A recent study found that adulterated dietary supplements remained on the market years after being issued a warning letter by the U.S. Food and Drug Administration (FDA).
A recent study published in JAMA found that adulterated dietary supplements remained on the market years after being issued a warning letter by the U.S. Food and Drug Administration (FDA). The thirty-one supplements included in the study were subject to warning letter because of the presence of amphetamine analogue β-methylphenethylamine (BMPEA), the ephedrine analogue methylsynephrine, or the dimethylamylamine analogue octodrine (DMHA). These warning letters were issued in 2015, 2016, and 2019.
Results showed that only one product was recalled by the manufacturer after being issued a warning letter. Nine of the products remained available to purchase online for a mean of six years, four of which listed the presence of at least one prohibited ingredient on the label. After chemical analysis, five of the nine products were found to contain at least one prohibited ingredient.
“This study raises questions regarding the FDA’s actions to ensure that manufacturers are compliant with the agency’s warning letters. The FDA should consider ways to ensure that prohibited drugs are removed from supplements, perhaps by testing products sold after warning letters and mandating recalls whenever products remain adulterated,” the study’s authors conclude.
Industry advocates have praised the study, and criticized FDA’s lack of enforcement, but drew different conclusions about what should be done. The Council for Responsible Nutrition (CRN; Washington, D.C.) believes this study demonstrates the need for new authorities for FDA to enforce regulation more effectively.
“FDA’s enforcement must have consequences. The perceived risk to bad actors must be greater than the gains possible by flouting the law,” said Megan Olsen, senior vice president and general counsel for CRN, in a press release. “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. With this authority explicitly stated in the law, FDA can—and must—go after the bad actors that are the subjects of these research exercises over and over again.”
On the other hand, the Natural Products Association (NPA; Washington, D.C.) does not see the value of giving FDA more authority with it doesn’t properly use the authority it already wields. “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,” said Daniel Fabricant, PhD, president and CEO of NPA, in a press release. NPA cites an Office of the Inspector General report published in 2017 that found a drop in the annual number of facility inspections despite increased spending for domestic facility inspections as well as a lack of action taken in response to significant inspection violations.
“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,” stated Fabricant. “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.”
The Consumer Healthcare Products Association (CHPA; Washington, D.C.) is calling for comprehensive reforms to dietary supplement regulation, citing recent efforts to impose a mandatory product listing insufficient.
“A single reform, such as mandatory product listing (MPL) by a supplement manufacturer – as proposed in the current user fee legislation under consideration by Congress – would not address the situation highlighted in JAMA," said Scott Melville, president and CEO of CHPA, in a press release. "However, comprehensive dietary supplement regulatory reform would not only provide FDA with the tools it needs to stop criminals, but it would further improve FDA’s ability to regulate the rapidly growing dietary supplement industry through new tools like Mandatory Product Listing, increased cGMP inspections, and Remote Regulatory Assessments.
“As the House and Senate confer on FDA user fee reauthorizations, the need to balance consumer access to safe and beneficial dietary supplements with FDA’s ability to swiftly remove dangerous and illegal products from the marketplace should be recognized to ensure that any agreed-to reforms are meaningful and not reform in name only.”
Updated 7/29/22 at 4:40 PM ET