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.
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:
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.