Regulatory

Leading CBD companies Charlotte’s Web and Irwin Naturals submitted NDI notifications for full-spectrum hemp extracts. FDA objected to the notifications on the grounds of the drug-exclusion clause and the agency’s concern about safety substantiation.

Upgrades were made to modernize the site and make it easier for users to find and share dietary supplement information.

In June 2021, dietary supplements company NOW purchased from Amazon.com 23 non-NOW turmeric/curcumin supplement products, plus two of its own supplement products, and tested them for potency, heavy metals, labeling accuracy, and potential addition of synthetic curcumin.

The first NPN is for the company’s BacoMind Children ingredient, and the second NPN is for the company’s BacoMind Adult ingredient.

How can you market pain-relief dietary supplements while staying on the right side of legally permissible health claims?

AHPA recently submitted comments to FDA, asking the agency to expand proposed research on front-of-package labels to include herbs, spices, and teas.

How has the COVID-19 pandemic changed the landscape of health claims and clinical trials for dietary supplements? A panel including FTC’s Richard Cleland and industry contract research organizations discussed at the Institute of Food Technologists’ FIRST virtual event.

Most recently, patents were awarded in Australia, Canada, Europe, and the U.S.

MitoPrime is said to help restore mitochondrial membrane potential (MMP). Increasing MMP is thought to help combat age-related muscle degeneration in aging adults.

During the 2021 Dietary Supplements Regulatory Summit, Cara Welch, PhD, acting director of FDA's Office of Dietary Supplement Programs, said that FDA was in favor of a mandatory product registry.

A label is a product’s calling card, a company’s effort to put its best foot forward. So why is it that dietary supplement labels are so often laden with problems?

Counterfeiting is a worsening problem in the dietary supplements industry. What can be done about it?

Legislation introduced by Majority Leader Chuck Schumer that would decriminalize cannabis federally also includes provisions for the regulation of cannabidiol (CBD).

American River Nutrition’s GG-Gold ingredient containing geranylgeraniol (GG) has been self-determined to be Generally Recognized as Safe (GRAS) for food and beverage use.

Nutrasource has received a patent for a method of testing GMOs as part of its International Genetically Modified Organism (GMO) Evaluation and Notification (IGEN) program.

ROC certification promotes holistic agriculture practices, including increasing soil organic matter and sequestering carbon, improving animal welfare, and providing economic stability and fairness to farmers, ranchers, and workers.

Delta-8 THC is a new cannabinoid that has come to market, testing the legal boundaries of hemp-derived cannabinoids.

Seraphina Therapeutics, a San Diego–based health and wellness company, says it discovered the fatty acid, which it sells as a trademarked ingredient called FA15 as well as in its own Fatty15 brand of dietary supplement.

A petition to add pullulan to the National List of Allowed and Prohibited Substances was first filed in January 2018, with the National Organic Standards Board recommending its addition in April 2019.

COVID-19 wrought havoc on botanical supplies even as it sent interest in the ingredients’ health-promoting properties through the roof.

The claims include, “Source of antioxidant probiotic” and “Source of antioxidant probiotic in elite athletes.”

Authors of a paper published in Nutrients suggest DRI changes for vitamin K, magnesium, lutein, and omega-3 fatty acids EPA and DHA.

Lawmakers had until June 10 to vote on the bill, but the legislature adjourned early in the morning on June 11 without bringing the bill up for discussion, ending any prospect of its passage during the current legislative session.

House Appropriations Committee Chair Rosa DeLauro (D-CT-03) recently introduced new legislation that would significantly alter the GRAS (generally recognized as safe) process.

The bill must now pass in the state assembly. However, the assembly only has until June 10 to vote on it before the legislature adjourns.

Four leading trade organizations have sent a letter to Senators Tammy Baldwin (D-WI) and John Hoeven (R-ND), ranking members of the Senate Committee on Appropriations’ subcommittee on agriculture, rural development, food and drug administration, and related agencies, to advocate for more funding for the FDA’s Office of Dietary Supplement Programs.

Nature’s Crops International has secured registration and protection for three varieties of Ahiflower under both the European and US Plant Variety Protection (PVP) programs.

The Council for Responsible Nutrition has submitted a citizen petition requesting that the U.S. Food and Drug Administration (FDA) reverse its position that the Federal Food, Drug, and Cosmetic Act (FDCA) prohibits manufacturers from marketing products containing N-acetyl-L-cysteine (NAC) as dietary supplements.

California Assembly Bill 1341 (AB 1341) has been held up in the state Appropriations Committee, seriously delaying its passage until the assembly reconvenes in January of 2022.

Voluntary remote regulatory assessments, plus a continued risk-based approach, are “efficiency” tools FDA is using as it clears through its inspection “backlog” resulting from the pandemic.