All articles tagged with #warning letters
The FDA issued about 100 warning letters to pharmaceutical companies and healthcare providers, including major drugmakers and telehealth firms, to stop or modify misleading drug advertisements, signaling an aggressive regulatory push despite concerns over resource limitations.
The FDA has issued around 100 warning letters to pharma and biotech companies for misleading direct-to-consumer drug advertisements, highlighting specific ads that falsely suggest benefits, downplay risks, or use attention-grabbing visuals that impair understanding, as part of increased enforcement efforts.
The FDA has issued warning letters to six companies for marketing unapproved, misbranded pain-relief products with higher-than-allowed concentrations of lidocaine, which can pose serious health risks including irregular heartbeat, seizures, and breathing issues. The products in question are used to alleviate pain associated with cosmetic procedures, but the FDA advises against using anything containing more than 4% lidocaine, using it on large areas of skin, or wrapping it with dressings or plastic wraps.
The FDA has issued warning letters to six companies for marketing unapproved and misbranded topical pain relief products containing high concentrations of lidocaine, which pose serious health risks when used before or during certain cosmetic procedures. Consumers are advised not to use over-the-counter pain relief products with more than 4% lidocaine, apply them heavily over large areas of skin, or wrap treated skin with plastic wrap. The FDA urges consumers and healthcare professionals to report any adverse events related to these products and has placed some companies on import alert to prevent their products from reaching consumers.
The US Food and Drug Administration (FDA) has issued warning letters to CVS, Walgreens, and other companies for manufacturing and marketing unapproved eye products that could pose risks to users. The products, illegally marketed to treat conditions such as conjunctivitis, glaucoma, and cataracts, were found to have sterility issues and some contained silver, which can cause permanent discoloration of the skin or eye. The FDA is concerned about the potential harm these unapproved drugs may cause, as they bypass the body's natural defenses. The companies have 15 days to respond and correct violations, or face legal action. CVS and Walgreens have already pulled the products from their shelves.
The FDA has issued warning letters to eight companies for manufacturing or marketing unapproved ophthalmic drug products, including eye products labeled to contain silver. These products are illegally marketed to treat conditions such as conjunctivitis, cataracts, and glaucoma. The FDA is concerned about the potential harm these unapproved drugs may cause, as they bypass the body's natural defenses and may lead to permanent discoloration of the skin and eye. Consumers are advised to consult their healthcare professionals if they are using any of the products mentioned in the warning letters. The FDA has requested the companies to respond within 15 days and failure to comply may result in legal action.
The FDA has issued warning letters to three infant formula manufacturers, ByHeart, Mead Johnson Nutrition, and Perrigo Wisconsin, for violating federal safety regulations. The letters were sent after FDA inspections revealed concerns about the presence of Cronobacter sakazakii, a bacterium that can be found in dry foods. The companies have been instructed to implement extensive cleaning and sanitation measures, conduct investigations into the contaminations, and reevaluate their sanitation policies. The FDA aims to prevent a repeat of last year's infant formula shortage and ensure the safety and nutrition of the formula consumed by children.
The US Food and Drug Administration (FDA) has issued warning letters to three infant formula makers, ByHeart Inc, Mead Johnson Nutrition (a unit of Reckitt Benckiser Group), and Perrigo's Wisconsin unit, for failing to establish adequate manufacturing processes to prevent bacterial contamination. The FDA does not anticipate any impact on the supply of infant formula. The warning letters were issued following recalls by the companies between December and March, which aimed to remove potentially contaminated products from the market. The FDA believes that the recalls were effective in addressing the issue. Infant formula manufacturing has faced increased scrutiny since last year's shortage caused by bacterial infections and recalls at Abbott Laboratories' facility in Michigan.
The FDA has issued warning letters to three infant formula manufacturers, ByHeart Inc., Mead Johnson Nutrition (Reckitt), and Perrigo Wisconsin, LLC, for violations of regulations and the Federal Food, Drug, and Cosmetic Act. The warning letters come after FDA inspections and recalls initiated by the companies to remove potentially contaminated products from the market. The FDA emphasizes that there is no need for parents and caregivers to discard or avoid purchasing any particular infant formula at this time. The agency is focused on enhancing regulatory oversight and ensuring the safety of infant formula manufacturing practices. The FDA will assess the companies' corrective actions and continue to strengthen the safety and resiliency of the infant formula supply in the U.S.
The FDA has issued warning letters to 189 retailers for selling unauthorized tobacco products, specifically Elf Bar and Esco Bars products, which are disposable e-cigarettes that come in flavors known to appeal to youth. Two studies published by the Centers for Disease Control and Prevention reinforce concerns about the risks of Elf Bar products among young people. The FDA continuously monitors the marketplace and took these actions as emerging marketplace data led to concerns over their appeal and risks to young people.