The U.S. Food and Drug Administration (“FDA”) regulates dietary supplements as food, not as drugs. In general, dietary supplements are taken orally and contain a dietary ingredient such as a vitamin, mineral, amino acid, herb, botanical, or other substance used to supplement the diet. The FDA warns consumers that dietary supplements may be harmful, may contain hidden or deceptively-labeled ingredients, and are not intended to treat, diagnose, cure, or alleviate the effects of any disease. In fact, the FDA has recalled numerous products containing potentially harmful ingredients.
Although federal law requires that dietary supplements be labeled as such (either as a “dietary supplement” or with “[ingredient description] supplement”) and that products be labeled correctly and advertised fairly, the FDA does not pre-approve dietary supplements or require that they be proven safe before they are marketed and sold. Nor does the Federal Trade Commission (“FTC”) pre-approve any advertising related to dietary supplements. As a result, there is no requirement that manufacturers/sellers prove that their products are safe or that all advertising claims are accurate before they market or sell the products. Instead, it is the company’s responsibility to ensure product safety and truthful advertising, and the FDA and FTC only get involved after such products have already entered the market—with the FDA regulating safety issues and the FTC regulating advertising issues.
To bolster its ability to regulate such safety issues, the FDA requires that sellers of dietary supplements report any serious adverse events reported by consumers or health care professionals within 15 days of receipt and that the FDA monitor and investigate those reports. Likewise, the FDA monitors and investigates any adverse event voluntarily reported by consumers or health care professionals and encourages such voluntary reports to be made directly to the FDA as soon as possible.
As always, manufacturers/sellers of dietary supplements should make sure that their products are safe, properly labeled, and advertised truthfully. In addition, companies should make sure to report any serious adverse events to the FDA within the required time frame.