A loophole could enable manufacturers of alternative medicines to sell their products without having to back them up, federal regulators charge.
The Federal Trade Commission wants the Food and Drug Administration to overhaul regulations of homeopathic medicines because of problems with bogus health claims. Homeopathic drugs have been around for more than 200 years, but scientists have found no reliable evidence that they work.
The FDA does not evaluate homeopathic drugs for approval, and therein lies the problem.
Any health claims made by an advertiser must be backed up by evidence, but the FDA’s regulations may have inadvertently created a loophole to that requirement, the FTC charged Friday in comments to the FDA.
In exchange for bypassing the FDA drug approval process, over-the-counter homeopathic drugs can be sold if they satisfy certain conditions, like including an indication for use on the product label.
The FDA does not, however, require sellers have “competent and reliable scientific evidence to support the indication for use,” the FTC said.
That is the problem. The FTC has a long-standing policy that says all health claims made in an advertisement must be substantiated.
The agency is concerned that the FDA’s current rules could lead some companies to skirt more stringent regulations for over-the-counter drugs or dietary supplements simply by labeling them as homeopathic.
FDA’s regulation has been in place since 1988, but the agency is thinking about changing it. It wants comments from the industry and other interested parties, and it held a public meeting earlier this year.
Homeopathy is based on the unconventional theory that taking a tiny dose of whatever makes you sick can make you better.
Homeopathic products are available through a pharmacist or over the counter as creams, lotions or pills.
The effectiveness of homeopathy hasn’t been entirely proven by science. A recent analysis of more than 170 studies didn’t find any reliable evidence that homeopathy is effective.
