UNPA / URGENT -- MAJOR FDA ANNOUNCEMENT REGARDING DS REGULATION

Dear Colleagues,

I attach an FDA statement just released by the Commissioner, Scott Gottlieb. (Press release announcing enforcement action found here, and Commissioner Gottlieb's announcement found here.)

Here is a brief summary.
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After 25 years since the passage of DSHEA in 1994, the dietary supplement industry has grown 10 fold. A growing percentage of consumers use dietary supplements, and yet the regulatory system under which dietary supplements are regulated may have not kept pace with the changes in society. FDA reaffirms that its two core goals are consumer access to lawful supplements and protecting the public from unsafe and unlawful products.

Today FDA is communicating several points:

1. FDA will focus on areas of unlawful claims. They specifically cite Alzheimer's, cancer, and opioid addiction treatments.
   
   
2. FDA is also establishing a dietary supplement working group within FDA to look at organizational structures, process, procedures, and practices to look for opportunities to modernize the oversight of dietary supplements.
   
   
3. FDA will also develop a new rapid response tool to alert the public to avoid violative products.
   
   
4. Interestingly, FDA will also be offering ideas about updating its NDI compliance policy.
   
   
5. FDA will hold a public meeting this spring to receive public comments on a range of issues, which will include some form of dietary supplement exclusivity, and to discuss the scope of permitted dietary ingredients. (We are unclear what that means.)
   
   
6. Also, FDA has established a Botanical Safety Consortium to evaluate state-of-the-art tools, which are alternatives to animal testing, to promote safety and product effectiveness.

In short, FDA is interested to explore modernization of DSHEA and state their openness and desire to consult with the public and the industry as they approach the prospect of amendments to DSHEA in order to serve today's consumer and industry.

UNPA NOTE:  We note that this important announcement falls on the 25th anniversary of DSHEA. We recognize that the world has changed. We will work closely with FDA on each of the stated objectives and the new ideas they propose, and to participate actively in the dietary supplement working group, once that becomes more public, as well as the Botanical Safety Consortium. The prospect of amendments to DSHEA has long been discussed as a non-starter. We, of course, will listen closely to FDA's ideas regarding DSHEA amendments and will work in close consultation with our members to that end. 

We have the tremendous asset of Peter Reinecke and Trish Knight who, as you know, are the original staffers to Senators Hatch and Harkin during the DSHEA negotiations and its passage. They continue to provide critical advice and support to UNPA. Their institutional knowledge and value have never been more important, and we will look to them for critical advice as well as liaison to FDA and Congress.

We will convene a member call to discuss specifics. In the meantime, we will be in contact with FDA to open a robust line of communication. 

Stay tuned...

Regards,

LDI