The FDA has suggested that a mandatory listing requirement for dietary supplements “could provide significant benefits by improving transparency” and help ID “bad actors who put the public at risk and undermine consumer confidence in the entire industry” (1). But is it really necessary?
Transparency as Disinfectant
By Steve Mister, Council for Responsible Nutrition
A century ago, Justice Louis Brandeis opined that sunlight is the best of disinfectants; electric light the most efficient policeman. He appreciated that transparency of financial and government institutions was the best way to combat corruption and a powerful way of stamping out unethical behavior. One hundred years later, consumers are demanding that same transparency in the products they purchase and the companies they patronize. The supplement industry should give FDA that same illumination.
Twenty-five years after Congress enacted DSHEA, the greatest weakness in the law is not any single flaw in the balance between public safety and consumer access, but rather FDA’s inability to see into the marketplace. FDA argues convincingly it’s difficult to regulate the industry when it has no way of knowing what products are in the market, which companies are producing supplements, and what ingredients they contain until after safety concerns have arisen, and the agency must scramble afterward. Companies who ignore their obligations—from failing to notify the FDA of their new dietary ingredients, to not reporting their serious adverse events—too easily can evade FDA’s scrutiny by staying in the shadows, out of view. A mandatory listing will turn on the light.
Requiring marketers to notify FDA of the supplements they market and provide a sample of their labeling would go a long way toward creating a stronger marketplace of responsible companies. If FDA knows when a product comes to market, it can more efficiently analyze labels that are likely to reveal illicit ingredients, find suspect products in the event of a recall, and prioritize inspections and other enforcement activity. Failure to file would create an administrative violation that’s easy for FDA to enforce without product testing, inspecting facilities or analyzing the legality of claims.
Some raise the possibility that FDA would misuse the listing, but that can be addressed with careful drafting of the legislation. Mandatory product listing would have to be like a birth certificate, not a driver’s license; FDA could not use this registry to deny marketers of their ability to go to market, to slow down introduction of new products. Rather the product listing would be just that: a collection of all labels in the U.S. marketplace, compliant and noncompliant, something even the ODS database isn’t because it isn’t mandatory.
Critics also argue a listing requirement would be too burdensome, but the industry’s voluntary experience with the Supplement OWL has demonstrated that firms of all sizes can compile and enter their products routinely.
Mandatory listing gives FDA transparency to see what’s actually in the supplement market. Twenty-first century consumers demand as much. And a little daylight might raise trust in the industry even more.
Weighing Opportunities to Make Supplement Regulation Even More Effective and Efficient
By Michael McGuffin, American Herbal Products Association
The American Herbal Products Association (AHPA) continuously evaluates the federal regulatory framework for dietary supplements, and regularly provides recommendations to make regulations more effective and efficient. These AHPA recommendations for the most part further priority goals shared with the FDA. These priorities are ensuring safety, maintaining product integrity, and enabling informed decision-making by supplement users.
AHPA has a long track record of advocating for improvements to FDA’s regulatory framework for supplements. For example, AHPA took the lead in 2005-06 to change the law to require companies to submit serious adverse event reports (SAERs) to the agency. This law clearly supports the shared priority of ensuring consumer safety.
At the present time, AHPA continues to recognize areas where current supplement regulations could be modified to better meet our common goals. Most obviously, supplement users would be better informed if current legal restrictions on dissemination of information on supplements are removed. AHPA has therefore identified the possibility of a statutory amendment to allow companies that sell supplements—whether in brick-and-mortar stores or through e-commerce—to provide truthful and non-misleading information on the products they sell. Such an amendment would contribute to informed decision making by supplement users.
On the priority of maintaining product integrity, AHPA has consistently encouraged FDA to implement all relevant regulations in alignment with the law, and to be consistent in conducting cGMP inspections of supplement manufacturers. The Program Alignment effort launched by FDA in 2017 was a step in the right direction, and AHPA will continue to encourage this sort of progress to meet this shared goal.
AHPA is aware that some in the industry are promoting an amendment to federal law to require dietary supplement companies to list their products with FDA. Though there are some in our membership who advocate for this idea, the majority of AHPA’s members have communicated a lack of support for this proposal. Regulators and consumers would not be able to accurately assume that products that would be merely listed with FDA are safe and legal, or that unlisted products represent a real danger or automatically merit enforcement action. Such a scheme would not benefit consumers, regulators or the industry, and in fact would risk distracting FDA’s resources away from its own identified priorities.
On the other hand, a voluntary product registration similar to the model successfully used by the cosmetic industry might be a better approach. FDA states that the Voluntary Cosmetic Registration Program (VCRP) assists the agency in carrying out its responsibility to regulate these products, and consideration could be given to adapting this model for supplements.
- “Statement from FDA Commissioner Scott Gottlieb, M.D., on the agency’s new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight,” fda.gov. Posted 2/11/19. Accessed 2/6/20. https://www.fda.gov/news-events/press-announcements/statement-fda-commissioner-scott-gottlieb-md-agencys-new-efforts-strengthen-regulation-dietary
Steve Mister is the president & CEO of the Council for Responsible Nutrition (CRN), the leading trade association for the dietary supplement and functional food industry.
Michael McGuffin is the President of the American Herbal Products Association (AHPA), the national trade association and voice of the herbal products industry.