Food and Drug Administration

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On Popular Asthma Pill, 'Something That's Concerning'

FDA ties Singular (aka montelukast) to mental health issues; it's not necessarily cause-effect

(Newser) - When Merck debuted its Singulair asthma pill in the late '90s, an appealing alternative to asthma sufferers who relied on inhalers, the pharmaceuticals company compared it to a "sugar pill" in terms of side effects, calling any distribution of the drug to the brains of the millions of...

Tom's of Maine Gets Into a Little Trouble With the FDA

Agency found bacteria, mold in a May inspection at a plant in Sanford, Maine

(Newser) - Tom's of Maine has found itself on the wrong side of the Food and Drug Administration. An inspection earlier this year at a plant in Sanford, Maine, surfaced a number of violations. As CNN reports, in a letter dated Nov. 5, the agency says inspectors found the following in...

FDA Agrees Ingredient in Cold Medicines Doesn't Work

Agency's advisers already decided oral phenylephrine is ineffective

(Newser) - After what the agency called a thorough review of the data, the Food and Drug Administration has proposed ending the use of an ingredient of many cold and allergy medications because it doesn't work. Oral phenylephrine doesn't ease nasal congestion, the agency said. That's the same conclusion...

Your Food Packaging May Soon Come With a Warning Label

FDA hopes to add warnings signaling high levels of sodium, saturated fat, added sugars

(Newser) - "Eating patterns in the US do not align with federal dietary recommendations." That's per a recent proclamation by the Food and Drug Administration, which warns we're a nation facing "an ever-growing epidemic of diet-related chronic diseases such as cardiovascular disease, diabetes, and obesity." One...

Report: FDA Has Fallen Far Behind in Drug Plant Checks

More than 2K plants are overdue for inspection

(Newser) - Federal regulators responsible for the safety of the US drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the US and across the world. An AP analysis of Food and Drug Administration data shows that agency staffers...

Updated COVID Shots to Be Available in Days
New COVID Shots Are Coming
Aug 22, 2024 3:44 PM CDT

New COVID Shots Are Coming

FDA clears vaccines, and Pfizer and Moderna are ready to ship

(Newser) - Federal regulators approved updated COVID-19 vaccines on Thursday, shots designed to more closely target recent virus strains—and ideally whatever variants cause trouble this winter, too. With the Food and Drug Administration's clearance, Pfizer and Moderna are set to begin shipping millions of doses, which should be available in...

Veggies Sold at Walmart, Kroger, Aldi Under Recall

More than a dozen vegetables, herbs out of Ohio's Wiers Farm may pose listeria risk

(Newser) - Summer is fruits and veggies time, but if you've picked up any of the latter lately, you may want to check the latest recall list. ABC News reports that the FDA has announced an expanded recall from Wiers Farm in Ohio that now covers 18 different vegetables and herbs...

FDA Bans Unsafe Ingredient Found in Some Sodas
So Long to This Controversial
Soft-Drink Ingredient
in case you missed it
Jul 7, 2024 7:30 AM CDT

So Long to This Controversial Soft-Drink Ingredient

FDA to enforce ban on brominated vegetable oil beginning in 2025

(Newser) - Say goodbye to BVO. The FDA announced Tuesday that brominated vegetable oil, the controversial ingredient found in some citrus-flavored soft drinks, will no longer be allowed in food or beverages in the US due to safety concerns. Used to keep citrus flavoring from rising to the top of drinks, the...

On Alzheimer's, an Advance 'We've All Been Waiting For'

Eli Lilly's donanemab, sold as Kisunla, gets the FDA green light to help slow disease progression

(Newser) - Last summer, the Food and Drug Administration gave the thumbs-up to Leqembi, the first drug shown to slow the progression of Alzheimer's disease. Now, almost a year to the day after that move, the government agency has greenlit a second drug: Eli Lilly's donanemab, sold under the brand...

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...

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