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FDA Office of Regulatory Affairs' warning letter to MusclMasster lists 12 separate violations of supplement GMP regulations. Puerto Rico firm is latest supplement own-labeler to receive GMP warnings.
Among firms exhibiting at Natural Product Expo East in Baltimore Sept. 14-16, NextFoods launches GoodBelly probiotics bars, infused beverages and new flavors through January; RichBody introduces Liquid Vitamin products; Healthy Ventures rolls out Berry Sleepy, Awake supplements; and more news in brief.
CRN recommends the International Trade Commission not investigate Amarin's complaint against dietary supplements containing primarily ethyl ester or re-esterified EPA. The firm markets Vascepa, a synthetically produced ethyl ester drug approved to reduce triglyceride levels in adults with severe hypertriglyceridemia.
Latest From Dietary Supplements
CRN pans AASLD study linking supplements to rash of liver injuries; ABC goes digital with "Identification of Medicinal Plants"; and AKA says DEA running "shadow campaign" to schedule kratom.
President Trump nominates as FTC chair Joseph Simons, an antitrust attorney who led its Bureau of Competition under former President Bush. Advertising law attorneys say Simons sees whether consumers incurred economic injury to be central to enforcement on false advertising complaints.
The drug maker says it's not asking ITC to interpret the FD&C Act, but to investigate whether some omega-3 ingredient suppliers and marketers are failing to fulfill "certain marketplace expectations about the nature" of their products. ITC on Oct. 27 will vote on whether to investigate the complaint targeting a large part of the omega-3 market.
Abbott Nutrition sales flat; Texas herbal coop gets FDA warning; And CRN appoints OWL advisory board.
FDA's Sept. 28 warning letter to Total Body Nutrition also noted violative claims and labeling for its products marketed with the TBN brand and listed GMP problems. First methylsynephrine in 2016, now DMAA land firm on FDA enforcement radar.
"Kratom illustrates the promise and the peril of dietary supplement regulation," says Jack Henningfield, Pinney Associates consultant and an expert on abuse liability of various substances. Kratom firms agree NDI notifications are needed for ingredients made from separate kratom alkaloids, but say the botanical itself has decades of safe use in the US.
American Kratom Association and independent researchers explain the ingredient's history of safe use in a media briefing. Medical examiners "have tried to pin on kratom" the recent deaths of men in Florida and New York, says trade group Chairman Dave Herman.
ProSupps initiates recall of fitness powders and drinks that contain picamilon, an unapproved ingredient that crosses the blood-brain barrier.
Warning letter and multiple form 483s fail to convince Custompax; Kellogg acquires RXBAR clean-label protein bars for $600m; NutraFuels used Blast Cap for products; and more news in brief.
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