New Dietary Ingredient
FDA Issues Warning Letters to Firms Marketing Products Containing 7-Hydroxymitragynine
On July 15, the U.S. Food and Drug Administration (FDA) announced seven recent warning letters sent to companies for illegally marketing products containing 7-hydroxymitragynine, also known as 7-OH. This action reflects the Agency’s growing concern around novel potent opioid products being marketed to U.S. consumers and sold online and in smoke shops, gas stations and ...
NPA Files Lawsuit Against FDA’s “Unlawful Application” of Food, Drug and Cosmetic Act
The Natural Products Association (NPA) filed a lawsuit on Aug. 28 against the U.S. Food and Drug Administration (FDA), requesting the agency cease its “unlawful retroactive application” of the Food, Drug and Cosmetic Act against nicotinamide mononucleotide (NMN). “We are extremely grateful for the leadership shown by our organization’s members in deciding to take this ...
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Food Safety and Applied Nutrition (CFSAN) published a notice in the Federal Register announcing the availability of a draft guidance, “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-market Notification.”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 ...
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 ...
AHPA to Host Inaugural Hemp-CBD Dietary Supplement Congress
The American Herbal Products Association (AHPA) is presenting a two-day Hemp-CBD Supplement Congress in Denver, CO this August to provide critical input for companies navigating the rapidly evolving legal, regulatory and financial landscapes to manufacture and market dietary supplement products with hemp or hemp-derived ingredients including cannabidiol (CBD). The event features presentations from federal officials, ...
Alkemist Labs and REJIMUS Collaborate for GMP Compliance Solutions
Alkemist Labs (Garden Grove, CA) and REJIMUS (Santa Ana, CA) have announced a collaboration to offer comprehensive GMP (good manufacturing practice) compliance solutions to clients, eliminating gaps where many companies are failing GMP audits, NDI (New Dietary Ingredient) applications, and other regulatory-related responsibilities. “FDA (U.S. Food and Drug Administration) has said time and time again ...
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