Roundup: FDA Ruling Limits Which Foods Can Be Labeled ‘Healthy’ on Packaging; and More News

FDA Ruling Limits Which Foods Can Be Labeled ‘Healthy’ on Packaging

The U.S. Food and Drug Administration (FDA) is changing the way food companies can claim their products are “healthy,” with new guidelines for food labels that focus on what we should eat, instead of what we shouldn’t.

Under the new guidelines, fortified white bread is out and fatty fish-like salmon is in. Most everything in the grocer’s produce section – whole fruits and vegetables – would qualify under the new rule issued Thursday. Other nutrient-rich foods, such as whole grains, dairy, eggs, beans, lentils, seafood, lean meat, nuts and seeds, also pass the test as long as they have limited added sugar, salt and saturated fat. Frozen and canned fruits and vegetables are included in the new “healthy” category.

It’s an attempt to help shoppers in other aisles confused by nutrition fact labels that don’t give any real-world guidance as to whether one product is better than another. “Now, people will be able to look for the ‘healthy’ claim to help them find foundational, nutritious foods for themselves and their families,” FDA Commissioner Robert Califf wrote in a media statement, adding that 75% of Americans lack adequate levels of fruit and vegetables in their diet.

Nutrition experts were largely encouraged by the change, according to the story by NBC. “It’s a terrific advance,” said Dr. Dariush Mozaffarian, a cardiologist and director of the Food is Medicine Institute at the Friedman School of Nutrition Science and Policy at Tufts University. “For the first time, FDA will be judging foods not based on a handful of negative nutrients like calories or fat or salt, but on whether the food has healthy ingredients.”

The previous rule set in 1994 had a cap on total fat, which excluded products with heart-healthy fat, such as avocados. Products could also qualify if they had at least 10% of the daily value for certain vitamins, calcium, iron, protein or fiber. Manufacturers found a loophole. Fruit juice could be labeled as “healthy” if they had enough vitamin C, for example, despite a tremendous amount of added sugar.

The new regulation eliminates those criteria. Products that can no longer claim to be healthy include fortified white bread and highly sweetened yogurts and cereals. The changes won't happen overnight, however. The FDA says that companies have until 2028 to comply.

Says Nancy Brown, chief executive of the American Heart Association, “The updated definition should give consumers more confidence when they see the ‘healthy’ claim while grocery shopping,” She says she hopes it will motivate food manufacturers “to develop new, healthier products that qualify to use the ‘healthy’ claim.”

Reported Use of Most Drugs Among Adolescents Remained Low in 2024

After declining significantly during the COVID-19 pandemic, substance use among adolescents continues to be holding steady or declining, according to the latest results from the Monitoring the Future Survey, which is funded by the National Institutes of Health (NIH).

“This trend in the reduction of substance use among teenagers is unprecedented,” said Nora D. Volkow, M.D., director of NIH’s National Institute on Drug Abuse (NIDA). “We must continue to investigate factors that have contributed to this lowered risk of substance use to tailor interventions to support the continuation of this trend.”

Reported use for almost all measured substances decreased dramatically between 2020 and 2021, after the onset of the COVID-19 pandemic and related changes like school closures and social distancing. In 2022 and 2023, most reported substance use among adolescents held steady at these lowered levels, with similar trends and some decreases in use in 2024.

The Monitoring the Future survey is conducted by researchers at the University of Michigan, Ann Arbor, and funded by NIDA. The survey is given annually to students in eighth, 10th, and 12th grades who self-report their substance use behaviors over various time periods, such as past 30 days, past 12 months, and lifetime. The survey also documents students’ perceptions of harm, disapproval of use, and perceived availability of drugs.

All participating students took the survey via the web – either on tablets or on a computer – with 99% of respondents taking the survey in-person in school in 2024. The survey results are released the same year the data are collected. From February through June 2024, the Monitoring the Future investigators collected 24,257 surveys from students enrolled across 272 public and private schools in the United States.

When breaking down the data by specific drugs, the survey found that adolescents most commonly reported use of alcohol, nicotine vaping, and cannabis in the 12 months prior to the survey, and levels generally declined from or held steady with the lowered use reported over the past few years.

“Kids who were in eighth grade at the start of the pandemic will be graduating from high school this year, and this unique cohort has ushered in the lowest rates of substance use we’ve seen in decades,” said Richard A. Miech, Ph.D., team lead of the Monitoring the Future survey at the University of Michigan. “Even as the drugs, culture, and landscape continue to evolve in future years, the Monitoring the Future survey will continue to nimbly adapt to measure and report on these trends – just as it has done for the past 50 years.”

FDA Approves Zepbound for Obstructive Sleep Apnea

In what has been called “a major step forward for patients with obstructive sleep apnea,” the U.S. Food and Drug Administration (FDA) approved the first prescription drug for treating moderate to severe obstructive sleep apnea (OSA) in adults with obesity. Studies show that when combined with a low-calorie diet and increased exercise, tirzepatide, sold under the brand name Zepbound, improves OSA symptoms by reducing body weight, particularly in those with weight-related health issues.

“Today’s approval marks the first drug treatment option for certain patients with obstructive sleep apnea,” said Sally Seymour, M.D., director of the Division of Pulmonology, Allergy, and Critical Care in the FDA’s Center for Drug Evaluation and Research. “This is a major step forward for patients with obstructive sleep apnea.”

According to the FDA, OSA occurs when a person’s upper airway becomes blocked, causing pauses in breathing during sleep (apnea) often followed by gasping, snorting or waking suddenly. OSA can reduce oxygen flow, disrupt heart rhythms and harm overall health. Common symptoms of OSA, such as snoring, tiredness, daytime sleepiness and disrupted sleep, often go unnoticed. While OSA can affect anyone, it is more common in people who have overweight or obesity, as excess neck weight can press down on the airway. 

Zepbound is an injectable medication that aims to treat OSA by causing weight loss. It works by activating receptors of hormones secreted from the intestine – (glucagon-like peptide-1 (GLP-1) and glucose-dependent insulinotropic polypeptide (GIP) – which help suppress appetite and reduce eating, the FDA explains. By reducing body weight, studies show that Zepbound also improves OSA.

This dual-receptor activation may offer more effective weight management than the drugs targeting only the GLP-1 receptor.  The approval was granted to Eli Lilly and Company, the drug’s maker, based on two clinical trials involving 469 adults without type 2 diabetes.

One study included patients using positive airway pressure (PAP), the standard treatment for moderate to severe OSA, while the other included people not using PAP. In both studies, participants were randomly given either Zepbound or a placebo weekly for 52 weeks. Results showed that Zepbound significantly reduced breathing interruptions (apnea and hypopnea) during sleep compared to the placebo. More patients treated with Zepbound saw their symptoms improve or resolve, along with notable weight loss, which likely contributed to improvement in their OSA symptoms.

The FDA statement details the side effects of Zepbound, which include nausea, vomiting, belching, acid reflux, stomach pain, diarrhea, constipation, injection site reactions, tiredness, allergic reactions (mostly fever and rash), and hair loss.