Washington, D.C.—AsWholeFoodsMagazinehas reported, a new reportpublishedin the Journal of the American Medical Association(JAMA; vol. 328, no. 4) suggests that FDAwarning lettersare falling short when it comes to deterring bad actors from selling dietary supplements adulterated with novel and unapproved stimulants linked to serious health risks.(Background: Study Points to FDA Shortcomings in Policing Adulterated Supplements.)

Pieter A. Cohen, M.D., of Cambridge Health Alliance, and his team reported that FDA sent warning letters targeting the presence of BMPEA, methylsynephrine, or DMHA in 31 supplement products. Of these 31 products:
  • 1 (3%) was recalled by the manufacturer.
  • 9 (29%) remained available for purchase online a mean of six years after the FDA issued warning letters.
  • 4 of those 9 available products (44%) listed the presence of at least 1 prohibited ingredient on the label. One product label declared the same prohibited ingredient that prompted the warning letter; the other three labels declared other FDA-prohibited ingredients.
  • The researchers also conducted chemical analysis, and found 5 of the 9 products (56%) contain at least 1 FDA-prohibited ingredient (see results here).

NPA points to FDA's "repeated absence of follow through"

The Natural Products Association(NPA) responded to the report. “This study reaffirms FDA’s performance failures gaps going back to a report published by the Office of the Inspector General in 2017,” said Daniel Fabricant, Ph.D., NPAPresident and CEO. “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.”

NPA explained that, in 2017, a report from the Office of the Inspector General highlighted that the annual number of facility inspections dropped despite increased spending for domestic facility inspections. In addition, the report found FDA “often took no action in response to significant inspection violations." What's more: "FDA did not proactively follow up with companies identified as having significant violations to ensure that all violations were correct."

Dr. Fabricant put this into perspective. “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," he said. "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.”

Related: NPA Applauds Senator Burr’s Position Against Including Dietary Supplement Provisions in Package NPA Points to Flawed Thinking in USPSTF Report on Dietary Supplements NPA Responds to CDC’s Data on Melatonin