The Food and Drug Administration

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FDA warns maker of Sara Lee and Entenmann’s not to claim foods contain allergens when they don’t

Federal food safety regulators said Tuesday that they have warned a top U.S. bakery to stop using labels that say its products contain potentially dangerous allergens when they don’t.

https://apnews.com/article/bimbo-bakeries-sesame-allergy-reaction-fb3f49f95515b9af3cf1bfd7ddbabed6?

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Copycat snacks

 

The FDA and the FTC issued warnings to five companies this week as part of a joint effort to crack down on illegal sales of copycat snacks containing delta-8 THC. The packaging for the THC edibles looks strikingly similar to that of popular foods such as Froot Loops cereal and Chips Ahoy! Cookies, for example, but the edibles contain potentially dangerous amounts of a psychoactive cannabinoid. The FDA has said it is concerned that these products can be easily mistaken for traditional foods, leading to accidental ingestion or overconsumption. If the violations are not promptly addressed within 15 days, the FDA said it may take legal action.

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Blood test for colon cancer screening is approved by US regulators

WASHINGTON (AP) — U.S. health regulators on Monday approved a first-of-its-kind blood test for colon cancer, offering a new way of screening for a leading cause of cancer deaths.

https://apnews.com/article/colon-cancer-blood-test-fda-guardant-a2c2cda2cdaa52f081860f0faed1e5cf?

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FDA warns about more ground cinnamon tainted with lead. Here’s what you need to know

U.S. health officials are warning that several types of ground cinnamon sold at certain discount and specialty grocery stores are contaminated with high levels of lead and should be discarded.

https://apnews.com/article/cinnamon-lead-poisoning-fda-19f62480b3d5d6bf9ae50faa87ab2df0?

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US FDA says all doses of Lilly's weight-loss and diabetes drug are now available

(Reuters) -All doses of Eli Lilly's weight-loss drug Zepbound and diabetes drug Mounjaro are now available, the U.S. Food and Drug Administration's updated shortage list showed on Friday.

https://www.newsbreak.com/news/3548830072322-us-fda-says-all-doses-of-lillys-weight-loss-and-diabetes-drug-are-now-available?

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FDA approves first nasal spray to treat dangerous allergic reactions

U.S. health officials on Friday approved a nasal spray to treat severe allergic reactions, the first needle-free alternative to shots like EpiPen.

https://apnews.com/article/epipen-nasal-spray-allergic-reaction-fda-32ef474cbe0a14bc854691ec44bbaf10?

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FDA approves updated COVID-19 vaccines, shots should be available in days

WASHINGTON (AP) — U.S. regulators approved updated COVID-19 vaccines on Thursday, shots designed to more closely target recent virus strains -- and hopefully whatever variants cause trouble this winter, too.

https://apnews.com/article/covid19-vaccines-virus-pfizer-moderna-fb542f97096e9759059c0bdd82a48a74?

FDA approves new COVID shots from Moderna, Pfizer

The Food and Drug Administration approved new formulations of both Moderna and the Pfizer-BioNTech COVID-19 vaccines on Thursday.

https://www.axios.com/2024/08/22/fda-approves-new-covid-shots-moderna-pfizer?

 

Covid-19 vaccines

 

The FDA on Thursday signed off on updated Covid-19 vaccines as health officials warn of another summer wave of infections. Moderna and Pfizer said the updated mRNA shots will be available in pharmacies and clinics in the days ahead. "Given waning immunity of the population from previous exposure to the virus and from prior vaccination, we strongly encourage those who are eligible to consider receiving an updated COVID-19 vaccine to provide better protection against currently circulating variants," said Dr. Peter Marks, director of the FDA's Center for Biologics Evaluation and Research. The prevalent strain in the US now is KP.3.1.1, estimated to account for 37% of cases over the past two weeks. That's triple its level a month ago.

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Walmart recalls apple juice sold in 25 states due to elevated arsenic levels

WASHINGTON (AP) — Walmart has recalled nearly 10,000 cases of apple juice sold in stores across the U.S. that were found to contain potentially harmful levels of inorganic arsenic.

https://apnews.com/article/walmart-apple-juice-recall-e4c185fd48af2438023ea94b3f6b2b74?

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FDA has massive backlog of factory inspections as staffers leave for private sector jobs

WASHINGTON (AP) — Federal regulators responsible for the safety of the U.S. drug supply are still struggling to get back to where they were in 2019, before the COVID-19 pandemic upended factory inspections in the U.S. and across the world, The Associated Press has found.

https://apnews.com/article/fda-inspections-drug-manufacturing-india-china-7b3a7e9b45bcc3aea86ce5bf781271f3?

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Hygiene products

 

The FDA announced Tuesday that it will examine the potential harm caused by heavy metals in hygiene products. The FDA's action comes after a small pilot study published in July found arsenic and lead in organic and nonorganic tampons. Although the levels of both metals were low, there is no safe level of exposure to lead, according to the EPA. Organic tampons contained higher levels of arsenic, while nonorganic tampons had higher levels of lead, the study found. Vaginal tissue is more permeable than other parts of the body, so if more extensive studies were to find that heavy metals — or worrisome chemicals — do leach from menstrual products into the body, it could be a significant problem, health experts said.

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Food safety concerns

Consumers are getting sick after eating untested ingredients. Here’s how a regulatory loophole is letting manufacturers bypass FDA oversight.

 

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McDonald’s and Boar’s Head outbreaks may have you worried. Experts say the food supply is safe

From Boar’s Head deli meat to TreeHouse Foods waffles to McDonald’s Quarter Pounders, this year’s illness outbreaks — some deadly — and food recalls may have Americans wondering whether there are new risks in the U.S. food supply.

https://apnews.com/article/mcdonalds-boars-head-ecoli-listeria-food-safety-1256564e2ec8baf6a96b27c7102e833e?

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FDA to pull common but ineffective cold medicine from market

The Food and Drug Administration announced Wednesday that it would seek to pull a widely used ingredient in cough and cold medicines from the market, after the agency's scientists concluded that the oral version of the drug is ineffective as a nasal decongestant.

https://www.cbsnews.com/news/fda-cold-medicine-phenylephrine-ineffective/?

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New FDA rules for TV drug ads: Simpler language and no distractions

WASHINGTON (AP) — Those ever-present TV drug ads showing patients hiking, biking or enjoying a day at the beach could soon have a different look: New rules require drugmakers to be clearer and more direct when explaining their medications’ risks and side effects.

https://apnews.com/article/drug-ads-fda-risks-side-effects-influencers-80bbe076f4ed743ebde3923dd28be004?

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Florida Gov. DeSantis’ Canadian Drug Import Plan Goes Nowhere After FDA Approval

Nearly a year after the Biden administration gave Florida the green light to become the first state to import lower-cost prescription drugs from Canada — a longtime goal of politicians across the political spectrum, including President-elect Donald Trump — the program has yet to begin.

https://floridaphoenix.com/2024/11/21/florida-gov-desantis-canadian-drug-import-plan-goes-nowhere-after-fda-approval/?

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FDA says decongestant in many cold medicines doesn’t work. So what does? Changes are coming to the cold and cough aisle of your local pharmacy: U.S. officials are moving to phase out the leading decongestant found in hundreds of over-the-counter medicines, concluding that it doesn’t actually relieve nasal congestion. Read more.

Why this matters: Phenylephrine is used in popular versions of Sudafed, Dayquil and other medications, but experts have long questioned its effectiveness. It’s a win for skeptical academics, including researchers at the University of Florida who petitioned the FDA to revisit the drug’s use in 2007 and again in 2015.   For consumers it will likely mean switching to alternatives, including an older decongestant that was moved behind the pharmacy counter nearly 20 years ago.  Other options are over-the-counter nasal sprays or solutions. Saline drops and rinses are a quick way to clear mucus from the nose. For long-term relief from seasonal stuffiness, itching and sneezing, many doctors recommend nasal steroids, sold as Flonase, Nasacort and Rhinocort.   Doctors say Americans will be better off without phenylephrine. “People walk into the drugstore today and see 55,000 medicines on the shelf and they pick one that is definitely not going to work,” said Dr. Brian Schroer of the Cleveland Clinic. “You take away that option and it will be easier for them to self-direct toward products that really will help them.”

RELATED COVERAGE ➤ FDA updates the definition of ‘healthy’ foods   US flu season is underway, as cases surge in some areas and vaccinations lag   Nearly 30% of US drugstores closed in one decade, study shows

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Nutrition labels

The US Food and Drug Administration wants nutrition information on the front of packaged foods to provide at-a-glance information about saturated fat, sodium and added sugar. The agency said the proposal would help consumers make informed decisions.

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FDA bans red dye No. 3 from foods

U.S. regulators on Wednesday banned the dye called Red 3 from the nation’s food supply, nearly 35 years after it was barred from cosmetics because of potential cancer risk.

https://apnews.com/article/fda-red-dye-no-3-ban-94c3e418584fb1e91ca3b0cbeb3d5a60?

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Option for smokers

For the first time, the Food and Drug Administration authorized the sale of nicotine pouches to help adult smokers cut back or quit cigarettes. Pouches are the fastest-growing segment of the US tobacco market, and the approved brand — Philip Morris International’s Zyn — comes in 10 flavors, including coffee and mint.

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Pain medication

The FDA on Thursday approved the first new type of pain medication in 25 years. The drug, suzetrigine, is a 50-milligram prescription pill that's taken every 12 hours after a larger starter dose. It will be sold under the brand name Journavx. About 80 million Americans fill prescriptions each year for medications to treat new instances of moderate to severe pain, according to a study by Vertex Pharmaceuticals, the company that developed the new drug. About half of those prescriptions are written for opioid medications, which can lead to dependence and addiction. Unlike opioid medications, which dull the sensation of pain in the brain, suzetrigine works by preventing pain-signaling nerves around the body from firing in the first place.

 

FDA approves painkiller designed to eliminate the risk of addiction associated with opioids Federal officials on Thursday approved a new type of pain pill designed to eliminate the risks of addiction and overdose associated with opioid medications like Vicodin and OxyContin. Read more.

Why this matters: The U.S. Food and Drug Administration said it approved Vertex Pharmaceuticals’ Journavx for short-term pain that often follows surgery or injuries. It’s the first new pharmaceutical approach to treating pain in more than 20 years, offering an alternative to both opioids and over-the-counter medications like ibuprofen and acetaminophen.   The new drug, however, will carry a list price of $15.50 per pill, making it many times more expensive than comparable opioids, which are often available as generics for $1 or less.

RELATED COVERAGE ➤ The tuberculosis outbreak in Kansas is alarming. It’s not the biggest in US history though, CDC says   Who funds the World Health Organization? A list of its biggest donors   Hospital nurse in Uganda dies in country’s first Ebola outbreak in 2 years

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FDA Approves New Non-Opioid Pain Treatment

Jan. 31, 2025 – The FDA has approved a new non-opioid oral drug for acute pain in adults. It is the first new class of non-opioid pain medicine approved in over 20 years, providing effective pain relief without the risk of addiction that can come with opioids.

https://www.webmd.com/pain-management/news/20250131/fda-approves-new-non-opioid-pain-treatment?

FDA Clears NSAID/Triptan Combo for Migraine in Adults

Jan. 31, 2025 – The FDA has approved Symbravo, a new migraine medication that combines two powerful ingredients—rizatriptan and meloxicam—to quickly relieve migraine pain. Symbravo is designed for adults with migraines, whether or not they experience aura (visual disturbances).

https://www.webmd.com/migraines-headaches/news/20250131/cm/fda-clears-new-migraine-drug-for-adults?

FDA OKs Ozempic for Kidney Disease in Diabetes Patients

Jan. 29, 2025 -- The FDA has approved Novo Nordisk's diabetes drug Ozempic to help reduce the risk of worsening kidney disease, kidney failure, and heart-related death in adults with type 2 diabetes and chronic kidney disease (CKD). With this approval, Ozempic becomes the most broadly indicated drug in its class, now covering diabetes control, heart disease risk reduction, and kidney protection.

https://www.webmd.com/diabetes/news/20250129/fda-oks-ozempic-kidney-disease?

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FDA Approves 5-in-1 Vaccine Against Meningococcal Disease

Feb. 18, 2025 – The FDA has approved a new 5-in-1 shot to protect against meningococcal infections or invasive meningococcal disease (IMD) in people ages 10 to 25 years

https://www.webmd.com/children/vaccines/news/20250218/fda-approves-5-in-1-vaccine-against-meningococcal-disease?

FDA OKs Vaccine for Mosquito-Borne Chikungunya

Feb. 18, 2025 – The FDA has approved a new vaccine to protect against chikungunya. This first-of-its-kind shot is approved to prevent this viral disease in people ages 12 and older.

https://www.webmd.com/vaccines/news/20250218/fda-oks-vaccine-for-mosquito-borne-chikungunya?

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FDA OKs New Antibiotic Combo for Serious Abdominal Infections

Feb. 10, 2025 -- The FDA has approved a new antibiotic combination called Emblaveo to treat serious infections of the abdomen in adults who have few or no other treatment options. It will be given through an IV and used with another antibiotic called metronidazole.

https://www.webmd.com/digestive-disorders/news/20250210/fda-oks-new-antibiotic-combo-abdominal-infections?

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FDA Approves New Label for Opioid Use Disorder Drug

Feb. 25, 2025 – The FDA has approved a new treatment plan for a long-acting injection, making it easier for people with moderate to severe opioid use disorder (OUD) to start and keep up with their treatment.

https://www.webmd.com/mental-health/addiction/news/20250225/fda-approves-new-label-for-opioid-use-disorder-drug?

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FDA OKs Triple Combo for Advanced Large B-Cell Lymphoma

Feb. 13, 2025 -- The FDA has approved a new three-drug combination to treat certain types of an aggressive blood cancer called large B-cell lymphoma (LBCL). 

https://www.webmd.com/cancer/lymphoma/news/20250213/fda-oks-triple-combo-advanced-large-b-cell-lymphoma?