Silver Spring, MD—FDA issued warning letters to Cali Botanicals of Folsom, CA, and Kratom NC of Wilmington, NC, for illegally selling unapproved misbranded kratom-containing drug products with unproven claims about their ability to treat or cure opioid addiction and withdrawal symptoms, according to a press release. Claims included treating pain...
Silver Spring, MD—FDA announced in a press release that it “does not intend to object” to the use of qualified health claims stating that EPA and DHA omega-3 fatty acids may reduce the risk of hypertension and coronary heart disease. FDA responded to a health claim petition submitted by the...
Washington, DC--The Natural Products Association (NPA) announced earlier this week that it was seeking help from Congress to encourage the Food and Drug Administration (FDA) to establish a safe use level for dietary supplement and conventional food CBD products. NPA reported that Congress and NPA were working together on an...
New York, NY—Day one of the 7th Annual Legal, Regulatory and Compliance Forum on Dietary Supplements by the American Conference Institute (ACI) together with the Council for Responsible Nutrition (CRN) covered a lot of ground. The keynote was given by Cara Welch, Ph.D., Acting Special Assistant to the Deputy Commissioner...
Washington, D.C.—FDA issued a statement warning women of childbearing age about use of vinpocetine, due to a recent report from the National Institute of Health’s National Toxicology Program that found that consumption of vinpocetine may cause a miscarriage or harm fetal development. The statement advises pregnant women and women who...
Fruit purees could be a viable solution for food companies looking to avoid added sugars, according to a press release from Welch’s. Given the FDA’s labeling regulations—introduced in 2016, with a compliance date of January 1, 2020 for large businesses—requiring all added sugars to be declared in nutrition facts panels,...
Washington, D.C.—The Food and Drug Administration (FDA) held a public hearing on Friday looking for scientific data and information regarding cannabis and cannabis-derived compounds. With over 100 speakers, it easily took up the allotted 9.5 hours, and offered a range of opinions. The top concerns were safety and time. Megan...
Washington, D.C.—Tomorrow, from 8:00 AM EDT to 6:00 PM EDT, FDA will hold a public hearing—to be webcast, here and here—entitled “Scientific Data and Information about Products Containing Cannabis or Cannabis-Derived Compounds.” The intent is to allow stakeholders to provide scientific data and information regarding compounds like CBD. Among the...
Salt Lake City, UT--GOED, the Global Organization for EPA and DHA Omega-3s, in conjunction with the United Natural Products Alliance (UNPA), will be hosting a webinar on June 12, from 12:00 PM to 1:00 PM EDT, to inform industry about the FDA's draft guidance on mitigation strategies to protect food against...
Washington, D.C., and Long Island, NY—The United States filed a civil complaint to stop Confidence USA Inc., company president Helen Chian, and company manager Jim Chao from marketing adulterated dietary supplements, according to a press release from the Department of Justice (DOJ). The complaint alleges that multiple inspections by FDA...
