FDA warns a Texas firm about marketing products as dietary supplements but spiked with drug ingredients a year after the firm recalled its products when the agency found banned weight loss drug sibutramine and the unapproved laxative phenolphthalein inside. According to a June 16 warning letter from FDA's Office of Regulatory Affairs Dallas District, agency officials found more products branded Smart Lipo continued the undeclared ingredients during inspections at Centro Naturista in Dallas and SmartLipo365 in Arlington, Texas. Smart Lipo supplements also are misbranded because they do not include adequate directions for the indicated use and because the indicated dosage is dangerous, ORA says.
Health And Wellness Industry Regulatory Roundup
Warning letter a year after recall; spiked supplement total climbs; FTC-USDA "organic" roundtable; and FTC ISO ICA for Herbalife.