Yesterday, the U.S. Food and Drug Administration ("FDA" or "Agency") Commissioner, Scott Gottlieb, MD, announced a plan to modernize FDA's approach to regulating dietary supplement products. In acknowledging the burgeoning industry, Commissioner Gottlieb, a physician himself, emphasized the importance of dietary supplements to consumer health. This announcement comes at a significant time for the dietary supplement industry, as October 2019 will mark 25 years since the Dietary Supplement Health and Education Act ("DSHEA") was signed into law.
In his remarks Commissioner Gottlieb acknowledges the critical need to balance encouraging innovation with preventing the distribution of unsafe products. In addressing the latter, he tweeted that the Agency needs to protect consumers from "a small number of bad actors." The tone of this announcement should be welcomed as a nod to the legitimacy of the industry, which at times has been viewed as unsophisticated, potentially nefarious, and operating in the shadows of FDA regulation. We are happy that the Agency is finally recognizing that significant changes are necessary to keep pace with the realities of the industry and consumers' needs.
Commissioner Gottlieb identified five elements of dietary supplement regulation that the Agency intends to prioritize as part of its modernization efforts.
Rapid Response Alerts
In an effort to increase the speed of communication to consumers regarding important safety information, the Agency has reportedly developed a rapid-response tool to alert consumers of unsafe ingredients and products. Currently, FDA issues safety alerts, recall notices, and warning letters concerning unsafe products. We are curious to see how the rapid-response tool differs from those existing mechanisms.
New Dietary Ingredient Notifications
According to the announcement, FDA also intends to amend its policies regarding new dietary ingredient notifications ("NDINs") to "foster the submission of [NDINs]." NDINs are required to be submitted for dietary ingredients that were first marketed after October 15, 1994, unless they were present in the food supply as an article used for food without chemical alteration.
The announcement states that FDA is "continuing to develop guidance for preparing [NDINs]" and is planning to "update [its] compliance policy regarding NDIs." FDA previously issued two iterations of draft guidance documents setting forth its policies on NDIN submission requirements. You can view our discussion of the most recent version of the draft guidance (2016) here. The Agency intends to hold a public meeting this spring to discuss improvements to the NDI process. We will provide details on that meeting as soon as they become available.
Botanical Safety Consortium
The Commissioner also announced the establishment of a public-private consortium to discuss the innovation and safety of botanical ingredients. Although not specifically mentioned, the creation of this group is no doubt in response to the growing interest in botanical supplements, including hemp-based supplements.
Unlawful Claims and Ingredients
The announcement acknowledged that FDA would continue taking enforcement action against bad actors that market dietary supplements as cures or treatments for diseases or conditions. In conjunction with the announcement, the Agency simultaneously posted 12 new warning letters and 5 online advisory letters. These letters were issued to marketers of more than 58 products, many sold as dietary supplements, which claimed to prevent, treat, or cure Alzheimer's disease and other serious health conditions. In response to these enforcement actions, the Commissioner commented that "health fraud scams prey on vulnerable populations, waste money and often delay proper medical care – and we will continue to take action to protect patients and caregivers from misleading, unproven products."
According to the announcement, the Agency is also making its internal process more efficient for taking enforcement action against marketers of products that contain unlawful ingredients, including drug ingredients. The announcement identifies actions taken over the past year against dietary supplements containing dangerous ingredients, including highly concentrated caffeine, active ingredients in erectile dysfunction prescription drugs, and tianeptine, an unsafe food additive marketed to treat opioid addiction.
Finally, the Commissioner announced that the Agency would engage in a public dialogue regarding whether additional steps could be taken to modernize DSHEA. The Commissioner notes, for example, that some stakeholders have suggested that the statute be amended to establish avenues for dietary supplement exclusively. The announcement also identifies product listing requirements as a potential revision to the law, suggesting that such a change could result in greater transparency and risk-based regulation.
What Happens Next?
We will be closely monitoring FDA's efforts with regard to the priorities listed above. FDA indicated that it would be providing updates "in the coming months." We anticipate attending the public meeting on how to improve the NDI process. In the interim, should you have any questions about the Commissioner's statements, or have specific questions regarding the NDI meeting, please do not hesitate to contact a member of Venable's Food and Drug Law Group.