Eats « Weekly Gravy

A new government report finds that federal regulators need to do more to help in the battle to keep kids and teens off tobacco. Among the report’s findings were that the U.S. Food and Drug Administration needs to get tough on retailers selling tobacco to youth and should improve its oversight of online retailers. The FDA should also work with the Bureau of Alcohol, Tobacco, Firearms and Explosives to help stop online tobacco sales to children, according to the report from the Office of the Inspector General (OIG). “Responding effectively to serial violators remains a challenge for FDA,” the report stated. “The small number of retailers that repeatedly violate the Tobacco Control Act are often not subjected to more punitive actions. This risks undermining FDA’s efforts to control youth access to tobacco and enforce other restrictions on tobacco intended to safeguard public health,” according to the report. The agency needs to prioritize enforcement actions against retailers with a history of noncompliance, the OIG said. The FDA plans to discuss stricter enforcement with internal experts by November, CNN reported, and the agency agreed that inspections are a key part of keeping kids from smoking or vaping. The FDA did more than 1 million inspections between 2010 and 2020 looking for underage sales, CNN reported. The agency inspected about 74% of 360,000 stores at least once. It… read on > read on >

Highly processed packaged foods and drinks may be quick, cheap and tasty, but new research suggests they’re also likely to up your risk for depression. Among big consumers of ultra-processed foods, depression risk may rise by as much as 50%, the new study found, particularly when those foods are artificially sweetened. “Given what we know about these foods and the important role of diet in mood, we were not surprised to find this association,” said study author Dr. Andrew Chan, vice chair of gastroenterology at Massachusetts General Hospital, and a professor of medicine at Harvard Medical School. At issue, he said, are foods that are “highly altered, often through industrial processes such as hydrogenation.” Hydrogenation is a chemical manufacturing process that significantly increases the amount of trans fat found in foods. Researchers have repeatedly linked trans fat intake to an increased risk for heart disease. The study looked at “ultra-processed” grain foods, sweet snacks, ready-to-eat meals, desserts, sauces, processed dairy products, savory snacks, processed meat, beverages, and/or artificial sweeteners. Such foods, Chan added, also “often contain additives such as dyes, stabilizers and emulsifiers. Examples include most so-called ‘fast food,’ cookies and chips.” In light of other research indicating that diet influences depression risk, Chan and his colleagues specifically set out to see what impact processed foods might have on depression risk. They looked at nearly… read on > read on >

In a surprising move, the U.S. Food and Drug Administration (FDA) has opted not to approve a needle-free alternative to the EpiPen for emergency treatment of severe allergic reactions. Approval of the Neffy nasal spray was widely anticipated. An FDA advisory panel voted to recommend approval of the drug for children and adults in May. While the FDA is not obligated to follow the advice of their advisory panels, it usually does. Instead, the FDA told the drug’s maker, ARS Pharmaceuticals, that it needed to conduct another study on the drug before it is approved, the company said in a statement late Tuesday night. “We are deeply disappointed that this action further delays the availability of Neffy for the millions of people who are at risk of a potentially life-threatening severe allergic reaction,” said Richard Lowenthal, co-founder, president and CEO of ARS Pharma. “We stand by the totality of the Neffy data package in a comprehensive registration program that was aligned upon with FDA and believe strongly in the value Neffy can provide for patients, families and caregivers living daily with severe allergic reactions,” he said in a company statement, adding that his firm will aim to complete the requested trial as soon as possible. The news was unwelcome on the front lines of health care. “It’s certainly disappointing as we were hoping to have… read on > read on >

Another diabetes drug maker is taking legal action against businesses in several states, alleging that they’re “fraudulently claiming” that their compounded products are the same as its medication. This time, it’s Eli Lilly suing certain medical spas, wellness centers and compounding pharmacies over its medication Mounjaro. Mounjaro contains the active ingredient tirzepatide and is approved by the U.S. Food and Drug Administration to treat type 2 diabetes. The lawsuits, filed Tuesday, are meant to stop the other companies from “the unlawful marketing and sale of non-FDA approved compounded products.” “Lilly filed this lawsuit to protect patients,” the company said in a statement issued Tuesday. “Lilly cannot validate the safety or effectiveness of products claiming to contain tirzepatide that are not our own branded product.” The company sells Mounjaro only in prefilled single-dose pens. “These entities should be stopped from providing drug products in violation of consumer protection laws, particularly where they promise their patients that their drugs offer the same safety profile and clinical benefits as Mounjaro,” the statement added. In June, Novo Nordisk sued businesses for making compounded versions of semaglutide, which is used in its type 2 diabetes drugs Ozempic and Rybelsus. The medication is also used to treat obesity under the brand name Wegovy. In its cases, Novo Nordisk has asked the companies “to cease and desist from false advertising, trademark infringement… read on > read on >

Before pouring another drink, consider this sobering new research: Heavy drinkers can develop fat around the heart, leading to heart failure and other cardiac problems. This so-called pericardial fat is associated with increased risk of heart disease. Researchers also linked heavy drinking to excess fat deposits around the liver and kidneys, which can result in diseases of these organs, too. “The accumulation of fats in these areas, especially at the heart, has been linked to higher risk of heart disease like heart failure, atrial fibrillation as well as coronary heart disease, which is the major killer of U.S. adults,” said lead researcher Dr. Richard Kazibwe, an assistant professor of internal medicine at Wake Forest University School of Medicine in Winston-Salem, N.C. Alcohol affects how the body handles fat, he said. “Drinking is a known risk for obesity. We know from the past that alcohol can influence metabolism. It can influence levels of hormones in the body that can lead to the distribution of fat in general, but also in various areas of the body,” Kazibwe said. That’s how fat ends up surrounding the heart, but if you stop imbibing will that fat disappear? Kazibwe said fat around the liver can be reduced if you stop drinking, but it isn’t known if the same is true for fat around the heart. The bottom line, in his… read on > read on >

Low-carb diets may be all the rage, but they’re not for kids with diabetes, according to the American Academy of Pediatrics (AAP). In a new report, the AAP says that low-carbohydrate diets cannot be recommended for children or teenagers with either type 1 or type 2 diabetes. That’s because there’s little evidence they’re helpful, but there are concerns about restricting kids’ diets to that degree. Instead, the AAP encourages families to focus on cutting out “bad” carbs: sugary drinks, sweets and other processed foods that are low in nutrients. Just as important, kids should get enough healthy carbs, including vegetables, beans and fiber-rich grains. The “keto” diet and similar ones popular among adults can put very strict limits on carbs, with a ceiling as low as 20 grams per day — equivalent to a half-cup of white rice. A big concern is that low-carb diets will shortchange kids on nutrients during critical periods of development, said Amy Reed, a pediatric dietitian with Cincinnati Children’s Hospital Medical Center. Reed, who was not involved in the AAP report, said she agrees with its recommendations. “The focus should be on healthy eating, rather than restriction,” said Reed, who is also a spokeswoman for the Academy of Nutrition and Dietetics. Diabetes exists in different forms: Type 1 diabetes arises from an immune system attack on the pancreatic cells that… read on > read on >

California is on track to become the first state to ban four food additives that some experts have linked to health issues ranging from behavioral problems in children to reproductive issues to cancer in lab animals. On Tuesday, the legislature passed Assembly Bill 418, which now awaits the signature of Gov. Gavin Newsom. The substances are permitted by the U.S. Food and Drug Administration, so this would be the first time a state has banned items allowed by federal regulators. The chemicals are already illegal in the European Union and other places around the world, NBC News reported. The ingredients are red dye No. 3, potassium bromate, brominated vegetable oil and propylparaben. The restriction would begin in 2027. “It’s going to make our food supply much safer,” Assembly member Jesse Gabriel, who introduced the bill along with Assembly member Buffy Wicks, told NBC News. “It’s going to give parents more confidence that when they’re buying foods at the grocery store, they don’t have to worry that there’s something in there that’s dangerous for their kids.” Although red dye No. 3 is banned in cosmetics because of its history of causing cancer in lab animals in high doses, it’s still allowed as a food coloring. Potassium bromate allows bread and baked goods to rise higher and improves texture. Brominated vegetable oil keeps flavoring from floating to… read on > read on >

Following an approval granted Monday by the U.S. Food and Drug Administration, the U.S. Centers for Disease Control and Prevention on Tuesday signed off on new COVID boosters for Americans. “We have more tools than ever to prevent the worst outcomes from COVID-19,” CDC Director Dr. Mandy Cohen said in an agency news release announcing the approval. “[The] CDC is now recommending updated COVID-19 vaccination for everyone 6 months and older to better protect you and your loved ones.” Hours earlier, the CDC’s Advisory Committee on Immunization Practices (ACIP) had voted to support the boosters for all Americans aged 6 months and older. The COVID shots from Pfizer and Moderna will join the flu shot and newly approved RSV shots as part of a three-pronged public health strategy to tame the spread of all three viruses this coming winter. The updated COVID vaccines are each fully approved for those 12 and older and are authorized under emergency use for individuals 6 months through 11 years of age. “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said Monday in an agency news release. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and… read on > read on >

For decades, sick people have been taking essentially worthless over-the-counter cold remedies to clear their stuffy noses, a key advisory panel for the U.S. Food and Drug Administration said Tuesday. The panel voted unanimously that nonprescription oral medications containing phenylephrine — including Sudafed PE, Vicks Sinex and Benadryl Allergy Plus Congestion — don’t do anything to ease congestion. The committee’s ruling could prompt the FDA to pull all oral decongestants containing phenylephrine from store shelves, leaving cold sufferers with limited options to relieve their misery. “I feel this drug in this oral dose should have been removed from the market a long time ago,” said Jennifer Schwartzott, the patient representative on the panel, the Associated Press reported. “Patients require and deserve medications that treat their symptoms safely and effectively, and I don’t believe that this medication does that.” Phenylephrine has been available in cold remedies since the 1970s, and can be taken as a liquid, pill or nasal spray. Tuesday’s decision does not include the nasal spray version. Medications with phenylephrine took on more prominence after the highly effective decongestant pseudoephedrine became harder to purchase in 2005, as part of legislation aimed at combatting the meth epidemic. More than 242 million bottles or packages of phenylephrine-containing cold remedies were sold in 2022, compared with about 51 million cold products containing pseudoephedrine, FDA briefing documents for… read on > read on >

The U.S. Food and Drug Administration on Monday gave the green light to new COVID boosters for Americans, setting the stage for the updated vaccines to become available within days. The COVID-19 shots from Pfizer and Moderna will join the flu shot and newly approved RSV shots as part of a three-pronged public health strategy to tame the spread of all three viruses this coming winter. The updated COVID vaccines are each fully approved for those 12 and older and are authorized under emergency use for individuals 6 months through 11 years of age. “Vaccination remains critical to public health and continued protection against serious consequences of COVID-19, including hospitalization and death,” Dr. Peter Marks, director of the FDA’s Center for Biologics Evaluation and Research, said in an agency news release. “The public can be assured that these updated vaccines have met the agency’s rigorous scientific standards for safety, effectiveness and manufacturing quality. We very much encourage those who are eligible to consider getting vaccinated.” One infectious diseases expert said the approvals matter most to vulnerable Americans. “Having an updated booster that more closely matches circulating strains is an important tool for high-risk individuals, who still remain at risk for severe disease, hospitalization and death,” said Dr. Amesh Adalja, a senior scholar with Johns Hopkins’ Center for Health Security in Baltimore. Next up? The Advisory… read on > read on >