NDI
FDA Releases New Dietary Ingredient Final Guidance, Associations Respond
On March 5, the U.S. Food and Drug Administration (FDA) announced the availability of a final guidance for industry titled “Dietary Supplements: New Dietary Ingredient Notification Procedures and Timeframes: Guidance for Industry.” According to the FDA, the guidance is intended to help manufacturers and distributors of new dietary ingredients (NDIs) and dietary supplements prepare and ...
Trade Associations Respond to FDA’s Denial of CBD Citizen Petitions
The Natural Products Association (NPA), the Council for Responsible Nutrition (CRN) and the Consumer Healthcare Products Association (CHPA) have responded to the U.S. Food and Drug Administration’s (FDA) denial of the associations’ CBD Citizen Petitions on Jan. 26. “This is an astonishing dereliction of duty, especially compared to the agility and professionalism the agency showed ...
Talking Regulatory Issues With Mark LeDoux
Nutrition Industry Executive magazine asked Mark LeDoux, Chairman & CEO of Natural Alternatives International based in Carlsbad, CA, for his take on three regulatory-related questions. NIE: What is the single biggest regulatory or enforcement problem that the natural products industry currently faces? To some degree, the largest challenge in the regulatory or enforcement area of ...
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Food Safety and Applied Nutrition (CFSAN) published a notice in the Federal Register announcing the availability of a draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.”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 ...
Open Book Extracts Completes Phase 1 of Toxicology and Safety Assessment for CBG, CBN and CBC
Open Book Extracts (OBX, Roxboro, NC) has announced the completion of phase one of the toxicology and safety results for its cannabinoid ingredients cannabigerol (CBG), cannabinol (CBN), and cannabichromene (CBC). OBX contracted respected scientific and regulatory consulting firm, AIBMR Life Sciences, Inc, to conduct the battery of toxicological studies to investigate the safety of the ...
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 ...
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 ...
Associations Comment on the Nomination of Robert M. Califf for FDA Commissioner
On Nov. 12, President Biden announced that he will nominate Robert M. Califf, MD for commissioner of the U.S. Food and Drug Administration (FDA). Califf is an internationally recognized expert in clinical trial research, health disparities, health care quality and cardiovascular medicine. He has nearly four decades of experience as a doctor, researcher, leader and ...
CRN: New FDA Announcement on CBD Signals Continued Agency Inaction
In response to a notice issued on Jan. 8, 2021, from the U.S. Food and Drug Administration (FDA), titled, “Better Data for a Better Understanding of the Use and Safety Profile of Cannabidiol (CBD) Products,” the Council for Responsible Nutrition (CRN) issued the following statement: “Today’s notice, late in the day, late in a week that ...
NPA Proposes Streamlined Data Sharing at FDA
The Natural Products Association (NPA) outlined a streamlined process to facilitate data sharing within the agency in comments to the U.S. Food and Drug Administration (FDA). Specifically, NPA suggested sharing data from the Office of Dietary Supplement Programs on structure/function claim notifications, new dietary ingredient (NDI) notifications, current good manufacturing practice (cGMP) inspections and certificate ...
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