Last week the Food and Drug Administration (“FDA”) announced the results of a year-long investigation of dietary supplements, which resulted in civil injunctions and criminal actions against 117 manufacturers and/or distributors of “tainted products falsely marketed as dietary supplements.” See FDA press release.
To provide a brief history, Congress first defined the term “dietary supplement” in its 1994 Dietary Supplement Health and Education Act (DSHEA) as a product taken by mouth that contains a dietary ingredient intended to supplement the diet. This characterization placed dietary supplements under the regulatory umbrella of foods and not drugs. As a practical matter, dietary supplements face laxer regulatory standards compared to their prescription counterparts. For example, unlike with prescription drugs, no prerequisites based on efficacy or safety exist for dietary supplements prior to their entry in the marketplace.
Largely because of the lax regulatory scheme and limited enforcement powers of the FDA, adulterated, misbranded and mislabeled dietary supplements have made their way to market. The FDA has attempted to control the problems plaguing the dietary supplement industry for decades. For example, in December 2010, the FDA sent a letter to manufacturers expressing “concern about undeclared or deceptively labeled ingredients in products marketed as dietary supplements.” See press release. However, five years ago, the FDA placed the onus on manufacturers and distributors to police themselves and “ensure that their products compl[ied] with the law.” Id. In other words, self-police and self-report.
Last week, the FDA supplemented (pun intended) its own limited enforcement powers by joining forces with the U.S. Department of Justice, the Internal Revenue Service’s Criminal Investigation Division, the Federal Trade Commission, the U.S. Postal Inspection Service, the Department of Defense and the U.S. Anti-Doping Agency to take action against alleged violators. See FDA press release. The synchronized operation resulted in arrests, seizure of investment accounts, real estate and even luxury cars. In addition, the FDA has issued warnings for more than 100 products found to contain hidden active ingredients, which could lead to additional recalls of dietary supplements.
According to the Washington Post, sales of dietary supplements in 2013 reached $13 billion. See article. According to one study examining reasons for use, it was reported that more than half of American adults use some form of dietary supplements. See study. The most common supplements fall into three categories: (1) body-building agents; (2) weight-loss aids; and (3) sexual enhancers.
From a products liability perspective, increased popularity and use often translates to inflated numbers of consumers that are eligible to join class actions or bring individual civil lawsuits in the wake of a major recall or government investigation. Thus, as consumers become more aware of the health risks associated with some dietary supplements, they may opt to renew gym memberships instead of refilling dietary pill bottles—and file a lawsuit or two. At the Monitor, we will keep a close eye on this developing area of the law.