Regulation of dietary supplements

Most American adults report taking vitamins, minerals, or other dietary supplements, but assessments of supplements’ potential benefits and risks are complicated by many scientific and regulatory factors. Although some of these dietary supplements are recommended by doctors for populations at risk of specific nutrient deficiencies, there is little evidence that supplements benefit generally healthy people.

How are supplements regulated?

• Unlike prescription drugs, supplements are not evaluated for approval by the Food and Drug Administration (FDA) and companies are not required to submit safety and efficacy data prior to marketing them.
• Instead, supplements are regulated by the FDA under the Dietary Supplement Health and Education Act, which holds that for all new dietary ingredients introduced after Act took effect in October of 1994, manufacturers must provide information showing why they are “reasonably expected to be safe.”
  • The types of information that can satisfy this requirement are broad and vaguely defined. They include: how much of the new ingredient is present in the product, information about the ordinary conditions of the ingredient’s use, and a history of use or other evidence of the ingredient’s safety.
  • For manufacturers that introduce new supplement products containing “old” ingredients (that is, dietary ingredients that were in the food supply prior to the Act taking effect), these rules do not apply.
• Manufacturers are not required to test new supplements in clinical trials that would reliably identify benefits or risks, including potentially dangerous interactions with other drugs. As a result, advertised benefits are often based on limited and often low-quality evidence.
• By law, supplement companies cannot explicitly claim that their products cure, treat, or prevent disease. Only FDA-approved drugs, which are required to undergo rigorous scientific evaluation, can make such claims.
• Instead, supplement companies can make claims that describe “the role of a substance intended to maintain the structure or function of the body.”
  • For example, a manufacturer can claim that its multivitamin “promotes” or “supports” heart health, even if there is no specific evidence to substantiate that claim, and as long as the statement is accompanied by the following disclaimer: “These statements have not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent any disease.”

How are supplement regulations enforced?

• The FDA has issued guidance to manufacturers describing its expectations for manufacturing practices, but in practice enforcement relies on after-the-fact reporting by consumers, health care providers, or supplement companies when problems arise. On its website, the FDA lists its “Current Good Manufacturing Practice” for dietary supplements as containing nonbinding recommendations, and notes that its “Dietary Supplement Labeling Guide” does “not establish legally enforceable responsibilities.”
• The FDA has the authority to remove supplement products from the market if they are found to be unsafe or if they are found to make false or misleading claims, but it can take years for the FDA to accumulate sufficient data to justify a product recall or ban.
• The FDA received more than 15,000 self-reported descriptions of health problems with suspected links to supplements, including 339 deaths and nearly 4,000 hospitalizations, between 2004 and 2013 .
• The FDA has issued warning letters to companies that promote supplements as “cures” for Alzheimer’s disease, opioid addiction, cancer, and other ailments. However, some products carrying those claims continue to be sold due in part to the ease with which companies can rebrand and update their marketing strategies.
• The Federal Trade Commission (FTC) regulates the advertising of supplements in marketing materials, such as print, broadcast, and online ads, although it generally defers to the judgment of the FDA. The FTC’s standards mandate that ads are truthful and substantiated, but it does not approve ads in advance.