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Tag: fda

  • Biden’s Weed Tweet Got Numbers and Feedback

    Biden’s Weed Tweet Got Numbers and Feedback

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    His mentioning marijuana at the State of The Union was historic, but boy did he get some feedback when he tweeted.

    The State of the Union address for many years was referred to as “the President’s Annual Message to Congress“. It is believed George Washington started the tradition and the term “State of the Union” first emerged in 1934 when used by Franklin D. Roosevelt (FDR). President Biden mention of marijuana was historic and also showed how the plants reputation has come a long way from the war on drugs.  And when he tweeted about it, things got spicy. Biden’s weed tweet got numbers and feedback – and the administration might be wise to pay attention.

    Related: California or New York, Which Has The Biggest Marijuana Mess

    The tweet on cannabis reached 14 million and had 12,000 comments and 104,000 likes.  The President mentioned his marijuana pardons which drew a significant amount of feedback. According to BDSA, a leading analytics firm covering cannabis, the industry generated $29.5 billion in revue in 2023.  When talking about a need to grow the economy and taxes, here is a fresh industry the public wants, but antiquated laws are punishing small businesses.

    When you subtract comments not relating to weed, they fall in three categories.  The first is the remaining resentment toward Vice President Harris for her historic stance on marijuana.  The industry was at first excited when Biden was elected as he indicated he would move opening up legalization for cannabis. His slow pace along with VP Harris’s previous role has frustrated the industry and it shows by the sharp remarks.

    Another large batch of comments were just about making a move already!  Science, the American Medical Association, and the federal departments of the Healthy and Human Services (HHS) and Food and Drug Administration (FDA) have all said there are benefits.  People are clamoring for him to act and act quickly. But, it seems to the public eye, the administration has been very slow in fullfilling this promise from over 2020.

    RELATED: Science Says Medical Marijuana Improves Quality Of Life

    The third big conversation is his perception his pardons did more than they actually did for prisoners.  Again, there is hard feelings about it and the online community want him to understand what he did and did not do.

    While the industry is expanding, it is still in growth mode and needs basic help in continuing to grow. Rescheduling would allow state cannabis operators to take federal tax deductions they’re currently barred from under an Internal Revenue Service (IRS) code known as 280E.  This would give immediate benefits to the cannabis industry which is 50+% small businesses.

     

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    Sarah Johns

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  • American consumers deserve the same food labeling standards as Europeans

    American consumers deserve the same food labeling standards as Europeans

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    America’s life expectancy is falling annually–and improper or inadequate nutrition is a major cause. A study in The Lancet from The Institute of Health and Metrics concludes that as many as 11 million deaths worldwide are attributable to a poor diet. That’s more than the 8 million deaths caused by tobacco use.

    The chief culprit? Primarily, it’s processed foods filled with salt, sugar, fats, and other additives. Those formulations may alter the taste or extend shelf life, but those foods lack the necessary whole grains, fiber, nutrients, and fruits that experts recommend. What’s more, the lower fiber content decreases satiety and contributes to the secretion of hormones that trigger hunger. It’s a formula for long-term health risks and complications.

    How can we turn this situation around? It starts with an informed consumer, a shopper who can properly assess a food product’s ingredients and their impact on health. Honesty is the best policy, and consumers want clearer nutritional information about the foods they–and their families–are eating.

    They also want to know that additives may be lurking in their food–which is why improved FDA labeling is key. Too often, food manufacturers “greenwash” their products by hiding the true composition of the product, for example, by using green-colored packaging that implies a product is natural/organic when it is absolutely not or is even highly processed.

    FMI-Nielsen found that an overwhelming 72% of shoppers report that more transparent product information and labeling are important to them. They want complete ingredient listings in plain English and more complete nutritional information than current labeling provides. And those consumers will speak with their wallets: FMI-Nielsen’s study also found that 64% of buyers would switch to a new brand that provides more and clearer nutritional information.

    That transparency leads to greater trust from consumers as well as purchasing decisions that can improve population health. That’s why the FDA must redouble its efforts to improve the clarity and completeness of food labeling.

    A new food labeling framework

    Unfortunately, food labeling initiatives in the U.S. have stagnated. For 30 years, the U.S. Food & Drug Administration (FDA) has required food manufacturers to provide ingredient and product information on packaging using the Standard Ingredient Label. But it’s becoming increasingly clear that this standard format needs to be reformatted to make it easier to read about the health effects of food. Is there too much salt or sugar? Are there additives that could be bad for my physical or mental health? Today’s consumers want direct, clear, readable labels to guide their purchasing decisions. The FDA must implement a more intuitive system that helps consumers identify healthier food options.

    What would new and improved labels look like? U.S. regulators can draw inspiration for a new and improved labeling framework from Europe’s Nutri-Score system to give buyers a more comprehensive view of nutrition. The Nutri-Score (also known as the “5-Colour Nutrition Label” or 5-CNL) was first implemented in France in 2017 to simplify the descriptions of the overall nutritional value of food products. It rates foods using a letter from A (best) to E (worst) as well as colors from green to red. This sort of scoring regimen would be an ideal complementary extension to the FDA’s Nutrition Facts labels, improving both public health and consumer satisfaction.

    The Nutri-Score factors in components such as calories, saturated fat, sugars, and salt, as well as fiber, proteins, nuts, fruit, and vegetables. Each food product earns color and letter based on the resulting score (calculated per 100g or 100ml).

    Fortunately, frameworks such as Nutri-Score and similar front-of-package labeling (FoPL) can make a meaningful difference. According to The International Journal of Behavioral Nutrition and Physical Activity, “approximately 3.4% of all deaths from diet-related non-communicable diseases was estimated to be avoidable when the Nutri-Score FoPL was used.” That’s more than 8,000 avoidable deaths.

    What’s more, the presence of stronger and clearer FoPLs can have a direct impact on the quality of foods as it encourages manufacturers to reformulate their products and switch up their ingredients and recipes to achieve higher scores and fend off competitors who rank higher. That’s because, among consumers who are familiar with the logo, more than 33% said they had already changed their purchasing habits by opting instead for products with a better score. What’s more, nearly 90% believe the Nutri-Score should appear on all packaging, and 70% believe the improved labeling has a positive impact on the brand.

    Good food is good business

    Some food processors will predictably resist with lobbying efforts to minimize labeling changes and seek loopholes and exceptions. However, forward-thinking manufacturers will recognize that enhanced labeling presents a business opportunity. Market research firm IRI found that products with Nutri-Score rankings of A and B saw their cumulative market share increase by 0.7 points over the period (+0.3 for A and +0.4 for B). Conversely, at the bottom of the scale, products with E ratings saw their market share decline by -0.5 points.

    It’s clear: Enhanced food labeling that provides more nutritional understanding can promote healthier eating habits, extend lifespans, improve health outcomes, reduce healthcare costs, and improve the quality of life for all demographic segments. In the U.S., regulators and public health advocates would be wise to explore the development and adoption of a FoPL strategy.

    Julie Chapon is a co-founder of Yuka.

    More must-read commentary published by Fortune:

    The opinions expressed in Fortune.com commentary pieces are solely the views of their authors and do not necessarily reflect the opinions and beliefs of Fortune.

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    Julie Chapon

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  • FDA: Yogurts Can Make Limited Claim That The Food Reduces Risk Of Type 2 Diabetes – KXL

    FDA: Yogurts Can Make Limited Claim That The Food Reduces Risk Of Type 2 Diabetes – KXL

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    (Associated Press) – Yogurt sold in the U.S. can make claims that the food may reduce the risk of type 2 diabetes based on limited evidence.

    The U.S. Food and Drug Administration has agreed that eating at least 2 cups of yogurt a week might reduce the risk of the disease.

    The agency granted a request for a qualified health claim from Danone North America.

    Such claims lack full scientific support but are allowed as long as they include disclaimers.

    Other such allowed claims include that some types of cocoa may reduce heart disease and cranberry juice might reduce the risk of recurrent UTIs.

    More about:

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    Grant McHill

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  • Michigan wants to study marijuana’s health benefits. It’s not easy. – Cannabis Business Executive – Cannabis and Marijuana industry news

    Michigan wants to study marijuana’s health benefits. It’s not easy. – Cannabis Business Executive – Cannabis and Marijuana industry news

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    Michigan wants to study marijuana’s health benefits. It’s not easy. – Cannabis Business Executive – Cannabis and Marijuana industry news




























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    AggregatedNews

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  • FDA warns against smartwatches, rings that claim to measure blood sugar without needles

    FDA warns against smartwatches, rings that claim to measure blood sugar without needles

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    Smartwatches and rings that claim to measure blood sugar levels for medical purposes without piercing the skin could be dangerous and should be avoided, the U.S. Food and Drug Administration warned Wednesday.

    The caution applies to any watch or ring, regardless of brand, that claims to measure blood glucose levels in a noninvasive way, the agency said. The FDA said it has not authorized any such device.

    The agency’s notice doesn’t apply to smartwatch apps linked to sensors, such as continuous glucose monitoring systems that measure blood sugar directly.

    Roughly 37 million Americans have diabetes. People with the disease aren’t able to effectively regulate their blood sugar because their bodies either don’t make enough of the hormone insulin or they have become resistant to insulin.

    To manage the condition, they must regularly check their blood sugar levels with a finger prick blood test or with a sensor that places needles just under the skin to monitor glucose levels continuously.

    Using the unapproved smartwatch and smart ring devices could result in inaccurate blood sugar measurements, with “potentially devastating” consequences, said Dr. Robert Gabbay, of the American Diabetes Association. That could cause patients to take the wrong doses of medication, leading to dangerous levels of blood sugar and possibly mental confusion, coma or even death.

    Several companies are working on noninvasive devices to measure blood sugar, but none has created a product accurate and secure enough to get FDA approval, said Dr. David Klonoff, who has researched diabetes technology for 25 years.

    The technology that allows smartwatches and rings to measure metrics like heart rate and blood oxygen is not accurate enough to measure blood sugar, said Klonoff, of the Sutter Health Mills-Peninsula Medical Center in San Mateo, California. Efforts to measure blood sugar in body fluids such as tears, sweat and saliva are not ready for prime time, either.

    “It’s challenging, and I believe at some point there will be at least one scientist or engineer to solve it,” Klonoff said.

    In the meantime, consumers who want to measure their blood sugar accurately can buy an FDA-cleared blood glucose monitor at any pharmacy.

    “It comes down to risk. If the FDA approves it, the risk is very small,” he said. “If you use a product that is not cleared by the FDA, very often the risk is very large.”

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  • South Carolina Bans CBD, Intoxicating Hemp Products in Extreme Crackdown | High Times

    South Carolina Bans CBD, Intoxicating Hemp Products in Extreme Crackdown | High Times

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    Yet another state is cracking down on hemp-derived products, some of which have intoxicating effects, and South Carolina’s approach to food products that contain hemp is among the most extreme. Even hemp microgreens are banned while only products with hemp seeds and their derivatives will be off the hook.

    The South Carolina Department of Health and Environmental Control (DHEC) issued a warning in a letter dated Jan. 22, banning the manufacture, distribution, and sale of food and beverage products containing hemp-derived products as ingredients in the state’s marketplace.

    But they’re not only going after hemp-derived cannabinoid products that are synthetically derived from hemp biomass, and known for psychoactive effects—i.e. delta-8 THC, THC-O, etc.—they’re going after products with CBD, hemp leaves, plant material and more as well. Delta-8 THC only appears in nature in minute amounts, and intoxicating amounts have to be re-added to hemp via a refluxing process in a lab. This is why states are opting to either crack down on it or regulate it like marijuana. The 2018 Farm Bill opened a legal loophole, accidentally legalizing these ingredients. Delta-8 THC products seeped into the medical markets in some states.

    South Carolina’s ban on CBD is among the most extreme measures taken by state officials to date. While CBD products can easily be found in most states thanks to a lack of clarity in federal regulations, the U.S. Food & Drug Administration (FDA) has repeatedly warned that products containing CBD are illegal under the Federal Food, Drug, and Cosmetic Act. 

    The FDA routinely issues warnings that adding CBD to a food means those products are adulterated, or against products with any sort of medical claims, but the agency has delayed finalizing rules.

    “Therefore, the following hemp products are NOT APPROVED to be added to food or beverage products,” the letter reads. 

    • Viable, non-sterilized hemp seeds, raw hemp leaves, and raw microgreens, and any other raw, unprocessed form of hemp biomass as they are considered “plant material” and may not be possessed without a Grower or Processor License 
    • Pure CBD Isolate 
    • Delta-8 THC, Delta-9 THC, or Delta-10 THC 
    • THC-0 or any other derivative 
    • “Full spectrum” whole-plant extract (i.e. “full spectrum hemp oil/extract” from biomass) if it includes health claims, or bears any sort of declaration of THC or CBD 
    • Any hemp product that is NOT manufactured in a food-grade establishment inspected under GMP or cGMP regulations. 
    • Any hemp or hemp-derived product that promotes its medical or health benefits

    The only exceptions are basically hemp seed derivatives. “The FDA evaluated three Generally Recognized As Safe (GRAS) notices for hemp products and found that the use of such products as described in the notices is safe. Therefore, the following hemp products may be legally marketed in human foods and are APPROVED to be used as ingredients in food and beverage products,” the letter continues.

    “While DHEC’s goal is to educate while we regulate this growing niche of manufacturers and distributors of foods and beverages containing hemp-derived products as ingredients, our obligation under the requirements of both federal and state law is to remove from commerce all food and beverage products containing non-conforming hemp-derived products as ingredients,” Sandra Craig, Director of the DEHC’s Division of Food and Lead Risk Assessments, said in a letter announcing the bans.

    Sellers can use full-spectrum whole-plant extract as an ingredient in food and beverage products if and only if the hemp-derived ingredient meets the following requirements: 

    • A “full spectrum” hemp oil or extract from biomass contains the naturally occurring ratios and array of phytonutrients found in hemp. 
    • Using a full spectrum hemp oil as an ingredient must be referred to in the ingredients list on the food or beverage label as “Full Spectrum Hemp Oil” or “Full Spectrum Hemp Extract.” The label may not contain health claims and may not bear any sort of declaration of “THC”, “CBD”, or “Delta-9” products or isolates. 
    • When companies in South Carolina receive their “full spectrum hemp oil/extract” from their approved supplier, it must contain no more than 0.3% Delta-9 THC, as evidenced by Certificates of Analysis (COAs). The use of concentrates or “work in progress hemp oil from biomass” containing more than 0.3% Delta-9 THC, is illegal. Companies may NOT use “crude” hemp-derived oil, “work in progress” hemp oils over 0.3% Delta-9 THC, non-food grade oils, or dilute hemp oils containing an illegal amount of THC (> 0.3%) to a “legal” level. Hemp products containing more than the legal limit of THC are no longer considered to be hemp but are a Schedule I Drug. Hemp products that contain more than 0.3% THC are NOT ALLOWED to be possessed by anyone in South Carolina, and they are NOT ALLOWED to be introduced into foods or beverages.

    The letter also bans any mention of THC, dosages, and several other restrictions. The letter also reminds hemp sellers that only intrastate hemp product sales are allowed.

    At least a dozen other states are actively pursuing solutions to ban hemp-derived products in one form or another.

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    Benjamin M. Adams

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  • ‘No hormones, ever,’ Shake Shack says about its chicken. Activist shareholders say that’s true for every other chicken sold in the U.S., too

    ‘No hormones, ever,’ Shake Shack says about its chicken. Activist shareholders say that’s true for every other chicken sold in the U.S., too

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    “No hormones, ever” is what Shake Shack said about the crispy fried chicken in its sandwiches. A shareholder group says that’s a paltry claim, because literally no restaurant chain in the country uses hormones in its chicken. 

    The company’s corporate communications and marketing are heavy on the claims. A 2023 letter from CEO Randy Garutti in its Stand For Something Good Report said the Shake Shack culinary team in 2023 focused on improving the food lineup with “hormone- and antibiotic-free proteins.” It touts its poultry – and bacon – as having no hormones, although the company notes with an asterisk that federal regulations prohibit the use of hormones or steroids in chicken and pork.  

    Now, the company is facing a potential shareholder proposal asking it to show exactly how its chicken is hormone free or to provide an explanation and to publish a risk analysis of making those statements. The shareholder activist, The Accountability Board, said the claims are “difficult to understand.” The group focuses on stewardship and transparency, according to its website, and its portfolio includes investments in other fast food businesses including Jack in the Box, McDonald’s and The Wendy’s Company.  

    Shake Shack this week asked the Securities and Exchange Commission to leave the proposal off its 2024 proxy statement without facing repercussions from the regulator. According to Shake Shack, it has already begun altering its wording to say, “no added hormones.”  

    Josh Balk, chief executive officer of the Accountability Board, isn’t satisfied with that change. “Shake Shack can’t make harmful and false claims for years and quietly sweep them under the rug when caught,” he said in an email to Bloomberg. “And especially so by simply replacing one misleading claim for another.” 

    A Shake Shack spokesperson acknowledged the change to “no added hormones” and added, “We are also not making any changes to our chicken suppliers or any of our supply chain and food policies — it is simply a language change.” 

    Shake Shack isn’t alone in facing down shareholders who are disenchanted with animal welfare issues.  

    Activist investor Carl Icahn famously took on McDonald’s for years over the fast food giant’s treatment of pigs. Icahn in his fight sought the help of other large investors but ultimately lost a proxy fight in 2022. 

    McDonald’s pledged to avoid the use of gestation crates for pregnant pigs entirely by 2024.  

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    Amanda Gerut

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  • Flu Shots Need to Stop Fighting ‘Something That Doesn’t Exist’

    Flu Shots Need to Stop Fighting ‘Something That Doesn’t Exist’

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    Listen to this article

    Produced by ElevenLabs and NOA, News Over Audio, using AI narration.

    In Arnold Monto’s ideal vision of this fall, the United States’ flu vaccines would be slated for some serious change—booting a major ingredient that they’ve consistently included since 2013. The component isn’t dangerous. And it made sense to use before. But to include it again now, Monto, an epidemiologist and a flu expert at the University of Michigan, told me, would mean vaccinating people “against something that doesn’t exist.”

    That probably nonexistent something is Yamagata, a lineage of influenza B viruses that hasn’t been spotted by global surveyors since March of 2020, shortly after COVID mitigations plummeted flu transmission to record lows. “And it isn’t for lack of looking,” Kanta Subbarao, the director of the WHO’s Collaborating Centre for Reference and Research on Influenza, told me. In a last-ditch attempt to find the missing pathogen, a worldwide network of monitoring centers tested nearly 16,000 influenza B virus samples collected from February to August of last year. Not a single one of them came up Yamagata. “The consensus is that it’s gone,” Cheryl Cohen, the head of South Africa’s Centre for Respiratory Diseases and Meningitis, told me. Officially removing an ingredient from flu vaccines will codify that sentiment, effectively publishing Yamagata’s obituary.

    Last year around this time, Subbarao told me, the WHO was already gently suggesting that the world might want to drop Yamagata from vaccines; by September, the agency had grown insistent, describing the ingredient as “no longer warranted” and urging that “every effort should be made to exclude it as soon as possible.” The following month, an advisory committee to the FDA unanimously voted to speedily adopt that same change.

    But the switch from a four-flu vaccine to a trivalent one, guarding against only three, isn’t as simple as ordering the usual, please, just hold the Yams. Trivalent vaccines require their own licensure, which some manufacturers may have allowed to lapse—or never had at all; manufacturers must also adhere to the regulatory pipelines specific to each country. “People think, ‘They change the strains every season; this should be no big deal,’” Paula Barbosa, the associate director of vaccine policy at the International Federation of Pharmaceutical Manufacturers and Associations, which represents vaccine manufacturers, told me. This situation is not so simple: “They need to change their whole manufacturing process.” At the FDA advisory-committee meeting in October, an industry representative cautioned that companies might need until the 2025–26 season to fully transition to trivalents in the Northern Hemisphere, a timeline that Barbosa, too, considers realistic. The South could take until 2026.

    In the U.S., though, where experts such as Monto have been pushing for expedient change, a Yamagata-less flu vaccine could be coming this fall. When I reached out to CSL Seqirus and GSK, two of the world’s major flu-vaccine producers, a spokesperson from each company told me that their firm was on track to deliver trivalent vaccines to the U.S. in time for the 2024–25 flu season, should the relevant agencies recommend and request it. (The WHO’s annual meeting to recommend the composition of the Northern Hemisphere’s flu vaccine isn’t scheduled until the end of February; an FDA advisory meeting on the same topic will follow shortly after.) Sanofi, another vaccine producer, was less definitive, but told me that, with sufficient notice from health authorities, its plans would allow for trivalent vaccines this year, “if there is a definitive switch.” AstraZeneca, which makes the FluMist nasal-spray vaccine, told me that it was “engaging with the appropriate regulatory bodies” to coordinate the shift to a trivalent vaccine “as soon as possible.”

    Quadrivalent flu vaccines are relatively new. Just over a decade ago, the world relied on immunizations that included two flu A strains (H1N1 and H3N2), plus one B: either Victoria or Yamagata, whichever scientists predicted might be the bigger scourge in the coming flu season. “Sometimes the world got it wrong,” Mark Jit, an epidemiologist at the London School of Hygiene & Tropical Medicine, told me. To hedge their bets, experts eventually began to recommend simply sticking in both. But quadrivalent vaccines typically cost more to manufacture, experts told me. And although several countries, including the U.S., quickly transitioned to the heftier shots, many nations—especially those with fewer resources—never did.

    Now “the extra component is a waste,” Vijay Dhanasekaran, a virologist at the University of Hong Kong, told me. It’s pointless to ask people’s bodies to mount a defense against an enemy that will never attack. Trimming Yamagata out of flu-vaccine recipes should also make them cheaper, Dhanasekaran said, which could improve global access. Plus, continuing to manufacture Yamagata-focused vaccines raises the small but serious risk that the lineage could be inadvertently reintroduced to the world, Subbarao told me, as companies grow gobs of the virus for their production pipeline. (Some vaccines, such as FluMist, also immunize people with live-but-weakened versions of flu viruses.)

    Some of the researchers I spoke with for this article weren’t ready to rule out the possibility—however slim—that Yamagata is still biding its time somewhere. (Victoria, a close cousin of Yamagata, and the other B lineage that pesters people, once went mostly quiet for about a decade, before roaring back in the early aughts.) But most experts, at this point, are quite convinced. The past couple of flu seasons have been heavy enough to offer even a rather rare lineage the chance to reappear. “If it had been circulating in any community, I’m pretty sure that global influenza surveillance would have detected it by now,” Dhanasekaran said. Plus, even before the pandemic began, Yamagata had been the wimpiest of the flu bunch, Jit told me: slow to evolve, crummy at transmitting, and already dipping in prevalence. When responses to the pandemic starved all flu viruses of hosts, he said, this lineage was the likeliest to be lost.

    Eventually, companies may return to including four types of flu in their products, swapping in, say, another strain of H3N2, the most severe and fastest-evolving of the bunch—a change that Subbarao and Monto both told me might actually be preferable. But incorporating a second H3N2 is even more of a headache than returning to a trivalent vaccine: Researchers would likely first need to run clinical trials, experts told me, to ensure that the new components played nicely with each other and conferred additional benefits.

    For the moment, a slimmed-down vaccine is the quickest way to keep up with the flu’s current antics. And in doing so, those vaccines will also reflect the strange reality of this new, COVID-modified world. “A whole lineage of flu has probably been eliminated through changes in human behavior,” Jit told me. Humanity may not have intended it. But our actions against one virus may have forever altered the course of another.

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    Katherine J. Wu

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  • Drug Maker Recalls ADHD Medicine Over Label Mixup | High Times

    Drug Maker Recalls ADHD Medicine Over Label Mixup | High Times

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    The U.S. Food and Drug Administration last week announced the voluntary recall of a medicine used to treat attention deficit hyperactivity disorder (ADHD) and narcolepsy after the manufacturer of the drug revealed that the wrong pills were found in packages of the medication. The recall covers one lot of the drug Zenzedi, an ADHD and narcolepsy medication manufactured by Massachusetts-based Azurity Pharmaceuticals.

    In a notice about the recall, the FDA noted that a pharmacist had reported finding pills of an antihistamine, carbinoxamine maleate, in a package of Zenzedi. The voluntary recall was announced by Azurity on January 24 and covers packages of Zenzedi 30 milligram tablets with lot number F230169A and an expiration date of June 2025.

    The recalled medication was distributed nationwide through retail pharmacies. Pharmacies and drug wholesalers have reportedly pulled the drug from their shelves to comply with the recall. Customers who purchased packages of the recalled lot of Zenzedi are urged to return any remaining pills to the place of purchase. Patients who take the mislabeled medication and have adverse reactions are encouraged to see their doctor. 

    Drugs Have Opposite Effects

    The two drugs have opposite effects when taken, according to a report from CBS News. Carbinoxamine maleate is an antihistamine that is used to treat allergies and has a sedative effect on some patients, while Zenzedi, a brand name for the drug dextroamphetamine sulfate,  is a stimulant that generally increases a patient’s attentiveness. Zenzedi is used to treat narcolepsy, a sleep disorder that causes overwhelming daytime drowsiness, and ADHD.

    The FDA added that patients who take carbinoxamine maleate instead of Zenzedi will experience undertreatment of their symptoms. Patients can also have a potentially deadly elevated risk of accidents or injuries and may have drowsiness, increased eye pressure, urinary obstruction and thyroid disorder, among other symptoms, according to the FDA’s recall notice.                                           

    “Patients who take carbinoxamine instead of Zenzedi® will experience undertreatment of their symptoms, which may result in functional impairment and an increased risk of accidents or injury,” the FDA wrote in a notice about the recall. “Patients who unknowingly consume carbinoxamine could experience adverse events which include, but are not limited to, drowsiness, sleepiness, central nervous system (CNS) depression, increased eye pressure, enlarged prostate urinary obstruction, and thyroid disorder.”

    Azurity Pharmaceuticals sent recall notification letters to drug wholesalers on January 4 via an overnight letter and has arranged for the return of all affected product at the wholesale level. The company said that no reports of serious injury have been made as a result of the mixup.   

    Recall Comes During Shortage of ADHD Meds

    The Zenzedi recall comes in the midst of a nationwide shortage of medications used to treat ADHD. The shortage has been affecting supplies of the drug Adderall since a manufacturer experienced production delays in Fall 2022, according to a report from CNN.

    At least 11 manufacturers of Adderall or generic versions of the drug were listed on the FDA’s shortage list in September 2023. The shortage of ADHD medication has left many patients struggling to fill their prescriptions, according to healthcare professionals. 

    “A lot of the young people that I’ve been treating have had difficulties getting their medications month to month,” Dr. Warren Ng, a professor of psychiatry at Columbia University Medical Center who also serves as president for the American Academy of Child and Adolescent Psychiatry, told CNN.

    When taking their prescribed medication, many patients with ADHD are able to function better. But when they run out of their medication, it can have a tremendous impact on their self-esteem.

    “I’ve seen kids who want to drop out of school, don’t want to continue with their educational path or drop out of college suddenly making the honor roll,” Ng said. And “instead of seeing, being seen as being lazy or dumb or slow, they can envision themselves really utilizing all of their mental, psychological and intellectual abilities to really see themselves for who they are, which is so much more.”

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    A.J. Herrington

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  • Chuck Schumer attacks lifesaving zyn nicotine pouches

    Chuck Schumer attacks lifesaving zyn nicotine pouches

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    Less than three months after launching an attack on energy drinks, Senate Majority Leader Chuck Schumer (D–N.Y.) has a new target: Zyn nicotine pouches.

    In a press release Sunday, Schumer labeled Zyn a “quiet and dangerous” alternative to vaping, claiming that with the decline in smoking, tobacco companies are adapting by focusing on new products like oral nicotine. Zyns are small pouches of nicotine meant to be placed between the lips and gums. Two strengths of the product are available at three and six milligrams of nicotine, and they come in several flavors.

    Schumer’s ire appears to have been raised by the rapid growth in sales of nicotine pouches and so-called “Zynfluecers” on TikTok promoting the product. Schumer fears nicotine pouches could become a teen trend, as vaping did in 2019 before rapidly declining as the tobacco age was raised to 21 and schools became more aware of the problem. To head off a potential increase in youth nicotine addiction, Schumer wants the Federal Trade Commission and the Food and Drug Administration to investigate the marketing of Zyn and potentially restrict their flavors.

    But Schumer’s framing has the story backward. Zyn is not a dangerous alternative to vaping but a dramatically safer alternative to smoking. One of the reasons smoking has declined substantially over the last decade is because safer nicotine alternatives like vapes and Zyn are switching smokers away from cigarettes. The closest equivalent for which we have decades of data is an oral smokeless tobacco called snus. Snus is most prevalent in Sweden, and not coincidentally, Sweden has the lowest smoking and lung cancer rates in Europe because those interested in using nicotine do so in a much safer form.

    Schumer is right that nicotine pouches are enjoying enormous sales, but he would be wrong to assume nicotine-naive youth are driving these sales. According to the National Youth Tobacco Survey, only 1.5 percent of middle and high schoolers use nicotine pouches, and just 2.3 percent have ever tried a nicotine pouch. Even among the minority of young people who use products like Zyn, most are not nicotine newbies. A study of adolescents and adults aged 15-24 who used nicotine pouches found the vast majority were smokers or had smoked cigarettes in the past at 73 percent and 81 percent, respectively. Just like with e-cigarettes, nicotine pouches disproportionately appeal to people who are already using nicotine most often in its most dangerous form, which is cigarettes.

    Schumer’s concern that Zyn comes in several flavors like cinnamon and citrus is also misguided. For one, Zyn has already applied to the FDA to be authorized for sale, and the agency will determine whether it presents a net benefit to public health. But suppose flavors in nicotine products are inherently youth-appealing, as Schumer suggests. In that case, he should be just as outraged that nicotine gums, which have been around for decades, are sold in flavors like “cinnamon surge,” “fruit chill,” and “spearmint burst.” Nicotine flavor bans have a poor track record in improving public health, with bans on flavored vapes associated with an increase in cigarette sales.

    Schumer’s intervention drew mockery on X (formerly known as Twitter), including from Republican lawmakers and conservative commentators defending Zyn. The reaction is perhaps unsurprising, given that Tucker Carlson is the most famous Zyn consumer.

    The most worrying aspect of Schumer’s demonization of Zyn is that it contributes to the false impression that just because something contains nicotine, it’s a threat to public health. What makes cigarettes so lethal is not nicotine but setting tobacco on fire and inhaling the smoke.

    Divorced from smoke, nicotine is a relatively benign stimulant with a similar risk profile to caffeine. Most adults incorrectly believe vaping is just as bad or worse than smoking. If these misperceptions were replicated for products like Zyn, the most likely effect would not be saving kids from the grips of nicotine addiction, as Schumer hopes, but to keep smokers smoking. Dr. Jeffrey A. Singer of the Cato Institute lamented the constant fearmongering around nicotine, writing, “I can only think of one explanation: an unfounded and irrational fear of nicotine. I call it nicotinophobia.

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    Guy Bentley

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  • All the Outcomes of a Marijuana Reschedule – Cannabis Business Executive – Cannabis and Marijuana industry news

    All the Outcomes of a Marijuana Reschedule – Cannabis Business Executive – Cannabis and Marijuana industry news

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    All the Outcomes of a Marijuana Reschedule – Cannabis Business Executive – Cannabis and Marijuana industry news





























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    Hilary Bricken

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  • Maybe Vitamins Shouldn’t Taste Like Candy

    Maybe Vitamins Shouldn’t Taste Like Candy

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    These days, the options for dietary supplements are virtually limitless. And whatever substance you want to ingest, you can find it in gummy form. Omega-3? You bet. Vitamin C? Absolutely. Iron? Calcium? Zinc? Yes, yes, and yes. There are peach collagen rings and strawberry-watermelon fiber rings. There are brambleberry probiotic gummies and “tropical zing” gummy worms that promise to put you in “an upbeat mood.” There are libido gummies and menopause gummies. There are gummies that claim to boost your metabolism, to reinforce your immune system, to strengthen your hair, your skin, your nails. For kids, there are Transformers multivitamin gummies and My Little Pony multivitamin gummies.

    I could go on. A simple search for gummy vitamins on the CVS website turns up more than 50 results. This is the golden age of gummies, and that can seem like a great thing. Who wouldn’t rather eat a peach ring than pop a pill? But if the notion that something healthy can taste exactly like candy seems too good to be true, that’s because it is.

    Gummy supplements are a relatively new phenomenon, but gummy candies are not. Starch-based Turkish delight has been around since the late 18th century. In 1860s England, some of the earliest gummies were popularly known as “unclaimed babies” (because they were shaped like infants, many more of which apparently were unclaimed back then). In the 1920s, the German confectioner Hans Riegel founded Haribo and created the gelatin-based gummy bears still consumed around the world today. It would be another 60 years, though, before Haribo gummies arrived on American shores. In the decades that followed, gummy sweets became ubiquitous, taking almost every shape imaginable: worms, frogs, sharks, snakes, watermelons, doughnuts, hamburgers, french fries, bacon, Coke bottles, bracelets, Band-Aids, brains, teeth, eyeballs, genitalia, soldiers, mustaches, Legos, and, as in days of old, children.

    Only in the late 1990s and early 2000s, though, did the supplement industry begin experimenting with gummies. The driving principle was not a new one: As Mary Poppins put it, “A spoonful of sugar makes the medicine go down.” Flintstones multivitamins have been around in their hard, chewable form since 1968; even if superior to pills, they basically taste like sweet, vaguely chemical chalk).

    Gummy vitamins, on the contrary, are virtually indistinguishable from the treats they’re modeled on. You could pop men’s multis at the movies the same way you could Sour Patch Kids. (Or Starburst gummies, or Skittles gummies, or Jolly Rancher gummies—pretty much every non-chocolate candy now comes in gummy form.) Which is probably why they’ve become so popular, says Tod Cooperman, the president of ConsumerLab, a watchdog site that reviews supplements. When he founded ConsumerLab in 1999, gummy supplements hardly existed. Adult gummy vitamins didn’t hit the market until 2012. Now, Nina Puch, a scientist who formulates gummies for the food and pharmaceutical consulting company Knechtel, told me, three-quarters of the gummies she designs are supplements rather than candies. Gummy supplements are everywhere. They’re a rapidly expanding seven-plus billion dollar industry, and by 2027 that figure is projected to double.

    But what makes gummy supplements appealing also makes them concerning. The reason they taste as good as candy, it turns out, is because on average, they can contain just as much sugar as candy does. The earliest gummy supplements, Cooperman told me, were basically just candy with vitamins sprayed on. They’ve come a long way since then: The active ingredients are now carefully integrated into the gummy itself by scientists such as Puch, and done so in a way that preserves as much of the gummy’s flavor and consistency as possible. But the nutritional essentials haven’t changed much—the average gummy vitamin contains about the same amount of sugar per serving as one piece of Sour Patch Kids does.

    A little extra sugar is not the end of the world. But there’s also the danger of overdoses. Especially for children, it’s important that medicines and supplements not taste too good, Cora Breuner, a professor of pediatrics at the University of Washington, told me. Consumed in excess, many of the vitamins and nutrients delivered in supplements can be toxic. They have to strike an appropriate balance, neither tasting so bad that kids refuse to take them nor so good that they’ll want too much. Most gummy supplements seemingly fail the latter test, and not without consequences. Annual calls to Poison Control for pediatric melatonin overdoses have risen 530 percent over the past decade, in part, experts suggested to me last year, because of the hormone’s increased availability in gummy form. The overdose numbers are also up for multivitamins.

    The risk of overdose can be greatly mitigated by simply taking care to store gummies where kids can’t get them. The more significant problem, Cooperman told me, is that gummies are simply a less reliable delivery mechanism than the alternatives. Vitamins and many other compounds degrade far faster in gummies’ half-liquid, half-solid state than in traditional pill or capsule form, he said, because gummies offer less protection from heat, light, moisture, and other contaminants.

    To compensate, supplement makers will in many cases load their products with far more of a substance than advertised on the packaging. Some overage is to be expected with all supplements, but the margins for many gummy supplements are gargantuan. “Gummy vitamins were the most likely form to contain much more of an ingredient than listed,” ConsumerLab wrote in its 2023 review of multivitamins and multiminerals. Of the four gummy supplements reviewed, three contained nearly twice as much of the relevant substance as they were supposed to, and the fourth contained only around three-quarters as much.

    A recent analysis of melatonin and CBD gummies yielded similar results: Some contained as much as 347 percent the amount of those substances stated on the label. Because the FDA generally does not regulate supplements as drugs, such wild variability is accepted in a way that it isn’t for actual pharmaceuticals. (In 2020, the FDA granted the first-ever Investigational New Drug Application for a gummy medication, though no such product appears to have come to market.) “If you have something that you need a specific amount of every time you take it, gummies are not the way to go,” says Pieter Cohen, a doctor at Cambridge Health Alliance, in Somerville, Massachusetts, and the lead author of the melatonin-CBD research. Taking too much of a supplement is generally not as dangerous as taking too much of a prescription drug, but, as Breuner noted, many supplements taken in sufficient excess can still be toxic. When I asked Cooperman what advice he had for people trying to navigate all of this, his answer was simple: “Don’t buy a gummy.”

    Perhaps the rise of gummy supplements was inevitable. The supplement industry has become so big in part because it can promote its products as, say, boosting the immune system or supporting healthy bones, without subjecting them to the strict regulatory demands imposed on pharmaceuticals. Supplements blur the line between food and drug, and gummy supplements—designed and marketed on the premise that healthy stuff can and should taste as good as candy—only intensify that blurring. Cohen, for one, thinks the distinction is worth preserving. Calcium supplements should not go down as easy as Haribos. That may be a bitter pill to swallow, but not everything can taste like candy.

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    Jacob Stern

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  • American Nurses Association Publicly Supports Rescheduling

    American Nurses Association Publicly Supports Rescheduling

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    Nurses, the front line works in patient healthcare, come out in support of rescheduling

    In the last election, President Biden promised to help the cannabis industry, two years into his term, he agreed to start the process. Now, joining the chorus of supporters, the American Nurses Association publicly supports rescheduling.  The medical community has recognized medical marijuana has significant medical benefits, especially in the fight against opioids.

    The American Nurses Association (ANA) joins bipartisan governors, Health and Human Service HHS), US Food & Drug Administration (FDA) in recommending the change.

    ANA shared this in a public statement “Marijuana and its derivatives continue to be used to alleviate disease-related symptoms and side effects. The findings of anecdotal and controlled studies regarding the efficacy for patient use are mixed. Current federal regulations impede the research necessary to evaluate and determine the therapeutic use of marijuana and related cannabinoids. This position statement does not extend to the current debate on the legalization of marijuana for recreational purposes. The goal is to develop an evidence-based approach to its use in the treatment of disease and symptom management.”

    RELATED: Science Says Medical Marijuana Improves Quality Of Life

    Cannabis is currently a Schedule I drug, listed among those considered to have no accepted medical use and have a high potential for abuse. This makes marijuana classified on the same level as heroin, LSD, MDMA and psilocybin mushrooms.

    Schedule III drugs are defined as having a moderate to low potential for physical and psychological dependence. They currently include ketamine, anabolic steroids, testosterone and acetaminophen with codeine.

    Photo by thegoodphoto/Getty Images

    Cannabis is currently a Schedule I drug, listed among those considered to have no accepted medical use and have a high potential for abuse. This makes marijuana classified on the same level as heroin, LSD, MDMA and psilocybin mushrooms.

    Schedule III drugs are defined as having a moderate to low potential for physical and psychological dependence. They currently include Ibuprofen,  ketamine, anabolic steroids, testosterone and acetaminophen with codeine.

    RELATED: The Most Popular Marijuana Flavors

    They continued to state “It is the shared responsibility of professional nursing organizations to speak for nurses collectively in shaping health care and to promulgate change for the improvement of health and health care”.  Therefore, the ANA strongly supports:

    • Scientific review of marijuana’s status as a federal Schedule I controlled substance and relisting marijuana as a federal Schedule II controlled substance for purposes of facilitating research.
    • Development of prescribing standards that includes indications for use, specific dose, route, expected effect and possible side effects, as well as indications for stopping a medication.
    • Establishing evidence-based standards for the use of marijuana and related cannabinoids.
    • Protection from criminal or civil penalties for patients using therapeutic marijuana and related cannabinoids as permitted under state laws.
    • Exemption from criminal prosecution, civil liability, or professional sanctioning, such as loss of licensure or credentialing, for health care practitioners who discuss treatment alternatives concerning marijuana or who prescribe, dispense or administer marijuana in accordance with professional standards and state laws.

    The Drug Enforcement Agency (DEA) has made it clear they are the final authority for rescheduling and it seems the Biden administration has not pushed toward a quick resolution.  It would be unprecedented for the DEA to go against the recommendations of HHS and the FDA, but it does mean it will follow or do it any time soon.  The statement from the ANA adds to the pressure to act.

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    Amy Hansen

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  • Quaker Oats recalls more granola products due to salmonella risk

    Quaker Oats recalls more granola products due to salmonella risk

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    Quaker Oats expands granola product recall


    Quaker Oats expands granola product recall due to salmonella risk

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    Quaker Oats is expanding a prior recall to include additional cereals, granola bars and snacks sold across the U.S. because they could be contaminated with salmonella.

    The recalled products are sold throughout the 50 states, Puerto Rico, Guam and Saipan, Quaker Oats said in a notice posted Thursday by the U.S. Food and Drug Administration. See here for a full list of the recalled items, including those listed in an initial recall in mid-December. 

    Salmonella can cause serious illness if it enters the bloodstream, especially in young children, elderly people and those with weakened immune systems. The organism causes an estimated 1.3 million infections in Americans every year, resulting in an average of more than 26,000 hospitalizations and 420 deaths, CDC data shows.

    Symptoms of infection usually occur within 12 hours to three days after eating contaminated food and include diarrhea, fever, nausea and abdominal cramps.

    The recall includes Quaker Chewy Granola Bars, Cap’n Crunch Bars and select Cap’n Crunch cereals and oatmeal, Quaker Chewy Granola Breakfast cereals and Quaker Oatmeal Squares, Gamesa Marias Cereal, Gatorade Peanut Butter Chocolate Protein Bars, Munchies Munch Mix, and snack boxes that include these products, according to the Chicago-based company, a division of PepsiCo. 

    The recall does not include Quaker Oats, Quaker Instant Oats, Quaker Grits, Quaker Oat Bran, Quaker Oat Flour and Quaker Rice Snacks.

    Consumers are urged to check their pantries for the recalled products and dispose of them. Additionally, consumers with any of the recalled products can contact Quaker Consumer Relations (9 a.m. – 4:30 p.m. CST, Mon.-Fri.) at 1-800-492-9322 or visit www.QuakerRecallUSA.com for additional information or product reimbursement.

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  • More Marijuana Rescheduling Hints

    More Marijuana Rescheduling Hints

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    Rescheduling is important to states and the marijuana industry…and people are looking for clues

    States with legal marijuana want the tax revenue.  Cannabis businesses need relief and help to continue and grow. The marijuana industry needs to move to the next level of legitimate industry. And consumers and patients need reliable, safe products which are the same from store to dispensary.  This is the role of the federal government, but for the first two years, the Biden industry dithered.  But the wheels have started turning and now they are more marijuana rescheduling hints.

    RELATED: California or New York, Which Has The Biggest Marijuana Mess

    The biggest hint is the breaking news came today during a short email sent from HHS. “Good afternoon and thank you for your patience,” a Department of Justice attorney said in an email on Thursday. “The agency has advised that it will release the letter and its enclosures in their entirety.”

    The letter and its enclosures mean The Department of Health and Human Services (HHS) has agreed to release documents related to its recommendation to federally reschedule marijuana in its entirety. This seems to be  do to potential litigation over a Freedom of Information Act (FOIA) request regarding the findings.  The release adds pressure if the DEA plans to break precedent by not following HHS’s recommendation.

    SAFER Banking advocate Senate Majority Leader Chuck Schumer shared HHS has recommended marijuana be moved from a Schedule I to a Schedule III controlled substance.

    According to the DEA, Schedule I drugs have no currently accepted medical use in the United States, a lack of accepted safety for use under medical supervision, and a high potential for abuse.  The National Institute of Health disagrees on their website.  And with rescheduling, the Food and Drug Administration (FDA) would become involved, while it is more of an onerous process, it would establish guidelines to make it more acceptable to major mainstream retailers and, more importantly, the medical community.

    Additionally, rescheduling the drug would reduce or potentially eliminate criminal penalties for possession. Marijuana is currently classified as a Schedule I drug, alongside heroin and LSD.

    RELATED: The Most Popular Marijuana Flavors

    The industry agrees with Schumer who made a clear appeal when he shared the “DEA should now follow through on this important step to greatly reduce the harm caused by draconian marijuana laws.”

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    Terry Hacienda

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  • Kratom faces scrutiny over health risks

    Kratom faces scrutiny over health risks

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    Kratom faces scrutiny over health risks – CBS News


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    Kratom is commonly marketed as a health wonder, but the FDA warns of “serious adverse effects.” It has even been blamed for several deaths. Mark Strassmann reports.

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  • Do CBD Gummies Actually Work

    Do CBD Gummies Actually Work

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    CBD has been touted as a gentle health aide a way to reduce stress, a way to sleep better and way to relax.  Found everywhere from Amazon to Walmart, you can pick it up – especially when you feel the need for help. But do CBD gummies actually work?

    CBD comes from cannabidiol, one of the two best-known active compounds derived from the marijuana plant. The other is tetrahydrocannabinol, or THC, which is the substance that that produces the “high” from marijuana. It can also be derived from hemp.

    CBD does not get you high, but it can your consciousness. You may feel mellow, experience less pain, and be more comfortable. Some CBD products do contain small amounts of THC.

    RELATED: Are CBD Drinks Legal?

    Epidiolex is the only FDA-approved prescription CBD medicine, which among many things, means that it has a safety and efficacy profile that has been thoroughly evaluated in clinical trials. The rest of the CBD industry is going through growing pains  there’s a mess going on with plenty of important guidelines, like dosage, purity and strength of the product. One of the many problems this disarray causes is the variability among CBD products. While some might provide noticeable effects, others might not even contain enough CBD to register in your system.

    Photo by Pharma Hemp Complex via Unsplash

     

    Yes, there is evidence CBD works for some conditions, but certainly not all the conditions it is being promoted for these days. According to different CBD gummy manufacturers, these products can provide relief for a wide range of ailments, including pain, anxiety, inflammation, insomnia and even depression. These statements have no scientific accuracy, however, since few tests have been conducted have been limited to CBD oil.

    Anecdotally, plenty of people believe in the effect of CBD gummies, although the dosage still causes some issues. While some claim to feel positive effects after consuming two gummies, others might have to up the dosage until they feel something. With all the hype surrounding CBD gummies, this “something” might also be imagined; a placebo effect could be at work making you feel like you should be experiencing some sort of sensation because you just ingested cannabis.

    RELATED: These Are The 4 Biggest Problems With CBD Products

    Although few scientific tests have been conducted, CBD oil has been associated with plenty of positive side effects, and all of these gummies, if purchased correctly, contain a good amount of oil. You can also expect some clarity in the near future, since the industry is growing and learning the nuance exists between the different cannabis products and plants.

    As usual, if you’re interested in trying out a new cannabis product, go slow. Purchase a bottle of reviewed CBD gummies and start off with a slow dose, checking in with your body for any changes and/or improvements. The worst thing which could happen is you ingest a ton of sugar and start to feel a little drowsy.

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    Maria Loreto

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  • FDA investigating lead poisoning outbreak tied to pouches of cinnamon applesauce for kids

    FDA investigating lead poisoning outbreak tied to pouches of cinnamon applesauce for kids

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    FDA investigating lead poisoning outbreak tied to pouches of cinnamon applesauce for kids – CBS News


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    There is growing concern over a lead poisoning outbreak tied to pouches of cinnamon applesauce for children, which one FDA official says could have been “intentional.” CBS News’ Meg Oliver reports.

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  • What's at stake in the Supreme Court's abortion pill case

    What's at stake in the Supreme Court's abortion pill case

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    The Supreme Court announced this morning that it would take up a pair of cases concerning access to mifepristone, the first pill in a two-pill regimen commonly used to induce abortion. Mifepristone has been the subject of a high-profile legal battle throughout the past year.

    Crucially, the Court will not consider whether the U.S. Food and Drug Administration (FDA) erred in its initial 2000 approval of the Mifeprex (a brand name version of mifepristone) or its subsequent generic approval in 2019—which means the pill should remain legal no matter what SCOTUS decides. Rather, the Court will consider whether subsequent FDA rules regarding mifepristone’s prescription are valid.

    At stake is whether doctors may prescribe mifepristone virtually, whether prescriptions can be shipped by mail, and whether it can be prescribed up to 10 weeks of pregnancy (instead of stopping at seven weeks).

    Judge Matthew Kacsmaryk of the U.S. District Court for the Northern District of Texas held in April that the whole approval process was tainted. According to Kacsmaryk, the FDA erred when it approved the drug initially and when it approved generics in 2019. The judge also agreed with the Alliance for Hippocratic Medicine—the group that brought the case—that the FDA’s subsequent loosening of rules around prescribing mifepristone had been wrong.

    Kacsmaryk suspended access to the pill entirely, but the Supreme Court paused enforcement of this decision while appeals were being resolved.

    On appeal, the U.S. Court of Appeals for the 5th Circuit rejected Kacsmaryk’s ruling with regard to the initial FDA approval and its later generic approval. But the 5th Circuit upheld his ruling with regard to the later loosening of prescription rules, including the FDA’s decisions to allow lower-dose prescriptions, virtual prescriptions, and shipping the drug through the mail.

    Following the 5th Circuit’s ruling, the Biden administration and Mifeprex maker Danco Laboratories asked the Supreme Court to take up the case and find that the 5th Circuit was wrong with regard to the parts of Kacsmaryk’s decision that it upheld. The Alliance for Hippocratic Medicine asked the Court to take up the case and find that the 5th Circuit was wrong with regard to the parts of Kacsmaryk’s decision that it rejected. The justices met last week to decide what to do.

    Today, the Court announced that it would hear the issue, consolidating the cases from Danco laboratories and the Biden administration. It declined to hear the cross-petition filed by the Alliance for Hippocratic Medicine.

    “What’s most important to know is that SCOTUS will not be looking at the original challenge to FDA approval of the drug,” notes Jessica Valenti of the Abortion Every Day substack. “Instead, they’ll review the 2016 and 2021 changes to restrictions around mifepristone, and whether or not the Alliance of Hippocratic Medicine (the anti-abortion group who brought the lawsuit) has standing.”

    “The decision here will undoubtedly affect the availability of mifepristone, but the case no longer includes the question of whether the FDA should have approved mifepristone for the purpose of terminating pregnancies in the first place,” explains Jonathan H. Adler at The Volokh Conspiracy.

    This is—as Law Dork’s Chris Geidner points out—”a best-case scenario for abortion rights supporters.” It leaves intact the general approval of mifepristone while opening up the possibility of reversing the 5th Circuit’s ruling regarding eased access to the drug.

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    Elizabeth Nolan Brown

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  • What to know about the dangerous bacteria found in powdered baby formula

    What to know about the dangerous bacteria found in powdered baby formula

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    The same bacteria that led to the 2022 baby formula recall and sparked shortages across the U.S., this year has caused the death of one newborn in Kentucky and brain damage in a Missouri infant, according to federal health officials.

    Food and Drug Administration (FDA) officials confirmed Thursday that two cases of life-threatening infections caused by Cronobacter sakazakii have been reported in 2023, both babies who consumed powdered formula made by Abbott Nutrition, the company involved in the 2022 recall. For the reported cases this year, both Abbott and the FDA have found no link to the formula maker’s facilities, saying contamination likely happened after the containers were opened at home.

    In February 2022, Abbott initiated a voluntary recall of its powder baby formulas for brands including Similac, Alimentum and EleCare that were manufactured at one of the company’s facilities in Sturgis, Michigan. The recall was due to the presence of Cronobacter sakazakii, which is a rare bacteria that the U.S. Centers for Disease and Control and Prevention (CDC) said has been found in powdered infant formula, skimmed milk powder, herbal teas and starches, and is “lethal for infants and can be serious among people with immunocompromising conditions and the elderly.”

    The FDA said on Thursday that there was no reason to issue new recalls for baby formula after an investigation found, despite two infants becoming infected by the bacteria this year, there was no evidence that the infections were linked to manufacturing, the Associated Press reported.

    “There is no indication of a broader public health concern related to this product at this time,” the FDA said in a statement.

    Newsweek reached out via email on Saturday to the FDA and CDC for comment.

    A photo of powdered baby formula. The FDA and CDC confirmed on December 7, 2023, that two cases of dangerous infections caused by cronobacter sakazakii have been reported this year, both in babies who consumed powdered formula made by Abbott Nutrition.
    Getty

    In March, then 6-week-old Mira White, of Sikeston, Missouri, was diagnosed with a serious brain infection caused by the bacteria, which was found in an open container of Similac NeoSure formula in the baby’s home, according to the AP.

    Mira’s mom told the AP that since her daughter became infected, she has suffered numerous seizures and said that brain scans show neurological damage caused by the infection.

    In Kentucky, health officials notified the CDC in November that a baby who consumed Similac Total Comfort powdered formula had died after being infected with Cronobacter sakazakii, according to the AP.

    John Koval, a spokesperson for Abbott, told Newsweek in an email on Saturday night that the reported infections in Missouri and Kentucky have not been linked to the company’s manufacturing facilities.

    “As Abbott and FDA have said, the unopened product was tested and came back negative, and the infections have not been linked to the manufacturing environment,” Koval said. “Cronobacter is naturally and commonly found in the environment, and can find its way into infant formula after the packaging is opened. We encourage parents and caregivers to consult resources published by the FDA and CDC on how to safely handle, store and prepare infant formula.”

    What is Cronobacter sakazakii?

    Cronobacter sakazakii is a germ found naturally in the environment and can live in dry foods, including powdered infant formula and powdered milk, according to the CDC.

    The CDC notes that powdered formula is not sterile, meaning it could become accidentally contaminated during the manufacturing process or after the container is opened at home.

    Cronobacter sakazakii can live on surfaces, such as kitchen counters or sinks, and in water, according to the CDC.

    Frequently and thoroughly cleaning surfaces, hands and baby products help reduce the risk. The CDC also advises parents to avoid setting formula scoops on the counter or in the sink, to keep lids and scoops clean and completely dry, and close containers of formula as soon as possible after using them.

    What is the risk?

    While the CDC states that Cronobacter infections are rare, they can be life-threatening in newborns. Serious infections in babies usually occur in the first few weeks of life.

    Yearly, between two to four cases are reported to the CDC, which adds that this figure may not reflect the true number of illnesses because most hospitals and laboratories are not required to report Cronobacter infections to health departments.

    Infants who are born prematurely and babies with weakened immune systems are more likely to develop serious symptoms if infected.

    Signs of Cronobacterillness in babies usually start with a fever and poor feeding, excessive crying, or very low energy, according to the CDC, which warns that some infants may also have seizures. An infant with these symptoms should be seen by a medical provider as soon as possible.

    Cronobacter germs can lead to sepsis, a dangerous blood infection, and cause the lining surrounding the brain and spinal cord to swell, also known as meningitis. Babies younger than two months are most at risk for developing meningitis if they get sick from Cronobacter.