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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





    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

    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.

    Jacob Stern

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  • American Nurses Association Publicly Supports Rescheduling

    American Nurses Association Publicly Supports Rescheduling

    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.

    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

    Quaker Oats expands granola product recall


    Quaker Oats expands granola product recall due to salmonella risk

    00:19

    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

    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.”

    Terry Hacienda

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  • Kratom faces scrutiny over health risks

    Kratom faces scrutiny over health risks

    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

    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.

    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

    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

    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.

    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

    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.