Rep. Duncan urging colleagues to strike dietary supplement language from FDA user fee bill

A U.S. congressman is leading an effort to urge his colleagues in the House of Representatives to strike dietary supplement provisions from a bill that more broadly funds FDA user fee programs for such commodities as medical devices and drugs.

A bill funding the programs passed the House on June 8, but a similar user fee bill under consideration in the Senate incorporates language that would give FDA more authority over dietary supplements, including a new requirement that manufacturers and distributors list their products with the agency. The bill also would require FDA to develop and maintain a public database of dietary supplement products, earmarking around $33 million for FDA to carry out its obligations over five years from FY23 to FY27.

Dietary supplement trade groups have raised concerns over the Food and Drug Administration Safety and Landmark Advancements (FDASLA) Act of 2022, which a Senate committee with oversight of FDA issues recently passed. The Senate Committee on Health, Education, Labor and Pensions (HELP) narrowly rejected an amendment offered by Sen. Mitt Romney (R-Utah), which was intended to placate some of industry stakeholders’ concerns.

In a draft letter being circulated on Capitol Hill and elsewhere, Rep. Jeff Duncan (R-S.C.) is urging his colleagues to strike provisions on dietary supplements from any final bill that would reauthorize FDA user fee programs.

Related:Industry laments Romney’s failed tweaks to dietary supplement listing bill

“The reauthorization of the FDA user fee programs is not the appropriate vehicle to advance this controversial legislation, especially since it has not undergone the appropriate committee review and debate,” Duncan wrote in the draft letter.

He said his concerns extend far “beyond process” to substantive issues, including a provision in the FDASLA Act that “would make it a new ‘prohibited act’ to introduce into interstate commerce ‘any product marketed as a dietary supplement that does not meet the definition of a dietary supplement under Section 201(ff)'” of the Federal Food, Drug & Cosmetic Act (FDCA).

The provision is not related to the bill’s “ostensible purposes,” according to Duncan. Rather, it would grant “FDA an administrative excuse to reject ingredients like CBD (cannabidiol) and NAC (N-acetyl-L-cysteine) from being marketed as dietary supplements, regardless of the science or history involved,” the congressman wrote.

Duncan is building co-sponsors for the letter, which has garnered the support of multiple groups, including the Natural Products Association (NPA), whose CEO Dan Fabricant previously directed what was then known as FDA’s Division of Dietary Supplement Programs.

A spokesperson for Duncan said his office has been working primarily with NPA and also obtained the support of multiple groups. They include the American Herbal Products Association (AHPA), American Kratom Association (AKA), Alliance for Natural Health (ANH), Health Advocacy Forum (HAF), National Health Freedom Federation (NHF) and NOW Foods.

In an email Thursday, AHPA encouraged its members to express their views on mandatory product listing (MPL) to their congressional delegation and referenced the letter from Duncan. AHPA said it has learned that a member of both the Congressional Dietary Supplement Caucus and House Energy and Commerce Committee—Rep. Tony Cárdenas (D-Calif.)—is co-signing the letter.

A spokesperson for Cárdenas did not immediately respond Thursday to a request for comment for this article.

AHPA encouraged members opposed to MPL to contact their representative in the House to express their opposition and request the lawmaker sign Duncan’s letter. The trade association is unaware of a similar letter being circulated in the Senate, but AHPA said it would alert its members if that changes.

AHPA, which also has members who support MPL, said they may wish to contact their representatives in the House and Senate to voice their support for the proposal.

Fabricant’s organization in Washington, D.C., has been vigorously opposed to MPL since the introduction of a standalone bill in the Senate. In an interview, he expressed his gratitude to Duncan and Cárdenas for their support of industry.

Last week, NPA’s board of directors delivered a letter to all the offices of the members who sit on the House Energy and Commerce Committee, Fabricant said.

In the letter, NPA’s board expressed procedural and substantive concerns with the FDASLA Act.

“With all due respect to the Senate, this was opportunistic legislating, as there was no full and open discussion of its merits, which would allow the Committee to make an informed judgment on the legislation, its intended and unintended consequences, and the legitimate arguments on both sides,” NPA’s board wrote.

The board of directors comprises representatives from Natural Alternatives International, Southtown Health Foods, CBD Industries LLC, Nutrabolt, NOW Foods, Nutrition 21, The Vitamin Shoppe, Glanbia, Lief Organics, International Flavors & Fragrances Inc., Innovations in Nutrition and Wellness, Arbonne International, Omni Actives and Arizona Nutritional Supplements.

Among some of the substantive concerns raised in their letter: The Senate bill would repeal protections in the Bioterrorism Act (Public Health Security and Bioterrorism Preparedness and Response Act of 2002), fail to provide safeguards for trade secrets and lead to “the misuse of a public-facing database as pre-market approval.”

The dietary supplement provisions in the Senate "would compromise the security of the supply chain by requiring FDA to maintain a 'publicly accessible' database of detailed information related to supplements, ingredients and formulations," according to Duncan's letter. "Currently, this type of information is available to FDA but is shielded from public disclosure under the Bioterrorism Act to protect it from falling into the hands of malicious actors seeking to introduce contaminants into the nation’s food supply."

"The Senate bill," the congressman added, "would undermine these carefully crafted protections."

NPA’s board requested lawmakers on the House Energy and Commerce Committee join Duncan’s letter to prevent the inclusion of dietary supplement provisions in a final bill reauthorizing FDA user fee programs.

“Not only will such Senate provisions undermine the hard work of leadership and the Energy and Commerce Committee to keep the reauthorization bipartisan…but it will have grave consequences for the millions of Americans who use a supplement daily to stay healthy,” NPA’s board of directors warned.

Several industry trade groups—including the Council for Responsible Nutrition (CRN), the Consumer Healthcare Products Association (CHPA) and United Natural Products Alliance (UNPA)—supported standalone MPL legislation introduced in April by Sen. Dick Durbin (D-Ill.) and co-sponsored by Sen. Mike Braun (R-Ind.). However, they have expressed opposition to the current form of the FDASLA Act, which differs in certain respects from the standalone bill and is considered more onerous by industry stakeholders.

Steve Mister, president and CEO of CRN, declined to comment on MPL other than saying “negotiations continue on Capitol Hill.”

“CRN continues to work to get our concerns addressed,” he said via email. “We have previously stated that CRN will oppose inclusion of the dietary supplement provisions in FDASLA if our issues are not addressed.”

In an emailed statement, Marc Schloss, vice president of federal government affairs with CHPA, said his organization "continues to voice its concerns about the scope of MPL and the prohibited acts language contained in the FDASLA Act, as we do not believe the dietary supplement provisions included in the current bill will pave the way for an appropriate listing system that benefits the consumer, the FDA and industry."

UNPA did not immediately respond to a request for comment.

The MPL language certainly has supporters in the Senate, chief among them Durbin and HELP Committee Chair Patty Murray (D-Wash.).

“Following so many alarming reports in the past of known carcinogens in products like baby powder, hair spray, and kids’ make up kits—and so many years of dietary supplement manufacturers making unsupported health claims without any serious FDA oversight—I’m glad we were able to work in this legislation to ensure FDA can at long-last provide meaningful oversight to cosmetics and dietary supplements,” Murray said June 14 before her committee voted 13 to 9 to pass the FDASLA Act.