A proposed amendment introduced by Sen. Mitt Romney to the FDA Safety and Landmark Advancements (FDASLA) Act was defeated Tuesday by the Senate Committee on Health, Education, Labor & Pensions (HELP), dealing a blow to dietary supplement trade groups seeking changes to the bill.
The amendment initially appeared to pass 12-10, but Sen. Ben Ray Luján (D-N.M.) asked to hear his initial vote (“aye”) and changed it to “nay,” leaving an 11-11 tally that meant the measure failed.
The vote leaves unchanged dietary supplement language in the “must pass” FDASLA Act, which was passed Tuesday by the Senate HELP Committee by a vote of 13 to 9.
The sweeping bill reauthorizes the user fees FDA can collect for certain commodities like generic and pharmaceutical drugs, while incorporating reforms to the cosmetic and dietary supplement industries.
A section previously added to the FDASLA Act would require a distributor, packer or manufacturer whose name appears on the label of the supplement to list their products with FDA. Among the disclosures: the name of the supplement and a statement of identity, a list of ingredients, allergen statements, warnings, and addresses of facilities where a product is manufactured, packaged, labeled or held.
Three industry trade organizations that generally support a requirement that dietary supplement products be listed with FDA have expressed concerns with certain provisions in the FDASLA Act.
“We are extremely disappointed that the Senate HELP Committee failed—on a tie vote—to approve common sense improvements to the dietary supplement provisions in its FDA user fee reauthorization bill,” United Natural Products Alliance (UNPA) President Loren Israelsen said in an email.
The development “leaves UNPA no choice but to withhold support for the bill as … reported,” said Israelsen, who expressed his gratitude to Romney for offering an amendment. “We will be working with our membership and other trade associations to rectify these shortcomings as the bill moves to the full U.S. Senate. UNPA remains hopeful that its recommended changes can be addressed and that a responsible and acceptable mandatory listing provision can be approved by the full Congress.”
Council for Responsible Nutrition (CRN) President and CEO Steve Mister also was disappointed in the outcome of a vote on a bill that he said “fails to include protections necessary for responsible industry to thrive.”
“As the industry’s leading proponent for a federal mandatory product listing program operated by FDA, CRN remains steadfast in our belief that such a program can provide consumers and the agency the transparency they want and need from the marketplace,” Mister commented in a statement. “However, that transparency does not require confidential business information to go unprotected and should not necessitate trading away assurances that the authority to create the listing will not be misused.”
In a news release Monday, Romney’s office said the Republican senator from Utah was offering “seven amendments to ensure dietary supplements companies, an industry vital to the state’s economy and health, can continue to thrive even as Congress looks to increase transparency.”
His release was issued prior to the Senate HELP Committee’s hearing to “mark up” the FDASLA Act, which represented the last chance to debate, amend and rewrite a bill in committee.
During Tuesday’s hearing, Romney said he was offering one amendment pertaining to dietary supplements that “says if trade secret information is provided that it would be treated with confidentiality, and if in fact a company is required to provide sensitive information, the FDA must explain why they’re asking for that information and retain its confidentiality.”
In the hearing, Romney said three trade groups supported the amendment: CRN, UNPA and the Consumer Healthcare Products Association (CHPA).
The amendment voted on in the Senate HELP Committee covered “confidentiality and the scope of listing,” according to CHPA spokesperson Logan Tucker. Romney’s staff did not respond to Natural Products Insider’s requests for comment on the scope of the amendment that committee members voted on.
Senate HELP Committee Chair Patty Murray (D-Wash.) described Romney’s amendment as undermining “the important consumer protections for dietary supplements that we have included in this package by eliminating FDA’s ability to collect key ingredient information from manufacturers.” She said she would vote “no” on his proposal.
Romney responded to his colleague, “[The] amendment is not designed to prevent the FDA from getting any information it wants. It’s only requiring them to explain why they want it and then to keep it confidential, but does not prevent them from gathering any information.”
Murray wasn’t persuaded, concluding she had a “difference of opinion.”
Reacting to the vote on Romney’s dietary supplement amendment, CHPA President and CEO Scott Melville expressed concerns with the bill in its current form.
“While CHPA remains highly supportive of an appropriate listing system for dietary supplements that will enhance consumer safety, we are strongly concerned that the dietary supplement provisions of this legislation are overly broad and will place unnecessary and costly burdens on the entire industry,” he said in a statement. “Moreover, the legislation falls short of the comprehensive reforms needed to appropriately and effectively modernize the regulatory framework for dietary supplements.”
He added, “CHPA remains committed to working with congressional leaders in both parties on an appropriate listing system that paves the way for increased visibility into the dietary supplement marketplace, while also providing consumers with the assurances they deserve regarding dietary supplements sold in the United States.”
CRN’s Mister said any bill his organization supports must protect from public release confidential or proprietary business information, restrict to items appearing on the label the information that must be provided to FDA and eliminate the creation of any “new prohibited acts” in the law that could produce unintended consequences. CRN and other trade associations also have called for changes to ensure FDA does not use the listing as a tool for premarket approval of dietary supplements.
In a phone conversation, Natural Products Association (NPA) President and CEO Dan Fabricant said he was disappointed no lawmakers introduced language to completely strike all the dietary supplement provisions from the FDASLA Act. NPA has vigorously opposed the FDASLA Act and been at odds with other trade organizations over their support for a stand-alone mandatory product listing bill introduced in April by Sen. Dick Durbin (D-Ill.) and co-sponsored by Sen. Mike Braun (R-Ind.): the Dietary Supplement Listing Act of 2022.
Many of the dietary supplement provisions incorporated in the FDASLA Act came from the stand-alone bill, though the subsequently introduced FDASLA Act also included language that riled industry. That included a provision making 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” federal law. Incidentally, Braun voted to approve the Romney amendment in the committee markup hearing.
Among NPA’s concerns is the FDASLA Act would grant FDA discretion to reject a product in the listing, such a supplement containing CBD or NAC (N-acetyl-L-cysteine), regardless of the ingredient’s history or science.
“We are disappointed that the significant economic, consumer and security-related concerns that have been raised by NPA, other experts and thousands of American constituents … appear to have fallen on deaf ears,” Fabricant said in a separate written statement. “We will redouble our efforts to continue educating members and staff about the deep negative impact of these provisions in hopes that we can get a fair hearing as the legislative process unfolds.”
Lawmakers in the House of Representatives recently passed a bill that would reauthorize FDA to collect user fees for certain commodities including drugs, though their version (H.R. 7667) does not include any dietary supplement provisions.
“We’re pleased the House, in its wisdom, did not include any of these unwise and dangerous provisions in its version of this legislation,” Fabricant said, “and we are asking the Senate to reject these provisions on the floor when it comes for a full vote and the House to reject these Senate provisions in any final agreement between the chambers.”