FDA

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.

Romaine Calm: Responding to Food Recalls

It seems as though every week we are learning about a new food recall. Most recently, we were alerted to an E. coli contamination in romaine lettuce and salmonella in ground beef. Due to these recalls, TONS of romaine lettuce and ground beef will be tossed in the trash. Most recently, it was reported that more than 12 MILLION pounds of ground beef are being recalled. So, what can we as consumers do to ensure we are eating food that won’t make us sick, without contributing to our already astounding food waste problem and continuing to support farmers?

The increasing use of technology can greatly improve how we handle food recalls. In October, I attended a conference where the then Vice President of Food Safety at Walmart, Frank Yiannis, now Deputy Commissioner of Food Policy and Response at the Food and Drug Administration, spoke about how Walmart is working with IBM to implement blockchain technology to track the source of food. This was fascinating to me as he described the process that usually takes days and often weeks to determine the source of recalled food, now only took seconds or minutes. This is not only a win for consumers but also for farmers and stores like Walmart. In the recent romaine recall, consumers were told to throw away ALL romaine lettuce and to not purchase or consume it. Shortly after that, we then learned that the contaminated lettuce was from certain areas in California. If we would have had this information sooner, we could have avoided throwing away tons of perfectly good produce!

As consumers, we also have the buying power to choose where we purchase our food, including produce and meats like ground beef. If we are purchasing directly from local farmers, we have more confidence in knowing where the food was grown, their growing practices, and whether it is safe. We also need to be more mindful in sharing information about food recalls on social media. Often, I will see an article shared about a food recall that isn’t recent. Spreading this misinformation is harmful to both producers and consumers.

Food recalls happen, but hopefully with the use of technology, we can continue to more quickly and effectively identify the region or area of contaminated food. By purchasing locally, directly from the farmers, we can also be more confident in knowing their growing practices and whether the food we purchased is part of a food recall.