Trade Groups Suggest Office Upgrade For FDA Supplement Division
This article was originally published in The Tan Sheet
Executive Summary
An upgrade “would enhance the effectiveness of dietary supplement regulation by allowing this new Office to better compete for resources and attention within the Agency,” say CPHPA, CRN, NPA and UNPA.
Dietary supplement regulation receives inadequate attention and resources as a division of FDA’s food safety center but would “compete” for more of both with an upgrade on the agency’s organization chart to an office, industry trade groups suggest.
An upgrade “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” the Center for Food Safety and Applied Nutrition’s jurisdiction, such as cosmetics, medical foods, the Consumer Healthcare Products Association, Council for Responsible Nutrition, Natural Products Association and United Natural Products Alliance state in an Aug. 18 letter to FDA and the Department of Health and Human Services.
Since FDA established the Division of Dietary Supplement Programs after Congress passed the Dietary Supplement Health and Education Act in 1994, annual supplement sales in the US have increased from around $6 billion to more than $35 billion in 2014, the trade groups say.
The growth has come with “new regulatory challenges to appropriately monitor this marketplace,” the groups say in the letter also submitted to the industry’s key Capitol Hill allies, Sens. Orrin Hatch, R-UT, and Martin Heinrich, D-NM.
“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,” they say.
As a CFSAN office, dietary supplement regulation would not compete for the center’s enforcement priorities as it does now as a division in the Office of Nutrition, Labeling, and Dietary Supplements, the groups say.
“Elevation of the Division of Dietary Supplement Programs to an office status would allow the current division to better operate within the FDA structure, by providing it with more funding, autonomy and more direct lines of reporting. Further, such a move would provide additional significance to dietary supplement issues and hopefully create a more robust environment for them within FDA,” UNPA President Loren Israelsen said in an email.
The groups note a particular concern of Sens. Hatch and Heinrich – products marketed as supplements but spiked with drug and steroid ingredients – in their argument for the change (Also see "Senators Push Park Doctrine Prosecution For Spiked Supplement ‘Criminal Endeavors’" - Pink Sheet, 20 May, 2015.).
The “industry is deeply concerned about entities – both individuals and companies – who engage in blatant criminal activity by manufacturing and marketing products that masquerade as ‘dietary supplements’ but contain anabolic steroids, active pharmaceutical ingredients” or their analogs, according to the letter.
While urging FDA to upgrade DDSP to an office, industry groups also have pushed the agency to appoint a permanent director of the division. Numerous agency officials have served as acting director since Daniel Fabricant, NPA CEO, left the post in April 2013; work such as publishing a revised new dietary ingredient notification draft guidance more likely would be completed with a permanent division director in place, stakeholders say (Also see "Protecting DSHEA, Pumping Up Profile Lead Dietary Supplement Industry Priorities For 2015" - Pink Sheet, 26 Jan, 2015.).
The American Herbal Products Association, also a major industry group, did not sign the letter. AHPA did not respond to a request for comment.