Category: FDA

FDA Finalizes Rule Enabling Access to OTC Hearing Aids for Millions of Americans

The Food and Drug Administration on Tuesday finalized regulations to make available hearing aids to millions of Americans without them requiring to see a doctor. The FDA’s move comes years after President Donald Trump signed the Over-the-Counter Hearing Aid Act of 2017, which would create a new category of hearing aids and replace state-level regulations…


FDA Warns Amazon, Other Vendors About Sale of Skin Tag Removal Products

The U.S. Food and Drug Administration on Tuesday issued warning letters to three companies, including Amazon, for selling unapproved products for removing moles and skin tags. No over-the-counter medications have FDA approval for that purpose, and the Food, Drug, and Cosmetic Act prohibits interstate sale of unapproved drugs and cosmetics. “It is the FDA’s duty…


A2 Milk’s Hopes to Sell Baby Food in US Curdled, Shares Plunge

A2 Milk Company Ltd. said on Wednesday the U.S. Food and Drug Administration (FDA) deferred its request to sell infant milk formula products in the United States, sending its shares down more than 12 percent. The dairy producer and rival Fonterra have been advised by U.S.-based trade group International Dairy Foods Association (IDFA) that the…


CDC, FDA Shouldn’t Have Cleared and Recommended COVID-19 Vaccines for Young Children: Complaint

Top U.S. health agencies should not have authorized and recommended COVID-19 vaccines for children under 5, a complaint lodged on Aug. 9 says. The Food and Drug Administration (FDA) and Centers for Disease Control and Prevention (CDC) appeared to violate their own standards when the agencies granted emergency authorization for the Pfizer and Moderna vaccines,…


US FDA Declines to Approve Expanded Use of Acadia’s Antipsychotic Drug

The U.S. Food and Drug Administration declined to approve expanded use of Acadia Pharmaceuticals Inc’s antipsychotic drug for treating psychosis related to Alzheimer’s disease, the company said on Thursday. The health regulator concluded there were limitations in the interpretability of Acadia’s antipsychotic drug study and an additional study would be required, according to the company….


A2 Milk Jumps Before Halt on FDA Nod News, Denies Report

Shares of New Zealand’s a2 Milk Co. Ltd jumped more than 12 percent before trading in the stock was halted, after local media reported that the dairy company was close to winning an approval to sell baby formula in the United States. A2 dismissed the report. The company had in May confirmed an application to…


Coffee and Protein Drinks Among 53 Products Recalled Due to Microbial Contamination: FDA

Lyons Magnus, a California-based food and beverage manufacturing company, voluntarily recalled dozens of nutritional and beverage products over potential microbial contamination—including from the organism cronobacter sakazakii. The U.S. Food and Drug Administration (FDA) announced in a July 28 recall notice that affected products are being sold at stores nationwide under 12 different brands, noting that some of…


Banana Boat Sunscreen Recalled Nationwide Over Cancer-Causing Chemical

Some Banana Boat sunscreens have been recalled owing to unexpected levels of benzene, a cancer-causing chemical. The nationwide voluntary recall issued by Edgewell Personal Care Company refers to three batches of Banana Boat Hair & Scalp Sunscreen Spray SPF 30. “An internal review found that some samples of the product contained trace levels of benzene….


LIVE NOW: Newly Uncovered Records Show Pressure on Doctors to Approve COVID Shots

Two top vaccine experts left the FDA abruptly before the agency greenlighted COVID-19 boosters. Thanks to a Judicial Watch investigation, now we know why: the Biden White House rushed vaccine approval to appease its big pharma donors. Judicial Watch’ss president Tom Fitton speaks to Lee Smith in this news-breaking episode of Over the Target Live. *…


Newly Uncovered Records Show Pressure on Doctors to Approve COVID Shots

Two top vaccine experts left the FDA abruptly before the agency greenlighted COVID-19 boosters. Thanks to a Judicial Watch investigation, now we know why: the Biden White House rushed vaccine approval to appease its big pharma donors. Judicial Watch’ss president Tom Fitton speaks to Lee Smith in this news-breaking episode of Over the Target Live. *…