fda
Industry Questions FDA Policy Notice on NDIs
On May 20, FDA’s (U.S. Food and Drug Administration) Center for Food Safety and Applied Nutrition (CFSAN) published a notice in the Federal Register announcing the availability of a draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.” Under the new policy described in this draft ...
NPA Responds to Report of Increased, Unintentional Pediatric Melatonin Ingestion
Over the past decade and particularly since the beginning of the COVID-19 pandemic, the use of melatonin supplements to address sleep issues has increased significantly by both adults and children. On Thursday, June 3, the Centers for Disease Control and Prevention (CDC) released a 10-year study that found a sharp increase in the use of ...
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 U.S. Food and Drug Administration (FDA). The Dietary Supplement Listing Act of 2022 would require companies to provide FDA with vital information about their ...
CRN Dismisses FDA Response on N-acetyl-cysteine (NAC)
The Council for Responsible Nutrition (CRN) on March 31 denounced the U.S. Food and Drug Administration’s (FDA) 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 ...
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 ...
NPA Files Citizen’s Petition With FDA on Specific CBD Relief
On Feb. 22, in a Citizen’s Petition to the U.S. Food and Drug Administration (FDA), the Natural Products Association (NPA) requested the FDA either: Determine cannabidiol (CBD) is not excluded from the definition of a dietary supplement under 21 U.S.C. §321(ff)(3)(B) allowing the Commissioner the ability to exercise enforcement discretion in a specific and selective ...
Senate Confirms Robert Califf as FDA Commission, Associations Respond
On Feb.15, the U.S. Senate confirmed Dr. Robert Califf to lead the U.S. Food and Drug Administration (FDA) for a second time in a 50-46 vote. In response to the confirmation, the Natural Products Association (NPA), the Council for Responsible Nutrition (CRN), and the Consumer Healthcare Products Association (CHPA) released the following statements: “This agency ...
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 ...
In Memoriam: James S. Turner, 81, Esq., Chairman & President, Citizens for Health
James S. Turner, Esq., Chairman and President of Citizens for Health (CFH), passed away suddenly at his Washington, D.C. home on January 25th; he was 81. One of Ralph Nader’s original “Nader’s Raiders,” Turner co-wrote the 1970 book, The Chemical Feast: Ralph Nader’s Study Group Report on the Food and Drug Administration. Time Magazine commented at the ...
California Assembly Votes to Restrict Access to Supplements, NPA Responds
On Jan. 27, the California Assembly passed legislation by a vote of 44-12 that would place age restrictions on nutritional supplements and impose costly burdens on small businesses. The bill will now go through the committee process in the California Senate. The Natural Products Association (NPA) warns that the bill will lead to unintended consequences that include ...
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