By Sean Moloughney, Editor04.14.22
Just before our April print issue went to press the FDA released its 413-page budget request for the 2023 fiscal year, totaling $8.4 billion. On page 54 the agency discussed the need to “modernize” the Dietary Supplement Health and Education Act (DSHEA) in order to strengthen enforcement and clarify the agency’s authorities.
Specifically, the agency is seeking to amend DSHEA to: “(1) require annual listing with FDA of individual dietary supplement products, including basic information about each unique product; and (2) clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products. These amendments would allow FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers when necessary.”
The Natural Products Association called mandatory product listing “a non-starter,” arguing it amounts to pre-market approval that jeopardizes safe and substantiated ingredients like NAC, CBD, and whatever else FDA itself may deem unlawful.
Meanwhile, the Council for Responsible Nutrition, which requires its members to include product and label information in its Dietary Supplement OWL (Online Wellness Library), said it supports FDA’s call for a mandatory product listing, and shares the agency’s “interest in creating a more transparent industry for regulators and consumers alike.”
This isn’t the first time the mandatory product listing issue has come up. In early 2019 then FDA Commissioner Scott Gottlieb said the agency would embark on a plan to implement “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”
Today, FDA’s budget request comes soon after the confirmation of new Commissioner Robert Califf. How the conversation about potential changes to DSHEA, which have been talked about for years, will unfold from here remains to be seen.
There’s common ground to find of course. No one thinks illegal, adulterated products that make egregious disease claims have a place in the dietary supplement industry. How do you ensure consumer safety while encouraging innovation within a health-minded industry that sells more than $50 billion worth of products per year? I expect this is the beginning—a continuation really—of a longer conversation and dialogue. As always, I’d be happy to hear your thoughts on this matter and other pressing issues.
Specifically, the agency is seeking to amend DSHEA to: “(1) require annual listing with FDA of individual dietary supplement products, including basic information about each unique product; and (2) clarify FDA’s authorities over products marketed as dietary supplements to facilitate enforcement against unlawfully marketed products. These amendments would allow FDA to know when new products are introduced, quickly identify dangerous or illegal products on the market, and take appropriate action to protect consumers when necessary.”
The Natural Products Association called mandatory product listing “a non-starter,” arguing it amounts to pre-market approval that jeopardizes safe and substantiated ingredients like NAC, CBD, and whatever else FDA itself may deem unlawful.
Meanwhile, the Council for Responsible Nutrition, which requires its members to include product and label information in its Dietary Supplement OWL (Online Wellness Library), said it supports FDA’s call for a mandatory product listing, and shares the agency’s “interest in creating a more transparent industry for regulators and consumers alike.”
This isn’t the first time the mandatory product listing issue has come up. In early 2019 then FDA Commissioner Scott Gottlieb said the agency would embark on a plan to implement “one of the most significant modernizations of dietary supplement regulation and oversight in more than 25 years.”
Today, FDA’s budget request comes soon after the confirmation of new Commissioner Robert Califf. How the conversation about potential changes to DSHEA, which have been talked about for years, will unfold from here remains to be seen.
There’s common ground to find of course. No one thinks illegal, adulterated products that make egregious disease claims have a place in the dietary supplement industry. How do you ensure consumer safety while encouraging innovation within a health-minded industry that sells more than $50 billion worth of products per year? I expect this is the beginning—a continuation really—of a longer conversation and dialogue. As always, I’d be happy to hear your thoughts on this matter and other pressing issues.
