Regulatory

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.

Following a GRAS (generally recognized as safe) notification for its Taxifolin BC-DHQ, Blue California’s has received a letter of no objection from FDA.

The voluntary program assures brand manufacturers that the ingredients have been routinely tested for a range of prohibited substances, and therefore safe for use by athletes.

One expert explains why the GRAS discussion is much more complex—and why it should be ongoing.

EpiCor, a postbiotic from Cargill received a letter of no objection for Cargill’s GRAS (generally recognized as safe) notice from FDA .

Senators Ron Wyden (D-Oregon), Rand Paul (R-Kentucky), and Jeff Merkley (D-Oregon) have introduced a new bill to regulate hemp and CBD products called the “Hemp Access and Consumer Safety Act.”

Lack of regulatory guidance makes hemp extracts a waiting game, with companies hedging their bets.

ParActin Andrographis paniculata from HP Ingredients, was granted a product license (#80109555) from Health Canada to support joint health symptoms.

The Council for Responsible Nutrition is calling on Congress to address an unintended “loophole” in the Food, Drug, and Cosmetic Act (FD&C Act) that casts doubt on the legal authority of the U.S. Food and Drug Administration (FDA) to regulate products that do not mee the strict definition of “dietary supplement” in the statute.

What are the biggest problems in the dietary supplements market, and will changing DSHEA fix them?

The act was created to protect financial institutions providing financial services to cannabis-related legitimate businesses and service providers.

Last week, California’s Assembly Health Committee voted to ban sales of weight-loss dietary supplements to minors. The bill is headed for another round of votes and could ultimately be signed into law.

Bio-Cat Microbials LLC has received a “Letter of No Objection” from the U.S. Food and Drug Administration (FDA) regarding the company’s GRAS (generally recognized as safe) notice for its Opti-Biome Bacillus subtilis MB40 probiotic.

Verdure Sciences launched Longvida, a turmeric extract standardized to curcumin and total curcuminoids (solid lipid curcumin particle - SLCP), in Brazil after receiving ANVISA approval through distribution partner Kilyos Nutrition

National and state efforts could expand or restrict access to a number of dietary supplement products.

CV Sciences, Inc. formed an ongoing partnership with Alkemist Labs to collaborate with the National Institute of Standards and Technology (NIST) on efforts to help cannabis testing labs demonstrate and improve measurement capabilities and comparability.

Vidya Herbs Inc. recently announced it achieved self-affirmed Generally Recognized as Safe (GRAS) designation for its green coffee extract, CGA-7.

Deerland Probiotics & Enzymes attained a list of published health claims following the inclusion of its DE111 probiotic as a food ingredient under the Food Standards Australia New Zealand (FSANZ) Code.

There’s renewed interest in respiratory-support ingredients. What’s in the toolbox, and do they work?

Preliminary findings show no evidence of liver disease in the 839 participants and no increase in the prevalence of elevated liver function tests.

Earlier this month, Folium Biosciences submitted a novel food application to the UK Food Standards Agency (FSA) for validation of its hemp-derived, 0.0% THC broad-spectrum cannabidiol (CBD) oil.

For leading medical nutrition companies, South Asia is a prime market for expansion.

The European Industrial Hemp Association’s (EIHA) Novel Food Consortium has received confirmation from the UK Food Standards Agency (FSA) that its novel foods application has been approved and its members’ CBD products can remain on UK shelves.

A recent study conducted by NSF International and Harvard Medical School found nine prohibited stimulants in 17 sports and weight loss supplements on top of the illegal Deterenol already on the label.