The Food and Drug Administration (FDA) is the federal agency that oversees both supplements and drugs, but the regulations for dietary supplements are different from those for prescription or over-the-counter drugs. Drugs must be approved by the FDA before they can be sold or marketed, while dietary supplements are regulated by the FDA as foods, not as drugs. However, many dietary supplements contain ingredients that have strong biological effects that may conflict with a medication you are taking or with a medical condition you may have. Products that contain hidden drugs are also sometimes falsely marketed as dietary supplements, putting consumers at even greater risk.
For these reasons, it's important to consult with a health professional before using any dietary supplement. The Dietary Supplement Health and Education Act of 1994 (DSHEA) is the primary law that regulates the dietary supplement industry in the United States. Four out of five American adults report consuming dietary supplements, including vitamins, minerals, herbs and amino acids. However, due to significant loopholes in this outdated law, the FDA is unable to effectively and efficiently protect public health.
Two key issues that need to be addressed are the FDA's inability to know what supplements are on the market and its inability to require the recall of supplements containing pharmacological ingredients. Part of the challenge is that the FDA relies heavily on post-marketing approaches (once the product is publicly available), such as Internet searches for illegal marketing claims, inspections of manufacturing facilities, and consumer or business reports, to identify products that may be causing harm. However, these tools provide a limited view of up to 80,000 products on the supplement market. This lack of basic market information makes the United States an outlier among higher-income countries; all regulatory agencies in Canada, Australia, China, and Europe have some kind of central registration or listing requirement for dietary supplements.
A mandatory requirement on the product list is a low-cost solution that would ensure that the FDA has the information it needs to properly monitor the supplement market. The vast majority of American adults (95%) support this requirement, and the agency has requested this authorization in multiple budget requests. While the FDA may require the recall of dietary supplements from the market, this authority does not extend to drugs, which must be voluntarily recalled by the manufacturer. In cases where a supplement is contaminated with a drug ingredient, a loophole in the law makes the agency's recall authority unclear.
These limitations raise serious questions about whether the FDA can take effective action when problems arise with supplements, especially if a company refuses to recall its products voluntarily. Taken together, the inclusion of products in the product list and clear recall authorization would greatly improve the FDA's oversight of supplements by providing it with critical information about products on the market and ensuring it can act quickly when it knows a product poses a public health risk. The FDA should have authority to know what supplement products are on the market. Under DSHEA terms, supplements with established ingredients (i.e., those that were sold in the United States before 1999) can be marketed without any evidence that they are effective or safe.
The main mechanism for monitoring safety of supplements is a voluntary reporting system established by the FDA Center for Food Safety and Applied Nutrition called CAERS. In addition, for new supplement ingredients DSHEA requires manufacturers to submit evidence to the FDA that a new ingredient must be safe. It's important to understand how dietary supplements are regulated in order to ensure safety when consuming them. Consult with a health professional before using any dietary supplement and read consumer updates for more information.
