Regulatory

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?

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.

The new guidelines acknowledge the use of dietary supplements to meet nutrient needs not easily obtained from food alone.

Sabinsa announces five new patents pertaining to digestive health, sports nutrition, heart health, and sexual health.

Chemi Nutra has been granted a new patent (United States Patent 10,869,843) for phosphatidic acid, claiming that its branded Mediator PA can increase muscle mass and strength when accompanied with resistance exercise.

FTC is taking action against six companies for allegedly making a wide range of scientifically unsubstantiated claims regarding CBD’s ability to treat serious health conditions such as cancer, heart disease, hypertension, and Alzheimer’s.

FDA found these products contain active pharmaceutical ingredients (APIs) not listed on their labels, including some with ingredients found in prescription drugs.

ANVISA (the National Health Surveillance Agency in Brazil) approves Verisol collagen peptides from Gelita for use in food supplements for skin health.

KGK Science has been contracted by Psyched Wellness, a Canadian health supplement company, to provide a regulatory package of services to support the launch of its Amanita muscaria mushroom extract in the U.S. and Canada.