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:
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.”