disease” is a health claim that must be pre-approved. • Dietary guidance statements. These statements can refer to the relationship between general categories of foods and disease. Unlike health claims, these claims must not refer to specific foods or substances, and they do not require pre-approval. An example of dietary guidance is the statement “diets rich in fruits and vegetables may reduce the risk of some types of cancer.” This is a still-developing category of claims on which the FDA is expected to provide more information. THROUGH THE OPEN DOOR Notwithstanding this rather simple summary of the FDA’s regulations in this area, the rules for making health-related labeling claims are unfortunately complicated. However, the fact is that the door is now open wider than ever before to tout potential health benefits. So far, companies have been slow to enter. Perhaps they have decided to use claims in advertising (the FTC permits them if they are substantiated) rather than seek FDA clearance to make label claims. Or perhaps they are concerned that the rules will change again; last September, consumer groups sued the FDA in an attempt to squelch qualified health claims. In the long run, however, the trend is clear: So long as health-related information is truthful and not misleading, consumers have a right to receive it. Thus, manufacturers are well-advised to marshal their science and write some useful claims, and consumers are well-advised to read these claims carefully. Anthony L. Young and Daniel R. Dwyer are partners with the D.C. firm of Kleinfeld, Kaplan and Becker. They counsel and represent domestic and foreign manufacturers with respect to laws enforced by the FDA and related federal and state agencies. They can be reached at [email protected] and [email protected], respectively. Their firm represents Seasilver USA in the matter discussed here.

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