A study recently published in JAMA by Pieter A. Cohen, MD; Bharathi Avula, PhD; and Kumar Katragunta, PhD, et al, has found that supplements with banned ingredients are still on the market despite the companies having received warning letters from the U.S. Food and Drug Administration (FDA). The study stated that “Some dietary supplements are adulterated with novel and unapproved stimulants. These analogues of amphetamine, ephedrine and other drugs have been linked to serious health risks, including hemorrhagic stroke and sudden death.”
The warning letters issued by FDA, according to the study, addressed the presence of BMPEA, methyl-synephrine or DMHA in 31 products. Researchers found that “Of these 31 products, [one] (3 [percent]) was recalled by the manufacturer. Nine of the 31 products (29 [percent]) remained available for purchase online a mean of [six] years after the FDA issued warning letters.”
Megan Olsen, senior vice president and general counsel, Council for Responsible Nutrition (CRN), stated, “CRN applauds Dr. Cohen for keeping FDA accountable. It is unfortunately the case that 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.
“This study demonstrates that warning letters alone are not viewed as 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.”
Furthermore, Olsen commented, “FDA has recently been asking for new so-called ‘prohibited acts’ authority to clean up the industry. In other words, FDA wants clear-cut ability to address illicit substances that have never been marketed as drugs, nor even studied for their potential effects, but are nevertheless marketed as supplements.
“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. 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.”
Daniel Fabricant, PhD, president and CEO of the Natural Products Association (NPA), concurred. “This study reaffirms FDA’s performance failures gaps going back to a report published by the Office of the Inspector General in 2017,” he stated. “Companies who receive a warning letter are required to notify 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. This should be considered low-hanging fruit for the agency, but it’s obvious there’s an element of willpower that’s absent.
“In 2017, the Office of the Inspector General published a report highlighting the annual number of facility inspections dropped despite increased spending for domestic facility inspections. Additionally, the report found the Agency often took no action in response to significant inspection violations nor did the FDA proactively follow up with companies identified as having significant violations to ensure that all violations were correct.
“These gaps in actions indicate that new authorities to the FDA clearly 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, the repeated absence of follow through requires oversight and accountability.”
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