Reviewing the FDA’s Regulatory Approach to Dietary Supplements

New research suggests that the FDA has fallen short in its regulation of the manufacturing practices for dietary supplements, according to a recent study published by the National Library of Medicine. For the study, the authors aimed to discover how efficient the FDA is when it comes to ensuring the safety and efficacy of dietary supplements.

Despite the establishment of the Dietary Supplement Health and Education Act (DSHEA) in 1994, which provided the agency with the authorization to promulgate good manufacturing practices for dietary supplements, the authors believe that the FDA has failed in this area. They further stress that they intended for the study to discern how the lack of efficacy in the FDA’s regulations of over-the-counter (OTC) dietary supplements inevitably inspired more harm than benefit.¹

The study relied on case studies from 2004-2021 that included young adolescents and adult consumers who experienced adverse events (AEs) from the use of dietary supplements that were reported through the FDA’s Center for Food Safety and Applied Nutrition Adverse Event Reporting System (CAERS). Highlighted supplements with high prevalence in AEs included vitamin E, beta-sitosterol, yohimbine, kava kava, kratom, garcinia cambogia, and OxyElite Pro.¹

Results showed that between 2004 and 2021, a total of 79,071 AEs related to the use of dietary supplements were reported to the Center for Food Safety and Applied Nutrition. They also observed a substantial number of AEs, such as toxicity from vitamin E and organ failure linked to herbal products, and severe consequences from weight-regulating products. The FDA’s responses are criticized for being limited to label updates, consumer warnings, and occasional recalls, showcasing a reactive rather than proactive regulatory approach.¹

Back in August, the FDA released a statement that their dietary supplements program remains a top priority, with a new human foods program (HFP) being put into place.²

“Under the new proposed HFP structure, the Office of Dietary Supplement Programs (ODSP) will report to the Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI),” explained Robert M. Califf, MD, FDA commissioner. “This proposed structure is designed to ensure that the dietary supplements program remains a critical priority for the agency. The reporting of ODSP to the OFCSDSI director is similar to its current reporting to an individual managing several Offices; however, the current individual reports to the CFSAN Center Director while the OFCSDSI director is proposed to report to a Deputy Commissioner.”

Yesterday, the first DSHEA summit was announced to be taking place in Salt Lake City, Utah, on June 10, 2024, marking the 30th anniversary of the law being enacted. The conference is expected to take a look at current industry compliance and federal enforcement while also exploring what the future of dietary supplement regulation should look like.³

“This will be an unprecedented gathering of the negotiators of DSHEA, former FDA officials, captains of industry, and maybe a critic or two who will reflect on why DSHEA was so necessary, so successful and yet remains so controversial,” said Loren Israelsen, president, founder, United Natural Products Alliance, in an interview with NutraIngredients USA. “After 30 years, the mythology and the reality of DSHEA have blurred. This panel will tell it as it was, as they see the industry today, and what the future of DSHEA will look like.”

The authors of the study concluded that there is a need for more stringent regulations, comparing the oversight of dietary supplements to that of prescription medications. They also recommended a comprehensive review process, including preclinical and clinical research, FDA scrutiny pre-approval, and ongoing post-marketing surveillance, stressing the urgency of closing the regulatory gap to protect public health and reduce AEs associated with dietary supplements.¹

“Given the easy access to dietary supplements encompassing vitamins, the public is more prone to resort to its consumption as opposed to contacting their physician for a regulated prescription medication, advice, or device,” the authors wrote. “Having only touched the surface of regulation, the FDA is in dire need of reform to control dietary supplements and prevent adverse effects through advancements in studies of efficacy and safety in addition to labeling updates emphasizing the potential harm stemming from use of these products. It is therefore highly recommended that this public health gap be closed by the FDA requiring safety and efficacy proof prior to marketing for supplements, as is done with most other health related products.”

References

1. Narrative Review: The FDA’s Perfunctory Approach of Dietary Supplement Regulations Giving Rise to Copious Reports of Adverse Events. National Library of Medicine. October 10, 2023. Accessed December 5, 2023. https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10686678/

2. FDA’s Dietary Supplements Program Remains a Critical Priority. FDA. August 14, 2023. Accessed December 5, 2023. https://www.fda.gov/news-events/fda-voices/fdas-dietary-supplements-program-remains-critical-priority

3. Announcing the DSHEA Summit: A landmark event bringing together the architects of the law & leading industry voices. NutraIngrediants USA. December 4, 2023. Accessed December 5, 2023. https://www.nutraingredients-usa.com/Article/2023/12/04/DSHEA-Summit-to-chart-the-past-present-and-future-of-US-supplements-industry#