Exaggerated claims about medical products date from the days of snake oil. But the Food and Drug Administration's (FDA) new crackdown on unproven over-the-counter treatments for STDs carries a particularly urgent thrust.
The FDA and Federal Trade Commission (FTC) have announced a joint effort to ban non-prescription products purporting to treat, cure and prevent STDs. That means companies selling such products have 15 days to respond to the agencies' written allegations that specific products are drugs subject to FDA regulation.
If the FDA determines any product is a drug and not a dietary supplement, the drug must be subject to rigorous scientific testing before it can be sold in the U.S.
And if the FTC determines that advertising contains false claims, the agency can order products off the market.
Here's a list of the products FDA has targeted.
The FDA warns the listed products are dangerous, since "they are targeted to patients with serious conditions, where treatment options proven to be safe and effective are available," said Deborah M. Autor of FDA's Center for Drug Evaluation and Research.
And the FDA warns such products are simply ineffective. "Consumers should be aware that there are no over-the-counter or online drugs or dietary supplements available to treat or prevent STDs."
The FTC has focused on the illegality of making false claims in product advertising. “Advertising health benefits that are not supported by rigorous scientific evidence violates the FTC Act,” said David Vladeck, director of the FTC’s Bureau of Consumer Protection.
The companies' failure to respond to the FDA's 15-day deadline can result in legal action, product seizures, or even criminal prosecutions. FDA's complaint line can be reached at 800-FDA-1088.
Related Resources:
- Feds take action against bogus STD cures (Associated Press)
- Protecting Consumer Safety Must Remain Top Priority in Drug Regulation (Findlaw)
- Drugs and Medical Device Recalls (Findlaw)