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Latest From Malcolm Spicer
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 asks Federal Circuit Court to direct US ITC to investigate its complaint that some omega-3 ingredients are unapproved drugs. Company questions FDA's request for policy deference given resource constraints and says Supreme Court rulings show compliance with FDA regulations in cosmetic and food labeling does not preclude litigation alleging the information renders a product an unapproved drug or represents false advertising.
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.
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.
Latest steps by US FDA targeting tobacco-related health problems are a Nicotine Steering Committee, headed by Commissioner Gottlieb, and a public docket, including a meeting in January, for suggestions on how novel products could be evaluated as safe and effective NRTs.
Report to key US legislators could boost efforts to revamp approaches to making nonprescription ingredients available.