Latest news with #F.D.A.
New York Times
7 days ago
- Health
- New York Times
F.D.A. Approves Juul Vapes After Yearslong Delay
The Food and Drug Administration authorized Juul e-cigarettes for the U.S. market on Thursday, ending a lengthy standoff with regulators and lawmakers who accused the company of spurring an epidemic of e-cigarette use among youths. The company was required to prove that the products were 'appropriate for the protection of public health' under agency rules. Juul said in a statement that it met the bar, in part, by showing that its products had helped about two million adults quit smoking cigarettes. The F.D.A. authorized both the e-cigarette system and menthol- and tobacco-flavored cartridges. Though concerns about the health effects of e-cigarettes are mounting, they are still widely viewed by experts as safer than cigarettes. 'Today's F.D.A. authorization of Juul products marks an important step toward making the cigarette obsolete,' K.C. Crosthwaite, the company's chief executive, said in a statement. Mr. Crosthwaite said underage use of Juul products was 'down 98 percent since 2019, to one-half of 1 percent of youth.' At least one lawmaker panned the decision. Senator Dick Durbin, Democrat of Illinois, recounted in a statement Thursday that Juul had 'ignited' an epidemic of vaping among youths and 'lied about the harms of their vapes.' Want all of The Times? Subscribe.
New York Times
01-05-2025
- Health
- New York Times
Kennedy Issues Demands for Vaccine Approvals that Could Affect Fall Covid Boosters
Health Secretary Robert F. Kennedy Jr. announced a plan that would require placebo-controlled studies for all new vaccines, surprising some experts who noted that such testing already routinely takes place. In a statement, Andrew Nixon, a spokesman for the Department of Health and Human Services, said that 'all new vaccines will undergo safety testing in placebo-controlled trials' before approval, and called the move a 'radical departure' from existing standards. Modern studies tend to use placebos. One exception has been the Covid booster shots, which have been authorized without human trials to target new strains of the virus as it has evolved. It's unclear how the announcement will affect availability of Covid vaccines that were expected to be updated for the fall. Mr. Kennedy also announced an effort Thursday for the National Institutes of Health to turbocharge the development of new inoculations for Covid, bird flu and seasonal flu. The new vaccine development initiative would involve methods other than the mRNA technology used to develop the dominant Covid vaccines that are already in use, a statement from the Health and Human Services department said. The mRNA shots have been the subject of conspiracy theories, and Mr. Kennedy has intensely criticized them. Taken together, the moves suggest that Mr. Kennedy will reach far into the details of vaccine development, an effort likely informed by his decades as one of the nation's most vocal critics of immunization oversight. Though some scientists say the quest to fully understand the possible unanticipated effects of vaccines is worthwhile, they also warn that doing so in a way that delays approval of lifesaving shots could jeopardize public health. Mr. Kennedy's activism in recent years included petitioning the Food and Drug Administration to pull the Covid vaccine off the market in 2021, during a deadly phase of the pandemic. He also urged the F.D.A. not to authorize Covid shots for children. Asked about how the new testing policy would affect Covid booster shots, Mr. Nixon suggested that new trials could be requested. Though the vaccines authorized by the F.D.A. were initially studied in large trials against placebos, Mr. Kennedy and others have criticized the lack of clinical trials for the boosters. 'As we've said before, trials from four years ago conducted in people without natural immunity no longer suffice,' Mr. Nixon said. 'A four-year-old trial is also not a blank check for new vaccines each year without clinical trial data, unlike the flu shot which has been tried and tested for more than 80 years. The public deserves transparency and gold-standard science — especially with evolving products.' Pfizer and Moderna, makers of the mRNA Covid shots, did not respond immediately to requests for comment. The Washington Post first reported the policy shift. Dr. Ofer Levy, a Harvard vaccine researcher and a member of the F.D.A.'s vaccine advisory committee, said exploring possible unexpected effects from vaccines would be a valuable effort. But he said officials must 'thread the needle' to be sure it is done in a way that did not leave older and immunocompromised people unprotected from Covid. He said that leaving a group taking the placebo vulnerable to Covid posed ethical concerns that would need to be carefully considered. Holding up authorization for updated Covid shots would be 'unacceptable,' he said. 'Tens of thousands of people can die without protection against Covid,' said Dr. Levy, who co-founded a company working on an opioid vaccine. The Centers for Disease Control and Prevention reported about 23,000 deaths from Covid since September, with as many as 1,000 a week that month and in January. Still, uptake of the Covid boosters has been low: About 23 percent of adults got the updated Covid shot released in the fall, according to the C.D.C. Mr. Kennedy's familiarity with the issue stems at least in part from his reviews of decades-old vaccine approvals, including for the polio vaccine and the measles, mumps rubella vaccine. He has also helped represent plaintiffs in lawsuits against manufacturers. He and the organization he founded and once led, Children's Health Defense, have repeatedly complained that vaccines are not tested against placebos in clinical trials when they are being developed. The organization has cited polio, hepatitis and meningitis vaccines as examples, all vaccines that were introduced decades ago. 'Every other medicine is tested against a placebo,' Mr. Kennedy said on a podcast in January 2020, in claiming that vaccines are exempt from that requirement. That, however, is not entirely correct. Cancer drugs and other medications authorized under the F.D.A.'s accelerated approval program are regularly authorized after trials without a placebo. And new vaccines, including the vaccines for Covid, were tested against placebos — inert substances, such as a saline injection, or in some cases against vaccines for other diseases. But new formulations of already approved vaccines are compared to those in existing vaccines in clinical trials, because it would be considered unethical to withhold effective vaccines from patients, including infants. 'We've required placebo-controlled trials for most vaccines, and sometimes it's an inert placebo, and sometimes it's an irrelevant vaccine,' said Dr. Peter Marks, who was the Food and Drug Administration's top vaccine official until he was forced out in March. 'The claim that we have not done randomized trials for pediatric vaccines aside from Covid is not correct.' Mr. Kennedy has also raised concerns in the past about testing a vaccine against what many consider a reasonable placebo: the same formula, but without the immune-activating agents. Mr. Kennedy has noted that the practice leaves uncertainty about whether ingredients in the formula could cause harm. The announcement that the National Institutes of Health will develop new technology for making flu and coronavirus vaccines to prevent against pandemics appears aimed at displacing the mRNA vaccine technology that has been a target of critics, including the health secretary. This 'next-generation vaccine platform' would be 'fully government-owned,' the department said. The N.I.H. helped develop the mRNA platform, and the vaccine maker Moderna paid the government hundreds of millions of dollars to license a key patent on the vaccine, though the company and the government later got into a dispute over the patent rights. The mRNA platform relies on small bits of genetic code, which generated online rumors and conspiracy theories that it was being used to insert microchips into vaccine recipients. The new platform, by contrast, would rely on a more traditional method of vaccine development, which uses inactivated viruses to provoke an immune response. The department said the new platform would be developed using beta-Propilactone, which is already a component in vaccine development but is considered a hazardous substance by the Environmental Protection Agency when people are exposed to it in large doses.
New York Times
25-04-2025
- Health
- New York Times
F.D.A. Scientists Are Reinstated at Agency Food Safety Labs
Federal health officials have reversed the decision to fire a few dozen scientists at the Food and Drug Administration's food-safety labs, and say they are conducting a review to determine if other critical posts were cut. A spokesman for the Department of Health and Human Services confirmed the rehirings and said that several employees would also be restored to the offices that deal with Freedom of Information requests, an area that was nearly wiped out. In the last few months, roughly 3,500 F.D.A. jobs, about 20 percent, were eliminated, representing one of the largest work force reductions among all government agencies targeted by the Trump administration. The H.H.S. spokesman said those employees called back had been inadvertently fired because of inaccurate job classification codes. The decision to rehire specialists on outbreaks of food-related illnesses and those who study the safety of products like infant formula follows contradictory assertions made by Dr. Marty Makary, the F.D.A. commissioner, in media interviews this week. 'I can tell you there were no cuts to scientists or inspectors,' Dr. Makary said Wednesday on CNN. In fact, scientists had been fired from several food and drug safety labs across the country, including in Puerto Rico, and from the veterinary division where bird flu safety work was underway. Scientists in the tobacco division who were dismissed in February — including some who studied the health effects of e-cigarettes — remain on paid leave and have not been tapped to return, according to employees who were put on leave. How many fired employees will be permitted to return remained unclear. About 40 employees at the Moffett Lab in Chicago and at a San Francisco-area lab are being offered their jobs back, the department spokesman said. Scientists in those labs studied a variety of aspects of food safety, from how chemicals and germs pass through food packaging to methods for keeping bacteria out of infant formula. Some scientists in Chicago reviewed the work and results of other labs to ensure that milk and seafood were safe. Dr. Robert Califf, the F.D.A. commissioner under President Joseph R. Biden, said the terms 'decapitated and eviscerated' seemed fitting to describe the steep loss of expertise at the agency. He said the F.D.A. was already falling behind on meetings meant to help companies develop safe products — and to design studies that give clear answers about their effectiveness. 'Most of it is really at this level of fundamental, day-to-day work that has a huge impact overall, but it's not very controversial,' he said. 'It's just that it takes work, and they have to have people to do the work.' Dr. Makary has also said the layoffs did not target product reviewers or inspectors. But their work has been hampered by voluntary departures, the elimination of support staff and the broader disruption at an agency where many are fleeing for the exits, according to former staff members. Hundreds of drug and medical device reviewers, who make up about one-fourth of the agency work force, have recused themselves from key projects, Dr. Scott Gottlieb, a former agency commissioner, said on CNBC. Under F.D.A. ethics rules, staff members who are interviewing for jobs cannot do agency review work on products by companies where they are seeking employment — or for a competitor. Dr. Gottlieb also said cuts to the office of generic drug policy wiped out employees with expertise in determining which brand-name drugs are eligible to be made as lower-cost generics, calling those job eliminations 'profound.' Approving generic drugs can save consumers billions of dollars. Support staff for inspectors investigating food and drug plants overseas were also cut, raising security concerns. Dozens of workers who lost their jobs attended to security monitoring to ensure that inspectors were safe, especially in hostile nations.
New York Times
25-04-2025
- Health
- New York Times
Kennedy Wants to Ban Some Food Dyes. Here's What the Data Shows.
The Department of Health and Human Services announced this week that it would work to remove some artificial dyes from the U.S. food supply, citing concerns about how they might affect children's health. Among the dyes that the health secretary, Robert F. Kennedy Jr., is targeting are colorings common in ultraprocessed foods like candy, chips and some cereals. In a news conference on Tuesday announcing the effort, Dr. Marty Makary, the Food and Drug Administration commissioner, linked these dyes to obesity, diabetes, attention deficit hyperactivity disorder, cancer and other health conditions in children. Several, mostly small studies have found a link between some artificial food dyes and behavioral issues, which medical experts have said is cause for concern and warrants further research. But some said it is unclear if removing the dyes would have a meaningful effect on rates of childhood obesity, diabetes or other problems. 'Nobody's going to be sad to see the food dyes go, but it's definitely not the panacea that it's being portrayed as,' said Lindsey Smith Taillie, an associate professor of nutrition at the University of North Carolina's Gillings School of Global Public Health. What dyes are supposed to be phased out? Dr. Makary named eight specific colorings that the agency would seek to phase out: Blue No. 1 and 2; Citrus Red No. 2; Green No. 3; Orange B; Red No. 40; and Yellow No. 5 and 6. Exactly how the agency plans to do that remains unclear. Mr. Kennedy said major food manufacturers had reached an 'understanding' with him. The F.D.A. said it would begin the process of revoking the authorizations of Citrus Red No. 2 and Orange B, which are not widely used. The other six would be subject to Mr. Kennedy's nonbinding agreement with manufacturers. Dr. Makary said in the news conference that the process would be complete by the end of 2026. But it remains to be seen whether that timeline is logistically possible or whether the government can enforce it. In January, during the final days of the Biden administration, the F.D.A. banned another coloring, Red Dye No. 3, from food products. Research has shown that the dye, which had already been banned from cosmetics and some medications, can cause cancer in male rats. Food manufacturers can use various natural compounds to color their products in the absence of artificial dyes, though switching a product from artificial to natural dyes requires time and testing. The F.D.A. said this week that it would 'fast-track' authorization of four alternatives: calcium phosphate, Galdieria extract blue, gardenia blue and butterfly pea flower extract. There is limited evidence around the health effects of those alternatives, said Emily Barrett, a professor of biostatistics and epidemiology at the Rutgers School of Public Health who has studied food contaminants. What does the research show? While there is some research on food dyes and health risks, there are a few factors that make the subject hard to study. It's challenging to examine any potential long-term effects, since the dyes pass relatively quickly through the body, said Dr. Sheela Sathyanarayana, a professor of pediatrics at the University of Washington. The trials that do exist in humans, Dr. Barrett noted, have largely examined the effects in the hours right after children consume artificial dyes. Many of the studies also look at mixtures of dyes, which makes it hard to say that any one in particular is the most problematic, explained Asa Bradman, a professor of public health at the University of California at Merced who has studied food dyes. But the evidence we do have points to a connection between certain synthetic dyes and behavioral changes in some children. One 2007 study out of Britain involved giving young children drinks containing blends of food additives like Yellow No. 5 and Yellow No. 6. The trial showed that these additives were linked with increased hyperactivity and lowered attention span over a six-week period. And in a 2021 report, scientists in California examined 27 studies in children, most of which were small, and concluded that common synthetic food dyes — FD&C Blue No. 1, Blue No. 2, Green No. 3, Red No. 3, Red No. 40, Yellow No. 5 and Yellow No. 6 — can interfere with normal behavior in some children. The food industry has long said that the ingredients it uses have been well-studied and shown to be safe. Nutrition experts noted that many ultraprocessed foods that contain artificial dyes also contain a lot of sugar, sodium and saturated fat, and far fewer nutrients than fresh foods do. While ultraprocessed foods have been linked to obesity and diabetes, there is no evidence directly linking artificial dyes to either condition, said Peter G. Lurie, the president of the nonprofit consumer advocacy group Center for Science in the Public Interest, which has lobbied to remove synthetic dyes from the food supply. When it comes to rising rates of A.D.H.D., 'it's certainly not that food dyes are the single culprit, by any means,' said Dr. Barrett, who peer-reviewed the California report. Dr. Barrett said she would welcome larger, stronger studies 'to actually answer some of these questions definitively.' Mr. Kennedy has said that the National Institutes of Health will study these kinds of food additives in more detail. Will removing the dyes make children healthier? Dr. Taillie said there was no harm in getting rid of artificial food dyes. Even if they don't cause serious health effects, she said, they don't provide benefits. But she does not expect such a switch to improve rates of obesity and chronic disease, which she said are largely driven by other ingredients in the foods that children consume, not the dyes. 'You can take the yellow dye out of mac and cheese and replace it with turmeric, but you're still giving your kid a food that's ultraprocessed and packed with sodium,' Dr. Taillie said. It's not clear what effect removing these dyes might have on children's behavior, Dr. Barrett said. Some European countries have stricter regulations on artificial colorings than the U.S., adding warning labels to foods with certain synthetic dyes. It isn't clear whether rates of A.D.H.D., for example, have decreased as a result of these policies. 'This one thing is unlikely to reduce A.D.H.D. diagnoses,' Dr. Sathyanarayana said. But, she added, it's possible that removing synthetic dyes might reduce children's symptoms in isolated cases. For example, a child who eats copious amounts of candy on Halloween may be less likely to become hyperactive afterward. Dr. Taillie expressed skepticism that manufacturers would comply with Mr. Kennedy's voluntary 'understanding.' She said that historically, mandates have been much more effective than voluntary measures at getting particular ingredients out of the food supply. For example, she said, there wasn't much movement on trans fat until the government required that it be listed on nutrition labels. Calley Means, a special government employee within the Department of Health and Human Services and an adviser to Mr. Kennedy, said, 'The food industry can do this the hard way or the easy way.' He added: 'We are confident they'll take the easy way.' In a statement on Tuesday, Melissa Hockstad, the president and chief executive of the Consumer Brands Association — which represents packaged goods companies including PepsiCo and Nestlé — said the companies she represented intended to 'increase the use of alternative ingredients.'
New York Times
25-04-2025
- Health
- New York Times
No More Food Dye in Froot Loops? Not So Fast.
Same cereal. Same sugary taste. Different hues. A box of Froot Loops sold in the United States contains vivid rings of red, orange, green, purple, yellow and blue — neon colors derived from synthetic dyes, like Red No. 40, Yellow No. 5, Blue No. 1 and Yellow No. 6. In a box sold in Canada, the colored rings obtain paler shades from the juices of blueberries, watermelon and huito, an Amazonian fruit. And not a single one is blue. The manufacturer in both countries, WK Kellogg, formerly known as the Kellogg Company, can clearly make Froot Loops without synthetic dyes. The question is: Will it and other big food companies adopt the approach in United States? And will consumers, raised on color-popping cereals, flame-colored nacho chips and neon blue sports drinks consume those foods if they are a bit more … beige? Robert F. Kennedy Jr., the secretary of the Department of Health and Human Services, wants them to. On Tuesday, Mr. Kennedy, who has long criticized artificial dyes used in Froot Loops and other processed foods as part of a larger food system that he says contributes to chronic disease and poor health, announced that he had reached 'an understanding' with major food manufacturers to remove commonly used petroleum-based food colorings from their products by 2026. The meaning of 'an understanding' remains unclear. No food companies attended the press conference, and few have said they will remove synthetic colors, which the Food and Drug Administration currently allows. But a shift may be coming. This week, citing expected demand from consumers, the beverage giant PepsiCo, which also makes Doritos and Lay's potato chips, said it would either phase out synthetic colors or offer consumers natural color options in the next couple of years. Mr. Kennedy is perhaps hoping that using his bully pulpit as head of the agency that oversees the F.D.A. will be enough to push big food companies to change their ways. They have responded to pressure before. About a decade ago, a number of companies tried shifting to natural colors. Most notably, Kraft Macaroni & Cheese successfully replicated its characteristic orange noodles by switching to turmeric and paprika. But other companies struggled. Some reverted to synthetic dyes after sales slumped. For some critics of synthetic dyes, however, Mr. Kennedy's announcement was a disappointment. Dr. Peter Lurie, a former F.D.A. official and the executive director of the Center for Science in the Public Interest, said the government should move more forcefully to eliminate the dyes. 'History tells us that relying on voluntary food industry compliance has all too often proven to be a fool's errand,' Dr. Lurie said in a statement. Rewriting the Recipe No matter how much pressure Washington exerts, shifting to natural colors won't happen overnight. It is not as easy as simply replacing Yellow No. 6 with carrot juice, said James Herrmann, director of food colors at Sensient Technologies, a company that manufactures colors — both artificial and natural — for the food and beverage industry. It can take up to two years to develop the seeds, grow the plants and concoct the combination of, say, red cabbage and black carrot extract that produces a desired shade, he said. And it's not just getting the color right. Food companies are likely to have to make adjustments to their manufacturing processes and facilities. Light and heat are enemies of natural colors, causing them to fade, change or even, in some cases, separate, Mr. Herrmann said. Natural colors must be kept cool, and they have a relatively short shelf life, which means adding refrigeration and ensuring a steady supply of them, he said. He added that colors from carrot or beet juice and their synthetic cousins might have different viscosities, requiring factories to change pumps or the piping used to apply the colors. Also, more natural dye is needed to achieve a satisfying color than synthetic dye, so recipes may have to be reformulated. 'Your sugar or flour may be off,' Mr. Herrmann said. And that's assuming enough carrots, cabbage, beets and spirulina (an algae) are available to replicate the oranges, greens and blues of chips and sports drinks. Mr. Herrmann, whose company uses proprietary seeds for most of its colorings, said he wouldn't 'put the seed in the ground for the crop until we know there's a customer there for it.' 'If everybody switches at once,' he added, 'there is simply not enough material around the world available to meet the demand.' Because it can take 10 times as much material from natural colors to mimic a small amount of synthetic dyes, costs could very likely climb as well. Late Tuesday, the Consumer Brands Association, the trade organization for the food industry, said in a statement that the ingredients in the food supply 'have been demonstrated to be safe' and 'removing these safe ingredients does not change the consumer packaged goods industry's commitment to providing safe, affordable and convenient product choices to consumers.' Stacy Flathau, a co-chief corporate affairs officer at WK Kellogg, said in an emailed statement that 85 percent of its cereals contained no artificial colors, but that it was removing synthetic colors from those sold in schools. The company added that it was looking forward to working with the F.D.A. to identify ways to remove artificial colors from foods containing them. Growing Colors From Scratch Concerns about the safety of food colorings, especially regarding behavior in children, have been on the rise. A 2021 health assessment by the State of California suggested that 'synthetic food dyes are associated with' behaviors 'such as inattentiveness, hyperactivity and restlessness in sensitive children.' In Europe, food containing some dyes come with a warning label to that effect. Health Canada, which allows the use of food dyes but with strict restrictions on the amounts, notes on its website that it deems the evidence of those effects in children to be insufficient. California banned artificial dyes in school meals in 2024, and just last month, West Virginia enacted a statewide ban, the most comprehensive in the country. More states are considering restrictions. Sensient had been building its portfolio of natural colors, assuming that, by 2030, food companies will have moved away from synthetics. But the timeline could be speeding up. Sensient develops its natural colors starting with the seed. It has developed a variety of beets, for instance, that are larger and more saturated in color, Mr. Herrmann said. The company provides those seeds to contract farmers around the world. After the produce is harvested, Sensient pulps, pulverizes and strains the purple sweet potatoes, red radishes and grapes into a rainbow of extracts, powders and liquids. The process also eliminates the flavors of most of the underlying fruits, vegetables or other plants, but not all. 'You're never going to take the taste out of strawberry juice. 'It's going to be a little acidic, a little strawberry-ish. And that works well for a strawberry flavor in a kids' cereal,' said Linsey Herman, a vice president of research and development at Nature's Path, which makes organic cereals and other foods. 'But nobody is dying for a carrot-flavored cereal.' Even though the color, whether natural or synthetic, doesn't often change the taste profile of the frosted pastry or chip or soda, the appearance does signal certain flavors — or intensity of flavors — to consumers, said Charles Spence, a professor of food psychology at the University of Oxford. 'If you reduce the color saturation level of a drink, your mind may tell you it's going to taste less sweet or less sour than the original color,' Mr. Spence said. 'Duller hues may signal that this is a duller flavor or stale for some people, while for others it may signal that it's a more natural color, something found more in nature.' In recent years, Mr. Herrmann said, about 80 percent of new foods and beverages hitting the market were being made with natural colors. But food companies have dragged their feet on making the switch with popular existing products over fear that consumers may spurn them. 'They have to understand what their die-hard fans want,' he said, 'and make sure the natural product reaches the synthetic shades as closely as possible.'
