The FDA and the FTC issued warning letters to seven companies for selling fraudulent COVID-19 products. These are unapproved drugs that pose significant risks to patient health and violate federal law, the agencies said. The warning letters are the first to be issued by the FDA for unapproved products intended to prevent or treat COVID-19. The jointly issued letters were sent to Vital Silver, Quinessence Aromatherapy Ltd., Xephyr LLC doing business as N-ergetics, Gurunanda LLC, Vivify Holistic Clinic, Herbal Amy LLC and The Jim Bakker Show.
The FDA issued a new draft guidance, “Type 2 Diabetes Mellitus: Evaluating the Safety of New Drugs for Improving Glycemic Control,” to solicit public comment on its proposals for broad safety evaluations before drug approval that look beyond ischemic cardiovascular (CV) disease, as well as for the inclusion of a broader scope of human subjects, such as older subjects and those with chronic kidney disease who may be more vulnerable to drug-related side effects. The new draft guidance does not contain the recommendation that sponsors of all new therapies for type 2 diabetes uniformly rule out a specific degree of risk for ischemic CV adverse outcomes, which was recommended in previous guidance and has typically been done through CV outcome trials, the agency said.