FDA ANNOUNCES PLAN TO MODERNIZE ITS APPROACH TO DIETARY SUPPLEMENT REGULATION

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:

    • A “rapid-response tool” to communicate more quickly to all stakeholders that FDA has concerns that a dietary supplement ingredient is unlawful and potentially dangerous;
    • New steps to foster the submission of new dietary ingredient (NDI) notifications;
    • Partnering with industry to advance FDA’s primary safety goal, including through collaborative research under the newly announced Botanical Safety Consortium, 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;
    • Continued actions like the above-referenced enforcement letters targeting alleged drug claims and development of new enforcement strategies, including for products labeled as dietary supplements that contain unlawful ingredients (e.g., drug ingredients) and for manufacturers that have shown persistent inability to comply with current good manufacturing practice (cGMPs) requirements; and
    • Public dialogue on additional steps necessary to modernize DSHEA (e.g., by adding dietary supplement exclusivity provisions, product listing requirements).

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.