regulations

The FDA is Reforming their Role in Dietary Supplement Oversight.. Finally!

Last week, the Food and Drug Administration (FDA) announced that it plans to overhaul regulations for the $50 billion a year dietary supplement industry. The FDA is planning much needed updates to the Dietary Supplement Health and Education Act (DSHEA) which passed in 1994. Alongside this announcement, the FDA sent advisory and warning letters to supplement companies that were selling products with illegal claims or that contained unapproved drugs. Some companies that received the advisory and warning letters were claiming that their products prevented, treated or cured Alzheimer’s disease and a number of other serious diseases and health conditions. According to the press release, “three out of every four American consumers take a dietary supplement on a regular basis”. The overhaul of the 25-year-old Act is music to this public health dietitian’s ears!

If you’re not familiar with the regulations surrounding the giant supplement industry, let me give you a quick introduction. Unlike medications or drugs, supplements are not required to undergo pre-market approval before being sold. The FDA leaves it up to supplement manufacturers to evaluate their own labeling and safeness of their products to make sure they meet regulations. It isn’t until AFTER the supplements have hit the market that the FDA steps in and then can take action against any “adulterated or misbranded dietary supplement”. Essentially the FDA’s current role for supplements, is to remove unsafe supplements from the market but this could occur years after the supplement was sold to an unknown number of consumers and could have caused adverse effects. Seems a little backwards, right?!

The FDA is finally stepping in and Commissioner Scott Gottlieb outlined three priorities as part of his statement. The first priority he outlines is safety and ensuring consumers are protected from harmful products. The second is product integrity and ensuring they contain only the ingredients listed and that they are “manufactured according to quality standards”. The third priority is informed decision-making among consumers and health care professionals.

I look forward to seeing more details unfold around this announcement and I truly hope that this will deter supplement companies from making false or misleading claims. I assume that the FDA’s Office of Dietary Supplement Programs, which was only created three years ago, will be integral throughout this process. In the press release and statement, the FDA has made it clear that they do not want to hinder innovation but they also are very aware of the problems that exist within the supplement industry. In a perfect world (ha!), supplements would go through the same approval as medications or drugs, and would not be allowed to be sold to consumers without some type of approval process but I’m not sure these regulatory changes will go that far. It would also be ideal to address the source of information and ensure that individuals or companies selling supplements are qualified to do so. I hope that the FDA will closely look at multi-level marketing companies selling supplements and products as well. Until we learn more about what this update/overhaul entails, I’ll continue to push back on supplements that claim to help someone lose 10 pounds in 2 days or promote “fat burning” keto coffee.