While affirming opposition to mandatory product listing, the American Herbal Products Association offered its feedback and suggested revisions to the discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act published by the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP).
While affirming its position that establishing a mandatory product listing is unnecessary, redundant, unlikely to address any of FDA’s actual regulatory needs, and inevitably reduce access to broad range of dietary supplement products, the American Herbal Products Association (AHPA; Washington, D.C.) offered its feedback and suggested revisions to the discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act published by the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP).
AHPA’s first suggestion is that compliance to the mandatory product listings should be simplified to include just “(1) identification of and contact information for the responsible person and the associated owner, operator or agent in charge (if a domestic firm) or U.S. agent (if a foreign entity), and (2) product labels.” The original language demands that dietary supplement manufacturers submit a great deal of information that is already present on the label. By simplifying these requirements, the burden on manufacturers would be significantly reduced, says AHPA, citing its recent cost analysis.
“A preliminary cost analysis performed by AHPA estimates that the covered industry would need to spend at least $20 million to provide all of the detailed information identified in each of the above cited paragraphs, if submission comes to require manual data entry to a system created by FDA,” states AHPA in its letter to Senators Murray and Burr of the Senate HELP Committee. “AHPA assumes that this cost will be significantly less if listing can be accomplished simply by submitting labels to FDA, with no reduction in the product information received by the agency.”
AHPA also strongly opposes requirements in the draft for manufacturers to disclose “the amount per serving of dietary ingredients within a proprietary blend,” because the “information is generally considered to be important intellectual property owned by a dietary supplement company and thus has significant economic value.” Moreover, FDA already has the ability to obtain this information through access to dietary supplement manufacturing records during facility inspections.
Nor does AHPA support a public facing database of dietary supplement labels because of concern that such a database would be exploited by opportunistic private plaintiffs. Additionally, the association points outs that cosmetic labels are not required to be published to a public facing database despite similar listing requirements. “Subtitle A of the discussion draft, relating to cosmetics regulation, includes a product listing requirement for cosmetic products, but does not authorize the creation of a publicly accessible database of cosmetics products,” states AHPA. “AHPA sees no additional utility, and significantly increased regulatory cost for FDA, in the creation and upkeep of a publicly available database for dietary supplement products.”
Perhaps the most important suggestion made by AHPA is language that clearly states FDA cannot refuse submission of product listing for any reason whatsoever. Premarket approval is a dealbreaker for any industry support of mandatory product listings, and much of the criticism levied against the recent proposals for mandatory product listings has to do with the lack of explicit wording that would prevent FDA from denying submissions.
Read AHPA’s full letter for more detailed commentary and suggestions.