Regulatory

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.

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.

The Council for Responsible Nutrition recently submitting comments regarding the Proposed Kentucky Administrative Regulation 902 KAR 45:190, hemp-derived cannabidiol products and labeling requirements.

NOW is expressing support for Amazon’s new policy requiring dietary supplement sellers to provide documentation that demonstrates their products meet label claims.

Nutralliance announced that the line of 11 lactic acid-producing probiotic species manufactured by Ildong Biosciences is now self-affirmed GRAS.

The Council for Responsible Nutrition has responded to FDA regarding recent warning letters from the Agency alleging that N-acetyl-L-cysteine (NAC) is not a dietary supplement, and therefore prohibited from being marketed as such under the Federal Food, Drug, and Cosmetic Act.

In the United States, probiotics remain stuck in a murky regulatory environment, one that stifles innovation and market growth, and, at the end of the day, blocks potential health benefits for the consumer.

The Botanical Adulterants Prevention Program (BAPP) issued its revised draft of "Best Practices Contract Language and Standard Operating Procedure (SOP) Templates for the Disposal/Destruction of Irreparably Defective Articles."

The Council for Responsible Nutrition has upgraded several aspects of its Supplement Online Wellness Library (OWL) to increase ease of use.

Don’t let your brand make these advertising mistakes.

NOW released a new report on alpha lipoic acid (ALA), its fifth report in 2020 regarding suspect brands whose main sales appear to be on Amazon.

AMA is strongly urging Congress to modify and modernize the Dietary Supplement Health and Education Act (DHSEA) to allow FDA the authority to establish a mandatory product registry.

GanedenBC30, a spore-forming probiotic ingredient by Kerry, was approved by Brazilian regulatory agency, ANVISA, for the following health claim: “Bacillus coagulans GBI-30, 6086 can contribute to the health of the gastrointestinal tract.”

Chenland Nutritionals Inc. has announced a successful New Dietary Ingredient Notification (NDIN) for its patented JointAlive ingredient.

The new appropriations bill from the Senate Agriculture Appropriations Committee urges changes to interim final rule that would protect U.S. hemp farmers and processors.

AHPA has promoted Amber Bennett to vice president of marketing and engagement, Rachel Haas to member services manager, and hired Robert Marriot to director of regulatory affairs.