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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
FDA’s NDI notification draft guidance should be rewritten and its Nutrition Facts and Supplement Facts Final Rule delayed, the Natural Products Association says in comments submitted to the agency in response to President Trump’s executive order aimed at cutting down on burdensome regulations.
FDA is considering whether a breach of duty to act or correct violations under the FDCA must occur before criminal charges are brought, Chief Counsel Rebecca Wood says. Clarity on FDA's view of 'vicarious criminal liability' would be welcome news to the pharma industry and suggests an early priority for the agency's new top lawyer.
Nestle to pay $2.3bn for firm Atrium Innovations, owner of US plant-based supplement marketer Garden of Life and other nutritional brands; Wellness Resources warned on disease claims for omega-3s; and latest health and wellness sector recalls.
Primus Pharmaceuticals say an insert in packages of its Limbrel capsules prescribed to manage metabolic processes associated with osteoarthritis advises that the ingredient baicalin could cause the lung condition acute hypersensitive pneumonitis and elevated liver enzymes in users with allergies to the flavonoid.
Amarin's petition to the Federal Circuit Court to direct ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs leans on Supreme Court decisions that compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information rendered a product an unapproved drug or represented false advertising.
Health Research Laboratories agrees to settle an FTC complaint alleging false "free" offers on top of bogus health claims; reports that biotin can interfere with certain lab tests are reminders for consumers to tell doctors about supplements they use, says CRN; kratom group asks FDA and states "to tone down their overheated rhetoric about the non-opiate botanical"; and health and wellness recalls.
Post-market surveillance system for dietary supplements should contain a process for identifying sentinel events, or low-incidence and unusual adverse events that can indicate big problems, says a toxicologist speaking during a recent Council for Responsible Nutrition webinar.
The number of facilities inspected for compliance with supplement GMP requirements is increasing annually as the agency meets targets set by FSMA, according to data the American Herbal Products Association presented during a webinar.
A JAMA study finds SARMs in 23 of 44 products marketed online as containing the steroid-like ingredient while the rest contained other unapproved drugs and substances. Sports medicine and doping researchers say e-commerce provides cover for firms to sell the risky bodybuilding drugs without consequence.
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