Elevating the division’s position would raise the profile of dietary supplements within FDA and could result in enhanced government resources and capabilities to regulate the industry.
Five leading U.S. dietary supplement trade associations endorsed a letter to Congress yesterday supporting Secretary of Health and Human Services Sylvia Burwell’s recent request to the lawmakers to boost FDA’s Division of Dietary Supplement Programs (DDSP) to full-scale “Office” status within FDA. Elevating the division’s position would raise the profile of dietary supplements within FDA and could result in enhanced government resources and capabilities to regulate the industry, which has grown $29 billion in annual sales since the Division of Dietary Supplement Programs was first founded in 1994.
The Division of Dietary Supplements currently competes with many other divisions within FDA’s Office of Nutrition, Labeling, and Dietary Supplements (ONLDS) for regulatory attention and resources. If dietary supplements were an official “office,” however, it would share equal standing with other offices within FDA’s overall Center for Food Safety and Applied Nutrition (CFSAN), such as the Office of Cosmetics, the Office of Food Additives, and the Office of Food Safety. (CFSAN falls under FDA’s broad Office of Foods and Veterinary Medicine.)
“Since DDSP was established within FDA, shortly after the passage of the Dietary Supplement Health and Education Act of 1994, the dietary supplements industry has grown from around $6 billion in annual sales to more than $35 billion in sales in 2014,” the association heads wrote, stating that such “robust growth” reflects increased consumer interest as well as the new regulatory challenges of a broader industry.
“We believe that the elevation of DDSP to an ‘Office’ would provide appropriate regulatory attention to the growing industry and increase FDA’s enforcement activities and priorities. In addition, we believe such a reorganization would enhance the effectiveness of dietary supplement regulation by allowing this new Office to better compete for resources and attention within the Agency, along with other products under CFSAN’s jurisdiction (e.g., cosmetics, medical foods).”
The five trade associations who signed the letter are the American Herbal Products Association, the Consumer Healthcare Products Association, the Council for Responsible Nutrition, the Natural Products Association, and the United Natural Products Alliance.
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