Earlier this week, in cooperation with the Food and Drug Administration, the Federal Trade Commission circulated a consumer-focused reminder regarding dietary supplements.
“Dietary supplements may seem like harmless health boosters. But while some have proven benefits, many don’t. Unlike drugs, dietary supplements aren’t evaluated or reviewed by FDA for safety and effectiveness, and even “natural” supplements can be risky depending on the medicines you take or the medical conditions you have. In recent years, hundreds of supplements also have been found to be tainted with drugs and other chemicals. Always talk to your doctor before you take a new supplement, and avoid any supplement claiming it’s a “cure.”
Dietary supplements include vitamins and minerals, amino acids, enzymes, herbs, animal extracts and probiotics. They can take numerous forms (e.g., capsules, liquids and powders). However, dietary supplements are not “drugs,” and do not undergo FDA review for safety and effectiveness prior to sale.
The Commission cautions that dietary supplements may not always be safe or harmless. In fact, even “natural” supplements can be risky for those that are taking certain medications or that possess certain medication conditions. According to the Commission, some supplements have been found to be tainted with drugs or other chemicals.
The FDA has discovered hundreds of “dietary supplements” containing drugs or other chemicals, particularly in products for weight loss, sexual enhancement or bodybuilding. The “extra ingredients” are not typically listed on the label but could potentially result in serious side effects or interact in dangerous ways with medicines or other supplements being taken.
Tainted supplements often are sold with deceptive claims, such as “100% natural” and “safe.”
Marketers should avoid misleading trigger terms and related claims, such as alternatives to FDA-approved drugs, effects similar to prescription drugs, legal alternatives to anabolic steroids, and rapid effects or results.
Even “traditional remedies” with a long history of use are not guaranteed to be safe in all cases.
Substances for which safety concerns have been raised include comfrey, chaparral, lobelia, germander, aristolochia, ephedra (ma huang), L-tryptophan, germanium, magnolia-stephania and stimulant laxative ingredients (like those found in dieter’s teas).
According to the Commission, comfrey, for example, contains certain alkaloids that can cause serious liver damage, and aristolochia can cause kidney failure.
Additionally, certain vitamins and minerals, when taken in inappropriate amounts, can potentially cause problems. For example, according to the National Academy of Sciences, too much vitamin A can reduce bone mineral density, cause birth defects, and lead to liver damage.
Promises for a quick cure or solution for a serious health problem will always draw the FTC’s ire. Pursuant to federal law, dietary supplements cannot be promoted for the treatment of a disease because they are not proven to be safe and effective.
Increased regulatory attention will also result from claims that a product cures a wide variety of health problems, suggestions a product can treat or cure diseases, words like scientific breakthrough or secret ingredient, misleading use of scientific-sounding terms, undocumented testimonials by patients or doctors claiming miraculous results, and representations of limited availability and a need to pay in advance.
Lastly, dietary supplements often include claims about the effect of a substance on maintaining the body’s normal structure or function (e.g., “Product X promotes healthy joints and bones”). Such claims must include the disclaimer: “This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent disease.”
Contact an experienced FTC defense lawyer to discuss dietary supplement marketing compliance considerations for affiliate advertisers.
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ADVERTISING MATERIAL. These materials are provided for informational purposes only and are not to be considered legal advice, nor do they create a lawyer-client relationship. No person should act or rely on any information in this article without seeking the advice of an attorney. Information on previous case results does not guarantee a similar future result. Hinch Newman LLP | 40 Wall St., 35thFloor, New York, NY 10005 | (212) 756-8777.