FDA unable to regulate supplement industry? Calls for Congress to step in

06 Jul 2022 --- The US Food and Drug Administration (FDA) is unable to properly regulate the supplement industry it is supposed to oversee and fails to enforce laws, carry out inspections and hold companies accountable, according to the Council for Responsible Nutrition (CRN).

The onslaught comes as the FDA concedes that the current framework has “no systematic way of knowing what dietary supplements are on the market when new products are introduced, or what they contain,” a spokesperson tells NutritionInsight.

Issues surrounding a power battle between the FDA and industry have been ongoing for a decade, with CRN arguing in favor of industry involvement in the regulatory framework.

FDA failing to carry out inspections?The FDA receives criticism from the industry for not doing enough.
According to Steve Mister, president of CRN, the agency “does not enforce the laws for dietary supplements as uniformly and routinely as the industry would like.”

“All supplement facilities are subject to mandatory inspections, but leading up to the pandemic, FDA was only inspecting about 5% of them each year. At that rate, it will take the FDA 20 years to get to everyone. Since the COVID-19 pandemic, inspections have been even more infrequent,” he tells NutritionInsight.

Questions surrounding the FDA’s competencies have come to the fore as the infant formula shortage in the US reached alarming heights. Recently, lawmakers accused the agency’s commissioner Dr. Robert Califf of favoring corporate interests over public health when it emerged the FDA took weeks to take action against a whistleblower detailing unhygienic practices by Abbott Nutrition.

Situation getting worse
The FDA spokesperson highlights that the agency is committed to doing “everything within its authorities and resources to regulate dietary supplements and to identify and remove unsafe and illegal products from the market.” 

Nonetheless, Mister outlines industry has been frustrated by the infrequency with which the FDA follows through on warning letters to firms suspected of violating the requirements. 

“While most firms in the industry try to do the right thing, the lack of follow-up enforcement actions to warning letters means there are few consequences for those who disregard the law. The situation is getting worse, not better.”

Scrutinizing policyAll parties state they aim to provide safe products to the market.
Through its concession, the FDA has also long admitted its policies may be lagging behind compared to the rapid speed the supplement industry has been growing. This was documented in a speech in 2019 by the FDA’s previous commissioner Scott Gottlieb.

“I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks. To continue to fulfill the public health obligations, we need to modernize and strengthen our overall approach to these products,” he said at the time.

The FDA has proposed contentious mandatory product listing to garner more authority over the industry. It has been met with support by the CRN but slammed by the Natural Products Association (NPA) and the American Herbal Products Association (AHPA), who have described it as “misguided and dangerous” to the industry.

Mandatory product listing
The FDA explains mandatory product listing would require all products marketed as dietary supplements to be listed and give the agency authority to act against non-compliant products and the manufacturers or distributors of such products.

“Such authority would allow the FDA to know when new products are introduced, quickly identify and act against dangerous or otherwise illegal products, improve transparency, and promote risk-based regulation.”

Under the Dietary Supplement Health and Education Act of 1994 (DSHEA), the FDA does not have the authority to approve dietary supplements or their labeling before they are sold to the public.

Instead, manufacturers and distributors of dietary supplements are responsible for evaluating the safety and labeling of their products before marketing to ensure that they meet all the Federal Food, Drug, and Cosmetic Act requirements and FDA regulations.

The list would also allow for transparency, an element previously criticized by the industry as “anyone can slap a label on the product and sell it as an efficient dietary supplement.” 

During a recent campaign by the FDA, “supplement your knowledge,” the agency received criticism as they focused too much on the harmful effects of supplements rather than the health benefits they provide, Mister previously told NutritionInsight.

Congress to step in?Congress is urged to take up mandatory product listing.
Mister describes the FDA’s lack of authority in enforcing laws on dietary supplements as “unfortunate” while stressing that this is an industry demand. He specifies the issue lies in enforcement rather than the framework itself. 

Nonetheless, he recognizes the agency cannot keep up with the range of products in the market and says the FDA needs more accountability to Congress and consumers on how it enforces the law, so companies who ignore their obligations are held accountable.

“Where they have been missing pieces, Congress has filled in by adding mandatory adverse event reporting in 2006 and facility registration in 2011.”

“Under the truism that FDA can’t effectively regulate what it can’t see, and the mantra that ‘transparency is the best disinfectant,’ we are urging Congress to enact a product registry that will fill in this missing link from the original law,” Mister underscores. 

By Beatrice Wihlander