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Tag: fda

  • The FDA Approves Two New COVID-19 Vaccines As Cases Remain On The Rise

    The FDA Approves Two New COVID-19 Vaccines As Cases Remain On The Rise

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    On Thursday, The U.S. Food and Drug Administration announced two new updated COVID-19 vaccines as cases tied to the largest spike in infections within the last two years remain high across the country.

    The vaccines, manufactured by Pfizer-BioTech and Moderna, target the KP.2 variant — one of the FLiRT variants — a descendant of the highly contagious JN.1 Omicron variant.

    The agency advised manufacturers that the updated vaccines should be monovalent vaccines that attack the selected strain to provide adequate protection against circulating variants after evaluating the recent uptick in infections.

    Initially, the FDA suggested they target JN.1, but the agency altered its suggestion after reviewing updated data.

    According to the U.S. Centers for Disease Control and Prevention, the current predominant strain of the virus is KP.3.11, another FLiRT variant. It has overtaken its parent lineage, KP.3, and previous dominant KP.2 variants.

    Within the first two-week period of August, KP.3.11 accounted for approximately 31 to 43 percent of cases across the country. Although the updated vaccines target KP.2, they’ve been proven to be significantly more effective against the JN lineage than the vaccines currently available.

    The CDC recommends that anyone six months and older receive an updated vaccine regardless of their previous vaccination status. Pfizer-BioTech and Moderna’s updated vaccines — Comirnaty and Spikevax — are available for people six months and older.

    Novavax is working on a third vaccine that follows the FDA’s original recommendation by aiming to protect against the earlier JN.1 variant. The agency is expected to approve this vaccine soon, and it will be available to people 12 years of age and older.

    Pfizer-Biotech and Moderna are expected to begin shipments of the vaccine to distributors within the coming days. The updated vaccines could cost up to $150 per dose for those paying out of pocket. However, most public and private health insurance plans should cover this cost.

    Some uninsured adults may have issues accessing the vaccine at no cost or at a lower cost as the CDC’s Bridge Access Program — which covers the costs of some vaccinations for those without coverage — could end in August.

    Those who rely on this program can opt to get their vaccines at community health centers or clinics, where they may be free or offered at a reduced rate.

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    Faith Bugenhagen

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  • FDA Holds Back MDMA Psychedelic Therapy Over Safety, Efficacy Concerns

    FDA Holds Back MDMA Psychedelic Therapy Over Safety, Efficacy Concerns

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    A company seeking to treat post-traumatic stress disorder with a combination of MDMA and talk therapy just suffered a major setback from the U.S. Food and Drug Administration.

    Lykos Therapeutics, the firm aiming for FDA approval, said on Friday that it received a rejection letter from the agency, which called for more research into the potential treatment’s safety and efficacy. Lykos said in response that it wants the FDA to reconsider the decision, adding that it will request a meeting to “further discuss the agency’s recommendations for a resubmission.” MDMA, also known as molly and ecstasy, is a lab-made drug developed more than a century ago by a chemist at the German pharmaceutical giant Merck.

    The decision follows an earlier vote from FDA advisors, who rejected the MDMA-assisted therapy in June. The panel questioned the treatment’s long-term efficacy and safety, the quality of Lykos’ data, and the conduct of therapists who participated in earlier Lykos studies. While the FDA had the option to act against its panel’s feedback, the agency reportedly reached a similar conclusion.

    According to Lykos CEO Amy Emerson, conducting a third phase 3 trial would set the firm back several years. Calling the FDA’s letter “deeply disappointing,” Emerson argued in a statement that the agency’s requests “can be addressed with existing data, post-approval requirements or through reference to the scientific literature.”

    Lykos did not publish the rejection letter, and the FDA did not immediately respond to Gizmodo’s request for more information. However, a spokesperson for the agency told NPR on Friday, “there are significant limitations to the data contained in the application that prevent the agency from concluding that this drug is safe and effective for the proposed indication.”

    The spokesperson added that the agency “will continue to encourage research and drug development that will further innovation for psychedelic treatments and other therapies.”

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    Harri Weber

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  • The FDA Just Rejected a Bid for MDMA’s Approval to Treat PTSD

    The FDA Just Rejected a Bid for MDMA’s Approval to Treat PTSD

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    The US Food and Drug Administration has rejected a first-of-its-kind proposal to use the psychedelic drug MDMA, also known as ecstasy or Molly, as a treatment for post-traumatic stress disorder.

    Drugmaker Lykos Therapeutics had asked the FDA to approve the drug in combination with talk therapy. The company said Friday that the regulatory agency has requested an additional Phase 3 trial so that the safety and efficacy of the therapy can be further studied. The decision comes after an FDA advisory panel in June concluded that there wasn’t enough evidence to recommend its approval.

    Lykos said it plans to request a meeting with the FDA to ask for reconsideration of the decision and to further discuss the agency’s recommendations. “The FDA request for another study is deeply disappointing, not just for all those who dedicated their lives to this pioneering effort, but principally for the millions of Americans with PTSD, along with their loved ones, who have not seen any new treatment options in over two decades,” said Lykos CEO Amy Emerson in a company statement. She added that conducting another Phase 3 trial would take several years.

    As many as 13 million Americans suffer from PTSD in any given year, according to the National Center for PTSD. Just two drugs have been specifically approved to treat the disorder, with the latest being greenlit by the FDA in 2000. The lack of options has turned combat veterans into unlikely advocates for MDMA-assisted therapy. In the days leading up to the FDA decision, veterans groups and members of Congress from both parties pressed for its approval.

    In a letter to President Biden, more than 300 veterans and representatives of veterans service organizations wrote that MDMA-assisted therapy “offers desperately needed hope for veterans and their families, with the potential to save and drastically improve countless lives over the coming years.”

    A bipartisan group of more than 60 members of the House of Representatives and 19 senators also voiced their support for the therapy this week. “Given the substantial burden of PTSD and the current treatment limitations, the possibility of new, more effective therapies is particularly meaningful,” the lawmakers wrote in a letter to FDA commissioner Robert Califf.

    There has been increasing interest in recent years in using MDMA and other psychedelics to treat severe mental illness. But with the FDA decision, MDMA will remain a federally prohibited substance listed as Schedule I drug, defined as those that have “no currently accepted medical use and a high potential for abuse.”

    During a nine-hour meeting on June 4, Lykos representatives made their case to an independent panel of FDA advisers. The company’s clinical trial data showed that more than 86 percent of study participants who underwent MDMA-assisted therapy experienced a measurable reduction in the severity of their PTSD symptoms, and 71 percent improved enough that they no longer met the criteria for a diagnosis. In a placebo group, 69 percent improved and nearly 48 percent no longer qualified for a PTSD diagnosis.

    Despite the positive results, advisory committee members cited concerns about the reliability of the clinical trial data, the long-term efficacy of the treatment, and the standardization of the talk therapy given during the MDMA sessions. One major question raised by the advisory committee was the extent to which the talk therapy contributes to the treatment benefit.

    The panel overwhelmingly voted that there wasn’t enough evidence to recommend approval. Just two of the 11 committee members agreed that MDMA-assisted therapy is effective based on the evidence Lykos presented, and only one thought its benefits outweighed the risks. The FDA usually follows the recommendations of advisory committees but is not obligated to do so.

    Lykos said it will “work diligently in the coming months to address FDA’s concerns and to take advantage of agency processes to resolve scientific disagreements.”

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    Emily Mullin

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  • It’s Shockingly Easy to Buy Off-Brand Ozempic Online, Even if You Don’t Need It

    It’s Shockingly Easy to Buy Off-Brand Ozempic Online, Even if You Don’t Need It

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    Eli Lilly and Novo Nordisk have both recently taken legal action against companies selling compounded versions of drugs, often alleging trademark infringement. Novo Nordisk has filed 21 lawsuits since last summer. This June, Eli Lilly initiated six lawsuits, following 10 other lawsuits that the pharmaceutical company began last fall. In one, filed against a company selling compounded GLP-1s online, it alleged that passing compounded drugs off as having identical active ingredients as its products was “not merely deceptive—it’s dangerous.”

    “Telehealth providers and compounding pharmacies that are claiming to offer or sell unapproved compounded products claiming to contain ‘semaglutide’ are sourcing their ingredients from entities other than Novo Nordisk,” Novo Nordisk spokesperson Jamie Bennett told WIRED. “As the FDA has cautioned, unapproved compounded ‘semaglutide’ drugs do not have the same safety, quality, and effectiveness assurances as Novo Nordisk’s FDA-approved semaglutide medicines, and patients should not use a compounded drug if an approved drug is available.”

    “There’s huge safety implications,” Ryder says. In 2012, a compounding pharmacy caused a fungal meningitis outbreak that killed at least 64 people, among the worst pharmaceutical drug-contamination disasters in the United States. The supervisory pharmacist who oversaw the manufacture of this medicine was sentenced to prison time, and the event led to tightened oversight and licensing requirements for compounders.

    Some of the leading compounding pharmacies that produce GLP-1 medications have landed in trouble for their practices. Hallandale Pharmacy, a popular supplier—two of my four vials came in its sleek blue packaging—has run into trouble with regulators for past infractions, which included concerns over record-keeping and facility conditions. It has received warning letters from the FDA, although the last one was closed out in May 2022, which means the FDA found that it had addressed outstanding issues. (Hallandale declined requests for comment.)

    The FDA has found issues with pharmaceutical companies, too, though. In 2023, FDA inspectors found bacterial contamination at a Novo Nordisk production plant in North Carolina. “Leadership addressed immediately, and the site received FDA approval for full production for market in August 2023,” Novo Nordisk’s Bennett says.

    Compounding advocates say that, although the drugs are not FDA-approved, they are still subject to rigorous quality control, in part due to post-2012 rule changes. Carroll, for example, says Hims did “due diligence” when choosing its pharmacy and that it has been satisfied with the medication quality. “We’ve seen an extremely good response from our customers,” he says. “No untoward side effects that we didn’t anticipate.” According to Carroll, Hims has not had to report any adverse effects to the FDA.

    What’s Next?

    As researchers continue to discover new potential use cases for GLP-1 drugs, and public interest and demand remains high, these drugs may be on the FDA’s official shortage list for months or even years to come. If the shortage ends, one type of compounding pharmacy (called 503a) would be required to stop production immediately, while 503b pharmacies, which typically produce on a larger scale, would have 60 days. An end to the shortage would require some substantial pivots within this booming cottage industry. None of the telehealth companies that sent compounded semaglutide to WIRED made mention of what might happen in this scenario during the intake process.

    Many people who take compounded drugs may be taken by surprise if they are told they must switch to brand names—and pay much higher prices—within a matter of months.

    However, even when the shortage does officially end, at least some of the telehealth companies do not plan to pivot from compounding. “We believe there’s going to be more and more demand for the medication, so that may actually prolong the shortage list,” says Hims’ Pat Caroll. “We are convinced there’s a pathway, even when it comes off the shortage list, to supply these compounded medications.”

    Even compounding skeptics suspect that it’s not going away anytime soon. With demand so high, Ryder suspects pharmaceutical companies will need to ramp up production to serve “basically 40 percent of the US population” before shortages end. Until then, Ryder suspects this telehealth boom will continue unabated.

    For now, the vials of compounded semaglutide WIRED ordered are sitting in the back of a fridge untouched.

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    Kate Knibbs

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  • Marylander among those made ill by microdosing candies behind nearly 50 illnesses – WTOP News

    Marylander among those made ill by microdosing candies behind nearly 50 illnesses – WTOP News

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    Food and Drug Administration officials said dozens of people have been made ill, including one person in Maryland, after consuming Diamond Shruumz.

    This image provided by the U.S. Food and Drug Administration shows Diamond Shruumz-brand products which have been recalled in June 2024. At least 48 people in 24 states said they got sick after eating Prophet Premium Blends LLC’s products including chocolate bars, cones and gummies, the U.S. Food and Drug Administration said Tuesday, July 2, 2024. One death is “potentially associated” with the outbreak and 27 people have been hospitalized, the agency said. (FDA via AP)

    Food and Drug Administration officials said dozens of people have been made ill, including one person in Maryland, after consuming Diamond Shruumz — a microdosing candy and gummy brand.

    Officials began an initial investigation on June 7, after receiving eight reports of illness connected with the brand’s chocolate bars. Those cases grew to include one unidentified Marylander by June 18, more than a week before the Santa Ana, California-based Prophet Premium Blends, issued a recall for the product.

    “As of July 1, 2024, a total of 48 illnesses have been reported from 24 states,” the FDA said in a July 2 update.

    Agency officials said that recalled products were sold online and in person at location across the U.S., including retails stores, smoke/vape shops and stores that sell hemp-derived products like CBD or delta-8 THC.

    The ingredient muscimol, which is found in some types of mushrooms, is believed to be linked with symptoms such as seizures, agitation, involuntary muscle contractions, loss of consciousness, confusion, sleepiness, nausea and vomiting, abnormal heart rates, and hyper/hypotension, reported by people who got sick.

    FDA investigators said they believe that a death may be related to consumption of one of the products, but the FDA has yet to confirm the details of that report.

    U.S. Centers for Disease Control and Prevention, FDA and America’s Poison Center investigators continue to look into the reports, and encourage anyone with symptoms to reach out to their health provider or the Health Resources & Services Administration Poison Help line at 1-800-222-1222.

    The Associated Press contributed to this report.

    Get breaking news and daily headlines delivered to your email inbox by signing up here.

    © 2024 WTOP. All Rights Reserved. This website is not intended for users located within the European Economic Area.

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    Ivy Lyons

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  • FDA gives green light to menthol flavored e-cigarettes for first time

    FDA gives green light to menthol flavored e-cigarettes for first time

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    What teens and parents should know about the dangers of vaping


    What teens and parents should know about the dangers of vaping

    03:53

    The Food and Drug Administration on Friday authorized menthol-flavored electronic cigarettes for adult smokers, the first time the agency has opened the door for vaping companies to sell non-tobacco flavored products.

    The FDA cleared Njoy, a vaping brand recently acquired by tobacco giant Altria, to market four menthol e-cigarettes. But regulators also said it would review applications for authorization of flavored e-cigarettes on a case-by-case basis and that its actions apply on to Njoy’s four products.

    In announcing its decision, the FDA said it found that menthol-flavored e-cigarettes can reduce the harms of traditional tobacco smoking. But the agency emphasized that it is not approving menthol vaping products, which would mean the FDA had determined a drug is safe and effective for its intended use. Instead, authorization by the agency only means Njoy has received regulatory approval to market its products to the public.

    “We are a data driven agency and will continue to follow the science to inform our review of premarket tobacco applications,”  Matthew Farrelly, director for the FDA’s Center for Tobacco Products, said in a statement. “Based upon our rigorous scientific review, in this instance, the strength of evidence of benefits to adult smokers from completely switching to a less harmful product was sufficient to outweigh the risks to youth.”

    The decision lends new credibility to vaping companies’ long-standing claim that their products can help blunt the toll of smoking, which is blamed for 480,000 U.S. deaths annually due to cancer, lung disease and heart disease.

    Parent groups and anti-tobacco advocates immediately criticized the decision, which comes after years of pushing regulators to keep menthol and other flavors that can appeal to teens off the market.

    “This decision could mean we’ll never be able to close the Pandora’s box of the youth vaping epidemic,” said Meredith Berkman, co-founder of Parents Against Vaping E-cigarettes. “FDA has once again failed American families by allowing a predatory industry to source its next generation of lifetime customers — America’s children.”


    Vaping just one time could put you at higher risk for heart failure, study says

    00:45

    Youth vaping has declined from all-time highs in recent years, with about 10% of high schoolers reporting e-cigarette use last year. Of those who vaped, 90% used flavors, including menthol.

    All the e-cigarettes previously authorized by the FDA have been tobacco, which isn’t widely used by young people who vape.

    Njoy is one of only three companies that previously received the FDA’s OK for vaping products. Like those products, the menthol varieties come as cartridges that plug into a reusable device that heats liquid nicotine, turning it into an inhalable aerosol.

    Njoy’s products accounted for less than 3% of U.S. e-cigarette sales in the past year, according to retail data from Nielsen. Vuse, owned by Reynolds American, and Juul control about 60% of the market, while hundreds of disposable brands account for the rest.

    Most teens who vape use disposable e-cigarettes, including brands like Elf Bar, which come in flavors such as watermelon and blueberry ice.

    The Njoy approval is part of a sweeping FDA review intended to bring scientific scrutiny to the multibillion-dollar vaping market after years of regulatory delays. Currently the U.S. market includes thousands of fruit- and candy-flavored vapes that are technically illegal but are widely available in convenience stores, gas stations and vape shops.

    —The Associated Press contributed to this report. 

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  • Children’s Cereals: Candy for Breakfast?  | NutritionFacts.org

    Children’s Cereals: Candy for Breakfast?  | NutritionFacts.org

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    Plastering front-of-package nutrient claims on cereal boxes is an attempt to distract us from the incongruity of feeding our children multicolored marshmallows for breakfast.

    The American Medical Association started warning people about excess sugar consumption more than 75 years ago, based in part on our understanding that “sugar supplies nothing in nutrition but calories, and the vitamins provided by other foods are sapped by sugar to liberate these calories.” So, added sugars aren’t just empty calories, but negative nutrition. “Thus, the more added sugars one consumes, the more nutritionally depleted one may become.”

    Given the “totality of publicly available scientific evidence,” the Food and Drug Administration (FDA) decided to make processed food manufacturers declare “added sugars” on their nutrition labels. The National Yogurt Association was livid and said it “continues to oppose the ‘added sugars’ declaration,” since it needed “‘added sugars’ to increase palatability” of its products. The junk food association questioned the science, whereas the ice cream folks seemed to imply that consumers are too stupid to “understand or know how to use the added sugar declaration,” so it’s better just to leave it off. The world’s biggest cereal company, Kellogg’s, took a similar tact, opposing it so as not “to confuse consumers.” Should the FDA proceed with such labeling against Kellogg’s objections, the cereal giant pressed that “an added sugars declaration…should be communicated as a footnote.” It claimed that its “goal is to provide consumers with useful information so they can make informed choices.” This is from a company that describes its Froot Loops as “packed with delicious fruity taste, fruity aroma, and bright colors.” Keep in mind that Froot Loops has more sugar than a Krispy Kreme doughnut, as you can see in the graph below and at 1:46 in my video Friday Favorites: Kids’ Breakfast Cereals as Nutritional Façade

    Froot Loops is more than 40 percent sugar by weight! You can see the cereal box’s Nutrition Facts label below and at 1:50 in my video

    The tobacco industry used similar terms, such as “light,” “low,” and “mild” to make its products appear healthier—before it was barred from doing so. “Now sugar interests are fighting similar battles over whether their terminology, including ‘healthy,’ ‘natural,’ ‘naturally sweetened,’ and even ‘lightly sweetened,’ is deceptive to consumers.”

    But if you look at the side of a cereal box, as shown below and at 2:13 in my video, you can see all those vitamins and minerals that have been added. That was one of the ways the cereal companies responded to calls for banning sugary cereals. General Mills defended the likes of Franken Berry, Trix, and Lucky Charms for being fortified with essential vitamins. 

    Sir Grapefellow, I learned, was a “grape-flavored oat cereal” complete with “sweet grape star bits”—that is, marshmallows. Don’t worry. It was “vitamin charged!” You can see that cereal box below and at 2:31 in my video

    Sugary breakfast cereals, said Dr. Jean Mayer from Harvard, “are not a complete food even if fortified with eight or 10 vitamins.” Senator McGovern replied, “I think your point is well taken that these products may be mislabeled or more correctly called candy vitamins than cereals.” 

    Plastering nutrient claims on cereal boxes can create “a ‘nutritional façade’ around a product, acting to distract attention away” from unsavory qualities, such as excess sugar content. Researchers found that the “majority of parents misinterpreted the meaning of claims commonly used on children’s cereals,” raising significant public health concerns. Ironically, cereal boxes bearing low-calorie claims were found to have more calories on average than those without such a claim. The cereal doth protest too much. 

    Even candy bar companies are getting in on the action, bragging about protein content because of some peanuts. Like the Baby Ruth, a candy bar that has 50 grams of sugar. Froot Loops could be considered breakfast candy, as the same serving would have 40 sugar grams, as you can see below and at 3:45 in my video

    Given that “research suggests that consumers believe front-of-package claims, perceive them to be government-endorsed, and use them to ignore the Nutrition Facts Panel,” there’s been a call from nutrition professionals to consider “an outright ban on all front-of-package claims.” The industry’s short-lived “Smart Choices” label, as you can see below and at 4:13 in my video, was met with disbelief when it was found adorning qualifying cereals like Froot Loops and Cookie Crisp. The processed food industry spent more than a billion dollars lobbying against the adoption of more informative labeling (a traffic-light approach), “opposing most aggressively the use of a red light suggesting that any food was too high in anything.” 

    I was invited to testify as an expert witness in a case against sugary cereal companies. (I donated my fee, of course.) Check out the related posts below for a video series and blogs that are a result of some of the research I did. 

    You may also be interested in videos and blogs on the food industry; see related posts below.

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    Michael Greger M.D. FACLM

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  • Psychedelic Drug MDMA Faces Questions As FDA Considers Approval For PTSD – KXL

    Psychedelic Drug MDMA Faces Questions As FDA Considers Approval For PTSD – KXL

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    WASHINGTON (AP) — Federal health regulators are set to review the first request to approve the mind-altering club drug MDMA as a treatment for PTSD.

    The Food and Drug Administration posted its review of the drug on Friday, raising questions about its effectiveness and potential risks, including heart problems.

    The drug application is part of a decades-long effort by advocates to move psychedelic drugs into the medical mainstream.

    If approved, MDMA would be made available to certified doctors and therapists.

    It’s the first in a series of psychedelics that are heading before the FDA after studies suggesting their potential to treat conditions like depression, addiction and anxiety.

    More about:

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    Grant McHill

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  • Statement by Fragrance Creators Association Calling on Congress to Provide Funding to Implement Modernized Cosmetic Regulations

    Statement by Fragrance Creators Association Calling on Congress to Provide Funding to Implement Modernized Cosmetic Regulations

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    Fragrance Creators Association (FCA) President and CEO Farah K. Ahmed issued the following statement on funding to support the Food and Drug Administration’s (FDA) implementation of the Modernization of Cosmetics Regulation Act (MoCRA): 

    “FCA is asking Congress to provide at least $8 million for the FDA’s work to implement MoCRA in fiscal year 2025 (FY25). MoCRA ushered in a new era in cosmetics regulations but its success hinges on adequate funding. Consequently, FCA submitted letters to Congress today urging it to prioritize sound science, safety, and innovation and appropriate at least $8 million for FY25.  

    “Fragrance plays an essential role in cosmetics and personal care products, products that nurture skin health and hygiene, empower self-expression, lift confidence, and more. Sufficient funding for FDA to implement MoCRA will support responsible fragrance industry innovation, uphold safety, increase consumer confidence in the products they know and love, and advance environmental sustainability.” 

    ###

    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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  • 5 Key Things To Check On A CBD Label

    5 Key Things To Check On A CBD Label

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    Science and the public have been good to CBD.  It helps with the ever popular issue of sleeping and it can help reduce anxiety.  Discreet, convenient and semi fast acting – it can be a help mate for first dates, stressful family events, or just rough days. The CBD/cannabis Epidiolex has been proven to reduce seizures and is the first cannabis-derived medicine approved by the FDA.  So lots of benefits, but since it is still a bit of a newbie on shelves…you need to be careful of what you buy.  Here are 5 key tags to check on a CBD label.

    RELATED: How To Use CBD For A Better Night’s Sleep

    Reading product labels is often confusing, overly technical and filled with materials no one understands. Add to the mix the fact CBD is still in FDA limbo, and you need a list like this to point you in the right direction. Here are 5 things to check when reading a CBD label.

    Make sure CBD is in on the label and in the product

    First thing’s first: make sure there’s actually CBD in your CBD product.  Today’s CBD landscape is filled with products that claim to contain CBD while really containing just hemp oil, or lie about the amount of CBD they contain. Look for either CBD or cannabidiol and be wary of products containing hemp seeds, cannabis sativa, hemp seed oil, etc. Although these ingredients sound weedy, they’re not the same thing as CBD.

     

    Photo by IRA_EVVA/Getty Images

    Check the dosage and ingredients

    Dosage in key in how effective it will be. Be understanding it you time the amount you need then time out when you might want to take it again.  Additionally, look for a full list of ingredients, including the carrier oil used. Check for any potential allergens or additives you want to avoid.

    RELATED: 5 Uses For Hemp Besides CBD Oil

    Keep an eye out for COA

    COAs guarantee the product you’re looking at has been tested by a third party facility that has no relationship to the maker. Their results are unbiased and thus trust worthy. Reputable companies should feature this information on their labels, which should come in the shape of a bar code and should be easily accessed via smartphone. If this isn’t the case, the COA should appear on the product’s website.

    Here's How Long It Takes To Feel CBD's Effects
    Photo by Sabrina Rohwer via Pexels

    Look for the CBD oil source

    One of the first red flags of fake CBD products is a label that’s vague or doesn’t state where the CBD oil was sourced. CBD can be sourced from cannabis plants or industrial hemp, and most quality products tend to be “full spectrum,” “broad spectrum,” or “CBD isolate.”

    Know your cannabis state laws

    This is important since CBD label requirements vary by state, with the best labels being from products sold in areas where marijuana is legal. If you’re purchasing a product from out of a legal state, these packages should at least imitate how regulated products look.

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    Sarah Johns

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  • No One Knows How Far Bird Flu Has Spread

    No One Knows How Far Bird Flu Has Spread

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    In late March, the US Department of Agriculture (USDA) announced it had detected cases of bird flu in dairy cattle. Initially discovered in dairy farms in Texas, Kansas, and New Mexico, there are now 36 confirmed outbreaks in dairy herds in nine states.

    Although the H5N1 virus circulates widely in wild birds, it is now circulating among dairy cattle in the US. The USDA has confirmed transmission between cows in the same herd, from cows to birds, and between different dairy cattle herds.

    But the reported outbreaks are likely to be a major underestimation of the true spread of the virus, says James Wood, head of veterinary medicine at the University of Cambridge. “It’s likely there is going to be a fair amount of underreporting and underdiagnosis,” he says.

    Tests by the Food and Drug Administration (FDA) of retail milk samples might give some indication of how widespread the virus is. The agency found viral fragments in one in five samples of commercial milk, although this virus had been deactivated by pasteurization so was not infectious.

    So far there is only one confirmed human infection in the outbreak: someone in Texas who had close contact with dairy cattle. Their only reported symptom was conjunctivitis, and the individual was told to isolate themselves and take an antiviral drug for flu. But anecdotal reports of illness on dairy farms hints that infections among humans may be more widespread than official data suggests. Although human infections have tended to be rare, the virus is dangerous—just over half of the human cases recorded by the World Health Organization over the past two decades have been fatal.

    Dairy workers are most at risk of possible infection in the current outbreak, but understanding the extent of any infections is extremely tricky, says James Lawler, professor of infectious diseases at University of Nebraska Medical Center. More than half of workers in the US dairy industry are immigrants, and many of them are undocumented.

    These undocumented workers are unlikely to want to put themselves at risk by coming for testing, Lawler says. “There’s an inherent disincentive that many of the workers, because of their status as undocumented immigrants, are not raising their hands.” The result, Lawler says, is that it’s difficult for scientists to track any possible spread of the virus through humans.

    Another issue is incentivizing owners of dairy farms to report when their animals seem sick. The USDA Animal and Plant Health Inspection Service specifically provides payments for poultry farmers who have to kill their livestock due to bird flu infections. Dairy farmers don’t get compensated for reporting infections, which incentivizes producers to keep quiet, upping the risk that outbreaks get out of hand and spread to other cattle or farm workers.

    This presents a major problem for tracking the spread of the disease. “From the perspective of a producer, how is it going to benefit them to share or even test and understand if there’s a virus circulating in their herd?” Lawler says.

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    Matt Reynolds

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  • Breaking down Supreme Court arguments in abortion pill case

    Breaking down Supreme Court arguments in abortion pill case

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    Breaking down Supreme Court arguments in abortion pill case – CBS News


    Watch CBS News



    The Supreme Court on Tuesday heard arguments on access to mifepristone, a pill that’s taken with another drug to terminate an early pregnancy. The high court will weigh if the Food and Drug Administration adequately considered safety when it expanded access to the medication in 2016 and 2021. Robin Nunn, a federal trial attorney, joins CBS News with more.

    Be the first to know

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  • Are Branched-Chain Amino Acids Good for Us?  | NutritionFacts.org

    Are Branched-Chain Amino Acids Good for Us?  | NutritionFacts.org

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    I discuss why we may not want to exceed the recommended intake of protein.

    Diabetes isn’t just about the amount of body fat, but also the distribution of body fat. At 0:26 in my video Are BCAA (Branched-Chain Amino Acids) Healthy?, you can view cross-sections of thighs from two different patients using MRI. In the images, the fat shows up as white and the thigh muscle is black. At first glance, you might think the bottom cross-section has more fat since it’s ringed with more white. That is the subcutaneous fat, the fat under the skin. But, if you look at the top cross-section, you’ll see how the middle of the thigh muscle is more marbled with fat, like those really fatty Japanese beef steaks. That is the fat infiltrating into the muscle. In the graph below and at 0:48 in my video, the two cross sections are colored so you can see the different types of fat: the fat infiltrating the muscle in red, the fat between the muscles in green, and subcutaneous fat outside of the muscles and under the skin in yellow. If you add up all three types of fat, both of those thighs actually have the same amount of fat—just distributed differently.

    This seems to be the critical factor in terms of determining insulin resistance, the cause of type 2 diabetes. Researchers found that the subcutaneous adipose tissue, the fat right under the skin, was not associated with insulin resistance. Going back to the two cross sections, as seen below and at 1:20 in my video, it is healthier to have the bottom thigh with the thicker ring of subcutaneous fat but less fat infiltrating muscle than the top thigh with more fat present in the muscle.

    Is it possible a more plant-based diet also affects a more healthful distribution of fat?

    We now know the effect of a vegetarian diet versus a conventional diabetic diet on thigh fat distribution in patients with type 2 diabetes. Researchers took 74 people with diabetes and randomly assigned them to follow either a vegetarian diet or a conventional diabetic diet. Both diets were calorie-restricted by the same number of calories. The vegetarian diet was also egg-free, and dairy was limited to a maximum of one serving of low-fat yogurt a day. What did the researchers find? The reduction in the more benign subcutaneous fat was comparable; it was about the same in both groups. However, the more dangerous fat—the fat lodged inside the muscle itself—“was reduced only in response to a vegetarian diet.” So, even getting the same number of calories, there can be a healthier weight loss on a more plant-based diet.

    Those eating strictly plant-based also had lower levels of fat stuck inside the individual muscle fibers themselves, which may help explain why vegans in particular are often found to have the lowest odds of diabetes. It is not just because vegans are generally slimmer either. Even if you match subjects pound for pound, there is significantly less fat inside the muscle cells of vegans compared to omnivores. This is a good thing, since storing fat in muscle cells “may be one of the primary causes of insulin resistance,” which is what’s behind both prediabetes and type 2 diabetes. On the other hand, if you put someone on a high-fat diet, the fat in their muscle cells shoots up by 54 percent in just a single week.

    What about a high-protein diet? That may undermine one of the principal benefits of weight loss: eliminating the weight-loss-induced improvement in insulin resistance. Researchers put obese individuals on a calorie-restricted diet of less than 1,400 calories a day until they lost 10 percent of their body weight. Half of the participants were getting more of a regular protein intake (73 grams a day), and the other half were on a higher-protein diet (about 105 daily grams). Normally, if you lose 10 percent of your body weight, your insulin resistance improves. That’s why it is so critical for obese individuals with type 2 diabetes to lose weight. However, the beneficial effect of a 10 percent weight loss was eliminated by the high protein intake. Those extra 32 grams of protein a day abolished the weight-loss benefit. “The failure to improve…insulin sensitivity in the WL-HP [weight-loss high-protein] group is clinically important because it reflects a failure to improve a major pathophysiological [cause-and-effect] mechanism involved in the development of T2D,” type 2 diabetes. In summary, the researchers concluded that they demonstrated “the protein content of a weight loss diet can have profound effects on metabolic function.” 

    Is this true of any protein? As you can see below and at 4:19 in my video, if you split it between animal protein versus plant protein, following people over time, intake of animal protein is associated with an increased risk of diabetes in most studies.

    Intake of plant protein, however, appears to have either a neutral or even protective association with diabetes, as shown below and at 4:25 in my video

    Those were just observational studies, though. People who eat a lot of animal protein might have many unhealthy behaviors. However, you see the same thing in randomized, controlled, interventional trials, where you can improve blood sugar control just by replacing sources of animal protein with plant protein.

    We think it may be the branched-chain amino acids concentrated in animal protein. Higher levels in the bloodstream are associated with obesity and the development of insulin resistance. As you can see below and at 5:00 in my video, we may be able to drop our levels by sticking to plant proteins, but you don’t know if that has metabolic effects until you put it to the test. 

    Ruining the suspense, researchers titled their study: “Decreased Consumption of Branched-Chain Amino Acids Improves Metabolic Health.” They demonstrated that “a moderate reduction in total dietary protein or selected amino acids can rapidly improve metabolic health,” and this included improving blood sugar control, while also decreasing body mass index (BMI) and body fat. As you can see at 5:27 in my video, the protein-restricted group was eating hundreds more calories per day, significantly more calories than the control group, so they should have gained weight. But, no. They lost weight! After about a month and a half, they were eating more calories but lost more weight—about five more pounds than participants in the control group who were eating fewer calories, as you can see at 5:38 in my video. What’s more, this “protein restriction” had people eat the recommended amount of protein per day, about 56 daily grams. They should have been called the normal protein group or the recommended protein group instead, and the group eating more typically American protein levels and suffering because of it should have been called the excess protein group. Just sticking to the recommended protein intake doubled the levels of a pro-longevity hormone called FGF21, too, but we’ll save that for another discussion.

    To better understand the negative impact of omnivores getting too much protein relative to vegetarians, see my video Flashback Friday: Do Vegetarians Get Enough Protein?.

    I have several additional videos and blogs that may help explain some of the benefits of plant-based proteins. Check in the related posts below.

    Of course, the best way to treat type 2 diabetes is to get rid of it by treating the underlying cause, as described in my video How Not to Die from Diabetes

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    Michael Greger M.D. FACLM

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  • FDA says marijuana has a legitimate medicinal purpose – Cannabis Business Executive – Cannabis and Marijuana industry news

    FDA says marijuana has a legitimate medicinal purpose – Cannabis Business Executive – Cannabis and Marijuana industry news

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    FDA says marijuana has a legitimate medicinal purpose – Cannabis Business Executive – Cannabis and Marijuana industry news




























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  • Has Kamala Harris Changed Her Stance On Marijuana Or

    Has Kamala Harris Changed Her Stance On Marijuana Or

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    Vice President Kamala Harris made the news about her supporting the need for rescheduling. Marijuana stocks jumped while the industry holds its breath. Harris was speaking at a meeting at the White House with people who received pardons from marijuana-related offices from the President. Joseph Cartagena aka the Rapper Fat Joe and Kentucky Gov. Andy Beshear (D) were among the crowd.  But has Kamala Harris changed her stance on Marijuana or is this another campaign promise which will take years to follow through.

    As a San Francisco prosecutor, Harris oversaw more than 1,900 cannabis related convictions, higher than her predecessors. When it was a key issue about the state voting for legal marijuana, Harris opted out of the discussion.  It wasn’t until 2020 with the presidential campaign she appeared to change her mind and followed Biden’s lead in promising the cannabis industry a friend in power.  But it would be 3.5 years before any real action took place.

    In 2020, the cannabis economy was just gaining major steam, but now with federal resistance, chaos in New York and California and flower price compression, it is critical something change.  Marijuana isa Schedule 1 drug as ruled by the Drug Enforcement Administration (DEA). The classification designates the plant as similar to heroin, LSD. It is seen as a dangerous drug with no medicinal uses. Science, the medical community and cannabis advocates have campaigning for the federal government to either reschedule marijuana to a different category or deschedule it entirely since it has proven medical benefits.  Alcohol is considered a drug but is not scheduled.

    President Joe Biden, running for re-election, has again brought marijuana into the picture, even mentioning it in his State of the Union address.  But he said he would work with the industry in 2020, took office in 2021 and finally, tentatively suggested a change in 2023.  Harris hasn’t been given a public role in the conversation until the meeting.

    The Biden/Harris campaign has sought to appeal to young voters which it needs.  But some of whom are dissatisfied with his sluggish policy reforms.  Going into election day with more talk and no real action could be a dangerous path for election.

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    Terry Hacienda

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  • The Efficacy of Weight-Loss Supplements  | NutritionFacts.org

    The Efficacy of Weight-Loss Supplements  | NutritionFacts.org

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    Are there any safe and effective dietary supplements for weight loss?

    In a previous discussion, I noted that an investigation found that four out of five bottles of commercial herbal supplements bought at major U.S. retailers—GNC, Walgreens, Target, and Walmart—didn’t contain any of the herbs listed on their labels, instead “often containing little more than cheap fillers like powdered rice, asparagus and houseplants…”

    You might hope your supplement just contains houseplants. Weight-loss supplements are infamous for being “adulterated with prescription and over-the-counter” drugs. In a sampling of 160 weight-loss supplements that “were claimed as 100% natural,” more than half were tainted with drugs and active pharmacological ingredients, ranging from antidepressants like Prozac to erectile dysfunction medications like Viagra. Diuretic drugs are frequent contaminants, which makes sense. In my previous videos on ketogenic diets, I talk about rapid water loss being “the $33-billion diet gimmick” that has sold low-carb diets for more than a century. But why the Viagra?

    At least the spiked Viagra and Prozac are legal drugs. Researchers in Denver tested every weight-loss supplement they could find within a ten-mile radius. Alarmingly, they found that a third were adulterated with banned ingredients. The most common illegal adulterant of weight-loss supplements is sibutramine, which was sold as Meridia before it was yanked off the market back in 2010 for heart attack and stroke risk. Now, it is also blamed for cases of slimming supplement–induced psychosis.

    An analysis of weight-loss supplements bought off the internet that were advertised with claims like “purely natural products,” “harmless,” or “traditional herbal” found that a third of them contained high doses of the banned drug sibutramine and the rest had caffeine. Wouldn’t you be able to tell if caffeine was added to a supplement? Perhaps not, if it also had temazepam, a controlled substance (benzodiazepine) “downer” sedative found in half of the caffeine-tainted supplements.

    Doesn’t the FDA demand recalls of adulterated supplements? Yes, but they often just pop back up on store shelves. Twenty-seven supplements were purchased at least six months after recalls were released, and two-thirds still contained banned substances. That’s 17 out of 27 with the same pharmaceutical adulterant found originally, and 6 containing one or more additional banned ingredients. Aren’t the manufacturers penalized for noncompliance? Yes, but “the fines for violations are small compared to the profits.”

    One of the ways supplement makers can skirt the law is by labeling them as “not intended for human consumption because it shifts the responsibility from the seller to the user”—for example, labeling the fatal fat-burner DNP as “an industrial- or research chemical.” This is how designer street drugs can be sold openly at gas stations and convenience stores as “bath salts.” Another way is to claim synthetic stimulants added to slimming supplements are actually natural food constituents, like listing the designer drug dimethylamylamine (DMAA) as “geranium oil extract.” The FDA banned it in 2012 after it was determined that DMAA “was not found in geraniums.” Who eats geraniums anyway? Despite being tentatively tied to cases of sudden death and associated with hemorrhagic stroke, DMAA has continued to be found in weight-loss supplements with innocuous names like Simply Skinny Pollen made by Bee Fit with Trish.

    There is little doubt that certain banned supplements, like ephedra, could help people lose weight. “There’s only one problem, and it’s a big one: This supplement may kill you,” wrote a founding member of the American Board of Integrative Medicine.

    Are there any safe and effective dietary supplements for weight loss? As I discuss in my video Friday Favorites: Are Weight-Loss Supplements Safe and Effective?, when popular slimming supplements were put to the test in a randomized placebo-controlled trial, not a single one could beat out placebo sugar pills. “A systematic review of systematic reviews” of diet pills came to a similar conclusion: None appears to generate appreciable impacts “on body weight without undue risks.” That was the conclusion reached in a similar review out of the Weight Management Center at Johns Hopkins, which ended with: “In closing, it is fitting to highlight that perhaps the most general and safest alternative/herbal approach to weight control is to substitute low-energy density [low-calorie] foods for high-energy density and processed foods, thereby reducing total energy intake.” In other words, eat more whole plant foods and fewer animal foods and junk. “By taking advantage of the low-energy density [low-calorie] and health-promoting effects of plant-based foods, one may be able to achieve weight loss, or at least assist weight maintenance without cutting” down on the volume of food consumed or compromising its nutrient value.

    Learn more about the risks of supplements in my video Are Weight Loss Supplements Safe?.

    I referred to a keto diet video I did, check out the related posts below the links to other videos and blogs in that series.

    Learn more about optimal weight loss in my book, How Not to Diet

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    Michael Greger M.D. FACLM

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  • The Perfect James Bond Martini

    The Perfect James Bond Martini

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    Did James Bond make the martini famous? Or did the martini help make Bond cool?

    The classic line of “shaken or stirred” has been used by men for decades.  Bond instructs the bartender in the phrase “shaken and not stirred” in Diamonds Are Forever and Dr No and it has been in our lexicon ever since. But did Bond make the martini famous – or did the martini help Bond. And what is the perfect James Bond Martini?

    The history of the martini is murky, “Professor” Jerry Thomas, a famous and influential 19th century bartender, invented the drink at the Occidental Hotel in San Francisco, sometime in the late 1850s or early 1860s. As the story goes, a miner, about to set out on a journey to Martinez, California, put a gold nugget on the bar and asked Thomas to mix him up something special. Thomas produced a drink containing Old Tom (sweetened) gin, vermouth, bitters and Maraschino, and dubbed it the “Martinez” in honor of the customer’s destination.

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

    The big question is gin or vodka? Purist insist it be gin for the classic martini, but numbers say vodka is preferred. Vodka sales are about $7.5 billion annually while gin is around $5 billion. If you order a classic martini, you will probably be served gin unless you say vodka. Bond seems fairly fluid in his choice, he orders 19 vodka martinis and 16 gin martinis throughout Fleming’s novels and short stories.

    Like Bond’s creator Ian Fleming, James Bond prefers his cocktails shaken and not stirred. A traditional martini is stirred rather than shaken, but Fleming’s biographer Andrew Lycett shared the author preferred martinis shaken since he believe it preserved the flavor.

    Internationally known celebrity chef Justin Khanna has his take on the martini.

    “The perfect Martini, to me, takes advantage of the “blank canvas” nature of this timeless cocktail. “Many cocktails restrict you to specific garnishes, and even fewer allow the liberty to swap the base spirit.

    With the Martini, a vodka base that’s heavy on the olives and light on the vermouth is just as “right” as one made with gin and a twist of lemon, even though they couldn’t be more different once you take your first sip. Accompanied by a bowl of olives, bleu cheese or salty potato chips to snack on, and I’ll savor this iconic cocktail in bliss.

    I personally love the body, complexity and herbaceous kick of vermouth, often making it a co-star in my version”

    The Khanna Martini

    Ingredients

    • 2 1/2 oz vodka
    • 3/4 oz dry vermouth
    • Ice
    • Lemon zest twist

    Create

    • Combine vodka and vermouth in a shaker with ice.
    • Shake for 10-20 seconds.
    • Strain into a chilled martini glass.
    • Garnish with a lemon twist, first rubbing it along the rim for a burst of citrus aroma.

    RELATED: Science Says Medical Marijuana Improves Quality Of Life

    Dean Martin, Humphrey Bogart, Bette Davis’s Margo Channing, FDR, Frank Sinatra, and Jessica Walter’s Lucille Bluth are all noted martini fans. One of the most fun is the great Megan Mullally’s Karen Walker from the show Will & Grace.

    The Karen Walker Martini

    Ingredients

    • 2.5 oz. High-end vodka
    • .5 oz. Dry vermouth
    • .5 oz. Olive brine

    Create

    • Pour all ingredients into shaker with ice cubes.
    • Shake well
    • Strain in chilled cocktail glass

    The Perfect James Bond Martini

    Ingredients

    • 2 ¼ ounces dry gin
    • 1 ounce dry vermouth
    • 1 lemon twist, for garnish
    • 1 olive (for garnish)

    Create

    • Combine vermouth and gin in a mixing glass filled with ice
    • Fill glass with ice and stir rapidly. Continue adding ice and stirring until the additional ice has been submerged within the cocktail
    • Strain the cocktail into the chilled martini glass
    • Express the lemon twist over the cocktail
    • Place expressed lemon twist and the skewered olive on the chilled rim

    As famed writer and wit Dorothy Parker shared about martinis:

    “I like to have a martini,
    Two at the very most.
    After three I’m under the table,
    after four I’m under my host.”

     

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    Anthony Washington

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  • The Safety of Weight-Loss Supplements  | NutritionFacts.org

    The Safety of Weight-Loss Supplements  | NutritionFacts.org

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    Only 2 out of 12 supplement companies were found to have weight-loss products that were even accurately labeled.

    According to a national survey, one-third of adults who have made serious attempts at weight loss have tried using dietary supplements, for which Americans spend billions of dollars every year. Most people mistakenly thought that over-the-counter appetite suppressants, herbal products, and weight-loss supplements had to be approved for safety by a governmental agency, like the U.S. Food and Drug Administration (FDA), before being sold to the public or at least include some kind of warning on the label about potential side effects. Nearly half even thought they had to demonstrate some sort of effectiveness. None of that is true.

    As I discuss in my video Friday Favorites: Are Weight Loss Supplements Safe and Effective?, the “FDA has estimated that dietary supplements cause 50,000 adverse events annually,” most commonly liver and kidney damage. Of course, prescription drugs don’t just have adverse effects; they kill more than 100,000 Americans every year. But, you at least notionally have the opportunity to parse out the risks versus benefits of prescription drugs, thanks to testing and monitoring requirements typically involving thousands of individuals.

    When the manufacturer of Metabolife 356, a supplement containing ephedrine, had it tested on 35 people, only minor side effects were found, such as dry mouth, headache, and insomnia. However, once unleashed on a broad population, nearly 15,000 adverse effects were reported, including heart attacks, strokes, seizures, and deaths, before it was pulled from the market.

    Given the lack of government oversight, there is no guarantee that what’s on the label is even in the bottle, as you can see in the graph below and at 1:55 in my video. FDA inspectors have found that 70 percent of supplement manufacturers violated so-called Good Manufacturing Practices, which are considered the minimum quality standards. This includes things like basic sanitation and ingredient identification. Not 7 percent in violation, but 70 percent.

    DNA testing of herbal supplements across North America found that most could not be authenticated. In a significant percentage of the supplements tested, the main labeled ingredient was missing completely and substituted with something else. For example, a so-called St. John’s wort supplement contained nothing but senna, a laxative that can cause anal blistering. Only 2 out of 12 supplement companies had products that were accurately labeled.

    This problem isn’t limited to fly-by-night phonies in some dark corner of the internet either. The New York State Attorney General commissioned DNA testing of 78 bottles of commercial herbal supplements sold by Walgreens, Walmart, Target, and GNC “and found that four out of five…did not contain any of the herbs on their labels.” Instead, the capsules “often contained little more than cheap fillers like powdered rice, asparagus and houseplants…”

    What about weight-loss medications? See Are Weight Loss Pills Safe? and Are Weight Loss Pills Effective?. Also, see related posts below.

    Take a deep dive into the best way to lose weight with my book How Not to Diet

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    Michael Greger M.D. FACLM

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  • Statement by Fragrance Creators Association on Funding to Support Implementation of the Modernization of Cosmetics Regulation Act

    Statement by Fragrance Creators Association on Funding to Support Implementation of the Modernization of Cosmetics Regulation Act

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    Fragrance Creators Association (FCA) and CEO Farah K. Ahmed issue the following statement on funding to support the Food and Drug Administration’s (FDA) implementation of the Modernization of Cosmetics Regulation Act (MoCRA):

    “We are pleased to note the allocation of $7 million for MoCRA implementation within the minibus package signed into law by President Biden last weekend. This allocation signifies a dedication to aiding the FDA in the transition towards a modernized cosmetics regulatory framework, a process extending beyond 2024.

    “In its fiscal year 2025 (FY25) budget request, released on March 11, the FDA has requested $8 million for MoCRA implementation. Following the passage of the remaining fiscal year 2024 appropriations bills, we urge Congress to prioritize sound science, safety, and innovation by appropriating at least $8 million for FY25.

    “Fragrance plays an important role in cosmetics and personal care products; products that nurture skin health and hygiene and empower self-expression. That is why FCA has consistently advocated for an adequately funded cosmetics program that will support responsible fragrance industry innovation that can improve the experience of our nation’s diverse consumer demographic, uphold safety, and advance environmental sustainability.” 

    ###

    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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  • The Ozempic Revolution Is Stuck

    The Ozempic Revolution Is Stuck

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    Millions more Americans are now eligible for obesity drugs. But the injections remain maddeningly hard to find.

    Illustration by The Atlantic. Source: Getty.

    The irony undergirding the new wave of obesity drugs is that they initially weren’t created for obesity at all. The weight loss spurred by Ozempic, a diabetes drug in the class of so-called GLP-1 agonists, gave way to Wegovy—the same drug, repackaged for obesity. Zepbound, another medication, soon followed. Now these drugs have a new purpose: heart health.

    On Friday, the FDA approved the use of Wegovy for reducing the risk of heart attack, stroke, and death in adults who are overweight and have cardiovascular disease. The move had been anticipated since the publication of a landmark trial in the fall, which showed the drug’s profound effects on cardiovascular  health. The decision could usher in a new era where GLP-1 drugs become mainstream, opening up access to millions of Americans who previously didn’t qualify for Wegovy.

    Some of the obstacles stopping people from getting the drug may also begin to crumble. Insurance companies commonly deny coverage of Wegovy because obesity is seen as a cosmetic concern rather than a medical one, but that argument may not hold up for cardiovascular disease. “This new FDA indication is HUGE,” Katherine Saunders, an obesity-medicine physician at Weill Cornell Medicine, told me in an email. Wegovy may soon be within reach for many more Americans—that is, if they can find it.

    In practice, Wegovy is maddeningly hard to get hold of. Shortages of injectable semaglutide, the active ingredient in Wegovy and Ozempic, have been ongoing since March 2022; currently, most doses of Wegovy are in limited supply. As the popularity of semaglutide has skyrocketed, demand has completely outstripped the capacity of its manufacturer, Novo Nordisk. The drug comes in injection pens containing a glass vial; “these are not easy products to make,” Lars Fruergaard Jørgensen, the CEO of Novo Nordisk, said in August. In response to the shortages, the company withheld its supply of lower Wegovy doses last year. Because treatment on the medication must begin in low doses, this meant that new patients who wanted to start on Wegovy functionally couldn’t. In January, the company began “more than doubling the amount of the lower-dose strengths” of the drug, a Novo Nordisk spokesperson told me, and it plans to gradually increase overall supply throughout the rest of the year.

    The ongoing shortages have left providers and patients feeling stuck. “It is devastating to prescribe a lifesaving medication for a patient and then find out it’s not covered or we can’t locate supply,” Saunders said. Doctors are scrambling to make do with what’s available. Ivania Rizo, an endocrinologist at Boston Medical Center, told me she has had to turn to older GLP-1 drugs such as Saxenda to “bridge” patients to higher doses of Wegovy, although now that is in shortage too. Patients can spend each day calling pharmacy after pharmacy in search of one with Wegovy in stock, Rizo said. In desperation, some have turned to versions of the drug that are custom-made by compounding pharmacies with little oversight, despite the FDA expressing concerns about them. The shots are supposed to be taken weekly, but others have attempted to stretch their doses beyond that.

    That the new FDA approval could very mainstream obesity drugs may create long-needed pressure to help resolve these shortages. It makes clear that Wegovy is a lifesaving medication not only for people with obesity but also for those with cardiovascular disease—the leading cause of death in the U.S.—putting the impetus on Novo Nordisk to ramp up production. But in the short term, the access issues may persist. “The new approval is very likely to worsen shortages, because the demand for Wegovy will continue to climb—now at an even faster pace,” Saunders said.

    If patients think they’re stuck now, they’re about to feel entrenched. Wegovy is the only obesity drug that has been approved to reduce the risk of heart attacks, but none of its competitors is easily available either. Supplies of certain dosages of Eli Lilly’s Mounjaro, a diabetes drug whose active ingredient is sold for obesity as Zepbound, are limited, and shortages are expected later this year. “We need supply to increase dramatically,” Saunders said. Both Novo Nordisk and Eli Lilly have invested heavily in expanding production capacity, but some of the new plants won’t open until 2029.

    For all of its advantages, the FDA approval has a sobering effect on the unrelenting hype around GLP-1s. So much of the excitement around obesity drugs has focused on the future, as dozens of pharmaceutical companies develop more powerful drugs, and commentators imagine a world without obesity. In the process, the issues of the present have gone overlooked. More drugs won’t make much of a difference if the drugs themselves are out of reach.

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    Yasmin Tayag

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