Five firms swept up in FDA/FTC fertility claims enforcement action
The enforcement action was announced yesterday. Warning letters were sent to the following five companies:
“not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner.”
Range of disease/conditions mentioned
Among the diseases or conditions that the five companies were allegedly claiming to treat are:
Amenorrhea
Apis mellifica (a homeopathic remedy derived from honey bees), ashwagandha, CoQ10
Viburnum opulus (rose) Dietary supplements that claim to cure, treat or prevent infertility and other reproductive health conditions can potentially harm consumers who use these products instead of seeking effective treatments, such as FDA-approved drugs or assisted reproductive technology,” said Judy McMeekin, Pharm.D., FDA’s Associate Commissioner for Regulatory Affairs.
FDA, FTC Warn Five Companies Illegally Selling Dietary Supplements Claiming to Treat Infertility
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SILVER SPRING, Md., May 27, 2021 /PRNewswire/ Today, the U.S. Food and Drug Administration and the Federal Trade Commission issued warning letters to five companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent infertility and other reproductive health disorders in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The warning letters were issued to: LeRoche Benicoeur/ConceiveEasy; EU Natural Inc.; Fertility Nutraceuticals LLC; SAL NATURE LLC/FertilHerb; and NS Products, Inc.
FDA, FTC target infertility supplements More than a year after being asked by a consumer advocacy group to take enforcement action against manufacturers of fertility supplements, FDA and FTC warned five companies in letters that their products are intended to treat diseases.
U.S. regulators on Wednesday announced sending warning letters to five companies for making unlawful claims that their dietary supplements cure, treat, mitigate or prevent infertility and other reproductive health disorders.
Such products intended to treat disease are considered drugs under the Federal Food, Drug & Cosmetic Act, even if they are labeled as dietary supplements, according to an FDA news release announcing the warning letters.
The Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) announced Wednesday that they sent warning letters to five companies accusing them of illegally selling dietary supplements that allegedly treat infertility and reproductive health disorders. The agencies issued the cautionary letters to the companies last week, saying that they violated federal laws by selling their products without FDA approval and by advertising.
FDA, FTC warn five companies over supplements sold to treat infertility, reproductive disorders thehill.com - get the latest breaking news, showbiz & celebrity photos, sport news & rumours, viral videos and top stories from thehill.com Daily Mail and Mail on Sunday newspapers.