Regulatory

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.

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Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification; Draft Guidance for Industry.”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Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification; Draft Guidance for Industry.”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.”

The ingredient is an herbal extract of Ageratum conyzoides that can stimulate hair growth and control hair loss and dandruff.

Alkemist advises companies to check pesticide testing reports to ensure they include Inorganic bromide and Dithiocarbamates measured and reported as carbon disulfide (CS2).

The express and implied claims in question were initially challenged by Nature’s Way Brands LLC.

Despite passing the state's Senate on June 7, the Rhode Island Senate Bill 2613, which would restrict access to weight management and sports nutrition products to minors, has failed to move forward after being referred to the House of Representative’s Health and Human Services Committee.

Now has notified Amazon about a brand posting Certificates of Analysis from a third-party testing lab on their website which confirm the fill weight of its products, but not the identity, potency, or purity.

Two federal class action lawsuits have been filed against Olly Public Benefit Corporation and The Procter & Gamble Company alleging that the companies are misleading consumers by inaccurately dosing their melatonin supplements.

The available claims for Bimuno GOS center around supporting the gut microbiome, maintaining digestive health, and supporting immune function.

California Assembly Bill 1341, which restricts minors from purchasing dietary supplements and OTC products marketed for weight management, has been passed by the state’s Senate Judiciary Committee on June 21, 2022 by a vote of 4 to 1.

The American Herbal Products Association has withdrawn its opposition for California Assembly Bill 1341 after being amended to resolve concerns of affected industry.

Here’s why this area of the world is one to watch for those who make and sell fortified-foods and premixes.