Regulatory

Supplements sold in Korea containing myHMB can now make product claims about improving exercise performance.

The Council for Responsible Nutrition has announced receipt of an interim response from the U.S. Food and Drug Administration (FDA) to the Council’s recent citizen petition requesting that the agency change the way it applies the drug preclusion clause to the Food, Drug, and Cosmetic Act (FD&C Act).

The independent GRAS conclusion was done in partnership with GRAS Associates, a SGS Nutrasource company. The conclusion was submitted to FDA's GRAS notification program.

U.S. Senator Kevin Cramer (R-ND) reintroduced the bill, previously introduced as S. 1654. The bill would amend the Internal Revenue Code of 1986 to include “over-the-counter dietary supplements products and foods, for special dietary uses as qualified medical expenses.”

Steve Mister, president and CEO of the Council for Responsible Nutrition reflects on the Council's 50 years of service to the industry and what he learned from interviewing FDA commissioner Robert Califf, MD.

Nutritional Outlook’s Editor-in-Chief Jennifer Grebow interviewed the Council for Responsible Nutrition’s Steve Mister at last week’s SupplySide West trade show.

New York Governor Kathy Hochul has signed into law a bill that would restrict minors from purchasing dietary supplements marketed toward “weight loss and muscle building.”

Here’s what brands can likely expect from an updated Green Guides.

The ingredients are GlyCare 2’-fucosyllactose (2’-FL) and GlyCare lacto-N-neotetraose (LNnT).

The company recently notified FDA of the Generally Recognized as Safe (GRAS) status of its Pomella pomegranate extract. FDA responded with a letter of no objection.

An increasingly unwieldly cannabinoid industry may force Congress to take action on hemp-derived cannabinoid regulation.

The decision marks the first time HMOs has been approved by China for use in infant formula.

The spotlight on delta-8 THC is heating up. Where will regulators ultimately land in regard to this controversial cannabinoid?

PLT Health Solution has announced the receipt of an expanded license from the Natural and Non-Prescription Health Products Directorate (NNHPD) of Health Canada to market its AlvioLife ingredient for respiratory health support in Canada.

FTC’s Endorsement Guides got a critical update this year.

Here’s what the new guidance entails.

The Federal Trade Commission's recent "Notice of Penalty Offenses" sent to hundreds of companies, in combination with its Health Products Compliance Guidance, imposes an unfair standard for substantiation for dietary supplement and OTC product manufacturers. The citizen petitions ask for the withdrawal of the notices and clarification on FTC's guidance.

CbdMD has announced the publication of safety data that support a safe upper dose of its proprietary broad spectrum CBD blend.

The claims regard supporting an antiviral response to the common cold as well as reducing the severity and duration of common cold symptoms, among other benefits.

The American Herbal Products Association has sent a letter to members of the U.S. Senate Committee on Agriculture and U.S. House Committee on Agriculture advocating for four priority issues to be considered in the 2023 Farm Bill Reauthorization measure.

The patent (number EP 3 538 085 B1) was granted on July 12, 2023, and was validated in Spain, France, Germany, Italy, the Netherlands, and the United Kingdom.

Called “FDA Invitation,” the campaign is launching messaging in various media outlets, including The New York Times.

Bimuno GOS is now allowed to use a total of 29 different health claims in Australia and New Zealand.

The U.S. Food and Drug Administration (FDA) has responded to a citizen petition from the Natural Products Association (NPA) and the Alliance for Natural Health (ANH) requesting that FDA reevaluate its position on nicotinamide mononucleotide.

The U.S. Hemp Roundtable is raising the alarm about an amendment to Assembly Bill 420 (AB420) filed by the California Department of Public Health.

The Consumer Healthcare Products Association has submitted comments to the citizen petition in opposition to the proposed repeal of regulation that allows for the use of titanium dioxide in food.

Industry concerns mount as FDA moves forward with plans to reorganize the agency, including the Office of Dietary Supplement Programs.

The seven claims bring the total self-substantiated claims submitted to FSANZ for Bimuno GOS to 29.