Regulatory

President Joe Biden has announced his nomination of Robert Califf, MD, to serve as the commissioner of the Food and Drug Administration.

The patent claim is stated as a “method of increasing GLP-1 levels in a subject in need thereof, comprising administering a composition comprising eriocitrin to the subject.”

At this October’s SupplySide West trade show, Nutritional Outlook interviewed Kyle Einhorn, HempRise’s vice president of sales, about why the company felt now is the right time to make this significant investment and about what its plans are as the U.S. dietary industry waits to find out whether hemp cannabidiol (CBD) will be made a legal dietary ingredient in the U.S.

The patent is for improving endurance and reducing fatigue during workout for pre and post workout product applications.

The new bill is a companion to Senate bill 1654.

NSF International created an introductory “GMPs for Dietary Supplements – 21 CFR 111 Overview” eLearning module, and with the promo code “DSHEA27” (from Oct 25 – 31, 2021), participants can access it at no cost.

The National Organic Program, managed by the U.S. Department of Agriculture, granted organic certification to BGG World and its subsidiary Algae Health Sciences for its astaxanthin supercritical CO2 oleoresin ingredient, AstaZine.

The Global Retail and Manufacturer Alliance (GRMA) named two new board members, Holly Korteway from Perrigo and Jeff Brams from Garden of Life.

The consent decree prohibits the defendants from manufacturing or distributing dietary supplements until they hire a labeling expert, pull violative labeling, and receive written permission from FDA to resume operations.

The Biden administration is considering nominating Robert M. Califf, former commissioner of the FDA who served between February 2016 and January 2017 under the Obama administration, to once again served as the agency’s chief.

Kaneka has announced that its Lactobacillus plantarum DR7 probiotic, designed to support the gut-brain axis, is now self-affirmed GRAS.

The ingredient is based on water-soluble eggshell membrane and has been shown to reduce hair breakage and improve hair growth in four weeks, thanks to constituents like collagen and elastin.

New California law to regulate industrial hemp products including CBD.

U.S. District Court of the Southern District of New York upholds the legality of FDA's GRAS process.

OmniActive Health Technologies announces the independent conclusion of GRAS for Gingever.

The American Herbal Products Association (AHPA; Silver Spring, MD) recently conducted a survey to determine what percentage of its membership is in favor of AHPA supporting a requirement for all dietary supplements in the U.S. to be listed in a federal database.

Given recent developments in the CBD space, what does the future hold for hemp-derived CBD and other cannabinoids?

MacKay, a doctor of naturopathic medicine, most recently served as senior vice president, scientific and regulatory affairs at CV Sciences.

NNB Nutrition’s MitoBurn, a non-protein amino acid metabolite of the branched-chain amino acid L-valine, is now self-affirmed GRAS as a powdered food ingredient in sports drinks and in grain-based bars, nutrition bars, and instant-powdered nutritional beverages.

Health Canada recognizes a probiotic from Lallemand Health Solutions for the support of a healthy vaginal microbiome.

New bill to expand HSA and FSA coverage to include dietary supplements as a medical expense.

FDA and FTC sent warning letters to ten companies.

More labeling transparency, strain specificity, and research is needed to strengthen the evidence linking probiotics with health benefits, said two experts at the Consumer Healthcare Products Association’s Regulatory, Scientific & Quality Conference last week.

Legislation could very well be in the works to propose mandatory product listing for dietary supplements in the U.S., said speakers at the Consumer Healthcare Products Association’s Regulatory, Scientific & Quality Conference last week.

NattoPharma has secured patents in Canada and South Korea for its proprietary process of synthesizing MenaQ7 PharmaPure Vitamin K2.

Bionap Bioactive Natural Products has achieved self-GRAS status with the help of GRAS Associates, a fully-owned subsidiary of Nutrasource.

AHPA submits comments to the Senate sponsoring office of the "Cannabis Administration and Opportunity Act."

Matt Storey of NuSachi Inc. discusses the challenges of establishing cannabis evidence to satisfy both regulators and consumers alike.