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  • 3 Judges Who Chipped Away Abortion Rights To Hear Federal Abortion Pill Appeal

    3 Judges Who Chipped Away Abortion Rights To Hear Federal Abortion Pill Appeal

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    NEW ORLEANS (AP) — Three conservative appeals court judges, each with a history of supporting restrictions on abortion, will hear arguments May 17 on whether a widely used abortion drug should remain available.

    The case involves a regulatory issue — whether the Food and Drug Administration’s approval of mifepristone, and subsequent actions making it easier to obtain, must be rolled back. The appellate hearing follows an April ruling by a federal judge in Texas, who ordered a hold on federal approval of mifepristone in a decision that overruled decades of scientific approval. His ruling was stayed pending appeal. The case was allotted to a panel made up of Jennifer Walker Elrod, James Ho and Cory Wilson.

    The three judges of the New Orleans-based 5th U.S. Circuit Court of Appeals won’t rule immediately. Their decision, whatever it is, is also unlikely to have an immediate effect pending an expected appeal to the U.S. Supreme Court.

    Here’s a look at who the judges are and their track records.

    Jennifer Walker Elrod

    Nominated to the court in 2007 by Republican President George W. Bush, Elrod was among several 5th Circuit judges allowing Texas to temporarily ban abortions as the coronavirus pandemic took hold in early 2020.

    Elrod also was co-author of the opinion when the full 5th Circuit upheld in 2021 a Texas law outlawing an abortion method commonly used to end second-trimester pregnancies.

    That same year, she wrote for a panel that refused to order Louisiana to issue a long-stalled license for a Planned Parenthood abortion clinic in New Orleans, saying “there is no free-standing federal right to receive an abortion-clinic license.”

    In the Texas case involving pandemic restrictions, she was part of a panel allowing what amounted to a ban on abortions — including medication abortions — by classifying them as non-essential procedures legally postponed under an order by Gov. Greg Abbott. The 2020 order was in effect for about a month.

    Elrod was in favor of decisions upholding Texas and Louisiana laws requiring doctors at abortion clinics to have admitting privileges at nearby hospitals — a move abortion rights advocates said would force some clinics to close.

    When the full court narrowly refused to let Louisiana officials cut off Medicaid funding for Planned Parenthood facilities in the state, Elrod wrote the dissent.

    Elrod also boasts a high profile in 5th Circuit decisions on regulatory issues. One, if upheld by the Supreme Court, could limit the authority of the Securities and Exchange Commission to impose hefty fees and fines. Another, eventually struck by the Supreme Court, held that the “individual mandate” in former President Barack Obama’s signature health care law had been rendered unconstitutional by congressional action.

    James Ho

    A former Texas solicitor general, Ho is the first Asian-American to serve on the 5th Circuit and is a former clerk for Supreme Court Justice Clarence Thomas. He was nominated to the 5th Circuit in 2017 by Republican President Donald Trump. His opposition to abortion and abortion rights was clear early in his tenure, including referring to abortion as a “moral tragedy” in one 2018 opinion.

    In 2019, he wrote a 15-page grudging concurrence in a ruling that said a Mississippi abortion ban had to be struck down under then-existing court precedent. “Nothing in the text or original understanding of the Constitution establishes a right to an abortion,” he wrote.

    He went on to cite “the racial history of abortion advocacy as a tool of the eugenics movement.” He harshly criticized a lower court for declining to consider arguments that a fetus can feel pain, and for displaying “an alarming disrespect for the millions of Americans who believe … that abortion is the immoral, tragic, and violent taking of innocent human life.”

    That opinion was written in the case the Supreme Court ultimately used to overturn Roe v. Wade.

    Cory Wilson

    Nominated to the federal appeals court in 2020 by Trump, Wilson is a former Mississippi appeals court judge who had a strong anti-abortion record when he served in the Mississippi House from January 2016 to February 2019 as a Republican. Abortion rights supporters opposed his confirmation to the federal appeals court. They noted he had expressed support for “complete and immediate reversal” of the Roe v. Wade decision in a questionnaire from Mississippi Right to Life’s political action committee.

    Wilson voted for anti-abortion measures in 2016, including one to stop Medicaid funding to Planned Parenthood facilities in the state — a measure rejected in court. In 2018 he voted for the Mississippi law that ultimately led to the demise of Roe v. Wade in 2022. The law prohibited most abortions after 15 weeks.

    At the 5th Circuit, Wilson joined Elrod, Ho and a majority of the full court in 2021 in upholding a Texas law outlawing an abortion method commonly used to end second-trimester pregnancies. He had voted for a similar law in the Mississippi Legislature.

    Associated Press reporter Emily Wagster Pettus in Jackson, Mississippi, contributed to this report.

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  • Beware the Ozempic Burp

    Beware the Ozempic Burp

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    On the November morning when the sulfur burps began, Derron Borders was welcoming prospective students at the graduate school where he works in New York. Every few minutes, no matter how hard he tried to stop, another foul-smelling cloud escaped his mouth. “Burps that taste and smell like rotten eggs—I think that’s what I typed in Google,” he told me.

    Eventually, Borders learned that his diabetes medication was to blame. Sulfur burps appear to be a somewhat rare side effect of semaglutide, tirzepatide, and other drugs in their class, known as GLP-1 receptor agonists. Over the past several years, these medications have become more popular under the brand names Ozempic, Wegovy, and Mounjaro, as a diabetes treatment and a weight-loss drug. And as prescription numbers rise, a strange and unpleasant side effect has been growing more apparent too.

    GLP-1 receptor agonists are well known to cause gastrointestinal symptoms, including abdominal pain, diarrhea, and vomiting. In clinical trials of semaglutide for weight loss, 44 percent of participants experienced nausea and 31 percent had diarrhea. (The same conditions afflicted only about one-sixth of participants who received a placebo.) Burping, a.k.a. “eructation,” showed up in about 9 percent of those who got the drug, versus less than 1 percent of those who took a placebo. The FDA lists eructation as a possible side effect for semaglutide and tirzepatide alike.

    But I couldn’t find any information in the clinical-trial reports or FDA fact sheets about sulfur burps in particular, and neither Novo Nordisk nor Eli Lilly, the companies that make these drugs, responded to my inquiries. Laura Davisson, the director of medical weight management at West Virginia University Health Sciences, told me that more than 1,000 of her clinic’s patients are currently on a GLP-1 receptor agonist, and about one-fifth experience sulfur burps at first. For all but a handful of these patients, she said, the issue goes away after a few months. Holly Lofton, an obesity-medicine specialist at NYU, guesses that it affects just 2 percent of her patients.

    Experts aren’t sure why taking GLP-1 receptor agonists might lead to having smelly burps, but they have some theories. Davisson proposed that semaglutide boosts the number of bacteria in patients’ digestive tracts that produce hydrogen sulfide, a gas that can be expelled from either end of the digestive tract, and that smells (as Borders found) like rotten eggs. She also noted that the drugs slow down digestion, which could give the stomach more time to break down food and produce gas. In this situation, Lofton told me, the putrid air may escape most readily up through the mouth, because it’s lighter than the liquids and semi-solids that also fill the stomach. “Whatever’s on top will come up,” she said.

    Read: We’ve had a cheaper, more potent Ozempic alternative for decades

    Eating more than usual while on the medications seems to be a common trigger. Davisson said that certain foods, such as dairy, may also lead to more odorous emissions. “Sometimes it’s a matter of trial and error,” she said. “Some tips that we give people are things like: Don’t eat really heavy meals; don’t eat large portions at once; don’t eat right before bed.” In addition to these behavioral approaches, Craig Gluckman, a gastroenterologist at UCLA Health, told me he recommends antacids and anti-gas medications to patients with GLP-1-agonist-related sulfur burps. (Online, apple-cider vinegar is commonly recommended as a fix, but Gluckman said he would not recommend it.)

    The providers I spoke with said that, in general, patients tend to experience sulfur burps when they’re first starting an Ozempic-like drug, or raising their dose. That was the case for Crystal Garcia, an HR administrator in Texas who started taking semaglutide from a compounding pharmacy after her doctor told her she was prediabetic. (Garcia vlogs about her experience with weight-loss drugs.) Three months later, while out to breakfast at a restaurant, Garcia’s family started to complain about a gross and eggy smell. Garcia figured that the smell was coming from the food, but it lingered in the car after the meal. The family wondered whether Garcia’s young son had had an accident. “I was like, it could not be me. There’s no way,” she told me. But when she burped again, she was forced to change her mind.

    Many patients are unaware that sulfur burps are a possible side effect of their medication until they start, well, burping sulfur. For a while, Borders had no idea that his diabetes medicine might be the culprit; when he saw a physician’s assistant to discuss his issue, “Ozempic didn’t even come up,” he said. The side effect is relatively new to physicians. Earlier GLP-1 agonists didn’t seem to produce sulfur burps so frequently, Lofton said. In her practice, the phenomenon wasn’t really apparent until Ozempic hit the American market in 2018, and even then, she learned about it only from her patients. “I’d never heard of sulfur burps before I started prescribing this medicine,” she said.

    Read: Ozempic is about to be old news

    Though the sulfur burps are (physically) harmless, some patients do stop taking their diabetes or weight-loss drugs because of them, Lofton told me. But most, including Garcia and Borders, end up sticking with their program. As bad as the side effects may be, patients think the drugs’ benefits are worth it. “I have had a patient say that her burps smelled like poop,” Davisson said. But even then, she did not want to stop the medication.

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    Rachel Gutman-Wei

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  • 88% Of Melatonin Gummy Products Inaccurately Labeled, Some Included CBD – Medical Marijuana Program Connection

    88% Of Melatonin Gummy Products Inaccurately Labeled, Some Included CBD – Medical Marijuana Program Connection

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    Are you in the dark about what’s actually in that melatonin product that you may have been taking? A study described in a JAMA research letter published on April 25 found that 22 of 25 melatonin gummy products analyzed had labels that did not accurately represent the contents of the products. That’s a whopping 88% if them. In fact, the actual levels of melatonin in the products ranged from 74% to 347% of what was listed on the labels. And while five of the products did list cannabidiol (CBD) on their labels—yes, that CBD—the actual levels of CBD ranged from 104% to 118% of what was indicated on the label. So, that gummy in your tummy may have a lot more or a lot less of what you are thinking that you are getting. That’s not the kind of news that will make you sleep better at night.

    Data have shown that an increasing number of Americans have been using melatonin products to sleep or relieve stress or both. As I covered for Forbes in February 2022, a study found that melatonin supplement use had increased over four-fold among Americans from 2000 to 2018. Such dietary supplements aren’t very closely regulated. They are typically sold over-the-counter and don’t go through the same U.S. Food and…

    Original Author Link click here to read complete story..

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    MMP News Author

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  • What Does Vaping Do? New Research Shows Damage and Addiction

    What Does Vaping Do? New Research Shows Damage and Addiction

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    SOURCES: 

    Jake Warn, Winslow, ME. 

    Mary Lou Warn, Winslow, ME.


    Tobacco Control: “Nicotine delivery and cigarette equivalents from vaping a JUULpod.”

    Maine Department of Health and Human Services: “Maine Integrated Youth Health Survey.”

    CDC: “Tobacco Product Use and Associated Factors Among Middle and High School Students – National Youth Tobacco Survey, United States, 2021,” “E-Cigarette, or Vaping, Products Visual Dictionary,” “Quick Facts on the Risks of E-cigarettes for Kids, Teens, and Young Adults.”

    American Cancer Society: “What Do We Know About E-cigarettes?” “The Study That Helped Spur the U.S. Stop-Smoking Movement,” “Key Statistics for Lung Cancer.”


    Drug and Alcohol Dependence: “Patterns of nicotine concentrations in electronic cigarettes sold in the United States, 2013-2018.”


    Insider: “The creator of the nicotine patch says that ‘anti-vaping forces’ are trying to kill the life-saving e-cig industry.”


    JAMA Network Open: “Nicotine Addiction and Intensity of e-Cigarette Use by Adolescents in the US, 2014 to 2021.”


    Expert Review of Respiratory Medicine: “The effect of e-cigarette aerosol emissions on respiratory health: a narrative review.”


    European Respiratory Journal: “E-cigarette use and respiratory disorders: an integrative review of converging evidence from epidemiological and laboratory studies.”


    American Journal of Preventive Medicine: “Association of E-Cigarette Use With Respiratory Disease Among Adults: A Longitudinal Analysis.”


    Toxicology Sciences: “E-Cigarette Aerosol Exposure Induces Reactive Oxygen Species, DNA Damage, and Cell Death in Vascular Endothelial Cells.”


    Nigar Nargis, PhD, senior scientific director of tobacco control research, American Cancer Society.


    Hilary Schneider, director of government relations, American Cancer Society Cancer Action Network, Maine. 


    Rachel Boykan, MD, clinical professor of pediatrics, attending doctor, Stony Brook Children’s Hospital, Stony Brook, NY.

     

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  • Biogen wins accelerated FDA approval for treatment for rare form of ALS

    Biogen wins accelerated FDA approval for treatment for rare form of ALS

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    The U.S. Food and Drug Administration said Tuesday it has granted accelerated approval to Biogen Inc.’s torferson, a treatment for a rare form of amyotrophic lateral sclerosis, or ALS.

    The accelerated program is used to approve drugs for serious conditions that have an unmet medical need, where a drug is shown to have an effect on an endpoint that is reasonably likely to predict a clinical benefit to patients.

    In…

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  • FDA pulls preterm-birth drug Makena and its generics from market after 12 years

    FDA pulls preterm-birth drug Makena and its generics from market after 12 years

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    The U.S. Food and Drug Administration said Thursday it had reached a final decision to fully withdraw approval of preterm-birth drug Makena and its generics, a full 12 years after the treatment hit the market.

    The drug was approved in 2011 using the agency’s accelerated-approval pathway as a treatment to reduce the risk of spontaneous preterm birth in pregnant women who had a history of the condition.

    The…

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  • FDA approves over-the-counter Narcan. Here’s what it means | Long Island Business News

    FDA approves over-the-counter Narcan. Here’s what it means | Long Island Business News

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    The U.S. Food and Drug Administration on Wednesday approved selling naloxone without a prescription, setting the overdose-reversing drug on course to become the first opioid treatment drug to be sold over the counter.

    It’s a move that some advocates have long sought as a way to improve access to a life-saving drug, though the exact impact will not be clear immediately.

    Here’s a look at the issues involved.

    WHAT IS NARCAN?

    The approved branded nasal spray from Gaithersburg, Maryland-based Emergent BioSolutions is the best-known form of naloxone.

    It can reverse overdoses of opioids, including street drugs such as heroin and fentanyl and prescription versions including oxycodone.

    Making naloxone available more widely is seen as a key strategy to control the nationwide overdose crisis, which has been linked to more than 100,000 U.S. deaths a year. The majority of those deaths are tied to opioids, primarily potent synthetic versions such as fentanyl that can take multiple doses of naloxone to reverse.

    Advocates believe it’s important to get naloxone to the people who are most likely to be around overdoses, including people who use drugs and their relatives.

    Police and other first responders also often carry it.

    ___

    WHAT DOES THE FDA APPROVAL MEAN?

    Narcan will become available over-the-counter by late summer, the company said.

    Other brands of naloxone and injectable forms will not yet be available over the counter, but they could be soon.

    The nonprofit Harm Reduction Therapeutics Inc., which has funding from OxyContin maker Purdue Pharma, has an application before the FDA to distribute its version of spray naloxone without a prescription.

    ___

    HOW IS NALOXONE DISTRIBUTED NOW?

    Even before the FDA’s action, pharmacies could sell naloxone without a prescription because officials in every state have allowed it.

    But not every pharmacy carries it. And buyers have to pay for the medication — either with an insurance co-pay or for the full retail price. The cost varies, but two doses of Narcan often go for around $50.

    The drug is also distributed by community organizations that serve people who use drugs, though it’s not easily accessible to everyone who needs it.

    Emergent has not announced its price and it’s not clear yet whether insurers will continue to cover it as a prescription drug if it’s available over the counter.

    ___

    DOES MAKING NALOXONE OVER-THE-COUNTER IMPROVE ACCESS?

    It clears the way for Narcan to be made available in places without pharmacies — convenience stores, supermarkets and online retailers, for instance.

    Jose Benitez, the lead executive officer at Prevention Point Philadelphia, an organization that tries to reduce risk for people who use drugs with services including handing out free naloxone, said it could help a lot for people who don’t seek services — or who live in places where they’re not available.

    Now, he said, some people are concerned about getting naloxone at pharmacies because their insurers will know they’re getting it.

    “Putting it out of the shelves is going to allows people just to pick it up, not have stigma attached to it and readily access this life-saving drug,” he said.

    But it remains to be seen how many stores will carry it and what the prices will be. The U.S. Centers for Medicaid and Medicare Services, which now cover prescription naloxone for people on the government insurance programs, says that coverage of over-the-counter naloxone would depend on the insurance program. The centers have not given any official guidance.

    Maya Doe-Simkins, a co-director of Remedy Alliance/For The People, which launched last year to provide low-cost — and sometimes free — naloxone to community organizations, said her group will continue to distribute injectable naloxone.

    ___

    ARE THERE DRAWBACKS TO OVER-THE-COUNTER SALES?

    One concern is whether people who buy Narcan over-the-counter will know how to use it properly, said Keith Humphreys, a Stanford University addiction expert, though the manufacturer is responsible for clear directions and online videos on that.

    One benefit of having pharmacists involved, he said, is that they can show buyers how to use it. One key thing people need to be reminded of: Call an ambulance for the person receiving naloxone after it’s been administered.

    He also said there are fears that if the drug isn’t profitable as an over-the-counter option, the drugmaker could stop producing it.

    “

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    The Associated Press

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  • Statement by Fragrance Creators’ President & CEO, Farah K. Ahmed, on the Need for a Properly Funded FDA

    Statement by Fragrance Creators’ President & CEO, Farah K. Ahmed, on the Need for a Properly Funded FDA

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    WASHINGTON, March 24, 2023 (Newswire.com)
    –
    “Last year, Congress passed the Modernization of Cosmetics Regulation Act (MOCRA), landmark legislation giving the Food and Drug Administration (FDA) expanded authority to advance sound science, safety, innovation, and public confidence in the cosmetics and personal care products Americans use every single day. It has been over 80 years since these regulations have been updated—now, more than ever, it is paramount that FDA has the funds to build a strong foundation upon which the cosmetics program will grow over the years to come. 

    “That is why today, Fragrance Creators wrote to Congressional leaders urging them to properly fund the FDA to facilitate a smooth transition to the modernized regulatory framework.    

    “Fragrance plays an important role in cosmetics and personal care products; products that nurture skin health and hygiene, empower self-expression and confidence, and deliver generational delight to billions of people every day. An adequately funded cosmetics program will support responsible fragrance industry innovation that can improve the experience of our nation’s diverse consumer demographic, uphold safety, and advance environmental sustainability. 

    “Advocating for appropriate funds for the FDA’s implementation of MOCRA is a top priority for our members. In addition to these letters, Fragrance Creators has mobilized our membership to engage dozens of Congressional offices and we continue to advocate and work with other industry stakeholders to call for sufficient funding.” 

    ###

    Fragrance Creators Association is the trade association representing the majority of fragrance manufacturing in North America. We also represent fragrance-related interests along the value chain. Fragrance Creators’ member companies are diverse, including large, medium, and small-sized companies that create, manufacture, and use fragrances and scents for home care, personal care, home design, fine fragrance, and industrial and institutional products, as well as those that supply fragrance ingredients, including natural extracts and other raw materials that are used in perfumery and fragrance mixtures. Fragrance Creators established and administers the Congressional Fragrance Caucus, ensuring ongoing dialogue with members of Congress and staff. Fragrance Creators also produces The Fragrance Conservatory, the comprehensive digital resource for high-quality information about fragrance—www.fragranceconservatory.com. Learn more about Fragrance Creators at fragrancecreators.org—for people, perfume, and the planet.

    Source: Fragrance Creators Association

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  • Milk Has Lost All Meaning

    Milk Has Lost All Meaning

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    You overhear a lot of strange things in coffee shops, but an order for an “almond-based dairy-alternative cappuccino” is not one of them. Ditto a “soy-beverage macchiato” or an “oat-drink latte.” Vocalizing such a request elicited a confidence-hollowing glare from my barista when I recently attempted this stunt in a New York City café. To most people, plant-based milk is plant-based milk.

    But though the American public has embraced this naming convention, the dairy industry has not. For more than a decade, companies have sought to convince the FDA that plant-based products shouldn’t be able to use the M-word. An early skirmish played out in 2008 over the name “soy milk,” which, the FDA acknowledged at the time, wasn’t exactly milk; a decade later, then-FDA Commissioner Scott Gottlieb pointed out that nut milk shouldn’t be called “milk” because “an almond doesn’t lactate.” To be safe, some fake-milk products have stuck to vaguer labels such as “drink,” “beverage,” and “dairy alternative.”

    But a few weeks ago, the FDA signaled an end to the debate by proposing long-awaited naming recommendations: Plant-based milk, the agency said, could be called “milk” if its plant origin was clearly identified (for example, “pistachio milk”). In addition, labels could clearly state how the product differs nutritionally from regular milk. A package labeled “rice milk” would be acceptable, but it should note when the product has less calcium or vitamin D than milk.

    Rather than prompt a détente, these recommendations are sucking milk into an existential crisis. Differentiating plant-based milk and milk requires defining what milk actually is, but doing so is at odds with the acknowledgement that plant-based milk is milk. It is impossible to compare plant-based and cow’s milk if there isn’t a standard nutrient content for cow’s milk, which comes in a range of formulations. This awkward moment is the culmination of a decades-long shift in the way the FDA—and consumers—have come to think about and define food in general. At this point, it’s unclear what milk is anymore.

    Technically, milk has an official definition, together with more than 250 other foods, including ketchup and peanut butter. In 1973, the FDA came up with this: “The lacteal secretion, practically free from colostrum, obtained by the complete milking of one or more healthy cows.” (Yum.) The recent guidance doesn’t override this definition but doesn’t uphold it either, so milk’s status remains vague. The agency doesn’t seem to mind; consumers understand that plant-based milk isn’t dairy milk, a spokesperson told me. But the FDA has long allowed for loose interpretations of this standard, which is why the lacteal secretions of sheep and goats can be called “milk.” As time goes on, what can be called “milk” seems to matter less and less.

    At one point, names mattered. In the late 1800s, people began to worry that their food was no longer “normal and natural and pure,” Xaq Frohlich, a food historian at Auburn University who is writing a book on the history of the FDA’s food standards, told me. As food production scaled up in the late 19th century, so did attempts to cut corners with cheap products parading as the real thing, such as margarine made with beef tallow. In 1939, the FDA began establishing so-called standards of identity based on traditional ideas of food.

    But the agency’s food definitions were malleable even before oat milk. The agency hasn’t been very strict about standards of identity, because consumers haven’t either. Around the 1960s, as people became aware of the ills of animal fat and cholesterol—and purchased the low-fat and diet foods that proliferated in response—the agency moved away from defining the identity of food toward a policy of “informative labeling” that provided nutritional information directly on the package so consumers knew exactly what they were eating. It became accepted that food was something that could be “tinkered with,” Frohlich said, and what mattered more than whether something was natural was whether it was healthy. In the midst of this change, milk was assigned its official identity, which came with caveats for added vitamins. Loosely interpreted, “milk” soon came to encompass that of other ruminants, as well as chocolate, strawberry, skim, lactose-free, and calcium-fortified stuff.

    In this context, the FDA’s recent expansion of this standard to accommodate plant-based milk is to be expected; Frohlich doesn’t think the plant-based or dairy industries “are particularly surprised by this proposal.” Very little will change if the new guidance becomes policy. (The decision has to go through a public-comment period before the FDA issues the final word.) If anything, there may be more plant-based products labeled “milk” at the supermarket, and perhaps the new labels will stave off any potential confusion that occurs. Pointing out nutritional differences between plant-based and dairy milk on packaging, the FDA spokesperson said, is meant to address the “potential public-health concern” that people will mistakenly expect these products to be nutritional substitutes for each other. But the nutritional value of dairy milk varies depending on the type, and in some cases, the nutrients are added in. Milk is just confusing, and perhaps that’s okay. For most consumers, milk will continue to be milk—a white-ish fluid, sourced from a variety of plants and animals, and ever-evolving.

    Milk aside, for most modern consumers, what to call a food matters less than other factors, such as what it consists of, where it comes from, how it’s made, and its impact on the planet. “Public understandings of food have really changed since the early 21st century,” Charlotte Biltekoff, a professor of food science and technology at UC Davis, told me. In some cases, people don’t define food by what it is so much as what it does. Many plant-based milks, Biltekoff said, don’t look or taste much like dairy milk but are accepted as milk because they’re used in the same way: splashed in coffee, poured into cereal, or as an ingredient in baked goods. In short, trying to define food with a standard identity can’t capture “the full scope of how most people interact with food and health right now,” she said. A name—or, indeed, a label pointing out nutritional differences between dairy and plant-based milk—can encompass only a fraction of what people want to know about milk, all of which is beyond what the FDA can regulate, Biltekoff added. No wonder its name doesn’t seem to matter much anymore.

    That’s not to say that all food names will eventually become diffuse to the point of meaninglessness. It’s hard to imagine peanut referring to anything but the legume, but then again, a debate over what counted as “peanut butter” lasted for a decade in the ’60s and ’70s. Naming clashes, in all likelihood, will occur over staple foods that already attract a lot of scrutiny and are produced by powerful industries, such as eggs or meat. For example, Americans use the term meat flexibly: In addition to animal flesh, it can also refer to products made from plants, fungi, or even mammal cells grown in a lab. Just as the dairy and plant-based industries fueled the naming debate over milk, there will undoubtedly be pushback from those holding on to and breaking meat conventions: “You will see the meat industry make similar arguments” about what constitutes a hamburger or what lab-grown chicken can be named, Frohlich said.

    So long as technology keeps pushing the boundaries of what food can be, food names will continue to shift, and the results won’t always be neat. Someone can value natural foods plucked from farmers’ markets and served to them at farm-to-table restaurants but at the same time champion technological advances that make different versions of our foods possible. Such a person might exclusively eat free-range organic bacon but demand highly processed oat milk for their cortado. These inner conflicts are inevitable as we undergo what Biltekoff calls “a kind of evolution in our understanding of what good food is.” Milk, for now, remains fluid—simultaneously many things and nothing at all.

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    Yasmin Tayag

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  • Politics, Media Erode Trust in Top Health Agencies, Survey Says

    Politics, Media Erode Trust in Top Health Agencies, Survey Says

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    March 7, 2023 — The political wars waged over public health recommendations on how to fight the COVID-19 pandemic have had a direct effect on the trust in public health agencies such as the CDC and FDA, according to the results of a survey conducted by Harvard researchers.

    The study, published on March 6 in the journal Health Affairs, found that people who had low or no trust in these and other public health agencies at the federal, state, and local levels believed that agency decisions are inconsistent, influenced by politics, and not based on science.

    Among respondents who had high trust in these agencies, just half said that doing a good job on controlling the pandemic was a major reason for that trust. Instead, their faith in federal public health agencies was mainly related to their belief that these institutions follow scientific evidence in developing policies. People who trusted state and local agencies cited their direct, compassionate care.

    The phone survey, conducted in February 2022, involved 4,208 U.S. adults. The authors say that theirs is the first study to look at the attitudes that contribute to or detract from trust in public health agencies.

    To put the public health trust data in perspective, information from doctors and nurses earned the highest trust of any category in the survey. Fifty-four percent of the respondents said they trust doctors, and 48% trust nurses. These professionals top the list in almost every survey because they are perceived as technically competent and compassionate, says lead study author Gillian SteelFisher, PhD, principal research scientist and deputy director of global polling at the Harvard Opinion Research Center. 

    Scientists (44%) and pharmacists (40%) also received a relatively high amount of trust. The CDC (37%) and the National Institutes of Health (33%) were on the next lower rungs of the list. About a quarter of respondents trusted their local and state health departments. For information about COVID-19, 42% of respondents trusted the CDC, and about a third of them trusted state or local health departments.

    Political Influence Suspected

    Among the reported reasons for low trust in the public health agencies, the one cited most often was the supposed political influence on their recommendations and policies. Roughly three-quarters of respondents with low trust in the agencies mentioned this as a factor in their attitudes. Half or more of respondents cited private sector influence on agency recommendations and policies. This was suggested more often for CDC than for other agencies (60% CDC, vs. 53% state agencies and 48% local agencies). Too many conflicting recommendations was another reason for low trust (73% for CDC, vs. 61% for state agencies and 58% for local agencies). 

    According to the study, the “influenced by politics” view might have been related to instances during the pandemic “in which the agencies’ legal authority to prevent and control the spread of COVID-19 has been shifted to elected officials.”

    Without giving specific examples, SteelFisher says, “What people want to see is that an agency is leading with science, that they’re making rational, logical, scientifically grounded decisions. It’s not that some people are saying, ‘I don’t believe in science.’ It’s that what they consider to be scientific is different [from what they’re hearing], and they worry that they’re not receiving the truth.”

    Public health agencies need “clear lanes of authority,” she says, and should give clear recommendations to elected officials instead of being swayed by those officials or others to “go in a certain direction.”

    Media Plays Major Role

    The news media and certain websites have contributed to this confusion by highlighting these controversies or promoting misinformation, she says. 

    “The policies around COVID got discussed in the media as being connected to politics,” she says. “So the media’s coverage of the influence of politics drives that concern.”

    People not paying enough attention to COVID-19-related news is not the problem, she says. They have [plenty] of information, but the issue is how much high-quality information is in their mix. 

    “Clickbait headlines can drive these attitudes, and the algorithms behind people’s newsgathering resources can drive them in a particular direction. That contributes to a distorted narrative behind what’s happening.”

    The survey results also showed that many people worry about corporations influencing public health policy, she says. 

    “This isn’t just related to COVID; it comes from a broader worry about the development of drugs and vaccines. People want to know there’s an independent body that is making well-informed decisions and is providing advice that is in the public’s best health interest. People are worried there’s something else behind the recommendations, and that drives a loss of trust.”

    Agencies Need to Build More Public Trust

    Trust in what public health agencies are saying is essential to enlisting the population’s help in fighting pandemics and other public health emergencies, the study said. GillFisher cited the controversy over the CDC’s changing recommendations on mask wearing. Early in the crisis, she noted, a lot was unknown about how the COVID-19 virus was transmitted; consequently, there were some well-publicized shifts in what the agency recommended on whether and where to wear masks and what kinds of masks to wear. 

    This should be regarded as natural in a public health emergency, where the scientific evidence keeps changing, she said. But if public trust is lacking, she noted, “there can be an inappropriate perception that policies are inconsistent. That’s also hard for the media environment, and there are media outlets that take advantage of that, too.”

    Where We Go From Here

    The paper makes a few recommendations on how public health agencies can improve public trust going forward. Among them are the following:

    • Make it clear that the public health agencies, and not elected officials, are the purveyors of scientific information to officials and the public.
    • Explain how agency decisions are anchored in scientific evidence, so that changes in policy or recommendations are seen not as conflicting but rather as responsive to new evidence.
    • Tailor communication approaches to specific segments of the public, depending on their trust level.
    • Use the influence of doctors and nurses, who are more trusted than the agencies, to deliver public health messages to their patients.

    The time is ripe to implement these strategies before the next pandemic, SteelFisher maintains. “Everyone is exhausted right now, so it’s hard to think about it. But it’s the right time, and we have some lessons learned.” 

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  • FDA: Oat, Almond Milk Can Be Called ‘Milk’ | Entrepreneur

    FDA: Oat, Almond Milk Can Be Called ‘Milk’ | Entrepreneur

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    You can still call your plant-based milk, milk.

    In a draft guidance released Wednesday, the Food and Drug Administration (FDA) said various plant-based kinds of “milk,” from oat to macadamia to almond, can use the word “milk” in labeling.

    The guidance was filed amid the dairy industry’s efforts (since at least the late 1990s) to prohibit plant-based milk alternatives from being labeled “milk.” At one point, it was even banned in the European Union to call plant-based milk “creamy” though it was eventually dropped, per Food Navigator.

    According to the agency’s research, which includes things like surveys and focus groups, “consumers understand that plant-based milk alternatives do not contain milk when shopping for various types of products labeled with the term” the agency wrote in its guidance.

    The FDA can issue legally-binding guidance based on laws passed by Congress, and it can also issue guidance that is not binding, as it did in this case. But it is likely the industry will follow the FDA’s proposed rules, The New York Times reported.

    Representatives of the dairy industry lobbied for a bill in Congress that would have narrowed the definition of what could be called milk to what comes from “hooved animals,” called the Dairy Pride Act in 2017. It did not move past committees.

    Regardless of the industry’s feelings, alternative milk consumption has been rising steadily.

    According to a 2021 Morning Consult survey, about 1 in 3 consumers use milk not made from cows once a week at least.

    Milk consumption has gone down by almost half since 1970, according to the U.S. Department of Agriculture.

    The president and CEO of the National Milk Producers Federation, Jim Mulhern, expressed disappointment about the draft guidance.

    “Today’s FDA announcement is a step toward labeling integrity for consumers of dairy products, even as it falls short of ending the decades-old problem of misleading plant-based labeling using dairy terminology,” Mulhern said in a statement.

    “We reject the agency’s circular logic that FDA’s past labeling enforcement inaction now justifies labeling such beverages,” it added.

    However, the FDA did say that manufacturers could put notes on their labeling indicating if plant-based milk has lower or different levels of nutrients like magnesium, potassium, or vitamin B12, than regular milk.

    “FDA recommends the use of these statements to help consumers understand certain nutritional differences between milk and plant-based milk alternatives that use the term ‘milk’ in their name,” the agency wrote.

    The FDA is taking comments until April 24 and then will release its final guidance.

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    Gabrielle Bienasz

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  • FDA Broadens Warning on Potentially Contaminated Eye Products

    FDA Broadens Warning on Potentially Contaminated Eye Products

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    Feb. 22, 2023 — Do not purchase or use Delsam Pharma’s Artificial Eye Ointment, the FDA warns. 

    The announcement released Wednesday adds to a previous warning issued earlier this month for EzriCare Artificial Tears or Delsam Pharma’s Artificial Tears due to potential bacterial contamination. All three products are manufactured by the same company, Global Pharma Healthcare, based in Tamilnadu, India.

    The FDA has faulted the company for multiple violations, including “lack of appropriate microbial testing” and “lack of proper controls concerning tamper-evident packaging,” and has banned imports to the United States.

    The updated warning from the FDA did not give additional information about the over-the-counter eye ointment beyond potential bacterial contamination. 

    On Feb. 1, the CDC issued an alert about an outbreak of a drug-resistant strain of bacteria, Pseudomonas aeruginosa, linked to artificial tear products. To date, 58 patients across 13 states have been identified, and the most commonly reported artificial tear brand was EzriCare Artificial Tears. Five patients had permanent vision loss, and one patient died.

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  • Alexis Ohanian Predicts: ‘Crypto, Bitcoin, Is Here To Stay’

    Alexis Ohanian Predicts: ‘Crypto, Bitcoin, Is Here To Stay’

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    Forbes sits with Alexis Ohanian at his Florida home to discuss the future of crypto following the fallout of FTX. The Reddit cofounder makes the argument for hard-to-seize assets before discussing his latest venture, Seven Seven Six, and more.

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    Kirsten Taggart, Forbes Staff

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  • Chicken farmers say their eggs could help reduce prices | Long Island Business News

    Chicken farmers say their eggs could help reduce prices | Long Island Business News

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    U.S. chicken producers want to do their part to bring down current soaring egg prices by selling their 400 million surplus eggs to food producers.

    But first they have to convince the FDA to change the rule that prevents eggs laid by chickens in the meat industry to be used for human consumption.

    Egg prices have surged over the past year thanks to the ongoing bird flu outbreak and the highest inflation in decades, prompting calls for a price-gouging investigation. The national average retail price of a dozen eggs hit $4.25 in December, up from $1.79 a year earlier, according to the latest government data.

    The National Chicken Council trade group submitted a formal petition to the Food and Drug Administration Thursday asking officials to drop a rule passed in 2009 that keeps chicken producers from selling their excess eggs because they aren’t refrigerated right away.

    “Already faced with record egg prices, consumers might be hit even harder in their wallets as we head into the Easter season unless FDA provides us with a pathway to put these eggs to good use,” said Ashley Peterson, the trade group’s senior vice president of scientific and regulatory affairs.

    The bird flu outbreak has had an outsized impact on egg prices because more than 43 million of the 58 million birds that have been slaughtered to help control the spread of the virus have been egg-laying hens. But egg farmers have also been grappling with high feed, fuel and labor costs that have contributed to the rising prices.

    It’s not clear exactly how big of an impact the eggs chicken producers want to sell might have on prices because there are roughly 100 billion eggs a year produced in the U.S., so adding 400 million more to the market may not have a huge effect.

    The FDA said it would review the Chicken Council’s petition and respond directly to that group. But concerns about food safety are what drove them to adopt the rule that prohibited the sale of the eggs in the first place.

    When a broiler hatchery produces eggs, they are kept at 65 degrees until they are ready to be placed in incubators to be hatched. The FDA said in its rule that eggs that are going to be used for food need to be stored at temperatures below 45 degrees within 36 hours.

    The Chicken Council said it believes the eggs would be safe because they would be pasteurized before they were used by food producers. The eggs that chicken producers don’t need to produce more chickens for meat production wouldn’t be sold to consumers in grocery stores. Instead they would go to makers of food products and processed eggs that are sold to bakers and other food companies.

    The Chicken Council estimates that this FDA rule prohibiting the sale of these eggs costs chicken farmers about $27 million a year because currently the eggs are either thrown away, rendered or used for animal food.

    But the United Egg Producers trade group said it would be a bad idea to relax food safety rules to allow these eggs laid by chicken producers to be sold.

    “The safety of eggs is always the priority for America’s egg farmers, as is firm compliance with all regulatory requirements related to food safety,” said Oscar Garrison, the egg trade group’s vice president of food safety regulatory affairs. “United Egg Producers opposes the petition by the National Chicken Council because it does not comply with the egg safety rule.”

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    The Associated Press

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  • The FDA’s New ‘Don’t Say Gay’ Policy for Blood Donation

    The FDA’s New ‘Don’t Say Gay’ Policy for Blood Donation

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    For decades now, gay men have been barred from giving blood. In 2015, what had been a lifetime ban was loosened, such that gay men could be donors if they’d abstained from sex for at least a year. This was later shortened to three months. Last week, the FDA put out a new and more inclusive plan: Sexually active gay and bisexual people would be permitted to donate so long as they have not recently engaged in anal sex with new or multiple partners. Assistant Secretary for Health Rachel Levine, the first Senate-confirmed transgender official in the U.S., issued a statement commending the proposal for “advancing equity.” It “treats everyone the same,” she said, “regardless of gender and sexual orientation.”

    As a member of the small but honorable league of gay pathologists, I’m affected by these proposed policy changes more than most Americans. I’m subject to restrictions on giving blood, and I’ve also been responsible for monitoring the complications that can arise from transfusions of infected blood. I am quite concerned about HIV, given that men who have sex with men are at much greater risk of contracting the virus than members of other groups. But it’s not the blood-borne illness that I, as a doctor, fear most. Common bacteria lead to far more transfusion-transmitted infections in the U.S. than any virus does, and most of those produce severe or fatal illness. The risk from viruses is extraordinarily low—there hasn’t been a single reported case of transfusion-associated HIV in the U.S. since 2008—because laboratories now use highly accurate tests to screen all donors and ensure the safety of our blood supply. This testing is so accurate that preventing anyone from donating based on their sexual behavior is no longer logical. Meanwhile, new dictates about anal sex, like older ones explicitly targeting men who have sex with men, still discriminate against the queer community—the FDA is simply struggling to find the most socially acceptable way to pursue a policy that it should have abandoned long ago.

    Strict precautions made more sense 30 years ago, when screening didn’t work nearly as well as it does today. Patients with hemophilia, many of whom rely on blood products to live, were prominent, early victims of our inability to keep HIV out of the blood supply. One patient who’d acquired the virus through a transfusion lamented to The New York Times in 1993 that he had already watched an uncle and a cousin die of AIDS. Those days of “shock and denial,” as the Times described it, are thankfully behind us. But for older patients, memories of the crisis in the ’80s and early ’90s linger, and cause significant anxiety. Even people unaware of this historical context may consider the receipt of someone else’s blood disturbing, threatening, or sinful.

    As a doctor, I’ve found that patients tend to be more hesitant about getting a blood transfusion than they are about taking a pill. I’ve had them ask for a detailed medical history of the donor, or say they’re willing to take blood only from a close relative. (Typically, neither of these requests can be fulfilled for reasons of privacy and practicality.) Yet the same patients may accept—without question—drugs that carry a risk of serious complication that is thousands of times higher than the risk of receiving infected blood. Even when it comes to blood-borne infections, patients seem to worry less about the greatest danger—bacterial contamination—than they do about the transfer of viruses such as HIV and hepatitis C. I can’t fault anyone for being sick and scared, but the risk of contracting HIV from a blood transfusion is not just low—it’s essentially nonexistent.

    Read: Blood plasma, sweat, and tears

    Donors’ feelings matter, too, and the FDA’s policies toward gay and bisexual men who wish to give blood have been unfair for many years. While officials speak in the supposedly objective language of risk and safety, their selective deployment of concern suggests a deeper homophobia. As one scholar put it in The American Journal of Bioethics more than a decade ago, “Discrimination resides not in the risk itself but in the FDA response to the risk.” Many demographic groups are at elevated risk of contracting HIV, yet the agency isn’t continually refining its exclusion criteria for young people or urban dwellers or Black and Hispanic people. Federal policy did prohibit Haitians from donating blood from 1983 to 1991, but activists successfully lobbied for the reversal of this ban with the powerful slogan “The H in HIV stands for human, not Haitian.” Nearly everyone today would find the idea of rejecting blood from one racial group to be morally repugnant. Under its new proposal, which purports to target anal sex instead of homosexuality itself, the FDA effectively persists in rejecting blood from sexual minorities.

    The planned update would certainly be an improvement. It comes out of years of advocacy by LGBTQ-rights organizations, and its details are apparently supported by newly conducted government research. Peter Marks, the director of the Center for Biologics Evaluation and Research at the FDA, cited an unpublished study showing that “a significant fraction” of men who have sex with men would now be able to donate. But the plan is still likely to exclude a large portion of them—even those who wear condoms or regularly test for sexually transmitted infections. An FDA spokesperson told me via email that “additional data are needed to determine what proportion of [men who have sex with men] would be able to donate under the proposed change.”

    Research done in France, Canada, and the U.K., where similar policies have since been adopted over the past two years, demonstrates the risk. A French blood-donation study, for instance, estimated that 70 percent of men who have sex with men had more than one recent partner; and when Canadian researchers surveyed queer communities in Montreal, Toronto, and Vancouver, they found that up to 63 percent would not be eligible to donate because they’d recently had anal sex with new or multiple partners. Just 1 percent of previously eligible donors would have been rejected by similar criteria. The U.K. assumed in its calculations that 35 to 50 percent of men who have sex with men would be ineligible under a policy much like the FDA’s, while only 1.4 percent of previous donors would be newly deferred. If the new rule’s net effect is that gay and bisexual men are turned away from blood centers at many times the rate of heterosexual individuals, what else can you call it but discrimination? The U.S. guidance is supposed to ban a lifestyle choice rather than an identity, but the implication is that too many queer men have chosen wrong. The FDA spokesperson told me, “Anal sex with more than one sexual partner has a significantly greater risk of HIV infection when compared to other sexual exposures, including oral sex or penile-vaginal sex.”

    If the FDA wants to pry into my sex life, it should have a good reason for doing so. The increasing granularity and intimacy of these policies—specifying numbers of partners, kinds of sex—gives the impression that the stakes are very high: If we don’t keep out the most dangerous donors, the blood supply could be ruined. But donor-screening questions are a crude tool for picking needles from a haystack. The only HIV infections that are likely to get missed by modern testing are those contracted within the previous week or two. This suggests that, at most, a couple thousand individuals—gay and straight—across the entire country are at risk of slipping past our testing defenses at any given time. Of course, very few of them will happen to donate blood right then. No voluntary questionnaire can ever totally exclude this possibility, but patients and doctors already accept other life-threatening transfusion risks that occur at much greater rates than HIV transmission ever could. When I would be on call for monitoring transfusion reactions at a single hospital, the phone would ring a few times every night. Yet blood has been given out tens of millions of times across the country since the last known instance of a transfusion resulting in a case of HIV.

    Read: How blood-plasma companies target the poorest Americans

    Early data suggest that the overall risk-benefit calculus of receiving blood isn’t likely to change. When eligibility criteria were first relaxed in the U.S. a few years ago, the already tiny rate of HIV-positive donations remained minuscule. Real-world results from other countries that have recently adopted sexual-orientation-neutral policies will become available in the coming years. But modeling studies already support removing any screening question that explicitly or implicitly targets queer men. A 2022 Canadian analysis suggested that removing all questions about men who have sex with men would not result in a significantly higher risk to patients. “Extra behavioral risk questions may not be necessary,” the researchers concluded. If there must be a restriction in place, then one narrowly tailored to the slim risk window of seven to 10 days before donation should be good enough. (The FDA says that its proposed policy “would be expected to reduce the likelihood of donations by individuals with new or recent HIV infection who may be in the window period.”)

    As a gay man, I realize that, brief periods of crisis during the coronavirus pandemic aside, no one needs my blood. Only 6.8 percent of men in the U.S. identify as gay or bisexual, so our potential benefit to the overall supply is inherently modest. If we went back to being banned completely, patients would not be harmed. But reversing that ban, both in letter and in spirit, would send a vital message: Our government and health-care system view sexual minorities as more than a disease vector. A policy that uses anal sex as a stand-in for men who have sex with men only further stigmatizes this population by impugning one of its main sources of sexual pleasure. There is no question that nonmonogamous queer men have a greater chance of contracting HIV. But a policy that truly treats everyone the same would accept a tiny amount of risk as the price of working with human beings.

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    Benjamin Mazer

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  • CDC urges people with weak immune systems to take extra precautions after Covid subvariants knock out Evusheld

    CDC urges people with weak immune systems to take extra precautions after Covid subvariants knock out Evusheld

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    The Centers for Disease Control and Prevention on Friday urged people with weak immune systems to take extra precautions to avoid Covid after the dominant omicron subvariants knocked out a key antibody treatment.

    These precautions include wearing a high quality mask and social distancing when it’s not possible to avoid crowded indoor spaces, according to the CDC.

    The guidance comes after the Food and Drug Administration on Thursday pulled its authorization of Evusheld, a combination antibody injection that people with weak immune systems took as an additional layer of protection to prevent Covid infection.

    The FDA pulled Evusheld because it is not effective against 95% of the omicron subvariants circulating in the U.S. This includes the XBB subvariants which are now causing 64% of new cases, as well as the BQ family that is responsible for 31% of reported infections.

    Although most Americans have largely returned to normal life as the Covid pandemic has ebbed, people with weak immune systems remain at higher risk of severe disease because they do not mount as strong of an immune response to the vaccines.

    Still, it is important for people with weak immune systems to stay up to date on their Covid vaccines by receiving the omicron booster because the shots can slash the risk of severe disease, according to the CDC.

    If you have a weak immune system and develop Covid symptoms, you should get tested as soon as possible and receive treatment with an antiviral within five to seven days, according to CDC.

    Available antivirals include Paxlovid, remdesivir or molnupiravir, but patients should talk to their doctor to find out which treatment is best. Some people cannot take Paxlovid due to how it interacts with other drugs they are taking.

    People with weak immune systems include cancer patients who are on chemotherapy, organ transplant patients who are taking medication for their transplant, people with advanced HIV infection, and those born with immune deficiencies.

    Some 7 million adults in the U.S. have a condition, like cancer, that compromises their immune system, according to the CDC.

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  • Is It Time for Yet Another COVID Booster? It’s Complicated

    Is It Time for Yet Another COVID Booster? It’s Complicated

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    SOURCES: 

    Peter Hotez, MD, PhD, dean, National School of Tropical Medicine, Baylor College of Medicine; co-director, Center for Vaccine Development, Texas Children’s Hospital, Houston.

    Paul Offit, MD, director, Vaccine Education Center and professor of pediatrics, Children’s Hospital of Philadelphia.

    Michael T. Osterholm, PhD, director, Center for Infectious Disease Research and Policy (CIDRAP), University of Minnesota, Minneapolis.

    Ground Truths. Eric Topol, MD: “The bivalent vaccine booster outperforms.” 

    CDC: “COVID Data Tracker: Weekly Review,” “Rates of Laboratory-Confirmed COVID-19 Hospitalizations by Vaccination Status,” “Trend in the Number of COVID-19 Vaccinations in the U.S.”

    FDA: “Vaccine and Related Biological Products Advisory Committee January 26 Meeting Announcement.”

    The New England Journal of Medicine: “Immunogenicity of BA.5 Bivalent mRNA Vaccine Boosters,” “Antibody Response to Omicron BA.4-BA.5 Bivalent Booster,” “Neutralization against BA.2.75.2, BQ.1.1, and XBB from mRNA Bivalent Booster,” “Bivalent Covid-19 Vaccines – A Cautionary Tale.”

    Nature Medicine: “Low neutralization of SARS-CoV-2 Omicron BA.2.75.2, BQ.1.1 and XBB.1 by parental mRNA vaccine or a BA.5 bivalent booster.”

    BioRxiv: “Bivalent mRNA vaccine improves antibody-mediated neutralization of many SARS-CoV-2 Omicron lineage variants,” “Improved Neutralization of Omicron BA.4/5, BA.4.6, BA.2.75.2, BQ.1.1, and XBB.1 with Bivalent BA.4/5 Vaccine.”

    Kaiser Family Foundation: “ How Much Could COVID-19 Vaccines Cost the U.S. After Commercialization?”

    Alison Chartan, spokesperson, Novavax.

    Pfizer Media Relations.

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  • Vapor Technology Association Statement on Critical Reagan-Udall Foundation Final Report

    Vapor Technology Association Statement on Critical Reagan-Udall Foundation Final Report

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    Leading Vapor Trade Group Urges FDA to Adopt Reforms to Protect Sanctity of Scientific Process

    Press Release
    –

    Dec 20, 2022


    WASHINGTON, December 20, 2022 (Newswire.com)
    –
    Following the Reagan Udall Foundation release of their final report reviewing the operations of FDA’s tobacco program, Vapor Technology Association Executive Director Tony Abboud released the following statement: 

    “The Reagan-Udall Foundation’s independent review of FDA’s tobacco program has uncovered systemic problems inside the Center for Tobacco Products that allowed political decisions to override the science-based recommendations of FDA professional staff concerning the authorization of vaping products that would provide safer alternatives for adult smokers looking to quit combustible cigarettes.  

    “The Reagan-Udall review was requested by FDA Commissioner Califf to address problems with the Center for Tobacco Products (CTP) programs for regulations and guidance, application review, compliance and enforcement, and communication with the public and other stakeholders. Their observations included the following:

    • CTP has no strategic plan and must create one that identifies the Center’s strategic objectives and plots an operational roadmap to achieve them.
    • CTP must resolve how to weigh the public health benefits of adults who use ENDS that will completely quit smoking combustible tobacco products against the potential public health harms to youth who use ENDS.
    • CTP has not clearly articulated what is required to meet the appropriateness for the protection of public health standard.
    • CTP struggles to function as a regulator due to some of its own policy choices.
    • CTP faces significant challenges in clearing policies through the career and political infrastructure.
    • CTP lacks consistent implementation of its own policies, particularly with respect to harm reduction.
    • CTP has not been transparent regarding its failure to clear the market of illegal products.
    • CTP’s current goals and priorities are unclear in communication and practice.

    “The Vapor Technology Association has raised concerns for years about the opaque and questionable operations of the CTP. Reagan-Udall’s review highlights a shifting and arbitrary decision-making process, untethered from science due to political or external pressures, that has damaged the marketplace for safer vaping products, impaired the FDA’s credibility, undermined the FDA’s mission of harm reduction by denying millions of American smokers truthful information and authorized products. We are pleased to see many of the recommendations VTA provided to the Reagan-Udall Foundation reflected in the Foundation’s report.

    “The fact that CTP has continued to issue major decisions despite deficiencies highlighted by Reagan-Udall is highly questionable. VTA agrees that ‘CTP must invest the time, now’…to create and implement a Strategic Plan’ and that ‘the path to resolving many of the Center’s current challenges starts with establishing the scientific and policy framework to make clear and timely product decisions.’ For that reason, the FDA Commissioner should instruct CTP to stand down on issuing any further denials of less harmful nicotine alternative product applications until CTP has been able to review and implement the safeguards and recommendations made by the Reagan-Udall Foundation, and VTA stands ready to assist FDA and CTP by providing the necessary stakeholder input that the Foundation also said was necessary,” said Tony Abboud.

    ABOUT VTA
    The Vapor Technology Association is the U.S. industry trade association whose members are dedicated to sound science-based regulation and selling innovative high-quality vapor products that provide adult smokers with a better alternative to combustible cigarettes. VTA represents the industry-leading manufacturers of vapor devices, e-liquids, and flavorings, as well as the distributors and retailers, including hardworking American mom-and-pop brick-and-mortar retail store owners.

    Source: Vapor Technology Association

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  • FDA Gives Safety Green Light to Lab-Grown Meat Startup Upside Foods

    FDA Gives Safety Green Light to Lab-Grown Meat Startup Upside Foods

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    Opinions expressed by Entrepreneur contributors are their own.

    California startup Upside Foods just cleared a major hurdle in bringing its lab-cultured chicken to a sandwich near you. The U.S. Food and Drug Administration (FDA) said in a press release published Wednesday that the agency had completed its “first pre-market consultation of a human food made from cultured animal cells.”


    Tek Image | Getty Images

    The FDA cleared Upside to continue creating meat products with its animal cell culture technology. Though the company still needs approval to sell its lab-grown chicken (or seafood or meat), the FDA has concluded by analyzing how Upside produces its meat that it is safe for consumption. The agency does not question its safety.

    This is a significant step forward for producers of meat grown from cultured cells. Upside Foods founder Uma Valeti said in a statement that the company has “made history … as the first company to receive a ‘No Questions’ letter from the FDA for cultivated meat.”

    “This milestone marks a major step towards a new era in meat production,” Valeti said, “and I’m thrilled that U.S. consumers will soon have the chance to eat delicious meat that’s grown directly from animal cells.”

    Upside Foods still has another major milestone to go, however, to receive permission to sell its product. In addition to FDA approval, the company also needs approval from the Food Safety and Inspection Service, which is under the U.S. Department of Agriculture (USDA).

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    Steve Huff

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  • An Abundance Agenda For America

    An Abundance Agenda For America

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    Third quarter GDP growth came in at 2.6%, reversing GDP declines in the first and second quarters, but there are still signs of economic weakness. Sales to U.S. consumers continue to slow, inflation remains high, and over the next decade the Congressional Budget Office predicts real GDP growth to average less than 2% per year. A struggling economy is not inevitable, however, and a new report from the Center for Growth and Opportunity (CGO) at Utah State University explains the policy reforms needed to achieve abundance rather than stagnation.

    In their new report, authors Taylor Barkley, Jennifer Morales, and Josh Smith explain that achieving abundance means faster economic growth, better living standards, a cleaner environment, and cheaper prices. They acknowledge that America faces headwinds—labor shortages, housing shortages, and various supply chain problems. But America is also the home of the world’s most innovative and successful companies, first-class universities, and remains the number one destination for immigrants.

    America has long been the world’s hub of innovation, and by leaning into our willingness to take risks we can continue to pace the world and ensure economic opportunities for everyone.

    The first piece of the abundance agenda is maintaining competitive markets. America’s strong system of property rights and efficient capital markets make it relatively easy (though not easy enough) to start and grow a business. Policies that change this, such as stifling so-called “Big Tech” with new antitrust rules or more government oversight and regulation, would reduce economic dynamism and make it harder for upstarts to compete and overtake entrenched incumbents.

    Studies show that more regulation increases prices, increases poverty, exacerbates income inequality, reduces employment, and decreases business investment. An abundance agenda streamlines regulation so duplicative and overly burdensome regulations do not impede entrepreneurs.

    A stark example from the report is the FDA approval process. The process is taking longer and longer, which prevents important medicines and medical devices from getting into the hands of consumers. The FDA should shorten approval times by allowing post-launch monitoring of drugs. This would enable consumers to use new drugs while the FDA continues to collect data on safety. The FDA should also shift its focus to safety monitoring rather than efficacy testing, as this would also make drugs available sooner.

    The authors also recommend removing barriers to transportation innovation. The Federal Aviation Administration should have a deadline for integrating drones into aviation rules. Drones are already providing immense benefits to consumers around the world, but America is falling behind due to regulatory uncertainty.

    Congress should also instruct the FAA to allow some supersonic flights to help create a market for faster air travel. There have been advances in supersonic flight, but until the rules change routine supersonic flights that dramatically speed up travel times—San Francisco to Tokyo in six hours instead of ten—will remain a dream.

    The report also discusses reforms to the National Environmental Policy Act, or NEPA. NEPA causes significant litigation and delays on projects from dams to solar panels, but a few changes could alleviate much of the problem.

    First, NEPA should be amended so that federal agencies can issue a Finding of No Significant Impact (FONSI) for projects without first conducting a longer, more complicated Environmental Assessment (EA). Currently, even if an agency believes a FONSI is appropriate, it still must conduct an EA. The proposed change does not preclude agencies from conducting an EA if they think it is necessary, it just does not require one.

    NEPA could also add geothermal projects to its list of categorical exclusions. Certain oil and gas projects are already excluded, and since geothermal projects are conducted in much the same way the exclusion makes sense. Geothermal is a relatively clean source of energy and new projects provide jobs for oil and gas workers looking to transition to a new industry since they require many of the same skills.

    In another study, Mario Loyola of the Competitive Enterprise Institute (CEI) makes additional recommendations to reform NEPA. He notes that the uncertainty of the NEPA process causes significant social losses and that the “uncertainty has many sources, most important of which is litigation risk, which maximizes the amount of time and resources that agencies devote to processing permit applications out of all proportion to the environmental costs and benefits at stake.”

    Loyola makes several recommendations to speed up the NEPA process and reduce litigation risk. First, Congress should allow project developers to prepare the materials needed for agency permit certification. If agencies take too long to issue or deny a permit based on these materials, developers should be given provisional permits to start construction subject to monitoring.

    Second, Congress should create a unified federal permitting process so project developers do not need to go through a half-dozen different agency processes to get the necessary approvals.

    Next, agencies should be held to a substantial-compliance standard so that provided reports and materials that are mostly right enable a project to move forward. Congress should also tighten the rules on standing to prevent parties that are clearly not affected by a project from holding it up with a lawsuit.

    Finally, Congress should establish programmatic and general permits for major categories of infrastructure projects that have similar environmental impacts. This would expedite the permitting process.

    Additional reforms mentioned in the CGO report include immigration reform, ideas for expanding broadband access, policy changes to protect the environment, and suggestions for increasing the resiliency of America’s electricity grids. Some state and local reforms not mentioned that would also improve economic growth include zoning and land-use reforms, occupational licensing reforms, and pro-growth tax reforms.

    So far, President Biden’s economic agenda has been the most anti-growth of the last 40 years. His administration’s barrage of regulations and profligate spending helped create the highest inflation rate in two generations. The Fed has been forced to raise interest rates in response, bringing us closer to a recession.

    It does not have to be this way. America’s workers and entrepreneurs are still capable of great things, but they cannot achieve them while held back by the weight of our current anti-growth policies. With the right policy reforms, we can remove the barriers people face and achieve abundance.

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    Adam A. Millsap, Contributor

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