Regulatory

Sabinsa (East Windsor, NJ) has been granted U.S. patent US10166261 for the administration of Bacillus coagulans MTCC 5856 (LactoSpore) at a dose of 2 billion CFU per day as a way to manage dementia and dementia-related sleep disorders, presented as symptoms of major depressive disorder, in humans with IBS.

Baby Colic is a clinically studied combination of two probiotic strains that the company says helps reduce the duration of crying episodes while also promoting infant gut health.

The House has passed a federal spending bill that includes $2 million for FDA to develop hemp-derived CBD enforcement discretion policy.

PanTheryx announced that an independent expert panel has affirmed its bovine colostrum as GRAS (generally recognized as safe) for specific food and beverage uses. 

The Senate confirmed Stephen Hahn, MD, an oncologist and top official at MD Anderson Cancer Center, as commissioner of the U.S. Food and Drug Administration with a vote of 72 to 18.

The Supreme Court’s denial means that the decision of the ITC to not investigate Amarin’s complaints remains upheld by the U.S. Circuit Court of Appeals for the Circuit Court, and no further appeals are possible. 

In Nutritional Outlook's 2019 Best of the Industry Awards, we are recognizing individuals, groups, and companies whose initiatives today may help shape, for the better, the state of the dietary supplement and food and beverage industries for years to come.

McGuffin celebrates his 20th year as the renowned president of the American Herbal Products Association.

Read Nutritional Outlook's extended interview with its 2019 Best of the Industry award winner, Industry Leader category: AHPA's president, Michael McGuffin.

Products cited include oils, gummies, pet products, and skincare products.

Merit Functional Foods announced that it has received a Letter of No Objection from FDA in response to a GRAS (generally recognized as safe) notification for its pea protein ingredients. 

What do we know, and how much do we still need to discover?

The New Jersey State Senate has approved a resolution urging the President of the United States and Congress to issue legislation that establishes a safe daily level of consumption for cannabidiol (CBD). 

In response to a voluntary recall from GL Holdings of its Green Lumber product, Annie Eng, CEO of HP Ingredients, has issued a statement urging finished product manufacturers and suppliers to trace and authenticate their supply of raw materials. 

Within leading dietary supplement associations, support for a mandatory product listing remains mixed.

Lowell Schiller, FDA principal associate commissioner for policy, delivered this message at the Council for Responsible Nutrition’s 2019 conference in Carlsbad, CA.

Will established certification companies and laboratories now starting to offer services for this market boost quality control in the industry and help everyone better navigate this hazy space?

Q4 2019 is when price increases could be the most painful, said Wilson Lau, vice president of sales and marketing for Nuherbs Co.

The USDA has established the Domestic Hemp Production Program, which creates a regulatory framework around hemp production throughout the U.S., as required by the 2018 Farm Bill. 

Also: What does the hemp supply landscape look like today?

Rooted Apothecary is the seventh CBD company to receive an FDA warning letter in 2019.

FDA today announced that during the first six months following the first compliance deadline-January 1, 2020-it will focus on helping companies meet the new rules, rather than coming out of the gate to immediately enforce the rules.

The guidelines, established in October, set forth a framework of best practices and compliance standards for hemp extract/cannabinoid products. They exclude synthetic CBD.

The Natural Products Association polled 1000 registered voters in early October.

HB Natural Ingredients, a subsidiary of BGG World, received a “Letter of No Objection” from FDA regarding the self-affirmed GRAS (generally recognized as safe) status of Vitosa, the firm’s line of stevia products. 

In a joint letter, the American Herbal Products Association, Consumer Healthcare Products Association, Council for Responsible Nutrition, and United Natural Products Alliance called on Congress “to pass legislation to clarify that CBD derived from the hemp plant is a lawful dietary ingredient.”

Nutritional Outlook asked a handful of supplement industry stakeholders about how DSHEA has aged-and what a DSHEA 2.0 should look like. What, if any, changes to the law are needed? What changes are needed in the way FDA polices the market?

Following its own evaluation of the safety and toxicology of AlaskOmega 50% and 70% omega-7 concentrates, the U.S. Food and Drug Administration does not dispute the GRAS status of the ingredient.