Dangerous supplements on the market: study slams FDA’s regulatory approach

27 Jul 2022 --- The US Food and Drug Administration’s (FDA) approach in attempting to remove dangerous supplements from the market appears to be ineffective, according to a new study. The findings reveal warning letters by the regulatory agency often go unheeded, with industry slamming the FDA for not doing its job.

“FDA is responsible for removing these hazardous supplements from the market, and the agency has attempted to do so by issuing warning letters to manufacturers,” the study says.

The Council of Responsible Nutrition (CRN) and the Natural Products Association (NPA) responded to the study, stressing that this action is insufficient.

“Unfortunately, the agency is not doing its job when one can find the same rogue ingredients in the same bad products six years after warning letters have been issued,”  says Megan Olsen, senior vice president and general counsel at CRN.

Not doing enoughOnly one out of 31 supplements with prohibited ingredients was recalled by the manufacturer by FDA warning letter.
Out of 31 warning letters sent by the FDA targeting the presence of β-Methylphenethylamine, Methylsynephrine or Dimethylhexylamine in supplements, only one product was recalled by the manufacturer. Out of the same products, nine remained available online, with a mean of six years after the warning letters were issued.

“Four of the nine available products (44%) listed the presence of at least one prohibited ingredient on the label: one product label declared the same prohibited ingredient that prompted the FDA warning letter and three product labels declared other FDA-prohibited ingredients,” the study stresses.

“This study demonstrates that warning letters alone are not considered sufficient threats by bad actors and outliers. FDA should stop assuming that everyone in the market wants to do the right thing. Unfortunately, it is the reality that there are bad guys out there who simply don’t,” Olsen underscores.

Previously, industry players told NutritionInsight that there is also a lack of regulation on labeling, as “anyone can slap a label on a product and sell it as an effective supplement.” Resulting in that the US is “flooded” with unregulated supplements.

“After chemical analysis, five of the nine products (56%) were found to contain at least one FDA-prohibited ingredient.” 

Additionally, one product contained three prohibited ingredients, and four products contained one.

Flouting the law?If laws and authority were implemented, the FDA would have no choice than to go after bad actors, according to the CRN.
The study stresses that the FDA should consider new ways to ensure manufacturers are complying with the agency's warning letters, and prohibited drugs must be removed from supplements.

“Companies who receive a warning letter are required to notify the FDA within 15 days of receipt of their warning letter and the specific steps they have taken to address any violations. Failure to do so is supposed to result in legal action, including seizure and injunction,” says Daniel Fabricant, president and CEO at NPA.

“This should be considered low-hanging fruit for the agency, but it’s obvious there’s an element of willpower that’s absent.” 

Olsen continues to highlight the need for consequences for FDA enforcement, as “the perceived risk to bad actors must be greater than the gains possible by flouting the law.”

Does it work in reality?
Previously, the FDA stressed its lack of authority in controlling supplements before they enter the market, calling for Congress to address the issue. 

“CRN supports giving FDA this authority and believes it will allow FDA to go after illicit substances not implicated by the ‘drug preclusion’ clause. These illicit substances may be currently caught in a legal no-man’s land—not supplements, not drugs, and without this new authority, not clearly within FDA’s enforcement,” Olsen adds. 

“This simple change to the law—currently part of the Senate HELP committee’s user fee legislation—would give FDA capacity that much of the industry believes it already has, but FDA has been requesting explicit statutory language to clarify.”

The new law would “force” the FDA to go after the bad actors repeatedly if given authority and explicitly stated in the law, the CRN says.

Fabricant comments on the lack of authority, stating “these gaps in actions indicate that new authorities to the FDA aren’t warranted, when current authorities where problems have been located, aren’t followed up with.” 

“This study makes it clear the agency has adequate authority to pursue products masquerading as dietary supplements, and the repeated absence of follow-through requires oversight and accountability,” he concludes.

By Beatrice Wihlander