FDA Would Like to Increase Regulation of Dietary Supplements But Can it?​
[Thursday, February 14, 2019]

In another flashy news designed to capture headlines, FDA issued Warning Letters simultaneously to 17 companies selling dietary supplements claiming to treat Alzheimer’s disease. In a detailed statement announcing the Letters, the FDA Commissioner listed several efforts FDA has implemented or planning soon to control dietary supplements. These include creation of special groups within FDA such as the Office of Dietary Supplement Programs (ODSP) and the Botanical Safety Consortium, development of rapid-response tools to inform public of bad supplements and increased public interactions to gather ideas for increased regulation of supplements. This is not the first time FDA has issued large number of simultaneous Warning Letters to several defaulters to create greater awareness. All these companies likely did not come about at the same time; so, these events make one think that does FDA knowingly not issue warnings to defaulters till it has amassed a significant number of similar players to create high profile events like this one? Besides creating news, do these events actually help reduce the acts? With more than 50,000 products and $40 billion annual revenue, the supplement industry is very large and diverse mostly unregulated section under FDA’s jurisdiction. Manufacturers do not need to pay any fees or register their products with FDA and can advertise their products mostly unchecked. The kind of FDA actions like today’s affect an infinitesimal small fraction of this industry. Most of these players simply change their names, rebrand their products, and get back in the market almost right away. On top since many of these sellers operate almost exclusively online and use internet-based marketing, they run on very low cost and easily close shop and open new ones. Many manufactures don’t even try to hide much. They even make infomercials that air on late night TV and radio, using celebrities to taut medicinal claims for supplements. There are no blacklists or debarment lists for supplement manufacturers and FDA can only require change in label. With no major punitive actions taken against supplement manufacturers by the FDA; these events appear hollow. FDA is also trying to recruit industry groups to increase self-regulation but that does not deter the manufacturers who clearly intent to break the law. It can be easily argued that manufacturers who were selling treatments for Alzheimer’s likely knew that they are breaking the law but did that anyway. And it also seems likely that FDA knew about them for some time but chose to ignore them till FDA had several similar manufacturers in its sights so it could create a news event. There is at present no political will to create new laws. FDA is doing what it can, basically shine the sunlight on the bad players but that is not enough. Unless laws are changed to give FDA additional rights, these news events will get there15 minutes in the limelight and fade.