Regulatory

Bestevia Rebaudioside B from SweeGen (Rancho Santa Margarita, CA) received a GRAS (generally recognized as safe) no objection letter from FDA.

Gencor announced that AGEprost is listed on Health Canada’s Licensed Natural Health Products Database (LNHPD) for prostate health claims.

The Natural Products Association recently testified at a public hearing before California’s Senate Committee on Health on new legislation the state is considering that would establish standards for CBD products, and prevent manufacturers as well as distributors from making false claims.

ABC-AHP-NCNPR Botanical Adulterant Prevention Program (BAPP) is celebrating 10 years of research and educational activities. The program was founded by the American Botanical Council (ABC) in 2011 in partnership with consortium members.

The European Industrial Hemp Association’s Novel Food Consortium has submitted its Novel Foods application to the UK Food Standards Authority (FSA) ahead of the March 31, 2021 deadline.

The 5-part program will dive deep into cultivation, extraction, processing, testing, third-party certifications, and more.

Pharmako Biotechnologies, the sister company of Gencor in the U.S., received approval from the Therapeutic Goods Administration (TGA), Department of Health and Aging for the Government of Australia, for its manufacturing facility.

The Council for Responsible Nutrition has launched a new Supplement OWL (Online Wellness Library) website, featuring an updated design that prioritizes user experience, welcomes a broader registry audience, and enables easier industry participation.

Indena has received authorization from the Italian Ministry of Health and Italian Medicines Agency (AIFA) to produce cannabinoid-based cannabis extracts.

New state legislation introduced in California could prohibit the sale of weight management dietary supplements to consumers under the age of 18.

Health Canada has recently reviewed and approved a new pain claim for Stratum Nutrition’s NEM brand eggshell membrane. The claim reads: “NEM helps provide relief from joint pain due to moderate intensity aerobic exercise as quickly as the first day.”

Kaneka Probiotics announced Cardio Probiotic (L. plantarum KABP-011, L. plantarum KABP-012, and L. plantarum KABP-013) achieved U.S. FDA GRAS (Generally Recognized as Safe) status.

Steven Tave has accepted a new role as director of the Office of Strategic Planning and Operational Policy. Cara Welch, PhD, current deputy director of ODSP will step in as acting director on March 15, when Tave will officially start his new role.

Industry must work to promote consumer access to supplements and fight initiatives to restrict access, especially at the state level, said NPA leaders during an association webcast.

One industry expert discusses the possibilities.

How the pandemic changed the realities of GMP audits and certification

The COVID-19 pandemic plus an unclear legal future slowed CBD sales in 2020. Will CBD's prospects improve in 2021?

Major retailers like Amazon and CVS now require dietary supplements to pass their own retailer standards, but some in industry signal potential for chaos.

The bipartisan bill has been introduced by Representatives Kurt Schrader (D-Oregon) and Morgan Griffith (R-Virginia) will make hemp-derived cannabidiol (CBD) lawful as a dietary supplement.

Senators Mike Lee and Tim Scott introduced an amendment during the Senate Budget Resolution hearing that would expand health savings accounts (HSA), health reimbursement arrangements, and flexible spending accounts (FSA) to cover dietary supplements.

Predictions from Nutritional Outlook's esteemed Editorial Advisory Board.

AIDP, Inc. has secured U.S. patent 10,881,675 B2 on Jan. 5, 2021 for the combination of Actazin, a green or gold kiwi extract powder rich in the digestive enzyme actinidin, with PreticX xylooligosaccharide (XOS), a prebiotic.

Have routine inspections resumed in any capacity? If not, what can industry members expect in 2021?

Stratum Nutrition and Ayalla announced ANVISA, the National Health Surveillance Agency of the Brazilian Ministry of Health, granted “safety and efficacy as a bioactive substance” pre-market approval of NEM brand eggshell membrane.

The NSF/ANSI 455 GMP standards were designed to strengthen safety, quality, and trust through the supply chain, as well as combine the regulatory requirements with retailer quality requirements, and reduce the number of audits and financial costs associated with audits.

Following an extended comment period, USDA made a number of revisions to rules regarding the testing, disposal, and regulation of hemp.

BGG World was issued a patent from the United States Patent and Trademark Office for the use of astaxanthin to support heart function during exercise (US Patent #10,827,775).

The New York State Department of Health recently proposed new cannabinoid hemp regulation which establishes requirements for licensure for extraction and manufacturing, as well as the sale of hemp-derived cannabidiol (CBD) products.

The Ninth Circuit Court of Appeals upholds ruling that federal dietary supplement framework preempts state law in case against biotin claims.

Dietary supplement industry associations and leaders share 2021 regulatory predictions.