Tuesday, May 17, 2022

User-fee draft in Senate calls for dietary supplement product listing – Natural Products INSIDER

Leaders of the Senate Health, Education, Labor and Pensions (HELP) Committee on Tuesday introduced a discussion draft of legislation that would reauthorize FDA user fee agreements for certain products, including drugs and medical devices.

More relevant to the natural products industry are provisions that would require manufacturers list their dietary supplement products with FDA. Dietary supplement products that failed to meet the listing requirement would be deemed “misbranded.”

Many provisions in the discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act largely mirror a dietary supplement bill introduced in April by Sens. Dick Durbin (D-Ill.) and Mike Braun (R-Ind.). But the discussion draft, which was introduced by Senate HELP Committee Chair Patty Murray (D-Wash.) and Ranking Member Richard Burr (R-N.C.), also exceeds the scope of the Dietary Supplement Listing Act of 2022.

Senate leaders proposed making it a “prohibited act” to introduce into interstate commerce a product marketed as a dietary supplement that does not meet the definition of a dietary supplement under U.S. law. CBD (cannabidiol) and NAC (N-acetyl-L-cysteine) are among the ingredients that FDA has concluded fall into the latter category, despite being widely marketed as dietary supplements in the U.S.

The draft also includes provisions modernizing regulation of cosmetics, including a requirement that FDA establish GMP (good manufacturing practice) regulations.

“This legislation will ensure FDA has the resources it needs to do its work—and will enable the agency to finally provide serious oversight of the cosmetics and dietary supplements people in Washington state use every day,” Murray said in a news release.

Relevant to dietary supplements, the discussion draft also would require FDA to:

– Publish final guidance on new dietary ingredient notifications within 18 months of the bill’s enactment; and 

– Direct its “resources to inspections of facilities, suppliers and dietary supplement types that present a high risk to public health.”

The Senate bill is considered a piece of must-pass legislation in Congress since FDA user fees under five-year-old agreements are set to expire Sept. 30.

A companion legislative package introduced May 4 in the House Energy and Commerce Committee doesn’t contain a requirement that supplements be listed with FDA.

It remains to be seen whether any final user-fee bill passed by Congress will incorporate provisions impacting manufacturers of dietary supplements.

Mandatory product listing has been a deeply divisive issue in the industry—with some trade associations, including the Natural Products Association (NPA), strongly opposed to the idea.

“The NPA is significantly concerned with Chair Murray and Republican Leader Burr, who failed to reject the radical and dangerous legislation from Senators Durbin and Braun that would require premarket approval for dietary supplements and weaken key privacy protections of the Bioterrorism Act, which protects the dietary supplement supply chain,” NPA President and CEO Dan Fabricant said in a written statement.

If the Senate legislation is passed, “it is abundantly clear” ingredients such as NAC and CBD would be removed from the market, according to Fabricant, who directed FDA’s Division of Dietary Supplement Programs from 2011 to 2014. CBD and NAC are the subject of disputes between FDA and industry regarding their legality in dietary supplements.

“Please tell me where it says [in the discussion draft] products that are the subject of a prohibited act are going to be on a mandatory product listing,” Fabricant said in a follow-up interview.

He argued there’s no chance FDA would list such products. Asked for this story what that would mean for CBD products labeled as supplements, Fabricant responded, “That means they’re gone. Good luck.”

Other industry trade groups in favor of mandatory product listing argue it does not amount to premarket approval of dietary supplements, will increase transparency and help FDA more effectively regulate an industry that has grown tremendously since passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA).

 “Mandatory product listing is an important component of modernizing DSHEA, but more needs to be done to enhance quality, ensure safety and provide the transparency and predictability needed to promote innovation in the dietary supplement industry,” Scott Melville, president and CEO of the Consumer Healthcare Products Association (CHPA), said in a statement after Durbin’s bill was introduced. ”We look forward to continuing to work with the bill sponsors on our shared commitment to provide greater oversight of products that 77 percent of Americans have used over the past calendar year.”

CHPA and the Council for Responsible Nutrition (CRN), which also has supported mandatory product listing, had no immediate comment on the Senate’s discussion draft.

The Pew Charitable Trusts, a nongovernmental policy group that also supports mandatory product listing, reacted to Tuesday’s development in an email to Natural Products Insider.

Liz Richardson, project director of Health Care Products with The Pew Charitable Trusts, said her organization was “pleased that the committee’s bipartisan bill recognizes the urgent need to improve safety and transparency in the dietary supplement marketplace.”

“Requiring supplement manufacturers to give the FDA basic information about their products will help protect the millions of Americans who use supplements,” she added. 

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