A new policy adopted by physicians at a meeting of the American Medical Association (AMA) advocates for stricter federal regulation of dietary supplements, including modernization of the Dietary Supplement Health and Education Act of 1994 (DSHEA).
AMA said it urged Congress to modernize DSHEA to grant FDA authority to create a mandatory product registry to help detect harmful dietary supplements and remove them from the market. FDA, as well as several consumer and industry trade groups, are in favor of a requirement that manufacturers of dietary supplements list their products with FDA.
The idea is to give FDA and the public—including physicians and pharmacists—the ability to search all dietary supplement product labels in a centralized location, increasing transparency and making it easier for FDA to identify products that may pose risks to consumers.
In 2019, in commenting on the agency’s efforts to strengthen its regulation of supplements, then-FDA commissioner Scott Gottlieb, M.D., said the market contained between 50,000 and 80,000 dietary supplement products, possibly more. FDA officials have complained they have little visibility into all the products on the vast market, which complicates their efforts to enforce against finished product brands or ingredient suppliers that may pose a risk to public health.
“Patients and physicians expect the dietary supplements they purchase and recommend to be safe, quality products that are accurately labeled with their contents,” AMA Immediate-past Board Chair Jesse M. Ehrenfeld, M.D., said in a Nov. 18 press release. “As the dietary supplement industry continues to grow with little oversight, many more people will use supplements without having a clear understanding of what’s contained in these products—potentially putting their health at risk. We need the federal government to step up its regulation and enforcement of the dietary supplement industry to remove unsafe products from the market and protect public health.”
AMA disclosed it further wants to strengthen FDA’s authority and resources to implement and enforce policies related to supplements, such as mandatory recall, risk-based inspections of manufacturing facilities and strengthening adverse event reporting systems.
FDA already has mandatory recall authority under the law and conducts risk-based inspections of dietary supplement facilities. In FY20, of 289 inspections conducted by FDA for compliance with cGMPs (current good manufacturing practices), the agency performed 74 “for cause” inspections of dietary supplement facilities to probe problems that have come to its attention, according to FDA records obtained by Natural Products Insider through a Freedom of Information Act (FOIA) request.
Under the Dietary Supplement and Nonprescription Drug Consumer Protection Act, manufacturers and distributors of dietary supplements also must report to…