By Will Woodlee
On February 11, 2019, FDA announced an intention to bring greater control to the dietary supplement marketplace. Twenty-five years after Congress passed the Dietary Supplement Health and Education Act (DSHEA), FDA Commissioner Scott Gottlieb announced new steps the Agency plans to advance to achieve the “twin goals” of (a) “ensuring that [FDA] achieves the right balance between preserving consumers’ access to lawful supplements” and (b) “still upholding [FDA’s] solemn obligation to protect the public from unsafe and unlawful products, . . . holding accountable those actors who are unable or unwilling to comply with the requirements of the law.”
First, FDA re-emphasized its commitment to policing product claims that stray beyond so-called structure-function claims to those that relate to serious diseases. In that regard, the Commissioner announced the issuance of 12 warning letters and five online advisory letters issued to companies that are allegedly marketing unapproved new drugs for diseases such as Alzheimer’s, cancer, and diabetes, some of which the companies labeled as dietary supplements. FDA issued several of these letters jointly with the Federal Trade Commission (FTC).
Second, the Commissioner announced that he recently directed the establishment of a Dietary Supplement Working Group tasked with reviewing organizational structures, processes, procedures, and practices to identify overnight modernization opportunities.
Third, the Commissioner reiterated FDA’s key priorities for dietary supplements: (1) safety; (2) product integrity (“we want to ensure that dietary supplements contain the ingredients they’re labeled to contain, and nothing else”); and (3) informed decision-making to foster an environment in which consumers and healthcare professionals can make informed decisions about dietary supplements.
Finally, FDA announced several specific future initiatives, balancing new policies to promote innovation and efficiency in the dietary supplement marketplace with increased steps to protect the public from potential safety issues. The initiatives FDA is currently considering or actively formulating include:
FDA also announced plans for a spring 2019 public meeting on the topic of responsible innovation in the dietary supplement industry. KKB will continue to closely monitor developments in this area.