AUSTIN, Texas (February 12, 2019) — In a statement released by the U.S. Food and Drug Administration (FDA) on February 11, 2019, Commissioner Scott Gottlieb unveiled the agency’s plans to modernize and reform FDA’s oversight on dietary supplements. According to the statement, ensuring the safety of dietary supplements is still the highest priority of the agency. The maintenance of product quality was pointed out as the second priority, while the goal to provide accurate information about a product to enable a more informed decision-making process by consumers and health care professionals was ranked third in order of importance.Commissioner Gottlieb also pointed towards a number of new initiatives towards achieving FDA’s policy goals. These include the following:
- A faster turnaround time to remove potentially dangerous products from the market. FDA is working on tools to alert consumers more rapidly if an unsafe dietary supplement is sold in an effort to prevent consumer purchases of such products.
- A new look at the new dietary ingredient (NDI) notification process. Based on the commissioner’s remarks, industry members can expect that the FDA will make further attempts to increase the number of industry’s NDI notifications to FDA by clarifying the existing notification process and by an increased number of enforcement actions.
- A focus on developing validated in vitro safety evaluation models. The Botanical Safety Consortium, a partnership among FDA, academia, industry members, and trade and non-profit organizations, has been established to provide dietary supplement industry members with the tools for a reliable ingredient safety assessment without necessitating the use of animal testing.
- Be more aggressive in enforcing the regulations against unlawful products, such as those where active pharmaceutical ingredients are illegally marketed as dietary supplements, or against products claimed to be effective in patients suffering from Alzheimer’s disease, cancer, and other serious diseases.
- A discussion around modifications in the Dietary Supplement Health and Education Act (DSHEA), particularly in the area of a mandatory dietary supplement product registration.
ABC welcomes the efforts by the FDA to help enhance product quality and to remove adulterated and illegal products from the market. In addition, ABCs Chief Science Officer, Dr. Stefan Gafner, is engaged in the Botanical Safety Consortium as a member of the steering committee. The consortium, a private-public partnership which was formed in September 2018, is tasked to develop new, non-animal assays to evaluate the safety of dietary ingredients in the areas of liver toxicity, genotoxicity, reproductive and developmental toxicity, cardiotoxicity, and systems toxicity. The development and validation of these assays are intended to help industry members avoid having to perform animal studies, and to put tools at their disposal that are more predictive about the safety of ingredients than some of the currently used tests.
FDA states that it will provide additional details on these new initiatives in the coming months.
The FDA’s complete statement can be read here.
The news was covered by many major media outlets. The New York Times article can be accessed here. The Washington Post article can be accessed here.