FDA’s Action-Inaction About Unapproved Drugs
[Posted on: Thursday, April 27, 2017] This week FDA announced that it sent Warning Letters to 14 manufacturers of about 65 dietary supplements making claims to treat cancer. One wonders what triggered this event and why did it take this long as obviously these companies did not spring up overnight. FDA’s news release about this event painted a rather innocent picture; “FDA’s reviewers in the Center for Nutrition and CDER got together with the investigators in the Office of Regulatory Affairs” between Dec 2016 and March 2017, and started searching the internet for products promoting cancer treatments. Why only cancer and why this time, is not clear. But not surprisingly they found several websites promoting dietary supplements for use in the treatment of cancer among many other things. And that lead to the Warning Letters. A review of the websites of all 14 companies listed on FDA’s announcement shows that all of them modified the claims offending to FDA from their website while the products were still available. One website even had a large banner, “FDA Approved” displayed prominently; and that is after the Warning Letter from FDA. Also there are other products on the same websites claiming other potential drug-like benefits in diseases such as sexual health, liver, prostate, arthritis, etc. And a search on the internet shows hundreds of websites promoting dietary supplements for practically all diseases. The dietary supplement industry has grown from a few million dollars per year to about $30 billion with more than 90,000 products in the last two decades and is expected to grow even more in the next decade. Products range from vitamins to sports drinks, purified from natural sources to synthetic molecules, animal and plant products, traditional medicine products, and everything in between. Frequently products that would be considered as drugs in other countries are brought into the US as dietary supplements and traditional food. Under US laws, dietary supplements do not need approval or even registration with FDA to be in the market. Supplements are available at more than 35,000 stores which number could be larger since even grocery stores carry these products. The online stores are the main source for uncommon supplements and those with dubious claims. And once found by FDA, all the manufacture needs to do is revise some verbiage on the labels and websites, or just reopen the shop in another name and restart the process. FDA is literally playing game of “Whack-A-Mole” with the supplement industry. No doubt that many dietary supplements play an important role in the nutritional management of consumers but there are also way too many products of the kind FDA warned about this week. There is no credible database of safety or futility issues related to supplements. So, these Warning Letters and news releases may sound good but they are barely the tip of the iceberg.
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