Does FDA Need a Dietary Supplement User Fee Act?

By Elizabeth Guo

Dietary supplements are dominating headlines these days – and not in a good way. Last Wednesday, Nevada officials found basketball star Lamar Odom unconscious at a brothel after taking cocaine along with ten pills of Reload, a sexual enhancement dietary supplement. That same week, the New England Journal of Medicine released an article finding that dietary supplements lead to roughly 23,000 emergency visits a year. Following these events, some officials have called on the Food and Drug Administration (FDA) to take a stronger role in regulating the dietary supplement industry.

Dietary supplements have had a long and storied past. As early as 1973, FDA tried to regulate dietary supplements regarding vitamin and mineral potency. The dietary supplement industry responded by challenging FDA in court, and Congress subsequently enacted the Proxmire Amendment, limiting FDA’s authority to regulate dietary supplements. However, by the 1990s, as consumers increasingly began to rely on dietary supplements, Congress passed the Dietary Supplement Health and Education Act of 1994, expanding FDA’s authority to regulate supplements by enacting special rules related to dietary supplement labeling and manufacturing.

Currently, FDA regulates dietary supplements as a special category of foods. Unlike manufacturers of over-the-counter drugs, dietary supplement manufacturers do not need to be registered with FDA and do not need list possible adverse events on supplement labeling. As Joanna Sax points out, this is a major problem because not all dietary supplements are the same. For example, certain weight loss or sexual enhancement supplements often contain chemicals associated with potentially serious side effects while other supplements containing chemicals such as Vitamin C pose less serious safety concerns.

Last week’s events illustrate that dietary supplements can pose a significant threat to public health, but to what extent should we hold FDA responsible? Some experts have blamed the events on a “lack of regulatory action,” stating “the FDA is simply not doing their job.” Others believe these adverse events stem from FDA’s limited statutory authority. In 2013, Senators Dick Durbin (D-Ill.) and Richard Blumenthal (D-Conn.) introduced the Dietary Supplement Labeling Act of 2013, which would require companies to register their products with FDA and would implement new mandatory warning requirements for some supplements. More recently, fourteen Attorney Generals sent a letter asking Congress to give FDA greater oversight over herbal supplements.

New regulatory oversight would be a good start, but needs to be paired with enough funding for FDA to tackle these new dietary supplement challenges. The dietary supplement industry has grown from a $5.8 billion to a $35 billion dollar industry in twenty years, but FDA appropriations have not kept up. Out of an estimated 85,000 supplement products on the market in 2013, FDA was budgeted to run just 1,000 tests per year.

FDA should receive more funding to regulate the booming dietary supplement industry. One potential solution would be for Congress to enact a dietary supplement user fee scheme. Under the scheme, dietary supplement manufacturers would pay an annual fee for FDA to monitor adverse events and test potentially problematic supplement products. A user fee scheme could ensure that FDA can carry out its regulatory functions without needing to rely solely on Congressional appropriations. User fee schemes have their own drawbacks, but the schemes have been remarkably effective. In fact, user fees have been so effective that a user fee scheme exists for every FDA-regulated product except for foods.

It’s about time that Congress gives FDA the authority and funding needed to fulfill its public health role. The dietary supplement headlines this last week show that the dietary supplement industry is getting more complicated. FDA needs new tools to ensure that its regulatory scheme can encourage the growth of the dietary supplement industry while protecting consumers from the industry’s potential harms.

cguo

cguo

2015-2016 Peter Barton Hutt Student Fellow During her fellowship year, Elizabeth Guo was a third year student in the JD/MPH Program at Harvard Law School and the Harvard School of Public Health. Her interests lie at the intersection of law, health care reimbursement, and biopharmaceutical regulation. Elizabeth graduated from Harvard University with a BA in social studies, focusing on the bioethics of assisted reproduction in China. Prior to law school, she was a senior associate at Avalere Health working with life science clients on a range of health policy topics, including Medicare coverage and reimbursement, biosimilar regulation, and healthcare quality programs. Elizabeth served as a student editor of the Journal of Law and Technology and a member of the Mississippi Delta Project’s Delta Project’s Food Policy Initiative. Elizabeth's fellowship paper was entitled: "Reputation and Judicial Deference: An Examination of FDA’s Reputation and Judicial Deference to Agency Action."

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