On February 11, 2019, Dr. Gottlieb issued a statement that appears to build on statements from December 2018. In December 2018, as part of remarks to the FDLI Enforcement, Litigation, and Compliance Conference, Dr. Gottlieb had alluded to FDA’s plans to step up its efforts regarding dietary supplement safety and deceptive claims. Dr. Gottlieb expressed concern that the industry had grown and outpaced the Agency’s capacity to manage new risks. As a first step, he had created a Dietary Supplement Working Group at the FDA, “comprised of representatives from multiple centers and offices across the agency” tasked to take “a hard look at what more the FDA can be doing within our existing authorities, including re-examining our own internal operating structure and procedures – and what new authorities might make sense.”
The February 11 statement provides additional details. As Dr. Gottlieb mentions, the Dietary Supplement Health Education Act (DSHEA) is almost 25 years old. The industry today is very different from the industry in 1994; among other things, it has grown significantly; “[w]hat was once a $4 billion industry comprised of about 4,000 unique products, is now an industry worth more than $40 billion, with more than 50,000 . . . different products available to consumers.” As a result, FDA has had to consider how to keep up with this growth and how it can continue to ensure that dietary supplements are safe, maintain product integrity, and to foster an environment of informed decision making by consumers and health care professionals.
Dr. Gottlieb announced five initiatives to increase oversight:
- Rapid response tool: Dr Gottlieb mentioned that, in an effort to increase communication speed to consumers, the Agency has developed a rapid-response tool to alert the public when a supplement contains an illegal ingredient or poses a health risk. No further details were provided.
- Update of FDA’s policies regarding New Dietary Ingredient Notifications (NDINs): Under the law, NDINs are required for new dietary ingredients (i.e., dietary ingredients that were first marketed after October 15, 1994) that are not already present in the food supply in a form not chemically altered. The NDINs provide FDA with an opportunity to evaluate safety. As readers of this blog know, FDA believes that the number of NDINs is too low; the Agency believes that there are many dietary ingredients marketed that are new dietary ingredients (NDIs) that would require an NDIN. Thus far, FDA has made two attempts to provide clarity about its policy regarding when an ingredient is an NDI and when an NDIN is needed. Gottlieb’s comments suggest that FDA may make another attempt. It plans to update its policy to “foster the submission” of NDINs by possibly providing some sort of reward (e.g, exclusivity) and help ensure that the regulatory framework is both sufficiently flexible and adequately protects public safety. FDA plans to schedule a meeting with industry this spring.
- Creation of a Botanical Safety Consortium, a public-private partnership with the goal of providing appropriate tools to evaluate the safety of botanical ingredients. Among other things, this group “will look at novel ways to use cutting-edge toxicology tools, including alternatives to animal testing, to promote the goals of safety and effectiveness we share with consumers and other stakeholders.”
- Enforcement actions against unlawful claims and ingredients: Dr. Gottlieb reports that FDA has improved efficiency of its internal processes regarding enforcement actions against illegal ingredients and points to actions against tianeptine, highly concentrated caffeine, and male enhancement products that contained sildenafil and/or tadalafil as examples. He mentions that the Agency will continue its efforts to take actions against unlawful claims and develop new enforcement strategies, and points to the concurrent press release regarding FDA’s action against companies marketing dietary supplements with illegal claims for Alzheimer’s. The Agency sent 12 warning letters and five advisory letters to marketers of more than 58 products which claims to prevent, treat, or cure Alzheimer’s disease and other serious health conditions such as diabetes and cancer. Three of these warning letters were jointly issued by FDA and the Federal Trade Commission.
- Modernization of DSHEA. DSHEA is approaching its 25th anniversary. While Dr. Gottlieb recognizes the need to preserve DSHEA’s “essential balance,” he believes it might be valuable to consider certain amendments. He mentions FDA plans to engage in a public dialogue regarding the possible need to modernize DSHEA to establish avenues for dietary supplement exclusivity, providing industry with incentives to develop new products. Dr. Gottlieb also mentions the possibility of creating an FDA registry, for the mandatory listing of dietary supplements and ingredients. Presumably, such a registry would allow FDA to better track dietary supplements and concentrate enforcement efforts.
We will be monitoring FDA’s actions in 2019.