The crusade against...supplements?

Beware of an even more deregulated industry

“The wellness and fitness industry is excited about a reversal of FDA’s 40-year crusade against dietary supplements.”

This statement comes from lawyer and supplements fan Rick Collins, discussing RFK Jr’s nomination to head the Department of Health and Human Services. An interesting sentiment given how loosely regulated supplements already are in America.

In general, the most regulatory teeth the FDA displays is sending warning letters to companies selling adulterated products—and it’s often the agency’s testing that discovers this faux pas. While the agency has the power to remove unsafe products from shelves, it’s a rare occurrence.

Here are a few examples of actual oversight:

• Since 2004, the FDA has pulled more than two dozen products marketed as "natural supplements" for erectile dysfunction off the shelves. This is due to them containing sildenafil (or a chemical cousin of it). Sildenafil is the active ingredient in Viagra, an FDA-regulated drug. Clinical testing is not required for supplements, but they also cannot sell products that are regulated as pharmaceuticals.

• In 2015, the agency issued warning letters to 14 companies regarding 17 products labeled as containing DMBA—adulterated products that have not met the necessary safety requirements.

• In June 2019, US Marshals seized 300,000 supplements bottles produced by Life Rising Corporation. These products did not meet current good manufacturing practice (CGMP) requirements:

  • “Among other observed deficiencies, the company failed to establish product specifications for the identity, purity, strength, and composition of each finished batch of dietary supplement, and for limits on certain types of contamination, to ensure the quality of the supplement. The company also lacked written procedures for pest control and for maintaining, cleaning, and sanitizing equipment and/or surfaces that came in contact with the dietary supplements, among other violations.”

• In 2022, the FDA sent warning letters to multiple companies for selling adulterated dietary supplements containing potentially harmful ingredients, including 5-alpha-hydroxy-laxogenin, higenamine, higenamine HCl, hordenine, hordenine HCl, and octopamine.

The FDA must first establish that products are adulterated or misbranded before taking action—a time-consuming process as supplements manufacturers do not provide this information in any form before marketing and selling their products.

These companies are also not required to confirm what’s inside of those bottles. A 2022 study found that 17 out of 30 products marketed for immune health had inaccurate labels. Thirteen listed ingredients that were not in the bottle, while nine contained ingredients not listed on the label.

All of which makes the idea of a “crusade” against supplements manufacturers absurd. Yet, according to the article above, Kennedy suggested “that vitamins and nutraceuticals are among the products stifled by the agency that play a role in promoting the health of Americans.”

This shouldn’t be surprising given how much money supplements manufacturers have poured into Washington through lobbying efforts. Let’s take a look.