Monday, January 20, 2014
FTC takes over for FDA
Or maybe this should be titled, “The FTC goes where the FDA cannot.” This month the Federal Trade Commission announced penalties and refunds levied against several companies selling diet aids for false advertising. They claimed that there was insufficient scientific proof that these products, including Sensa, L’Occitane skin cream and HCG Diet Direct actually benefited consumers in terms of weight loss. The implication is that in order to advertise health benefits for “supplements” or any other commodity, the sponsor would have to demonstrate “scientific proof” of efficacy. The question is, what constitutes scientific proof? Does it have to be randomized double blind trials as the FDA requires. The answer may be a resounding “yes!”
If all of this is true, then how come these products are not regulated by the FDA who actually have the expertise to evaluate whether or not they have achieved proof of efficacy or not? Well, because these products are not considered drugs and therefore, according to congress and the laws of the land, do not fall under the aegis of the FDA even if they claim drug like properties or effects from such products. Personally, I think any product making a health claim should fall under the FDA for approval to market based on such claims. Under the Dietary Supplement Health and Education Act (DSHEA) of 1994, the sponsor is responsible for ensuring that the product is safe prior to marketing. Apparently, there is no requirement that the product actually provide any benefit whatsoever. The FDA can only intervene if there is reason to believe that the product is unsafe after it has been placed on the market. Does anyone (besides supplement manufacturers) believe that this makes any sense at all? It is clear that the majority of the time being spent by the FDA office of investigation is focused on bogus and unsafe supplements with undeclared additives, unlabeled ingredients and other problems all putting the health of Americans at risk.
Why do I, an infectious diseases physician, care about this topic? Just do a Google search on the term antibacterial supplements and you will see. There are myriad products out there from garlic to grape seeds to St. John’s Wort that are claimed to provide beneficial effects for infections sometimes when applied topically – but more importantly, when ingested. The data to support these claims, for the most part, do not come up to any standard of proof recognized by any sophisticated physician or scientist. For bacterial infections in particular, the ingestion of these so called cures could delay appropriate antibiotic therapy and lead to more severe illness and even death. But these claims are being allowed to stand as is on the internet, in newspapers and in health food stores.
It is time for congress either to give the FDA the power to protect us from these patently false claims of effectiveness or for the FTC to come to our rescue and prevent these manufacturers from continuing to bamboozle the American public. This is a potentially dangerous practice that should be stopped immediately.
What is wrong with us?