Food and Drug Administration

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FDA to Bakery: Stop Saying Your Products Have Allergens

Agency says Bimbo has been labeling foods as having allergens that don't actually have them

(Newser) - Federal food safety regulators said Tuesday that they've warned a top US bakery to stop using labels that say its products contain potentially dangerous allergens when they don't. Food and Drug Administration inspectors found that Bimbo Bakeries USA—which includes brands such as Sara Lee, Thomas', Entenmann's,...

Critics Slam FDA, 'Predatory Industry' on Menthol E-Cigs

Parent, anti-smoking groups say first product of its kind will continue to encourage teen vaping

(Newser) - The Food and Drug Administration on Friday authorized the first menthol-flavored electronic cigarettes for adult smokers, acknowledging that vaping flavors can reduce the harms of traditional tobacco smoking. The FDA said it authorized four menthol e-cigarettes from NJOY, the vaping brand recently acquired by tobacco giant Altria, which also sells...

FDA Says Microdosing Candy Bars Are Making People Sick
FDA Says Microdosing Candy
Bars Are Making People Sick
IN CASE YOU MISSED IT
Jun 15, 2024 4:15 PM CDT

FDA Says Microdosing Candy Bars Are Making People Sick

6 people have been hospitalized so far

(Newser) - According to the FDA, a brand of microdosing chocolate bars sent some consumers on a very unwanted trip, and now the agency is warning others not to eat the bars. Eight people so far have reported getting sick after eating one of the bars from Diamond Shruumz, and six of...

Expert Panel Recommends FDA Approve Alzheimer's Drug

Advisers vote unanimously to back donanemab despite risks

(Newser) - A closely watched Alzheimer's drug from Eli Lilly won the backing of federal health advisers on Monday, setting the stage for the treatment's expected approval for people with mild dementia caused by the brain-robbing disease. Food and Drug Administration advisers voted unanimously that the drug's ability to...

FDA Panel Rejects MDMA Treatment
FDA Panel Rejects
MDMA Treatment
the rundown
Jun 5, 2024 12:39 AM CDT

FDA Panel Rejects MDMA Treatment

It was the first time FDA advisers considered a Schedule I psychedelic drug for medical use

(Newser) - Advocates have long pushed for the psychedelic drug known as MDMA, ecstasy, or molly to be approved as a prescription drug for those with post-traumatic stress disorder , but the movement suffered a big setback Tuesday. A Food and Drug Administration advisory panel voted—"overwhelmingly," CNN reports—against recommending...

Neuralink Is Going to Give Implant a Second Shot

FDA approves fix to issue of neural threads dislodging

(Newser) - The FDA has approved Neuralink's plan to put its brain implant in a second human patient—with adjustments for issues that arose with the first . Some 85% of the implant's electrode-containing threads became dislodged from Noland Arbaugh's motor cortex, severely limiting the data that could be gained...

Nut Products Recalled Over E. Coli, Listeria Risk

Walnuts linked to E. coli outbreak, Planters products linked to listeria risk

(Newser) - At least a dozen people in California and Washington have been sickened with E. coli food poisoning linked to organic walnuts sold in bulk in 19 states, US health officials said Tuesday. The nuts were sold in natural food and co-op stores such as Whole Foods and Market of Choice,...

FDA Delays Approval of Eli Lilly's Alzheimer's Drug
FDA Stalls on New
Alzheimer's Drug
Mar 8, 2024 8:55 AM CST

FDA Stalls on New Alzheimer's Drug

'We were not expecting this,' says Eli Lilly president

(Newser) - Eli Lilly's experimental Alzheimer's drug is facing yet another delay on the path toward FDA approval. The company's donanemab medication was first expected to be cleared last year and later by the end of this month. However, the drugmaker announced Friday that approval isn't expected until...

Lab Wants Recall of Common Acne Meds

They may contain elevated levels of a cancer-causing chemical

(Newser) - An independent lab is calling on the FDA to suspend sales of benzoyl peroxide after finding the acne medication degraded into a cancer-causing chemical in products from popular brands like ProActiv and Clearasil. Valisure analyzed 99 acne treatment products containing benzoyl peroxide (BPO). Before heating, the carcinogen benzene was detected...

First Drug for Severe Food Allergies Is Approved

FDA says Xolair can help people with allergies to milk, eggs, nuts, other sources

(Newser) - A medication used to treat asthma can now be used to help people with food allergies avoid severe reactions, says the FDA. Xolair, the brand name for the drug omalizumab, became the first medication approved to reduce allergic reactions caused by accidental exposure to food triggers, per the AP . Patients...

Biogen Abandons Aduhelm After Problem-Filled Launch
Maker Gives Up
on Alzheimer's Drug
Jan 31, 2024 7:05 PM CST

Maker Gives Up on Alzheimer's Drug

Approval process, pricing, and murky benefits contributed to Aduhelm's failure on the market

(Newser) - Biogen announced Wednesday that it is stopping its clinical trials of an Alzheimer's drug, will no longer sell it, and is forsaking the ownership rights. Along with federal regulators, the company had faced major criticism over the development and pricing—at $56,000 per year—of Aduhelm. Biogen said...

Eyedrops Recalls Illustrate Holes in FDA Oversight

Agency needs greater authority to ensure safety, experts say

(Newser) - When you buy eyedrops at a US store, you might assume the product was made in a clean, well-maintained factory that's passed muster with health regulators. But repeated recalls involving over-the-counter drops are drawing new attention to just how little US officials know about the conditions at some manufacturing...

FDA Ties Lead-Tainted Applesauce to Cinnamon

'WaPo' probe finds nearly 120 kids with lead poisoning after consuming applesauce pouches

(Newser) - Back in October, a handful of kids in North Carolina turned up with elevated lead levels in their blood, tied back to the WanaBana brand of applesauce pouches. Now, the Washington Post reveals that nearly 120 children may be victims of such poisoning. The paper reports that, per its own...

This Is Why You Shouldn't Bring a Gun Into an MRI

Patient, 57, ended up shot in the butt after sneaking a firearm into the machine

(Newser) - It might seem obvious to most that one probably shouldn't bring a firearm into a large machine with a powerful magnetic field, but one woman learned that lesson the hard way. The Messenger first reported on the "adverse event" cited by the Food and Drug Administration , in which...

Salmonella Infections Linked to Cantaloupe Kill 3

Authorities warn people not to eat pre-cut cantaloupe if they don't know the source

(Newser) - Consumers shouldn't eat pre-cut cantaloupe if they don't know the source, US health officials said Thursday, as the number of illnesses and recalls tied to a deadly salmonella outbreak grows. At least 117 people in 34 US states have been sickened by contaminated cantaloupe, including 61 who were...

FDA Proposes Banning Controversial Pop Ingredient

California has already banned brominated vegetable oil

(Newser) - The Food and Drug Administration might follow California's lead with a ban on a controversial ingredient found in some citrus-flavored soft drinks. CBS News reports that the agency has proposed banning brominated vegetable oil, which has been used in drinks for around a century. The ingredient, which includes bromine,...

FDA: These Eyedrops Could Blind You
FDA Warns:
These Eyedrops
Could Blind You
IN CASE YOU MISSED IT
Nov 4, 2023 4:10 PM CDT

FDA Warns: These Eyedrops Could Blind You

Affected eyedrops should no longer be used, agency warns

(Newser) - US health regulators are warning consumers not to use more than two dozen varieties of over-the-counter eyedrops because of the risk of infections that could lead to blindness, the AP reports. The Food and Drug Administration advisory applies to lubricating drops sold by six companies, including CVS Health, Target, Rite...

It Feels 'Like Being Stabbed All Over.' A New Cure Is Closer

Panel clears CRISPR gene-editing product for sickle cell disease patients; FDA to weigh in

(Newser) - Sickle cell disease is a painful, debilitating, and possibly deadly inherited disorder that currently can only be remedied with a bone marrow transplant. Now, Boston's Vertex Pharmaceuticals hopes exa-cel, its treatment developed with CRISPR Therapeutics, will soon be approved by the FDA following a thumbs-up from a panel of...

If You Had This Fruit Puree Pouch, Get a Blood Test

FDA says some WanaBana products have 'extremely high concentrations of lead'

(Newser) - WanaBana fruit puree pouches might sound like a healthy option for parents to give their kids, but the FDA is warning that anyone who consumed one should get their blood tested for what appears to be "extremely high concentrations of lead." As the New York Times reports, the...

CVS Yanks Completely Ineffective Cold Meds

Move comes after FDA found oral phenylephrine to be a useless decongestant

(Newser) - CVS Health is pulling various cough and cold medicines from its shelves after an FDA advisory panel determined the active ingredient doesn't work. Phenylephrine, approved in the 1930s, has long been found in over-the-counter syrups and pills meant to resolve sinus congestion. However, an FDA analysis found the ingredient,...

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