FDA Unveils List of Suspected Unlawful Ingredients in Dietary Supplements

Editor's note: This analysis was updated on May 20, 2019, to correct the name of a supplement ingredient that might be unsafe.

The Food and Drug Administration unveiled a new effort last month to protect consumers from potentially unsafe dietary supplements that may contain unlawful ingredients. The Dietary Supplement Ingredient Advisory List, an online tool, alerts the public to chemical compounds that may not meet legal requirements for use in supplements.

Only substances that meet FDA’s definition of dietary ingredients can lawfully be included in supplements. But the process for making final determinations can take time, and consumers may unknowingly consume unlawful ingredients during that process. With the new list, FDA can flag suspect ingredients before a final decision.

Dietary supplements are regulated by FDA as a category of food. Supplement manufacturers—unlike drug companies—do not need to prove that a product is safe and effective before marketing it, but there are rules about which ingredients can be included in supplements.

Qualified ingredients can be vitamins, herbs, botanicals, or amino acids, among other substances. To be considered lawful, older ingredients must have been in the food supply when the law that governs FDA authority over supplements was enacted in October 1994 and they cannot be chemically altered. On the other hand, manufacturers of any product that contains a new dietary ingredient that was not in the food supply at that time must demonstrate a history of use or other evidence that the ingredient “will be reasonably expected to be safe,” according to FDA standards.

Housed on the FDA website, the new list can be used by consumers who do not want to buy dietary supplements containing questionable substances as well as manufacturers eager to avoid including these ingredients in their products. The Council for Responsible Nutrition, a dietary supplement industry group, supports the approach, issuing a statement characterizing the tool “as a clear warning to bad actors in the fringes of our industry—the regulators are coming for you if you attempt to skirt the law.”

Although some ingredients on the list have been shown to be potentially unsafe, such as the stimulant higenamine, the agency says its decision to include an ingredient on the site does not necessarily indicate a safety problem. FDA says it will communicate separately and clearly any time it identifies safety concerns about specific dietary ingredients or supplements, and deploy other enforcement tools, such as safety warnings, when appropriate.

The new list is part of FDA’s ongoing effort to strengthen oversight of supplements and better protect consumers from unsafe products. The agency launched the initiative in February with an announcement that it is considering the most significant changes to its approach to supplements in 25 years. Because the list will be updated regularly, FDA encourages stakeholders to submit information that may support or refute preliminary assessments about various ingredients.

On May 16, the agency will hold a public meeting on how FDA can incentivize “responsible innovation” in the supplement market, the next step in its modernization effort. The Pew Charitable Trusts will be looking at any proposals offered through the lens of how they might affect safety.

In addition to implementing the new advisory list, FDA should continue to support legislation to institute a product listing requirement, under which manufacturers would have to share certain basic information about each product with the agency, such as its name, ingredients, and product label. This information would allow FDA to prioritize how it uses its resources, enabling it to take more effective, risk-based enforcement actions. If a possible safety problem with a dietary ingredient is identified and that ingredient is included on the advisory list, a comprehensive roster of supplements on the market would help FDA quickly identify other products that contain the same ingredient.

Sandra Eskin directs The Pew Charitable Trusts’ safe food project.