Regulatory

AHPA provides three sets of examples: the marketing of NAC as an ingredient for use in conventional foods and dietary supplements, the use of NAC in dietary supplements, and the marketing of NAC as a conventional food prior to October 1994.

In comments submitted to FDA on January 25, CRN says the agency continues to fail to address the key question the association asked in a citizen petition last year—whether NAC can be banned as a supplement ingredient under the FD&C Act’s drug preclusion clause—and is now demanding the agency respond within 30 days.

AOAC International and the Global Retailer and Manufacturer Alliance has signed a memorandum of understanding (MOU) that establishes a strategic partnership for the advancement of their shared goals of consumer product safety standards.

Although companies often market their products to include naturally sourced cinnamon bark oil, the industry faces a high risk of fraudulent claims due to acts of economically motivated adulteration.

There’s more at stake than just one ingredient in the battle between the supplements industry and FDA over N-acetyl-L-cysteine (NAC).

The international food standard safety authority, Codex Alimentarius, has adopted the Framework for Steviol Glycosides, which encompasses four technologies used in the production of steviol glycosides.

Nutritional Outlook’s Editorial Advisory Board shares its predictions and tips for success in 2022.

A more active and aggressive FTC, as well as scrutiny from other regulators, will keep dietary supplement and nutrition brands on their toes in 2022. Here’s what one lawyer says you should watch out for.

HempFusion Wellness Inc. has announced that its proprietary hemp-derived CBD extract has achieved self-affirmed GRAS (Generally Recognized as Safe) status.

Dietary supplement industry leaders and associations share their 2022 regulatory predictions.

In its letter, CRN takes issue with FDA’s “tentative response” which side-stepped any legal issues raised in the citizen petition.

The Federal Government of Malaysia now recognizes NSF Shanghai’s dietary supplements GMP certification (NSF/ANSI 455-2 GMP) as a requirement for Chinese manufacturers seeking to export supplement products into the Malaysian market.

The BRC standard provides a framework for the management of product safety, authenticity, quality, and legality, rating companies on a scale from AA to D.

Recent NAD cases demonstrate that brands must stay vigilant or risk regulatory action.

The China National Intellectual Property Administration issued Patent No. ZL 2017 1 1177638.2 for Certified Nutraceuticals’ Type I, Type II, Type V hydrolyzed jellyfish collagen: KollaJell.

In a recent op-ed, Marielle Weintraub, PhD, president of the U.S. Hemp Authority, warns stakeholders of the hemp and CBD industry about the importance of using trustworthy certification programs.

GRMA has partnered with IPA to establish a Probiotics Working group that will harmonize GMP requirements for probiotic dietary supplements.

The rule, issued by OSHA, requires all employers with more than 100 employees to mandate that their workers are fully vaccinated against COVID-19 or to require weekly testing and masking of unvaccinated employees.

An expert reviews the important compliance checks needed to ensure the quality of dietary supplements during packaging.

The Statement of Commitment provided by NSF demonstrates and legitimizes a continued commitment to quality, compliance, and safety.

Stratum Nutrition and its Indian partner, Zenova Bionutrition Pvt. Ltd., were granted pre-market approval of its NEM brand partially hydrolyzed chicken eggshell membrane powder from the Food Safety Standards Authority of India

The Natural Products Association filed suit against FDA on December 6, calling FDA’s action to “retroactively” apply the drug-exclusion clause of the Food, Drug, and Cosmetic Act in order to ban N-acetyl-L-cysteine (NAC) unlawful.

Health Canada has approved an amendment to a Controlled Drugs and Substances Dealer’s License the agency issued to Nutrasource Pharmaceutical and Nutraceutical Services earlier this year.

Cosun Beet Company, Ingredion Inc., Matsutani Chemical Industry, and Samyang Corp. have formed a new consortium designed to help bring allulose to the European Union and United Kingdom, and support its nutritional labeling as a carbohydrate.

FDA has issued a “tentative response” to a citizen petition submitted by CRN for the agency to reverse its decision to prohibit manufacturers from marketing products containing N-acetyl-L-cysteine (NAC) as dietary supplements.

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.”