The U.S. Food and Drug Administration’s Commissioner Scott Gottlieb has announced that the agency will work to modernize dietary supplement regulations for the first time in more than 25 years. Since the passage of the Dietary Supplement Health and Education Act (DSHEA) in 1994, the dietary supplement market has grown significantly.

“I’m concerned that changes in the supplement market may have outpaced the evolution of our own policies and our capacity to manage emerging risks,” said Gottlieb. “To continue to fulfill our public health obligations we need to modernize and strengthen our overall approach to these products.”

In the coming months, the FDA plans to provide additional details on the steps it is taking to continue moving the dietary supplement program forward. “Our new approach benefits consumers by balancing new policies to promote innovation and efficiency in the marketplace for dietary supplements with increased steps to protect the public from potential safety issues,” said Gottlieb.

To begin with, the FDA plans to focus its efforts on the following steps:

  1. Develop a new rapid-response tool to alert consumers when the agency has concerns that an ingredient is unlawful and potentially dangerous and should not be marketed in dietary supplements.
  2. Foster the submission of new dietary ingredient (NDI) notifications. The agency is developing guidance for preparing NDI notifications to ensure it can thoroughly review the safety of these ingredients. In conjunction with this effort, the FDA is planning to update its compliance policy regarding NDIs.
  3. Leverage existing resources and authorities to evaluate new products and ingredients as they are introduced by the industry. The FDA recently created the 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.
  4. Develop new enforcement strategies as the risks evolve. The agency is improving its internal processes for taking enforcement action when products claiming to be supplements contain unlawful ingredients, including drug ingredients.
  5. Engage a public dialogue around whether additional steps to modernize DSHEA are necessary. “We’re interested in hearing other ideas our stakeholders may have, and not just those limited to changes to the law, so we can go about the task of regulating this space in a way that reflects where the industry is today, and continue to safeguard consumers’ ability to access safe, compliant dietary supplements for the next 25 years,” said Gottlieb.

As part of the agency’s efforts, it sent 12 warning letters and five online advisory letters to companies whose products, many of which are marketed as dietary supplements, are being illegally marketed as unapproved new drugs because the products bear unproven claims to prevent, treat, or cure Alzheimer’s disease, as well as a number of other serious diseases and health conditions, including diabetes and cancer. Dietary supplements can, when substantiated, claim several potential benefits to consumer health, but they cannot claim to prevent, treat, or cure diseases like Alzheimer’s.

Finally, the FDA is planning a public meeting this spring on the topic of responsible innovation in the dietary supplement industry. The feedback received during this meeting will be essential as the agency moves to modernize its approach toward NDIs.

In response to the announcement, the Council for Responsible Nutrition (CRN) released the following statement: “CRN looks forward to engaging with FDA as we learn more about the specific initiatives Dr. Gottlieb promises. When these new FDA proposals enhance the safety and informed decision making of consumers, improve the health, transparency, and innovation of the industry, promote greater practitioner confidence, and do not restrict access or create unwarranted regulatory burdens for industry, FDA will have a willing and enthusiastic partner in CRN and its member companies.”

Press release

Warning letters release

CRN statement

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