Regulatory

FDA's content regarding dietary supplements overemphasizing negative aspects of dietary supplement industry, says CRN in feedback to the Agency.

Hofseth BioCare has announced a no-objection letter from FDA following an NDI notification for its ProGo bioactive peptides ingredient.

In response to NIH’s ODS request for comments, industry stakeholders such as the American Herbal Products Association and The Council for Responsible Nutrition, and The Consumer Healthcare Products Association submitted comments on Aug. 31.

The two probiotic strains were approved for two Canadian health claims regarding the ingredients’ abilities to help formula-fed babies develop a similar microflora as to breast-fed infants.

The Consumer Affairs Agency in Japan authorized the use of 600mg/d of ApplePhenon for people with relatively high BMI for the reduction of abdominal fat.

The company operates according to cGMPs under 21 CFR part 111 and part 117, with an FDA-compliant fulfillment facility in Reno, NV.

TOC analyzers measure the amount of organic, inorganic, or total carbon in water samples by oxidizing the organic compound into a form that can be quantified.

This lexicon further supports the standardization of terminology used in the cultivation, processing, manufacturing, and labeling of hemp.

California Assembly Bill 1341 passes Assembly Floor. The bill would restrict sale of weight management supplements to minors.

It’s no wonder that the botanical industry has fixated on fears of adulteration in these challenging times.

A bipartisan group of members from the House Energy and Commerce Committee has sent a letter to Speaker Nancy Pelosi and Minority Leader Kevin McCarthy requesting that the use fee reauthorization agreement not include the dietary supplement provision found in the FDA Safety and Landmark Advancements (FDASLA) Act.

Hemp advocacy group the U.S. Hemp Roundtable reiterated its belief that legal protections should cover all hemp cannabinoids and not just CBD.

In an August 8 open letter to the dietary supplements industry about the FDA Safety & Landmark Advancements Act (FDASLA) and mandatory product listing proposals, the Council for Responsible Nutrition’s President and CEO Steve Mister reports that “negotiations for dietary supplement product listing continue with progress made each day toward getting a final bill that CRN can support.”

ODS supports research and research training on dietary supplements at NIH Institutes, Centers, and Offices.

Kelai Pharmaceutical’s goal is to identify drug candidates in botanical plants to develop pharmaceuticals.

FDA maintains that NAC is not a dietary supplement, but is considering initiating rulemaking on the ingredient, and will be exercising a policy of enforcement discretion on NAC products.

A recent study found that adulterated dietary supplements remained on the market years after being issued a warning letter by the U.S. Food and Drug Administration (FDA).

The company’s All-in-One equipment series incorporates multiple inspection controls into single machines, maximizing production space and manpower efficiencies.

CBN is gaining popularity in the hemp world. But is it truly promising?

The American Herbal Products Association has issued comments to the U.S. Food and Drug Administration (FDA), regarding the Agency’s “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification; Draft Guidance for Industry.”

The Council for Responsible Nutrition has submitted comments to the U.S. Food and Drug Administration (FDA) regarding its “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification; Draft Guidance for Industry.”

Avoid the risk of a product recall, and protect your brand and reputation.

The Food Safety Administration Act of 2022 would separate the regulation of food from drugs, medical devices, and other products currently regulated by the Food and Drug Administration.

The company calls the new health claim a milestone for the Japan market.

Class action lawsuits are becoming more clever and aggressive according to speakers this year’s Legal, Regulatory, and Compliance Forum on Dietary Supplements, hosted by the American Conference Institute, in collaboration with The Council for Responsible Nutrition.

Senator Richard Burr (R- NC), ranking member of the Senate Committee on Health, Education, Labor and Pensions (HELP), has introduced new FDA user fee reauthorization legislation titled “Food and Drug Administration Simple Reauthorization Act.”

The ingredient’s maker, Enovate Biolife, says this is the first branded arjuna bark extract to gain a Health Canada NPN.

The prebiotic galactooligosaccharide (GOS) ingredient is also now permitted use of the following health claims in the Philippines: “enhances gut health” and “helps maintain regularity.”