S20: Regulatory and Compliance Challenges of Dietary Supplements in the A`reas of Quality and Therapeutic Claims
University of Southern California United States
To identify and categorize frequently observed regulatory challenges and draw attention to public health concerns regarding dietary supplements by examining both the United States Food and Drug Administration (FDA) Recalls, Market Withdrawals & Safety Alerts and FDA Warning Letters databases.
FDA enforcement actions from January 2015 to July 2020 for dietary supplements were identified and relevant data (date of event, issuing office, manufacturer, product name, reason for the warning letter or recall (ex. drug claims, adulterated, misbranded, other)) were analyzed.
Between January 2015 to July 2020, the FDA recalled 426 dietary supplements. Approximately half (48.6%) were recalled due to a drug contaminant. Prescription drug substances, commonly sildenafil and tadalafil, were found in 125 cases and banned drug substances like sibutramine were found in 71 cases. Multiple dietary supplements (53) contained between two and five drug contaminants, and 38 contained an unspecified number of active pharmaceutical ingredients. Over a quarter (27%) of the dietary supplement recalls were due to Good Manufacturing Practice (cGMP) violations. Other recalls included the potential to or did contain salmonella (16%), an allergen (3%), or elevated lead levels (3%). Similarly, between January 2015 through December 2020, manufacturers of 1,877 dietary supplements received a warning letter. Unlike recalls, warning letters were frequently issued for more than one reason. The most common reasons dietary supplements received a warning letter was adulteration due to cGMP violations (1,208 cases) or because they were promoted as drugs by making claims they could treat, cure, or prevent a disease (1,082 cases). Specifically, 56 dietary supplements made claims in the past year that the product could either treat, cure, or prevent COVID-19. There were 842 dietary supplements that received a warning letter for being misbranded, 263 contained a component which is excluded from the definition of a dietary ingredient (ex. CBD, DMHA, unsafe food additives, steroids, and drugs such as sildenafil and sibutramine), and 74 fell under the category “other” which typically included that the supplement was not intended to be ingested or the serving size was not possible for the general public to adhere to. The most frequent of the observed violations with respect to disease claims, manufacturing deficiencies and unsatisfactory labeling will be further examined and presented.
Dietary supplements are popular in the United States with approximately $36 billion spent annually on these products, which are consumed by 76% of the population. Given the widespread use of dietary supplements by Americans, it is important that these products are safe, and that the public understands what they are consuming. The findings of this research show dietary supplements are appearing on the market while containing unapproved drugs, with 207 dietary supplements being recalled in the past five years due to a drug contaminant. Therefore, there is a genuine concern that many Americans are consuming dietary supplements that may contain undeclared drug substances. Currently, the regulatory framework is inadequate in preventing contaminating dietary supplements from entering the market. Moreover, the system is inadequate in protecting the American public from being misled with false and unsubstantiated advertising. With 1,082 dietary supplements being cited for unsubstantiated advertising in the past five years, it is likely that consumers are being misled through false advertising. Manufacturing quality for the dietary supplement industry remains a serious concern in that two-thirds of the dietary supplements receiving a warning letter have in some form violated cGMP requirements. The results of this study indicate the current regulatory framework for dietary supplements may not be adequate in protecting the safety of the U.S. public in that the system cannot prevent adulterated or misbranded dietary supplements from entering the marketplace. Further, the results of this study may help to inform the dietary supplement stakeholders including consumers and policy makers on the common challenges faced by the industry in ways that could facilitate changes in the future.