FDA Commissioner Scott Gottlieb, M.D., today issued a press release to announce that the agency is planning “new efforts to strengthen regulation of dietary supplements by modernizing and reforming FDA’s oversight,” with a goal of implementing “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”
The Commissioner’s statement acknowledged the wide use of supplements by Americans and also that “most players in this industry act responsibly” under the regulatory framework that exists under current law. He emphasized though that “bad actors” have been able to “exploit the halo” created by good companies, and so are able to distribute and sell dangerous products that put consumers at risk.
“As we celebrate in 2019 the 25th anniversary of the passage of DSHEA, AHPA shares Commissioner Gottlieb’s vision, as articulated in today’s press release, of finding the right balance between preserving consumers’ access to lawful supplements, while also protecting the public from unsafe and unlawful products and holding accountable companies that are not in compliance with the law,” noted AHPA President Michael McGuffin. “AHPA has previously communicated specific suggestions for regulatory improvements to FDA and we look forward to a robust and transparent discussion on how best to serve Americans who include supplement products in their families’ health care choices.”
One area emphasized in Commissioner Gottlieb’s statement is FDA’s intention to take steps to foster the submission of new dietary ingredient (NDI) notifications, including plans to update the agency’s compliance policy regarding NDIs and continuing to develop guidance for industry for preparing NDI notifications. FDA is also planning a public meeting this spring (date TBD) on the topic of “responsible innovation in the dietary supplement industry” as a forum to receive feedback on how to modernize its approach toward NDIs.
“AHPA has invested significant resources to assist industry in submitting NDI notifications that meet the statutory requirements to bring a new ingredient to market,” added McGuffin. “We have also submitted thoughtful comments to FDA’s prior draft NDI guidance documents and will continue to provide input so that any eventual guidance is both useful to the trade and does not stray from FDA’s statutory authority.”
Today’s press release also highlighted FDA’s interest in engaging stakeholders to evaluate whether changes to the law are now needed. Specifically mentioned in this regard were two topics described as already suggested by some stakeholders: establishment of “avenues for dietary supplement exclusivity” and addition of “a product listing requirement.” Dr. Gottlieb’s statement described the latter as possibly able to “provide significant benefits by improving transparency in the marketplace and promoting risk-based regulation [and] help[ing] facilitate efficient enforcement of the law and establish new mechanisms to identify bad actors who put the public at risk and undermine consumer confidence in the entire industry.” He went on to ask if it’s possible “to design a product listing regime that helps us protect consumers and level the playing field for responsible industry participants by making it easier for us to take swift action against illegitimate and dangerous products, such as products that are tainted with drug ingredients,” while also avoiding any disruption to “the balance struck by DSHEA, and without imposing any significant new burdens on responsible firms.”
“AHPA’s Board of Trustees adopted a policy last November that recognizes that the current federal legal and regulatory framework for dietary supplements supports the supplement industry and supplement consumers and provides FDA all of the authority needed to properly regulate lawful supplements, such that the laws and regulations do not need to be revised to include a mandatory premarket registration or notification requirement for dietary supplement products,” commented McGuffin. “Any reconsideration of this position on a dietary supplement product listing regime would depend on whether the legislative package also includes provisions that appropriately reduce burdens on the industry or create new opportunities for it and the consumers it serves, for example in the context of nutrient content claims. ”
Today’s press release also identified several other specific topics relevant to this new FDA initiative, including:
- Development of a new “rapid-response tool” to alert the public so consumers can avoid buying or using products with problematic ingredients, and to notify responsible industry participants to avoid making or selling them.
- Creation of a Botanical Safety Consortium, described as a public-private partnership that will gather leading scientific minds from industry, academia and government to promote scientific advances in evaluating the safety of botanical ingredients and mixtures in dietary supplements. AHPA has been aware of this program in development and has communicated interest in adding the expertise of AHPA’s staff and membership to this important work.
- Developing new enforcement strategies to protect consumers, with attention on products claiming to be supplements but that contain unlawful ingredients, including drug ingredients; illegal drug claims; persistent noncompliance with the current good manufacturing practice requirements for dietary supplements; and unsafe imports and recalled products.