Washington, D.C.—Earlier this year, the Senate Health, Education, Labor, and Pensions (HELP) Committee released a discussion draft of legislation to reauthorize FDA user fees for drugs, biologics, and medical devices—and the legislation includes the Durbin-Braun premarket approval concept.
As WholeFoods Magazine reported, the Natural Products Association (NPA) has been cautioning that this would be damaging to the industry. In a series of letters, NPA requested that the Senate HELP committee strike the entire dietary supplement section of the Food and Drug Administration Safety and Landmark Advancement (FDASLA) Act of 2022 (S.4348). Alternatively, NPA asked for the inclusion of provisions that prohibit FDA from excluding or removing products from the listing unless and until the product is subject to final agency action.
Daniel Fabricant, Ph.D., President and CEO, explained NPA’s concerns. “The reauthorization of the FDA user fee program is not the appropriate vehicle to include controversial dietary supplement legislation, especially since it has not undergone the appropriate committee review and debate,” Dr. Fabricant said. “A public database as proposed in the FDASLA is completely inconsistent with the facility registration provisions of the Bioterrorism Act. Twenty years ago, Congress decided there was a compelling reason to protect specific information about dietary supplement production from falling into the hands of people with malicious intent. The current version of the FDASLA insufficiently shields critical pieces of information.”
Industry Takes Action
NPA launched a grassroots campaign to fight the legislation. “Over 100,000 constituents have contacted to register their strong opposition to the dietary supplement provisions in the FDASLA,” Dr. Fabricant shared. “Our industry has never been required to pay user fees, nor do we have pre-emption from state tort claims that exist for other FDA-regulated products. Prohibiting the FDA from excluding or removing products from the listing unless there is final agency action is the only way the industry can preserve any due-process rights against the agency should a dispute arrive, like the current disputes over cannabidiol (CBD), N-acetyl cysteine (NAC). Otherwise, the agency could still use MPL as a basis to deny or de-list products containing disputed ingredients, even if the ‘prohibited act’ language discussed earlier were removed and even with the addition of the language about premarket approval.”
On June 14, the Senate HELP Committee passed FDASLA.
NPA stressed that that the legislation removes protections for dietary supplement manufacturers under the Bioterrorism Act and would allow FDA to “administratively, without checks and balances, reject ingredients like CBD and NAC from being marketed as dietary supplements, regardless of the science or history involved.”
Regarding this latest development, Dr. Fabricant said: “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, have to this point, appear to have fallen on deaf ears. 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.”
Dr. Fabricant added, “We’re pleased the House in its wisdom did not include any of these unwise and dangerous provisions in its version of this legislation, 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.”
CHPA “Strongly Concerned”
Consumer Healthcare Products Association (CHPA) President and CEO Scott Melville released statement today following the Senate HELP Committee’s passage of the FDA Safety and Landmark Advancement (FDASLA) Act of 2022. “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,” Melville said. “Moreover, the legislation falls short of the comprehensive reforms needed to appropriately and effectively modernize the regulatory framework for dietary supplements.
“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.”
NPA Calls for Grassroots Action
NPA again stressed the importance of action. The organization encouraged all health and wellness advocates to continue writing their members of Congress through the NPA Action Center. As NPA noted, “Grassroots involvement has been critical and continued pressure is needed to defeat this proposal.”