The U.S. Food and Drug Administration said it sent warning letters to 11 companies for marketing dietary supplements that don’t meet its guidelines.
The agency issued warnings to three companies for marketing dietary supplements containing phenibut, which is sometimes sold as a sleep aid or to treat anxiety. It said that phenibut doesn’t meet the statutory definition of a dietary ingredient, which is generally a vitamin, herb or other natural substance used to supplement the diet.
A Wall Street Journal article last week on the $40 billion supplement industry said that phenibut, developed as a drug in the former Soviet Union, was being marketed as a “nootropic,” or brain supplement, in the U.S. A spokeswoman for the FDA said that the agency was already investigating phenibut.
The FDA also issued warnings to eight companies for marketing dietary supplements containing DMHA, a stimulant sometimes found in exercise and weight-loss supplements. The companies have 15 business days to inform the FDA of steps they will take to bring their products into compliance. That could include a decision to recall, reformulate or discontinue sales.
Supplements aren’t tightly regulated by the FDA like prescription drugs. Dietary-supplement manufacturers don’t need approval from the FDA before introducing their products to the market. The FDA has oversight for taking action against any misbranded supplement after it reaches the market.
The FDA said it is launching a new online tool to help warn consumers of ingredients that appear to be unlawfully marketed in supplements. The agency said the Dietary Supplement Ingredient Advisory List will help get cautionary information to the public more quickly before it issues any final determination. It is on the FDA website, and consumers can also sign up to receive updates and changes to the list.
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