U.S. Food and Drug Administration
FDA’s Long-Sought Guidance on NAC Follows NPA’s Lawsuit and Citizen’s Petition
Following a Citizen’s petition and lawsuit filed by the Natural Products Association (NPA) against the U.S. Food and Drug Administration (FDA) for a dietary supplement issued enforcement discretion for N-Acetyl-Cysteine (NAC) has resulted in the agency issuing final guidance. “This is a big win but it is bittersweet for sure. Although it was NPA’s leadership ...
Senate HELP Committee Leaders Looks to Advance FDASLA With Controversial Provisions
On June 13, the United States Senate ignored the dietary supplement industry by continuing to move forward with provisions left in the Food and Drug Administration Safety and Landmark Advancement Act (FDASLA), according to the Natural Products Association (NPA). The NPA requested from the Senate HELP committee in a series of letters that the committee strike the ...
NPA Applauds House Energy & Commerce Committee for Excluding Dietary Supplements from User-fee Reauthorization Legislative Package
On May 4, the United States House of Representatives Energy and Commerce Committee unveiled its FDA User Fee legislative package, which did not include the “mandatory product listing” concept in its legislation to reauthorize FDA user fees for drugs, biologics and medical devices. “The NPA applauds Chairman Frank Pallone and Republican Leader Cathy McMorris Rodgers ...
Durbin, Braun Introduce Legislation to Mandate Product Listings for Dietary Supplements
U.S. Senate Majority Whip Dick Durbin (D-IL) and U.S. Senator Mike Braun (R-IN) introduced the Dietary Supplement Listing Act of 2022, bipartisan legislation to require dietary supplement manufacturers to list their products with the Food and Drug Administration (FDA). The Dietary Supplement Listing Act of 2022 would require companies to provide FDA with vital information about their products, ...
CRN and NPA Respond to FDA’s Enforcement Discretion Guidance on NAC
Both the Council for Responsible Nutrition (CRN) and the Natural Products Association (NPA) have responded to the U.S. Food and Drug Administration’s (FDA) draft enforcement discretion guidance on the use of NAC (n-acetyl-cysteine). Steve Mister, president and CEO of CRN, stated that “CRN appreciates FDA’s quick action following its March 31 response to our citizen petition with ...
NPA Says Mandatory Product Listing is a “Non-Starter” and Amounts to “Pre-Market Approval”
The Natural Products Association (NPA) has issued a statement on the President’s FY 2023 Budget Request to Congress regarding the section on the U.S. Food and Drug Administration (FDA). “FDA’s proposal to include mandatory product listing in their FY23 budget request is a non-starter,” said Dr. Daniel Fabricant, the association’s president and CEO. “Year after ...
CRN Dismisses FDA Response on N-acetyl-cysteine (NAC)
The Council for Responsible Nutrition (CRN) on March 31 denounced FDA’s decision regarding the legal status of n-acetyl-cysteine (NAC) as a dietary ingredient. “CRN is extremely disappointed and unconvinced by FDA’s response today that it has chosen to deny CRN’s citizen’s petition while holding out the possibility that it may open a rulemaking specific to NAC instead,” ...
CHPA, NPA and CRN Release Statements on New FDA Commissioner Califf
The Consumer Healthcare Products Association (CHPA), the Natural Products Association (NPA) and the Council for Responsible Nutrition (CRN) all issued statements on Feb. 15 regarding the confirmation of Robert Califf, M.D., as the new U.S. Food and Drug Administration (FDA) commissioner. Scott Melville, president and CEO of CHPA, said the following: Dr. Robert Califf “Dr. ...
CRN Responds to Commentary on Supplement Use by U.S. Troops
The Council for Responsible Nutrition (CRN) has responded to a recent commentary appearing in the Military Times and other publications that called for a centralized reporting system in the military for adverse events reported by dietary supplement users. CRN President and CEO Steve Mister advised, “CRN enthusiastically agrees we all have a role in ensuring that supplements ...
ICYMI: NPA’s Fabricant Appears on CBS “The Doctors”
Daniel Fabricant, PhD., president and CEO of the Natural Products Association (NPA) and the former chief regulator of the dietary supplement industry appeared on the CBS show “The Doctors” on February 7, 2022. Fabricant discussed the unintended consequences of legislation in California that would place age restrictions on nutritional supplements. The legislation recently passed by ...
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