Do i need to register with the fda Hello everyone, I was wondering if I plan to start a Shopify store in the states and sell prescription eye glasses, would i need to register with the fda and pay the fee? Thank you! submitted by /u/Stunning-Variety-298

RFK Jr.’s Lawyer Has Asked the FDA to Revoke Polio Vaccine Approval Aaron Siri, who specializes in vaccine lawsuits, has been at Robert F. Kennedy Jr.’s side reviewing candidates for top jobs at the Department of Health and Human Services.

Renewing FDA registration for a food manufacturer? This is a very specific subject, but I figured I might as well try, someone here must have knowledge on this subject. A friend has a food manufacturing plant based outside of the US (they sell via e-commerce B2C as well as large orders), they currently have (as required) a Food Facility Registration with the FDA. Their expiration is December 31s…

FDA Tries Last-Ditch Move to Slash Nicotine Levels in Cigarettes The agency is asking the White House, in the final days of the Biden era, to move ahead with plans to drastically reduce the addictive substance in traditional tobacco cigarettes.

Robert F. Kennedy Jr.’s FDA Wish List: Raw Milk, Stem Cells, Heavy Metals Robert F. Kennedy Jr., one of President-elect Donald J. Trump’s advisers on health, is taking aim at the agency’s oversight on many fronts.

The FDA Is Finally Pulling a Useless Cold Medicine From the Market Scientists have known for years phenylephrine is ineffective.

FDA Names a New Chief of Medical Devices Patient advocates hope Dr. Michelle Tarver will lead the agency to focus more on safety and less on rapid approvals.

FDA Panel Rejects Use of MDMA for Treatment of PTSD An independent group of experts expressed concerns that the data from clinical trials did not outweigh risks for treatment of post-traumatic stress disorder.

FDA Reviews MDMA Therapy for PTSD, Citing Health Risks and Study Flaws The agency’s staff analysis suggests that approval of the illegal drug known as Ecstasy for treatment of PTSD is far from certain, with advisers meeting next week to consider the proposed therapy.

Why the FDA Keeps Recalling Eye Drops You might be tired of hearing about eye drop recalls, but the FDA has issued a new list of eye drops to stop using. This time, it includes store brand lubricant eye drops from Target, CVS, and Rite Aid. They haven’t officially been recalled, but the FDA has recommended a recall based on tests that revealed potential… Read more…

Yes, the FDA Really Did Issue a Warning About Black Licorice The FDA advisory about licorice is a few years old, but the memes about it will live on forever. “FDA issues warning about black licorice for halloween,” one headline read. And then below that, in a screenshot taken for posterity, somebody comments that the warning must have been “It tastes like shit.” Read more…

FDA Warns of Hidden Ingredients in Arthritis, Pain Products Certain products may contain active ingredients found in prescription-only drugs.

FDA Approves Pfizer’s Vaccine for Meningococcal Disease The U.S. Food and Drug Administration has approved Pfizer’s application for Penbraya, a vaccine for people 10 through 25 that will offer protection against the five main kinds of bacteria that cause meningitis and blood poisoning.

FDA Wants to Oversee Lab Tests It Says Put Patients ‘At Risk’ Genetic testing that reveals potential cancer risks or other maladies with no regulatory oversight is among the targets of the agency’s proposed review.

FDA Adds Warning of Intestinal Blockages to Ozempic Label The FDA has received more than 8,500 reports of gastrointestinal issues among people taking medications like Ozempic and Wegovy, the latter of which is approved for weight loss.

Why It Took So Long for the FDA to Tackle a Cold Medicine Pharmacists affiliated with the University of Florida have spent decades nudging the agency to pull a decongestant from over-the-counter medicines.

FDA Finally Admits the Most Popular Oral Decongestant Doesn’t Work When pseudoephedrine was banned from off-the-shelf sale in 2006 (it’s still available “over the counter,” but kept behind the counter), Sudafed and other companies had to come up with a way to keep something available for easy purchase. That’s why Sudafed PE—an entirely different, and allegedly ineffective, product—is… Read more…

Popular OTC Decongestants Don’t Really Work, FDA Says Many products, including Sudafed PE, contain phenylephrine, which an FDA committee said is ineffective.

Throw Out These Illegally Produced Home Pregnancy Tests, FDA Says In the wake of a bust on an illegal medical lab in California involving a dozen government agencies, the Food and Drug Administration is warning consumers not to use at-home pregnancy tests made by Universal Meditech, Inc. (UMI), which were distributed under multiple names and sold on multiple online platforms Read more…

FDA Approves First Pill for Postpartum Depression Because the pill works faster than other antidepressants and is taken for only two weeks, it may encourage more treatment of the debilitating condition.