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FDA Takes Action Against Fraudulent OTC Products
Food and Drug Administration (FDA), in partnership with the Federal Trade Commission, has taken action against over-the-counter (OTC) products marketed as treatments, cures, and for prevention of sexually transmitted diseases (STDs). The agencies have sent letters to companies making such products, warning that they are in violation of both the Federal Food, Drug, and Cosmetic Act (FD&C Act) and the Federal Trade Commission Act by selling unapproved products claimed to treat diseases and by making unsupported treatment claims about the products. The companies have 15 days to notify FDA of how they are correcting the violations cited, and failure to do so may result in legal action. FDA notes in a press release the importance of educating consumers that there are no OTC drugs or dietary supplements available to treat or prevent STDs. Consumers should be aware that there are many FDA-approved medications available for treating STDs, but they do require a prescription under the supervision of a health care provider.
In Texas, FDA is partnering with the state’s Department of State Health Services (DSHS) to investigate the origin, distribution, labeling, and advertising of OTC products being marketed as antibiotics. The products are sold as dietary supplements under names such as amoxilina, pentrexcilina, ampitrexyl, citricillin, amoximiel, and pentreximil, and the product labeling falsely claims that the products are prescription antibiotics. The products do not appear to have any active drug ingredients and are not approved to treat medical conditions. DSHS officials are concerned that people using the products will falsely believe the products provide the same treatment effects of a prescription antibiotic. More information about the investigation is available in a Texas DSHS press release.
