Regulatory

AHPA says its $20 million estimate covers only the cost of preparing product listings (including data entry) and “does not include associated training costs or other year-over-year costs of continuing compliance.”

The discretion period would last 180 from the time a final guidance is published.

A new safety study conducted by Validcare demonstrates the strong safety profile of orally-ingested CBD. This study builds on the results of a previous safety study that included a cohort of 839 subjects taking CBD products manufactured by 12 companies.

The US. Senate Committee on Health, Education, Labor, and Pensions (HELP) has released a discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act, which is legislation that would reauthorize FDA’s prescription drug, generic drug, biosimilar, and medical device user fee agreements.

The European Commission is now banning titanium dioxide as a food additive in the EU, with a six-month phaseout period that ends August 7, 2022.

Clasado Biosciences has announced that the European Food Safety Authority (EFSA) has given a positive opinion on the extension of the use of galactooligosaccharides (GOS) as a novel food in food for special medical purposes (‘FSMP’) in the EU.

EFSA’s opinion stated beta-lactoglobulin is safe and suitable for use in food products in the European Union. The European Commission is expected to grant final authorization later in the year.

Criminal compliance consists of processes, controls, and tools that ensure greater control and surveillance in preventing criminal risk within an organization. 

In May 2021, the International Scientific Association for Probiotics and Prebiotics (ISAPP) formally defined what, operationally speaking, a postbiotic is. So what does this signal for the postbiotics market?

According to FDA, the products violate the Federal Food, Drug, and Cosmetic Act (FD&C Act) by making unapproved claims to diagnose, cure, mitigate, treat, or prevent diseases.

Open Book Extracts has announced the results of the first phase of toxicology and safety studies of their cannabinoid ingredients: cannabigerol (CBG), cannabinol (CBN), and cannabichromene (CBC).

How does the regulatory process for supplements differ in emerging markets around the world? One expert reviews the differences.

The Natural Products Association is concerned that legislation recently introduced to the Senate that would establish a mandatory product listing, may undermine homeland security.

A panel of the National Advertising Review Board determined Goli Nutrition, Inc. supported its express use of the term “Apple Cider Vinegar” in the product name of its Apple Cider Vinegar (ACV) Gummies dietary supplement.

The pandemic saw an influx of opportunities and challenges for dietary supplements, including the emergence of more bad actors in the market. A CBD executive discusses one way the industry can continue to maintain quality and consumer trust: a monograph system.

U.S. Senate Majority Whip Dick Durbin (D-IL), introduced the Dietary Supplement Listing Act of 2022 on Tuesday. The bipartisan legislation, co-sponsored by Senator Mike Braun (R-IN), would require dietary supplement manufacturers to list their products with the U.S. Food and Drug Administration.

The draft guidance sets in motion FDA’s policy of enforcement discretion while the agency reviews NAC’s safety.

One expert explains why sustainability and food safety go hand in hand.

The annual Legal, Regulatory & Compliance Forum on Dietary Supplements will take place in person on June 29-30 at the Westin Grand Central hotel in New York City.

Canyon Labs opened a 17,000 square foot, full-service lab in Salt Lake City that offers testing, scientific and technical consulting, and Institutional Review Board (IRB) clinical services.

The GRAS status of these strains completes the portfolio of 19 strains of quadruple-coated probiotics offered by Nutralliance, available in single-strain solutions and custom blends.

The UK's Food Standards Agency’s published a list of cannabinoid products that are permitted for sale to consumers—only these products are authorized for sale. Full authorization is expected in 2023.

Industry associations discuss with Nutritional Outlook what their next steps could be.

Ingredients by Nature announced the self-affirmed GRAS (generally recognized as safe) status of Eriomin, a high potency standardized extract of lemon-based flavonoids.

Three human clinical studies show that the ingredient can help manage symptoms related to upper respiratory challenges and can help positively modulate immune responses, the company says.

The world of natural products for smokers’ health is complex and perilous. Can dietary supplements succeed in this market?

A recent budget request submitted by the U.S. Food and Drug Administration for Fiscal Year 2023 states that requested funds could help support the establishing of a “product listing requirement.”

On February 22, 2022, a new regulation kicked into effect in the EU for infant formulas and follow-on formulas containing protein hydrolysates, requiring companies to submit dossiers on their ingredients so that EFSA can evaluate their safety and suitability for use in these products.