FDA head Marty Makary on food dyes, ultra-processed foods and the MAHA agenda
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Products with opioid-like effects sold at gas stations may be banned as illicit substances
The Food and Drug Administration (FDA) is recommending banning a compound found in unregulated tablets, gummies and drink mixes sold online and at gas stations and convenience stores, the Trump administration announced this week. The substance, known as 7-OH, will be scheduled as an illicit drug if the Drug Enforcement Administration − a branch of the US Justice Department responsible for classifying drugs as controlled substances − approves the sanction after a review. "Dark innovations in chemistry have exacerbated the addiction crisis in this country," US Department of Health and Human Services Deputy Secretary Jim O'Neil told reporters during a Tuesday, July 29, press conference in Washington DC. "Synthetic opioids like carfentanill and the substance we're here to take action on today: 7-Hydroxymitragynine." O'Neil said 7-hydroxymitragynine, 7-OH, is deliberately addictive and a powerful opioid agonist many times more potent than morphine. Calling it "a recipe for public health disaster," O'Neill, said 7-OH products are often sold without warnings or controls. "We've seen a disturbing rise in reports of overdoses, poisonings and emergency room visits linked to products containing 7-OH,' O'Neil said. "These substances are often sold online or in convenience stores with no quality control, no dosage control and no warnings." 'They've killed thousands and thousands' During the press conference, FDA commissioner Martin Makary spoke alongside US Health and Human Services Secretary Robert F. Kennedy, Jr., as they announced they planned to send warning letters to companies for illegally marketing products containing 7-OH in an effort to combat the country's opioid addiction problem. 'We have a history in public health of being asleep at the wheel,' Makary said. 'Public health is supposed to prevent disasters, not just clean them up after they've killed thousands and thousands of people.' Which states felt tsunami waves? See list of where it hit after Russia earthquake What is 7-OH? The compound 7-OH is a naturally occurring substance in the kratom plant (Mitragyna speciosa), according to the FDA, but only a minor component comprising less than 2% of the alkaloid content in natural kratom leaves. "However, 7-OH demonstrates substantially greater mu-opioid receptor potency than kratom's primary alkaloid constituent mitragynine, as well as other classical opioids such as morphine," the FDA wrote in its findings. Mu-opioid receptors, found in the brain and spinal cord, are primarily responsible for pain relief and other opioid effects like euphoria and respiratory depression, according to research published on the National Institutes of Health's National Library of Medicine. Contributing: Adrianna Rodriguez Natalie Neysa Alund is a senior reporter for USA TODAY. Reach her at nalund@ and follow her on X @nataliealund. (This story was updated to include video.) This article originally appeared on USA TODAY: What is 7-OH? Opioid-like product may get banned by FDA Solve the daily Crossword
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6 hours ago
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RFK Jr's MAHA tour branded 'performative'
Robert F Kennedy, Jr's (RFK Jr) statewide tour promoting his Make America Healthy Again (MAHA) agenda has been called 'performative' by a US health consultancy. Since taking an axe to the health agencies nested under the US Department of Health and Human Services (HHS) in April, RFK Jr has toured states, including Colorado and Idaho, to promote his MAHA agenda. According to the White House's MAHA report, a key tenet of the initiative is to assist President Trump in addressing what the US health secretary has called the 'childhood chronic disease crisis', and includes vague aims to deliver more nutrient-dense food to the US population. Wellness Equity Alliance CEO Dr Tyler B Evans told Medical Device Network: "What we're witnessing with RFK Jr's roadshow is not leadership, it's theatre. 'The health secretary is cloaking vague rhetoric under the MAHA banner and selling it as reform, but the movement lacks policy substance and remains disconnected from the realities of public health. At best, it's a distraction. At worst, it's a dangerous misdirection that erodes trust in the institutions we need the most.' In April, RFK Jr delivered a speech at the US Food and Drug Administration (FDA), coinciding with the announcement of 10,000 planned job cuts across health agencies, including the FDA and the National Institutes of Health (NIH). The 40-minute speech included a range of baseless claims on various topics, according to a transcript of the speech seen by Politico. During his speech, RFK Jr stated that 'this whole generation is damaged' and claimed that rising rates of chronic disease, allergies and other illnesses were attributable to 'some environmental toxin'. How effective leadership at the HHS should look Evans emphasised that leadership at the HHS should be grounded in science, transparency, and accountability. 'It requires listening to public health professionals, not sidelining them, and to prioritise data over disinformation,' Evans said. 'I've worked on pandemic responses, from Ebola in West Africa to HIV/AIDS in South Africa to Covid-19 in NYC. What I've learned is simple: when health leadership is weak or politicised, people die unnecessarily. RFK Jr's decision to dismantle the department's capacity, especially during ongoing public health crises, is not reform. It is sabotage.' RFK Jr's MAHA tour has continued through July following the passage of Trump's 'One Big Beautiful Bill Act', which the Congressional Budget Office (CBO) estimates will leave 11.8 million people without health insurance by 2034. In a post to X following the bill's success in the Senate, Democratic senator Alexandria Ocasio-Cortez called the outcome 'an absolute and utter betrayal of working families'. To best serve the US's health, Evans said RFK Jr should focus on rebuilding trust with those most harmed by systemic neglect and called the current outcomes under the health secretary's leadership 'deeply troubling'. Evans concluded: 'Rebuilding trust requires investing in public health infrastructure, supporting workforce development, and addressing social determinants like housing, education, and food security. A national tour is not a substitute for that kind of real work.' "RFK Jr's MAHA tour branded 'performative'" was originally created and published by Medical Device Network, a GlobalData owned brand. The information on this site has been included in good faith for general informational purposes only. It is not intended to amount to advice on which you should rely, and we give no representation, warranty or guarantee, whether express or implied as to its accuracy or completeness. You must obtain professional or specialist advice before taking, or refraining from, any action on the basis of the content on our site. Error in retrieving data Sign in to access your portfolio Error in retrieving data Error in retrieving data Error in retrieving data Error in retrieving data
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18 hours ago
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FDA Elevates Recall of 64,800 Lbs. of Butter to Second-Highest Warning Level
Bunge North America Inc. initially issued a voluntary recall of 64,800 lbs. of its European Style Butter Blend on July 14NEED TO KNOW Bunge North America Inc. issued a nationwide recall of 64,800 lbs. (or 1,800 cases) of its European Style Butter Blend 1 lb. product on July 14 due to undeclared milk, which was not listed on the label The Food and Drug Administration (FDA) raised the risk classification for the recall to Class II — the second-highest warning level — on July 30 The FDA said users who begins to experience any allergy symptoms by eating the affected product should 'stop eating the food immediately, evaluate the need to use emergency medication (such as epinephrine) and seek medical attention'A recent nationwide butter recall has been escalated by the U.S. Food and Drug Administration (FDA) to a higher risk FDA raised the risk classification for the recall of one of Bunge North America Inc.'s butter products to Class II — the second-highest warning level — on Wednesday, July 30. A Class II recall indicates 'a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote," according to the FDA's website. Bunge, which is based in Chesterfield, Mo., initially announced a voluntary recall of 64,800 lbs. (or 1,800 cases) of its European Style Butter Blend 1 lb. product on July 14 due to undeclared milk, which was not listed on the product label. The company said the butter was 'packed in white paperboard cases,' with '36 blocks to a case,' and sent to a dozen distribution centers throughout the U.S. and one distribution center in the Dominican Republic. The lot code number for the butter is 5064036503. The FDA did not say whether anyone has been affected in connection with the recall. Bunge North America Inc. did not immediately respond to PEOPLE's request for comment on Aug. 2. Milk is listed as one of the nine major food allergens on the FDA's website. The FDA said food-related allergic reactions can vary in severity and include mild symptoms, such as hives, face and lip swelling, vomiting, coughing or swelling. However, people may also get more severe reactions like anaphylaxis, which 'causes the immune system to release a flood of chemicals' that can cause a person to go into shock and can be fatal, per the Mayo Clinic. The FDA said that because of this, it 'enforces regulations' to require companies to list ingredients on packaged foods and beverages. The agency added that there are 'more specific labeling requirements' for foods that can 'cause allergies or other hypersensitivity reactions.' The FDA advised that if anyone who eats the affected products begins to experience any allergy symptoms, they should 'stop eating the food immediately, evaluate the need to use emergency medication (such as epinephrine) and seek medical attention.' Other major food allergens listed by the FDA include eggs, fish, crustacean shellfish, tree nuts, peanuts, wheat, soybeans and sesame. Read the original article on People