Washington, D.C.—At the Council for Responsible Nutrition (CRN) Regulatory Summit, Steve Tate, acting director at the Office of Dietary Supplement Programs for the U.S. Food and Drug Administration (FDA), offered an update of FDA’s latest enforcement actions and priorities.
One key topic of discussion was FDA’s elevation of the Dietary Supplement Programs from a division to an office, which he stated, “reflects the increased size and scope of the dietary supplement industry.”
In the mid-1990s, the supplement industry was composed of about 2,000 companies, and earned approximately $4 billion in sales. Today, the industry has approximately 7,000 facilities known to FDA, comprising $40 billion annual sales.
Tate went on to explain the oversight structure for the new office, which is under the jurisdiction of the Deputy Director for Regulatory Affairs, and acting under the Offer of the Center Director.
Placing supplements in its own office, says Tate, will open the “opportunity for enhanced external partnerships with academia, consumers, federal and state agencies, healthcare providers and industry.”
Industry had a lot to put on its “wish list” for the shape of the new office.
Steve Mister, President and CEO of the Council for Responsible Nutrition, and Michael McGuffin, President of the American Herbal Products Association, recommended hiring staff that had an expertise in nutrition, probiotics, herbals, individuals with industry experience, such as manufacturing dietary supplements and individuals who are savvy with being able to leverage resources.
Besides hiring a specialist, Mister and McGuffin would also like to see an investment in technology.
Tate also noted that FDA has been busy recently with several enforcement actions including sending numerous warning letters related to methylsynephrine, Acacia rigidula, picamilon and CGMPs; seizures of kratom, injunction cases and more.
He closed by noting that it is important for the Agency to be proactive in ensuring product integrity and CGMP compliance, and believes it is important for FDA to evaluate the need for even more guidance in certain areas.
Published in WholeFoods Magazine Online, May 19, 2016