FDA Increasing Regulation on Dietary Supplements

It doesn't come as a surprise to hear that the FDA (Food and Drug Administration) plans to increase their regulation of the dietary supplement market. What is a surprise is that it took this long.

The dietary supplement industry is regulated by the FDA, just not in the same way as prescription drugs and over-the-counter medicines. The FDA doesn't review and approve if the supplement works or if it is safe. That is, unless there is a reason to step in and review (i.e. illness, death, etc). This may all change now.

On Monday, February 11, 2019, the FDA Commissioner Scott Gottlieb, M.D. made a statement in which the FDA is planning a new policy with the "goal of implementing one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years."

The Dietary Supplement Health and Education Act of 1994 ("DSHEA") is really the only form of policy on the dietary supplement industry. That was 25-years ago. Back when this policy was signed, the dietary supplement industry was valued at approximately $4 billion with 4,000 unique properties. In today's world, the dietary supplement industry is worth north of $40 billion and comprised of over 80,000 products.

DSHEA imposes a number of requirements around the manufacture and labeling of dietary supplements. We know that most players in this industry act responsibly. But there are opportunities for bad actors to exploit the halo created by quality work of legitimate manufacturers to instead distribute and sell dangerous products that put consumers at risk. As the popularity of supplements has grown, so have the number of entities marketing potentially dangerous products or making unproven or misleading claims about the health benefits they may deliver. - Commissioner Scott Gottlieb

The new plans set forth by the FDA contains several steps. First, the FDA will communicate to the public as soon as possible when there is a concern about a dietary supplement on the market. Second, ensuring that the regulatory framework is flexible enough to adequately evaluate product safety while also promoting innovation. Third, continue to work closely with our industry partners, developing new enforcement strategies. Fourth, continue to take action to protect public health. Finally, continuing to engage in a public dialogue to get valuable feedback from dietary supplement stakeholders.

The FDA didn't waste any time enforcing their new found vision on dietary supplements. The FDA sent out 12 warning letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer.

Commissioner Scott Gottlieb stated that the FDA has three priorities:

1. Ensuring the safety of all consumers
2. Maintaining product integrity (ensure that dietary supplements contain the ingredients that they’re labeled to contain, and nothing else, and that those products are consistently manufactured according to quality standards.)
3. Informed decision-making (foster an environment where consumers and health care professionals are able to make informed decisions before recommending, purchasing or using dietary supplements.)

This is just the beginning. It sounds like the FDA will continue to take steps to regulate the industry to a much greater attention to detail. More to come...

Fitness Informant's POV

Honestly I am shocked it took this long. For the longest time nothing would happen unless someone got really sick. Then they would send their warning letters and the products would be removed after the fact. I am all about government staying out of our lives as much as possible, but in the case where companies are making products in a bathtub (literally some do) or non-approved facilities, it can be dangerous for the consumer. You don't know what you're getting in that bottle unless it is tested and ran in an approved facility.

I really enjoyed his last priority: informed decision-making. That's what we are all about. That's why FI exists. We are here to help you make an informed decision. Be Informed. Live Fit.

It will be interesting to see how this all unfolds, but I know the pace at which these things move. They may have made this statement this week, but it could take many years for them to catch-up to where the supplement industry is today. We will bring Mark Glazier back to the podcast to discuss this as he's spent time on capital hill discussing this.