Regulatory
Prenexus Health’s prebiotic ingredient achieves GRAS status
August 23rd 2019Prenexus Health has received a “no questions” letter from FDA following its GRAS (generally recognized as safe) notification for the use of its xylooligosaccharide (XOS) prebiotic, at levels up to 2.4 grams per day, in a variety of foods.
The Impossible Burger can now be sold at retail, following FDA’s approval of color additive
August 7th 2019Prior to FDA's amended color additive regulation, soy leghemoglobin, used in the Impossible Burger for meat-like taste, texture, and aroma was only approved in products sold to consumers in cooked form, meaning that Impossible Burger was only available in participating food service locations.
Amarin Pharma petitions Supreme Court to review lower court decision on omega-3 supplements
July 31st 2019Amarin Pharma has filed a petition for certiorari asking the Supreme Court to review a decision made by the U.S. Court of Appeals for the Federal Circuit to uphold a 2017 decision of the International Trade Commission (ITC) not to investigate Amarin’s complaints against manufacturers of omega-3 EPA concentrates.
Senate hearing looks at hemp-growing obstacles for farmers and state and tribal governments
July 25th 2019The meeting convened federal agencies USDA, FDA, and EPA as well as the testimony of industry stakeholders providing important perspectives when it comes to farming and testing of hemp crops and extracts.
AHPA wants targeted guidance on key NDIN issues, according to comments submitted to FDA
July 18th 2019In public comments submitted to FDA on July 15, 2019, the American Herbal Products Association made a number of suggestions to the agency, which has been in dialogue with the industry to modernize regulation of dietary supplements.
Amarin will file citizen petition to FDA asserting ethyl ester omega-3s are not legally supplements
July 17th 2019In comments submitted to FDA, Amarin Pharma, maker of the omega-3 drug Vascepa, stated its intentions to file a citizen petition to FDA asserting that ethyl ester omega-3s are not legally allowed to be marketed as dietary supplements.