New supplement rules tacked on to bill authorizing FDA fees
The bill comes out of the Senate HELP (Health, Education, Labor and Pensions) Committee and bears the names of Chair Sen. Patty Murray (D-WA) and Ranking Member Sen. Richard Burr, (R-NC).
Called the FDA Safety and Landmark Advancements (FDASLA) Act, the bill reauthorizes FDA’s prescription drug, generic drug, biosimilar, and medical device user fee agreements. Significantly, however, it is also contains provisions meant, in Sen. Murray’s words, to “provide long overdue oversight of cosmetics and dietary supplements.”
Such fee reauthorization bills are generally boilerplate affairs that generate little to no controversy. Indeed a House reauthorization bill, which does not contain dietary supplement provisions, passed yesterday on a 392-28 vote.
Bill sets out new listing requirements, makes other changes
That’s why some in the industry have viewed with concern the tacking on of the supplement provisions into a bill that’s sure to pass in one form or another. It’s something akin to the practice of trying to slip in not very closely related riders into bills funding basic Federal government operations, which must be passed at some point.
The portions of the bill aimed at dietary supplements would require manufacturers to submit a listing of the product to FDA prior to going to market. The bill has eight individual citations relating to this requirement. Products that don’t comply with the listing requirement would be judged to be misbranded.
In addition the bill would direct FDA to publish final guidance on New Dietary Ingredients within 18 months. It also delineates two additional prohibited acts. One would be to market a supplement that contains an ingredient that “does not meet the definition of a dietary supplement” The other would be for someone who has been debarred from the industry to market a supplement. The Senate is set to consider its version of the bill on June 14. The current FDA fee authorization expires at the end of September, and lawmakers have said they want a new version in place before the August recess.
NPA: Fee bill wrong place to make changes to supplement regs
The Natural Products Association reacted most stridently to the wording of the bill. President and CEO Daniel Fabricant, PhD, said he can understand how some lawmakers might become frustrated with the pace of change at FDA, but he sees no justification in trying to do an end run of sorts by attaching these ideas to the user fees reauthorization tool.
In a letter to the two Senators, Fabricant wrote, “As the former Director of the Division of Dietary Supplement Programs and now an industry executive, I write to you with grave concerns about the FDA Safety and Landmark Advancement Act (FDASLA) and its inclusion of dietary supplement provisions. In the history of the user-fee reauthorization, dietary supplements have never been included, and rightfully so. Dietary supplements are not prescription drugs, generic drugs, biosimilars, or medical devices, which the reauthorization has always been intended to cover.”
“The NPA strongly urges the committee to drop this section and re-direct the authorized spending to higher priority challenges faced by CFSAN. The FDASLA provides the FDA with an excessive administrative burden that exceeds the current scientific safety evaluation for FDA when companies wish to introduce a new supplement into the market. Providing the FDA with authority to decide administratively what is to be listed will only be abused, causing extreme economic harm. Additionally, as administrative disagreements do arise (i.e. CBD, NAC etc.) between the industry and the FDA on the ingredient’s status rather than a scientific rendering, should this become law, it will eliminate a product from a listing and the marketplace purely on their biases and do so administratively, without any due process,” the letter continued.
Israelsen: Work going on behind scenes to alter bill
Loren Israelsen, president of the United Natural Products Alliance (UNPA), said his organization has been working in concert with the Consumer Products Healthcare Alliance (CHPA) and the Council for Responsible Nutrition (CRN) to suggest changes to the bill that the industry could live with.
While the three associations have been generally on board with a Mandatory Product Listing requirement, Israelsen said four key sticking points have cropped up, which, if not altered, could trigger opposition to this bill. They are:
Requiring information beyond that which is on the label, not structure/function or health claims that appear elsewhere
Failure to provide clear protections against disclosure of confidential business information
Lack of a clear statement that nothing in the bill grants or permits any pre-approval requirement for supplements
Inclusion of a new prohibited act that would allow seizure of a product on highly technical grounds.
For the complete current working of the bill, click here.
