Perception that the dietary supplements industry is operating in an unregulated environment is a central threat to all companies making safe and effective products, according to Steve Mister, president and CEO of the Council for Responsible Nutrition (CRN).

Addressing attendees of CRN’s Now, New, Next event in Phoenix, AZ, Mister said it’s imperative to set the record straight on misperceptions about how the dietary supplements industry is regulated. Importantly, the industry must tangibly demonstrate self-regulation and a willingness to have a constructive role in creating new policy, he said. 

“On an almost daily basis, we pick up headlines that carry this false narrative from the New England Journal of Medicine, who incidentally should know better, to the New York Times, Atlanta Journal-Constitution, Forbes, and the Wall Street Journal,” Mister said. “But this problem is not limited to the media. Recently, we’ve seen examples where even the FDA seems to perpetuate this perception as well.”

Mister said CRN discussed with FDA a number of concerns with the agency’s Supplement Your Knowledge Program. CRN found the presentation, tone, and language of FDA’s content objectionable. Specifically, the literature intended for schools, healthcare practitioners, and other consumers overemphasized perceived risk while doing little to acknowledge any potential benefit that comes with the use of dietary supplements, according to Mister.

In the portion of the program intended for teachers, “There were no less than 65 references to potential danger or harm from using supplements, compared to only 15 acknowledgements in the materials that there were benefits,” Mister said. “FDA also released a new continuing education program for doctors developed in conjunction with the American Medical Association […] If you wanted to have a training program on what not to do in order to have a constructive dialogue with your patients, this is it. If you want to scare your patients and discourage them from being honest about their supplement usage, or dismiss their attempts to improve their own nutrition, this is your video series.”

Selective Coverage of Research

Mister said that mainstream media is often more inclined to cover nutrition studies that yield negative results, while ignoring a broader context of studies in which positive results have been found.

For instance, “There are now over 100 studies and 13 meta-analyses showing a relationship between vitamin D levels and incidence or severity of COVID-19 and a vast majority of this research shows an inverse relationship,” Mister noted. “Not all of the results have been positive, and it’s the negative ones that seem to get the most attention.”

Most negative studies had serious design limitations, such as control groups electing to take vitamin D supplements on their own or a vaccine rollout occurring during study treatment, Mister noted.

“This facet of public perception is important because if consumers don’t see value in these products, it becomes easier to amplify supposed risks,” Mister continued. “This is leading to a resurgence of the precautionary principle, in which it’s widely accepted that governments should err on the side of not accepting any risk whatsoever for consumers […] it’s a mindset that selectively gets applied in the face of any uncertainty.”

Working With Regulators

According to Mister, taking a constructive role as opposed to resistance with authorities gives the industry the strongest advantage for both public perception and how supplements are regulated.

“We need to advocate for new tools and resources to demonstrate how we’re regulated […] mandatory product listing is at the top of that list. It makes common sense to give the agency the ability to see into the industry that it regulates,” Mister said, adding that opposing it on principle “undermines any credibility” for dietary supplement companies.

The push for mandatory product listing continues, and public-private collaboration has been key to addressing many of the industry’s concerns, Mister noted. Sponsors have inserted specific language into the bill which prohibits the agency from utilizing the list as a form of “premarket approval,” and the bill does not allow the agency to disclose the locations of manufacturing facilities.

Mister said that concerns about the agency using mandatory product listing as a way to target specific ingredients through drug preclusion is unfounded. FDA has interpreted several ingredients such as CBD and N-acetyl-cysteine as drugs under the framework of the Dietary Supplement Health and Education Act (DSHEA).

“The problem there is that the current law already gives FDA that authority,” he said. “Opponents say that FDA isn’t doing enough to enforce the law now […] but FDA doesn’t have a clear snapshot of the whole industry. Why not enact mandatory product listing and then hold the agency accountable? Mandatory listing isn’t a monumental change to the balance of DSHEA, it’s a new tool for the agency.”

Power Vacuums

Without strong collaboration between FDA and industry, Mister said, class action plaintiffs attorneys, state governments, retailers, and international regulators are more keen to take on the role of the enforcer.

He noted the recently-vetoed California State Assembly bill to restrict underage access to weight loss supplements. The industry “dodged a bullet” by narrowing down language to high-priority items most relevant to products with prohibited ingredients, Mister said.

“We could’ve just dug in and opposed the original version of the bill, but I think that we would’ve seen that bill pass, restricting an entire category of products without putting the onus on the Department of Health to prove which ones are not safe,” Mister said. This ended up being a “poison pill,” since Governor Gavin Newsom expressed intentions to go forward with a bill in 2023 that doesn’t require the state to undertake costly pharmacological studies on supplements, Mister said. But, “we tried to do the right thing by our consumers, and live to fight another day with our credibility intact.”

As a result of retailers “leaving FDA behind” to impose unique testing and manufacturing requirements, proactive industry efforts to streamline certification programs are “more important than ever,” Mister said.