Regulatory

FDA has sent warning letters to four companies for selling “unapproved animal drugs containing cannabidiol (CBD)” that are marketed for use in food-producing animals.

The new webpage, called Supplement Your Knowledge, includes informational sheets advising the public about what to consider when purchasing or prescribing supplements, warnings about safe usage, and information about how FDA regulates supplements.

The National Advertising Division of BBB National Programs recommended Goli discontinue claims regarding sexual function, weight loss and management, and physical performance after reviewing Goli’s evidence and determining that much of it was not sufficient to support its claims.

Newly proposed legislation is driving the urgency to build support for or against mandatory product listing. What are the topline arguments?

Senate HELP Committee has introduced FDASLA without addressing industry concerns about the bill's discussion draft.

The nutrition industry is one in which the actions of a “rogue” influencer can detonate any number of legal landmines.

The European Food Safety Authority (EFSA) published an opinion that bovine milk osteopontin(OPN) is safe for use in infant formula, follow-on formula, and ready-to-eat dairy-based meals for children.

A Rhode Island bill (S.2613) is on the agenda to be place for a vote before the full Senate on May 31, 2022.

Consumer trust is paramount to ensure long-term success as legislators broadly smear the category as unsafe.

The patents, already approved in the U.S., were recently accepted in Europe and Canada.

To complete its transparency analysis, Leafreport examined Certificates of Analysis (C of A’s) of 188 brands, as advertised on their website, for a total of 4,384 products.

While affirming opposition to mandatory product listing, the American Herbal Products Association offered its feedback and suggested revisions to the discussion draft of the FDA Safety and Landmark Advancements (FDASLA) Act published by the U.S. Senate Committee on Health, Education, Labor, and Pensions (HELP).

The mark is the outcome of successful objective and independent verification informed by facility audits and product testing to verify the accuracy of the supplement and nutritional facts panel.

The online course, which NSF helped create, will be taught by the Southwest College of Naturopathic Medicine & Health Sciences.

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?

The newly proposed “Dietary Supplement Listing Act of 2022” lights a fire under the debate over mandatory product listing.

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.