FDA

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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...

The Rise of the Unregulated Home Health Test
The Rise of the
Unregulated
Home Health Test
longform
Jul 20, 2024 5:00 PM CDT

The Rise of the Unregulated Home Health Test

More people are turning to them if doctors aren't giving them answers

(Newser) - From babies with mysterious gastrointestinal issues to adults with unexplained chronic pain, an increasing number of people are turning to unregulated home health tests for answers they're not getting from doctors. The Washington Post delves into the phenomenon with the story of Annika Sharma, who, at 6 months old,...

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...

FDA Warns of Poisoning From Shellfish in 2 States
FDA Issues Shellfish Warning
Jun 11, 2024 2:28 PM CDT

FDA Issues Shellfish Warning

Toxins have sickened at least 31 people in Oregon alone

(Newser) - The Food and Drug Administration says consumers should avoid eating shellfish from Oregon and Washington state, as they may be contaminated with toxins that cause paralytic shellfish poisoning. At least 31 people have been sickened in Oregon so far, according to state health officials. Here's the situation, per the...

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...

There's a New, Less-Invasive Way to Test for HPV

FDA approves self-testing kits to expand access to screening

(Newser) - The FDA is making it a whole lot easier to test for human papillomavirus, which can cause six types of cancer and accounts for more than 95% of cervical cancers. HPV is typically detected through cell samples collected from a woman's cervix during a Pap smear. But in a...

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,...

Biden Administration Stalls FDA Ban on Menthol Cigarettes

White House officials have been meeting with opponents of the rule ahead of the election

(Newser) - For the second time in recent months, President Biden's administration has delayed a sweeping plan to ban menthol cigarettes, a decision that is certain to infuriate anti-smoking advocates but could avoid angering Black voters ahead of November elections. In a statement Friday, Biden's top health official gave no...

It's 'a Difficult Moment for the ALS Community'

Relyvrio being pulled from the market after it was found to be ineffectual for Lou Gehrig's disease

(Newser) - The maker of a drug for Lou Gehrig's disease that recently failed in a large study said Thursday it will pull the medicine from the market, per the AP . Amylyx Pharmaceuticals announced it will voluntarily halt sales and marketing of Relyvrio in the US and Canada, where new patients...

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