Let's Better Regulate the Supplement Industry

 

 

As someone who has been directly involved in both using and selling dietary supplements for over 15 years, I might seem to be an unusual advocate for stricter and more comprehensive government regulation of the industry. But that is exactly the reason that I am.

It is not true that supplements are "unregulated" in the US. The Dietary Supplement Health and Education Act of 1994 (DSHEA) establishes the legal framework under which the FDA has authority to regulate dietary supplements. Under DSHEA manufacturers and distributors of dietary supplements are prohibited from marketing products that are adulterated or misbranded. But there is a catch. These firms are responsible for self-evaluating the safety and labeling of their products before marketing them to ensure that they meet all the requirements of DSHEA and FDA regulations. If they do not, there is no mechanism for the FDA to discover this other than complaints and lawsuits from users of the products. 

Worse, while the FDA is responsible for taking action against any unsafe, adulterated or misbranded dietary supplement product after it reaches the market, manufacturers are not required to prove the safety or efficacy of their products to anyone prior to marketing them. They are required to report any safety issues to the FDA once they "become known".

Finally, the FDAs actual enforcement powers are limited and largely underfunded. The industry is regularly criticized for problems related to poor quality control, safety, misbranding, and adulteration by independent watchdog groups, the very things the Act is supposed to prevent.

Misleading or outright false claims, products that do not contain what their labeling says they do, dangerous ingredients and poor quality are so common they no longer produce surprise or outrage. If and when the FDA does manage to stop a producer from violating minimal safety or truthfulness standards, they simply close down and reopen under a new name.

Here is just one example.

Dr. Joseph Mercola, is an osteopathic physician who claims to want to inspire people to take control of their health. He markets a variety of vitamin and mineral supplements under his own name. Specifically, in the last 2 years, he has been marketing Vitamin C and D, selenium, zinc, melatonin, probiotics and more as preventatives or cures for Covid-19 infection. He has even advised people to purposely contract Covid after taking his supplements to "safely build their immunity" to the virus.

The FDA took no action until it received multiple complaints, after which it required him only to cease marketing his products as a cure for Covid-19. They are still available, and now he is claiming to be the victim of a massive conspiracy by Bill Gates and other millionaires to suppress his work. Sadly this is not an isolated+ example.

All of this creates an environment of suspicion and lack of trust that penalizes those manufacturers who do follow the rules, maintain high quality standards, guarantee their products and avoid making false, unsubstantiated claims. Quality is not cheap, so they may also find themselves at a disadvantage in a marketplace where uninformed people often shop by price alone.

Americans are entitled to know that what they buy is what they are getting, that it is safe to use and that it will do what they are told it will do. Better regulation and better enforcement would benefit not only consumers but reputable companies as well.