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Tag: FDA (Food and Drug Administration)

  • Wegovy is now available as a pill. Here’s what you need to know

    (CNN) — Americans seeking to lose weight now have a new option – taking Wegovy as a daily pill, rather than a weekly injection.

    Patients with a prescription could obtain the starter 1.5 mg dose of the tablet as of Monday, with the higher doses becoming available by the end of the week, according to manufacturer Novo Nordisk.

    Being able to address obesity with a GLP-1 pill is a significant advance in weight management. Eli Lilly is expected to receive US Food and Drug Administration approval for its oral medication, which is called orforglipron until it receives a brand name, by summer.

    But the arrival of an oral option has also sparked a multitude of questions. Here’s what we know:

    Where can I get the Wegovy pill?

    The tablet form of Wegovy can be found at pharmacies, including CVS and Costco, certain telehealth providers, such as Ro and LifeMD and Weight Watchers, NovoCare Pharmacy, GoodRx and other locations.

    Will it be hard to find?

    While overwhelming demand led to initial shortages of the GLP-1 injections, Novo Nordisk said it is confident that it can meet the demand for the Wegovy tablet.

    The Danish drug maker noted that it has invested in its manufacturing capabilities for several years. The Wegovy pill is produced entirely in its North Carolina facilities.

    How much will the pill cost?

    The 1.5 mg starter dose of the pill costs $149 a month for patients who pay cash, as part of a recent deal Novo Nordisk made with the Trump administration. The 4 mg dose costs the same amount until April 15, after which the price will increase to $199.

    However, the 9 mg and 25 mg doses cost $299 a month.

    That compares to a $349 monthly price tag for the injectable version for self-pay consumers, though new patients can receive two months of the lowest two doses for $199 each until March.

    Patients whose insurance plans cover the drug for obesity could pay as little as $25 a month for the pill or injection under a savings program offered by Novo Nordisk.

    How is the pill different from the injection?

    The pill uses the same active ingredient, semaglutide, as the injection. They’re approved by the US Food and Drug Administration for the same groups of people: those with obesity, typically defined as having a body mass index of 30 or higher, and those with overweight, or a BMI of 27 or more along with a weight-related health issue such as high blood pressure.

    The main difference between the two is how you take them – as a daily pill versus a weekly shot. The pill also must be taken on an empty stomach, with a small amount of water and no other food, drink or medicines for at least 30 minutes.

    The medicine won’t be effective if patients don’t wait 30 minutes to give the tablet time to absorb, according to Novo Nordisk.

    How much weight could I lose?

    The Wegovy tablet and injection resulted in similar weight loss in clinical trials.

    The pill showed average weight loss of 14% over 64 weeks, compared with 2% for a placebo. The injection showed weight loss of 15% in its key trial, versus 2% for placebo.

    Eli Lilly’s orforglipron showed 11% weight loss over 72 weeks on its highest dose, compared with 2% for the placebo group. Zepbound, Eli Lilly’s injectable weight loss drug, showed weight loss of 21% on its highest dose, compared with 3% for those on a placebo.

    What are the side effects of the Wegovy pill?

    Like all medicines in the class known as GLP-1s, the Wegovy pill is also associated with side effects such as nausea, vomiting, constipation and diarrhea. The pill and injection had similar tolerability in clinical trials.

    Should I consider switching from the injection to the pill?

    That depends on your specific circumstances, doctors say. If you’re someone who’d prefer a daily pill to a weekly shot, and can deal with delaying food, drink and other medications for 30 minutes after taking the Wegovy pill, it might be the right choice. Others may prefer the simplicity of a weekly injection, if they don’t mind needles.

    Dr. Jorge Moreno, an obesity specialist with Yale Medicine, said a switch to the pill may be a consideration for people who’ve experienced more tolerability issues with the injections.

    “If patients have not tolerated the injection or are having a tough time going up on the dose, they may opt to switch to the Wegovy pill,” Moreno told CNN.

    Dr. Judith Korner, an endocrinologist and director of the Metabolic and Weight Control Center at Columbia University Vagelos College of Physicians and Surgeons, pointed out that the weekly injections might be “a bit longer-lasting,” and so any uncomfortable side effects patients experience “may last longer than if you take a pill” as well, where “if you really don’t like the way you feel you don’t take it the next day.”

    If you miss a dose of the pill, that dose should be skipped, and the next dose should be taken the following day.

    Both doctors emphasized that cost also plays a large role in decision-making.

    “Insurance coverage is still hard to predict at this point,” Moreno said. “I am hopeful with lower costs for the Wegovy pill, more insurances will opt to cover it.”

    Tami Luhby, Meg Tirrell and CNN

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  • CDC website changed to include false claims that link autism and vaccines

    (CNN) — Scientific information on the US Centers for Disease Control and Prevention’s website was replaced Wednesday with anti-vaccine talking points that don’t rule out a link between vaccines and autism, despite an abundance of evidence that there’s no connection.

    Bullet points on the top of the page now state that “vaccines do not cause autism is not an evidence-based claim” because studies have not ruled out the possibility that infant vaccines cause autism.

    The language is a common tactic used to cast doubt on the safety of vaccines, said Alison Singer, president and co-founder of the Autism Science Foundation.

    “You can’t do a scientific study to show that something does not cause something else,” she said Thursday.

    “All we can do in the scientific community is point to the preponderance of the evidence, the number of studies, the fact that the studies are so conclusive,” Singer said. “These studies all agree. They’re very clear, and it’s time to move on.”

    The preponderance of scientific evidence shows that vaccines do not cause autism, Singer said.

    “No environmental factor has been better studied as a potential cause of autism than vaccines. This includes vaccine ingredients as well as the body’s response to vaccines,” the Autism Science Foundation said in a statement Thursday.

    Dr. Paul Offit agrees. In a post on Substack on Thursday, Offit, a pediatrician and director of the Vaccine Education Center at Children’s Hospital of Philadelphia, said scientific studies can “never prove never.”

    “If RFK Jr. wanted to be honest with the American public, he would make it clear on the CDC’s website that chicken nuggets also might cause autism, which has never been and will never be disproven,” Offit wrote.

    HHS spokesperson Andrew Nixon said Thursday, “We are updating the CDC’s website to reflect gold standard, evidence-based science.”

    However, Dr. Marty Makary, commissioner of the US Food and Drug Administration, recently told CNN Chief Medical Correspondent Dr. Sanjay Gupta on an episode of his “Chasing Life” podcast that he doesn’t think vaccines cause autism.

    “I think there’s no medicine that’s 1,000% safe,” Makary said. “And I think we have to remember that with everything. I think the absolutism around some of this stuff creates mistrust. And when we say they’re 1,000% safe and it’s impossible for there to be a single complication of a vaccine, that’s the kind of rhetoric, I think, that doesn’t resonate well. So I think we have be humble and take a very honest approach.”

    Studies find no relationship

    Other bullets on the updated CDC page say studies supporting a link between vaccines and autism have been ignored by health authorities. This too is not true: Studies showing a connection between vaccines and autism have proved to be poorly done or were fraudulent. There are, however, many well-done, credible studies that find no such relationship.

    One of the largest studies looking at this question was published in 2019. Researchers in Denmark enrolled more than 650,000 children born between 1999 and 2011 and followed them from the time they were 1 year of age until the end of August 2013. Roughly 6,500 children were diagnosed with autism during the study period.

    When the researchers compared those who received the MMR vaccine with those who did not, they found no significant difference in the risk of developing autism. That held true whether the kids got other vaccines, such as the diphtheria, tetanus and pertussis vaccine; whether they had siblings with autism; or a host of other factors, such as whether certain kids might be prone to developing a form of regressive autism after getting their shots.

    “This study strongly supports that MMR vaccine does not increase the risk for autism,” the authors wrote in the conclusion.

    This study is not cited on the CDC’s updated “state of the evidence” on MMR vaccines, however. Instead, it mentions older evidence reviews and raises questions about aluminum, an ingredient added to some vaccines to boost their protection.

    The new CDC updates do mention another recent Danish study, published in 2025, which found no link between aluminum in childhood vaccines and any of 50 disorders, including neurodevelopmental disorders such as autism. But instead of accepting the overall conclusion of the study, the new CDC page tries to cast doubt on it by homing in on details of data in a supplementary table, saying the findings and other “warrant further investigation” into aluminum exposure and chronic diseases.

    The CDC page also says the US Department of Health and Human Services has launched a comprehensive assessment of the causes of autism, including investigations on plausible biologic mechanisms and potential causal links.

    Singer said this is a waste of valuable research money and a distraction from strong science showing that most cases of autism can be traced to genes that affect a baby’s brain development.

    The main heading on the page states that “Vaccines do not cause Autism,” but it has an asterisk that directs readers to a footnote: “The header ‘Vaccines do not cause autism’ has not been removed due to an agreement with the chair of the U.S. Senate Health, Education, Labor, and Pensions Committee that it would remain on the CDC website.”

    The footnote seems to refer to a commitment by HHS Secretary Robert F. Kennedy Jr. to Sen. Bill Cassidy, a physician and Republican from Louisiana, during his confirmation process that language on the CDC website “pointing out that vaccines do not cause autism” would not be removed. Cassidy described the promise in a speech in which he explained his support for Kennedy, a longtime anti-vaccine activist.

    Cassidy told CNN on Thursday that he had spoken with Kennedy.

    In a statement posted on X on Thursday, Cassidy said, “I’m a doctor who has seen people die from vaccine-preventable diseases. What parents need to hear right now is vaccines for measles, polio, hepatitis B and other childhood diseases are safe and effective and will not cause autism. Any statement to the contrary is wrong, irresponsible, and actively makes Americans sicker.”

    ‘Dangerous health disinformation’

    Dr. Peter Hotez, who is director of the Center for Vaccine Development at Texas Children’s Hospital and wrote a book called “Vaccines Did Not Cause Rachel’s Autism” about his daughter’s diagnosis, said the updated information on the CDC’s page follows a well-worn playbook.

    “They’ve decided they want to prove vaccines cause autism. So they keep making a series of assertions,” Hotez said, going back to debunked research that claimed the MMR vaccines caused autism and a retracted 2005 Rolling Stone article by Kennedy that asserted the preservative thimerosal caused autism.

    There have also been claims that aluminum in vaccines was a cause of autism, and those have been disproved, Hotez said.

    Hotez says the updates to the CDC’s page are “pure garbage.”

    “I consider it a piece of dangerous health disinformation, and it needs to be removed right away,” he said.

    Dr. Demetre Daskalakis, who recently resigned as director of the CDC’s National Center on Immunization and Respiratory Diseases, said on social media late Wednesday that the changes are “a national embarrassment.”

    “The weaponization of the voice of CDC is getting worse. This is a public health emergency,” he wrote.

    Daskalakis said the agency’s scientists were completely blindsided by the page update.

    “This distortion of science under the CDC moniker is the reason I resigned with my colleagues,” he told CNN.

    Rather than restoring trust in America’s health agencies, moves like this have undermined it, said Dr. Sean O’ Leary, a pediatrician who chairs the Committee on Infectious Diseases for the American Academy of Pediatrics.

    “I fear that it’s going to lead to fewer children being vaccinated, children suffering from diseases they didn’t need to suffer from,” O’Leary said.

    This is the latest move by the Trump administration to alter longstanding US vaccine policy and practice and cast doubt on vaccinations.

    Kennedy has hired longtime anti-vax allies – including David Geier, a discredited researcher who was once disciplined by the Maryland State Board of Physicians for practicing medicine without a license, and Lyn Redwood, a nurse who was president of the World Mercury Project, which later became Children’s Health Defense, an anti-vaccine group Kennedy ran before campaigning for office – to undertake new evaluations of government data in an effort to prove conspiracy theories that hazards of vaccines have long been hidden from the public.

    The rate of routine childhood vaccinations has dropped in the United States, allowing preventable diseases including measles and whooping cough to surge. In a call with state health officials Monday, the CDC disease detectives leading the measles response suggested that the US status as a country that has eliminated continuous measles spread was in jeopardy.

    Brenda Goodman and CNN

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  • Tylenol’s maker pushes back against possible label change linking pain reliever’s use in pregnancy to autism

    (CNN) — Kenvue, the American company that makes Tylenol, says the US Food and Drug Administration should not make proposed changes to the product’s safety label to reflect research about a possible connection between its use in pregnancy and diagnoses of autism or ADHD in children.

    Kenvue says that acetaminophen, the generic name for the painkiller and fever reducer also known as paracetamol, is “one of the most studied medicines in history” and that “adoption of the proposed labeling revisions would be arbitrary, capricious, and contrary to law.”

    Tylenol generates $1 billion annually for the company and is considered the company’s biggest-selling brand, according to the brokerage Morningstar.

    The current label instructs people who are pregnant or breastfeeding to “ask a health professional before use.”

    The push for a label change came after President Donald Trump held a news conference last month in which he told pregnant women who are in pain to try to “tough it out” instead of taking Tylenol, even though acetaminophen is the one over-the-counter pain reliever considered safe for pregnant people to take.

    The president claimed without evidence that Tylenol use during pregnancy was linked to a “very increased risk of autism.”

    “Fight like hell not to take it,” Trump urged.

    Most people use acetaminophen at some point during their pregnancy, studies show. Other common pain or fever treatments like ibuprofen or regular-dose aspirin can increase the risk of serious complications when used during pregnancy.

    Untreated pain or fever can be dangerous for the mother and the fetus, possibly leading to problems like miscarriage, birth defects or high blood pressure.

    Beginning the process to change the safety label on acetaminophen products was just one action the Trump administration planned to take.

    US Health and Human Services Secretary Robert F. Kennedy Jr. said at the news conference last month that his agency would launch a public service campaign about the issue.

    The FDA also sent a letter to physicians saying that the choice to take Tylenol “still belongs with parents” but that use during pregnancy may cause an “increased risk of neurological conditions such as autism and ADHD in children.”

    However, the letter also noted that “a causal relationship has not been established” and that studies about a link are “contradictory.”

    The Informed Consent Action Network, an anti-vaccine nonprofit with close ties Kennedy, said in a letter dated the day of Trump’s news conference that it had filed a citizen’s petition with the FDA. Such filings are a way for individuals, industry or consumer groups to ask the agency to take action on a specific issue.

    The petition says that because of the “urgent public health implications,” the FDA should act quickly to add a more detailed warning to the labels of over-the-counter drug products that contain acetaminophen to spell out that “studies show that frequent use of this product during pregnancy may increase your child’s risk of neurodevelopmental disorders, including autism spectrum disorder and attention-deficit/hyperactivity disorder.”

    On Friday, Kenvue asked the FDA to deny the petition, saying that suggested changes to the label are unsupported by scientific evidence “and would represent an unexplained departure from FDA’s longstanding position on acetaminophen during pregnancy.”

    The company said it met with Kennedy in early September, after the HHS secretary reached out to say he believed there was a connection between acetaminophen use during pregnancy and autism, and it told him there was no such link.

    An HHS spokesperson said Monday that the FDA doesn’t comment on product-specific matters.

    The FDA website on acetaminophen has not changed to reflect the Trump administration’s views. It says it was last updated in August and specifies, “to date, FDA has not found clear evidence that appropriate use of acetaminophen during pregnancy causes adverse pregnancy, birth, neurobehavioral, or developmental outcomes.”

    Acetaminophen has been studied for decades to find any problems it may cause in pregnancy, according to the American College of Obstetricians & Gynecologists. Not one reputable study has concluded that acetaminophen use in any trimester of pregnancy causes neurodevelopmental disorders in children.

    That group points to a study published last year of more than 2 million children that found no significant associations between acetaminophen use during pregnancy and children’s risk of autism, ADHD or intellectual disability.

    Another study published in August analyzed 46 studies on acetaminophen use during pregnancy and neurodevelopmental disorders. Six of the studies specifically examined acetaminophen use and autism. Overall, the analysis concluded that there was “strong evidence of an association” between acetaminophen use during pregnancy and autism, but the authors were careful to say that the paper could only show an association, the research could not show that acetaminophen caused autism.

    “We recommend judicious acetaminophen use — lowest effective dose, shortest duration — under medical guidance, tailored to individual risk–benefit assessments, rather than a broad limitation,” the researchers wrote in that analysis.

    After the Trump news conference, medicine regulatory agencies for the European Union and the United Kingdom and Health Canada quickly issued statements confirming that taking the over-the-counter pain-reliever during pregnancy remains safe.

    Jen Christensen and CNN

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  • With CDC signoff, CVS says Covid-19 vaccines will be available nationwide without a prescription

    (CNN) — The US Centers for Disease Control and Prevention signed off on a recommendation that patients must consult a health care provider to get a Covid-19 vaccine, although they don’t necessarily need a prescription.

    The updated CDC recommendation — made by a new panel of vaccine advisers chosen by US Health and Human Services Secretary Robert F. Kennedy Jr. — shifted away from a broader push in past years for most people to get an updated Covid-19 vaccine. It became final with signoff from Acting CDC Director Jim O’Neill.

    The new recommendations mean people ages 6 months and older can get Covid-19 vaccines after consulting with a qualified health care provider, which keeps the shots available but may also create more barriers to access than in past years.

    Before the finalized recommendation this year, access to Covid-19 shots has differed from state to state as pharmacies and providers navigated new federal vaccine policies. CVS, which had previously limited access to Covid-19 shots in some places, said Monday that it was “updating our systems to be able to offer the updated COVID-19 vaccines to patients nationwide” and that “prescriptions from outside prescribers will no longer be required in any states.”

    The signoff is also coming later than usual for the fall respiratory virus season. With the recommendation, the government can finally distribute Covid-19 vaccines through its Vaccines for Children program, which provides free inoculations to about half of US children.

    The CDC’s independent vaccine advisers, the Advisory Committee on Immunization Practices, voted unanimously last month that people who want a Covid-19 vaccine should consult with a health care provider, a process called shared clinical decision-making. However, they narrowly voted down a recommendation that a prescription should be required to get the shot.

    In August, the US Food and Drug Administration moved to limit approval of Covid-19 vaccines to adults 65 and older as well as younger people who are at higher risk of severe illness because of other health conditions.

    A study published last month in the journal JAMA Network Open found that a universal Covid-19 vaccine recommendation — as had been in place for the US in recent years — could save thousands more lives than limiting the recommendation to high-risk groups.

    Experts said that even requiring shared clinical decision-making could make Covid-19 shots harder to get.

    The recommendation “assumes health care and insurance,” said Dr. Demetre Daskalakis, who recently resigned as head of the CDC’s National Center for Immunization and Respiratory Diseases. “We do not have universal health care in this country, and we know millions of people are losing insurance.”

    HHS said it was bringing back “informed consent” ahead of vaccination.

    “CDC’s 2022 blanket recommendation for perpetual COVID-19 boosters deterred health care providers from talking about the risks and benefits of vaccination for the individual patient or parent. That changes today,” O’Neill, who is also the deputy secretary of HHS, said in a statement.

    Another new recommendation will mean toddlers get their first vaccines against measles and chickenpox separately, around their first birthdays. In this case, the ACIP guidance formalizes an existing recommendation, which is designed to reduce a very rare, slightly elevated risk of seizures when the two shots are combined into a single injection.

    The CDC advisers said that the single-dose measles, mumps, rubella and varicella vaccine was not recommended before age 4 and that younger kids should get the varicella vaccine, which protects against chickenpox, separately from the shot that protects against measles, mumps and rubella.

    Brenda Goodman, Katherine Dillinger and CNN

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  • In meeting with RFK Jr., CEO of Tylenol maker stresses there is no clear link between medication and autism, WSJ reports

    (CNN) — The interim CEO and director of drugmaker Kenvue, which makes the common pain reliever Tylenol, met with US Health and Human Services Secretary Robert F. Kennedy Jr. privately this week in an attempt to dissuade him from including the drug as a potential cause of autism in an upcoming report, the Wall Street Journal reported Friday.

    HHS officials have announced that the department is conducting a study of the causes of autism, and recent reports suggest that HHS will issue an analysis that links the development of autism to the mother’s use of Tylenol during pregnancy, among other potential causes. The report is expected to be released this month.

    Tylenol is a brand name for the pain reliever acetaminophen.

    The American College of Obstetricians and Gynecologists has said that there is no proof of a causal link between Tylenol use in pregnancy and a child’s diagnosis of autism.

    In a statement Friday, a spokesperson for HHS said that officials routinely meet with stakeholders for their perspectives.

    “We are using gold-standard science to get to the bottom of America’s unprecedented rise in autism rates. HHS officials regularly meet with stakeholders to get their perspective about our agenda to Make America Healthy Again. Any claims regarding this or any other specific meeting, however, are nothing more than speculation unless officially discussed by HHS,” HHS spokesperson Andrew Nixon said.

    Kenvue said in its own statement Friday that it engaged in a “scientific exchange” with HHS officials but that it is concerned about the forthcoming HHS report potentially causing confusion.

    “As we would with any regulator who reaches out to us, we engaged in a scientific exchange with the Secretary and members of his staff as it relates to the safety of our products. Our position remains the same: in evaluating available science, we continue to believe that taking acetaminophen does not cause autism, and global health regulators, independent public health organizations, and medical professionals agree,” Kenvue said.

    “We are concerned about the potential for consumer confusion and misinformation about the safety of taking acetaminophen during pregnancy, particularly as cough, cold and flu season approaches,” the statement said. “We encourage regulators to continue to objectively review the scientific evidence on this issue, as they have done for many years. FDA has been looking at this issue for over a decade and has conducted multiple reviews since 2014 and continues to recommend acetaminophen in pregnancy and maintain the same labeling requirements.”

    The company also recommended that expecting mothers speak to their health care provider before taking any over-the-counter medications, including acetaminophen, which is also indicated on the product label.

    Tylenol is widely used in the US, including during pregnancy. The US Food and Drug Administration recommends against using other common pain relievers, nonsteroidal anti-inflammatory drugs, in pregnancy at 20 weeks or later because they can result in low amniotic fluid.

    “There is no clear evidence that proves a direct relationship between the prudent use of acetaminophen during pregnancy and fetal developmental issues,” Dr. Christopher Zahn, chief of clinical practice for the American College of Obstetricians and Gynecologists, said in a statement this month. “Neurodevelopmental disorders, in particular, are multifactorial and very difficult to associate with a singular cause. Pregnant patients should not be frightened away from the many benefits of acetaminophen, which is safe and one of the few options pregnant people have for pain relief.”

    Jacqueline Howard, Deidre McPhillips and CNN

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  • RFK Jr. promised to ‘Make Our Children Healthy Again.’ Here’s how he plans to do it

    (CNN) — President Donald Trump’s strategy to ‘Make America Healthy Again’ includes investigating vaccine injuries and pharmaceutical practices but stops short of new regulatory action, for now.

    US Health and Human Services Secretary Robert F. Kennedy Jr. unveiled the MAHA strategy on Tuesday, joined by Agriculture Department Secretary Brooke Rollins, Environmental Protection Agency Administrator Lee Zeldin, and other top Trump officials.

    The report hews closely to a draft document circulated in August that cites earlier Trump administration announcements — developing a definition for ultraprocessed foods, educating the public about synthetic kratom — but largely bypassed industry crackdowns.

    Language around pesticides strategy also remained unchanged. Environmental and food activists had rallied for the administration to include steps to reduce pesticide usage and probe potential health risks of commonly used chemicals such as RoundUp.

    The report says that USDA, EPA and the National Institutes of Health will develop a framework to study cumulative exposures to chemicals including pesticides and microplastics. USDA and EPA will also invest in new farming approaches to reduce chemical use, and EPA will launch a public awareness campaign about the limited risk of approved products.

    The commission’s first report this May suggested a broad range of factors driving chronic disease in the US, including ultraprocessed foods, environmental exposures, and overprescription of pharmaceuticals like antidepressants.

    The report noted previous announcements that HHS, the NIH and the Centers for Medicare and Medicaid Services are studying the causes of autism. Kennedy had previously promised some answers on the root causes in September; NIH is expected to announce autism research grants this month.

    Recent reports suggest that HHS will issue a report that links the development of autism to taking Tylenol during pregnancy.

    Medicines and vaccines

    Kennedy has drawn criticism for suggesting antidepressants, particularly those that are part of a family known as SSRIs are as addictive as heroin and can be dangerous. Following the August 27 shooting in Minneapolis, he told Fox News that HHS is launching studies “on the potential contribution of some of the SSRI drugs and some of the other psychiatric drugs that might be contributing to violence.”

    SSRIs, or selective serotonin reuptake inhibitors, are the most prescribed class of antidepressants for depression, anxiety disorders and many other mental health conditions. Several SSRIs have been on the market in the United States since the 1990s, including Prozac, Zoloft and Celexa. Experts agree that there is no scientific evidence or correlation between these drugs and violence towards others.

    Tuesday’s report states that HHS will assemble a working group of federal officials to evaluate SSRI prescribing patterns, specifically among children. HHS will also “evaluate the therapeutic harms and benefits of current diagnostic thresholds,” or the current common practices doctors use to diagnose patients with mental health disorders.

    Dr. Theresa Miskimen Rivera, president of the American Psychiatric Association said access to care, not over-medication is the bigger problem when it comes to helping kids’ mental health in the country, and there is no mention of the issue in the report. The report said addressing a child’s nutrition, screen time, and exercise can improve their mental health, but can’t address everything. “Psychiatric conditions are complex in nature,” she said. Extreme poverty, post traumatic stress disorder, trauma-related factors should also be addressed, but there is no mention in the report of any of those issues either.

    “In terms of over medication, that’s not what we do. We have a comprehensive evaluation and we are evidence based. We diagnose than create a comprehensive treatment plan, “ Miskimen Rivera told CNN. “Medication can save lives, not only in children, but in adults and elderly.”

    When asked about whether or not the commission chose to consider gun violence – the leading cause of death for children – as one of the issues to be investigated, Kennedy doubled down on the issue of prescription drugs, saying “We are doing studies now, or initiating studies to look at the correlation and the connection, potential connection between over medicating our kids and this violence.”

    HHS will also work with the White House Domestic Policy Council on a new vaccine framework that, the report said, will ensure “America has the best childhood vaccine schedule” and ensure “scientific and medical freedom.”

    The report comes as Kennedy continues to defend his shakeup of the US Centers for Disease Control and Prevention over vaccine policy, including the ouster of CDC Director Dr. Susan Monarez.

    The administration will also increase oversight of “deceptive” direct-to-consumer advertising of pharmaceutical products, including from social media influencers and telehealth companies, it said.

    Food policy stays the course

    FDA will continue work on developing a definition for ultraprocessed foods, but the report bypasses recommendations, like those of former FDA Director Dr. David Kessler, to essentially order certain additives off the market until they are reviewed.

    Dr. Dariush Mozaffarian, director of Tufts Food is Medicine Institute said a definition of ultraprocessed foods would be “really important.” With more than half of calories in the food supply coming from ultraprocessed foods, addressing this and other issues involving the nation’s diet would mean a “massive fight with the industry and is going to be incredibly controversial, but is much needed.”

    “Overall, this is really quite thorough, quite specific, and even if parts of this are accomplished, this could have tremendous positive impact for Americans,” Mozaffarian told CNN.

    Other experts, like Marion Nestle, agreed the report was ambitious in scope, but noted it fell short on regulatory action. “What’s still missing is regulation. So much of this is voluntary, work with, promote, partner,” said Nestle, who is the Paulette Goddard professor emerita of nutrition, food studies and public health at New York University.

    The report also nods to new, user-friendly dietary guidelines expected later this year. Kennedy has promised a vastly shortened set of recommendations that will emphasize whole foods.

    The commission also cited ongoing work to reduce ultraprocessed foods in the Supplemental Nutrition Assistance Program (SNAP) and Head Start.

    While the report also touches on agriculture deregulation with the aim of making it easier for small farms to get greater access to markets and schools, Ken Cook, co-founder of the Environmental Working Group, a health advocacy organization said the report abandons earlier MAHA promises to ban toxic pesticides and instead “echoes the pesticide industry’s talking points.”

    “Secretary Kennedy and President Trump cynically convinced millions they’d protect children from harmful farm chemicals – promises now exposed as hollow,” Cook said in a statement.

    There were minor changes from the draft document leaked in August. For instance, the August 6 draft stated that the FDA and other agencies will crack down on “Illegal Chinese Vapes,” while the final version promises enforcement on vapes more broadly.

    “We support the goal of making children healthier and addressing and preventing chronic disease, but unfortunately, the recommendations fall short in some really critical ways,” Laura Kate Bender, vice president nationwide advocacy and public policy for the American Lung Association told CNN.

    “They continue to cast doubt on vaccines, one of the most, important, proven public health interventions that we can have for kids health. They don’t address some major contributors to diseases in kids like pollution, tobacco use, beyond the mention of vaping, and this report is coming out at the same time that we’re continuing to see dramatic cuts in staff and funding of a lot of the programs that could make the good parts of the report a reality.”

    The report’s emphasis on kids’ health can help overall, Dr. Michelle Macy, director of the Mary Ann & J. Milburn Smith Child Health Outcomes, Research and Evaluation Center in Chicago told CNN. “I’m really trying to look for bright spots in this report, and I think that the focus on data and infrastructure for us to be able to answer big questions about what environmental and food exposures and medication exposures do to shape the trajectory of someone’s health and chronic disease across the lifespan is something that has promise and potential.”

    Dr. Richard Besser, pediatrician and president and CEO of the Robert Wood Johnson Foundation said that having a focus on preventing chronic disease in children is a good thing, but he said, with Kennedy’s track record that includes firing thousands of federal health employees, slashing millions in health research funding, dismantling entire offices that managed important issues like smoking and chronic disease specifically, in addition to his “assault on vaccinations” will undermine any potential good of this kind of report.

    “Neither RFK Jr.’s record, nor his policies outlined in the report give me confidence that he is going to make any difference whatsoever on chronic diseases in children,” Besser told CNN.

    Sarah Owermohle, Jen Christensen and CNN

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