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Widely Used Pills Recalled for Deadly Flaw, FDA Yet to Act

The AHA! Team — Mon, 07 Jul 2025 05:39:14 +0000

Patrick Tims via NaturalHealth365 – An alert has been issued cautioning consumers against using a popular potassium chloride pill. The pills were recalled after a potentially fatal flaw was discovered. However, the Food and Drug Administration (FDA) has yet to act. This lack of immediate oversight raises serious concerns about the regulatory framework to protect public health. With millions of lives potentially at risk, the issue demands urgent attention. Potentially deadly flaw in commonly used pills all consumers should know about Official records reveal that Glenmark Pharmaceuticals issued over half a dozen recalls for its potassium chloride pills. The pills fail to properly dissolve when contacting moisture, such as saliva and other water, in the human body. This failure to dissolve has the potential to lead to pain, hospitalization, and death. The shocking twist is that the FDA has dragged its feet on investigating the Glenmark Pharmaceuticals drug factory’s flawed operations. To date, there has been no government inspection of the drug factory. The FDA is aware that the pills have the potential to cause deadly potassium spikes, yet it refuses to take meaningful action. The pills were produced at a single factory in India. If our federal government were the watchdog it claims to be, it would have prevented Glenmark Pharmaceuticals from shipping pills produced at the Mumbai factory to the rest of the United States. Why the potassium chloride pills have the potential to kill healthy people There is a widespread misconception that potassium chloride is entirely safe simply because it has been on the market for decades. The drug is frequently prescribed to address issues with muscle and nerve function and is particularly valued for its benefits to heart health. While potassium chloride pills are effective for individuals with low potassium levels, they can pose significant risks under certain conditions. Excessive amounts of the drug can have lethal consequences. High doses of potassium chloride can result in complete heart failure, a risk that cannot be ignored. This danger is so pronounced that potassium chloride is a key component in lethal injections used for executions in several states. This reality highlights just how deadly the drug can be when misused or improperly formulated. Is a recall of the drug enough? The danger of Glenmark Pharmaceuticals’ potassium chloride pills became apparent in May when the Indian drugmaker recalled nearly 47 million capsules. The extended-release medication’s failure to dissolve prompted the FDA to issue its own recall of the defective product. Shockingly, the FDA was already aware of manufacturing issues at Glenmark Pharmaceuticals’ facilities at the time of the recall. Over the previous eight months, the Mumbai-based drugmaker had been responsible for four separate recalls. In the months following, two more recalls were issued, each citing the same critical flaw: the pills’ inability to dissolve properly. While recalls play a crucial role in protecting consumers, they are far from sufficient in addressing systemic issues. The FDA has failed to prevent Glenmark from continuing to distribute potentially dangerous pills to the American market. Even more troubling is the agency’s failure to thoroughly investigate the root cause of the problem. Despite the glaring risks, the FDA has not conducted an on-site inspection of Glenmark’s Mumbai facility since its last review – more than four years ago. This glaring oversight raises serious concerns about the FDA’s capacity to enforce meaningful accountability and ensure the safety of imported drugs. Glenmark Pharmaceuticals: A case study in corporate negligence It seems we have drifted too far toward a laissez-faire economy, where corporate greed often goes unchecked. Within a single year, Glenmark Pharmaceuticals issued seven recalls for medications that failed to dissolve as intended, yet no significant government action has been taken to address the underlying issues. Glenmark’s public relations team has acknowledged three deaths and several hospitalizations linked to their defective products. FDA records corroborate these reports, confirming the dangers of potassium chloride pills. However, the FDA appears reluctant to formally attribute these deaths and hospitalizations to the drug, allowing Glenmark’s pursuit of profit to continue virtually unimpeded. The time has come for a comprehensive overhaul of the FDA. The agency currently lacks the resources and authority to effectively oversee the manufacturing, distribution, and recall of generic medications produced in factories outside the United States. If the FDA were fulfilling its intended role, it would immediately take decisive action against Glenmark. Sources for this article include: IPDpharma.com Childrenshealthdefense.org To read the original article click here.

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FDA Finally Bans Red Dye No. 3 – What This Means for Food Safety in the U.S.

The AHA! Team — Wed, 26 Mar 2025 05:07:33 +0000

Patrick Tims via NaturalHealth365 – The FDA now admits red dye No. 3 is dangerous to human health. Years ago, those who insisted the food dyes used in sports drinks, food, and other consumer products were labeled conspiracy theorists. Those once considered to be on the fringes of society are now in the mainstream. The transition is exemplified by the Food and Drug Administration (FDA) recently acknowledging that red dye No. 3 is harmful to the human body. The federal agency has officially revoked authorization for the dye’s use using the Federal Food, Drug, and Cosmetic Act’s Delaney Clause. However, less harmful variations of red dye are still permissible. The FDA now admits red dye No. 3 is dangerous to human health The FDA has finally acknowledged what many of us suspected all along – red dye No. 3 isn’t good for us. This ban is a big win for food safety in America and for our health overall. Artificial dyes make our food look prettier, but at what cost? That bright red color enhancing our drinks, candy, cereal, and even some medications just isn’t worth the health risks. Over 8,000 food products contained red dye No. 3 a few years back. Think about it – sodas, cookies, cereals, cake mixes, icings, sprinkles, gum, ice cream … it was everywhere. As more people started googling ingredients and asking questions online, the FDA finally had to pay attention. The growing concerns pushed them to take a closer look and actually do something about it. Here’s the reality: red dye No. 3 and other artificial colors are linked to real health problems. Kids become more hyperactive, allergic reactions increase, and some animal studies even point to cancer risks. The evidence speaks for itself. The FDA is finally taking direct aim at harmful additives The FDA’s ban on red dye No. 3, also called erythrosine, was made official on January 15, 2025. Using the dye in food, beverages, and medications is now illegal. Moreover, the dye cannot be added to dietary supplements. The surprising twist to the FDA’s decision that most Americans are unaware of is that our federal regulators dragged their feet much longer than governments in other parts of the world. Red dye No. 3 was restricted in New Zealand, Australia, and Europe years before it was banned in the United States. California set the tone, implementing a ban on the dye in 2023. However, the Golden State’s ban won’t be implemented until 2027. Though public health advocates in California presented convincing evidence linking the dye to carcinogenic risks, the FDA turned a blind eye until this year. The elimination of red dye No. 3 might only be the beginning of food additive bans in the United States Red dye No. 3 isn’t the only concerning food coloring in our food supply. Yellow No. 5, found in Gatorade and many popular products, has been questioned since the 1980s. Yet, numerous synthetic dyes remain perfectly legal in foods sold across America. Check your food and drink labels, and you’ll find blue No. 1, yellow No. 5, and yellow No. 6 in everything from baked goods and packaged snacks to medications and cosmetics. While scientists continue studying these synthetic additives, existing research has already linked them to health problems. They’ve been connected to increased hyperactivity in children and allergic reactions in some people. More concerning are studies suggesting potential long-term health risks. The FDA’s ban on red dye No. 3 is commendable but addresses only one part of a larger problem. A government’s main purpose should be to protect its citizens from potential harm. If the FDA truly honors its responsibility to public health, it should examine all potentially harmful food dyes with the same scrutiny – putting our well-being above the aesthetic appeal of colored foods. The solution to the FDA’s incompetence: Engage in conscious consumerism Let’s say the obvious, the FDA has been compromised by food industry money. But we still have options. Your grocery choices matter. Buying organic, whole foods without artificial additives keeps harmful ingredients out of your body and sends companies a message about what people want. Read labels before buying food, drinks, medicine, or cosmetics. You’ll be surprised what’s hiding in everyday products. Nature makes better food coloring anyway. Turmeric, beets, spirulina, and purple carrots add color naturally and contain antioxidants that benefit your health. Speaking up works, too. Consumer groups have successfully pushed for food safety improvements. Join them or contact your representatives to help build pressure for better regulations. Look at Europe – they’ve banned dozens of additives we still allow in America. Their food industry adapted just fine, showing better standards are completely possible. Sources for this article include: FDA.gov Goodhousekeeping.com To read the original article click here.

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Breakthrough UC San Diego Brain Recording Device Receives FDA Approval for a Clinical Trial

The AHA! Team — Fri, 02 Aug 2024 08:21:00 +0000

University of California San Diego via Newswise – The Federal Drug Administration approved a clinical trial to test the effectiveness of an electronic grid that records brain activity during surgery, developed by engineers at the University of California San Diego. The device with nanoscale sensors records electrical signals directly from the surface of the human brain in record-breaking detail. The grid’s breakthrough resolution could provide better guidance for planning and performing surgeries to remove brain tumors and treat drug-resistant epilepsy. The grid’s higher resolution for recording brain signals could improve neurosurgeons’ ability to minimize damage to healthy brain tissue. During epilepsy surgery, the novel grid could improve the ability to precisely identify the regions of the brain where epileptic seizures originate for safe and effective treatment. The new brain sensor array, known as platinum nanorod grid (PtNRGrid) features a densely packed grid of a record-breaking 1,024 embedded electrocorticography (ECoG) sensors. The device rests on the surface of the brain and is approximately 6 microns thin–smaller than one tenth of the human hair–and flexible. As a result, it can both adhere and conform to the surface of the brain, bending as the brain moves while providing high-quality, high-resolution recordings of brain activity. In contrast, the ECoG grids most commonly used in surgeries today typically have between 16 and 64 sensors. These grids are rigid, stiffer and more than 0.5 mm in thickness and do not conform to the curved surface of the brain. The PtNRGrid was invented by Shadi Dayeh, a Professor in the Department of Electrical and Computer Engineering at the University of California San Diego and members of his team. Over the years, the team developed the PtNRGrid technology in collaboration with neurosurgeons and medical researchers from UC San Diego, Massachusetts General Hospital (MGH) and Oregon Health & Science University (OHSU). “This accomplishment ushers in a new era of clinical neuroscience and neuromonitoring,” Dayeh said. “We are very excited to receive the FDA approval to apply our groundbreaking PtNRGrid in a clinical setting. It is a credit to the hard work of my team members who worked tirelessly to meet the quality criteria mandated by the FDA. I am also grateful to my clinical partners, the support of the NIH, and to the campus leadership that fostered an impactful ecosystem across engineering and medicine to transform the future of healthcare.” The FDA approved an investigational device exemption (IDE) for a “pivotal study [titled] “Systematic Evaluation of Platinum Nanorod Grids (PtNRGrids) for Intraoperative Mapping and Neurophysiological Monitoring (IONM) During Brain Surgeries.” Specifically, the clinical trial is designed to demonstrate the effectiveness of the PtNRGrid device to map both normal and pathological brain activity. During the trial, UC San Diego engineers will partner with clinician-scientists: Drs. Sharona Ben-Haim and Eric Halgren at UC San Diego, Dr. Sydney Cash at MGH, and Dr. Ahmed Raslan at OHSU. In a first phase, surgeons will implant the PtNRGrid in 20 patients, then measure and compare the grid’s performance with the present state-of-the-art. The PtNRGrid will be deployed in surgeries to remove brain tumors and to remove tissue that causes epileptic seizures. Record-breaking density Dayeh’s team has pioneered human brain and spinal cord mapping with thousands of channels since 2019, and has reported early safety and efficacy results in a series of articles published in Science Translational Medicine in 2022 in human subjects. PtNRGrid is the only device with thousands of channels to demonstrate in peer-reviewed publications that it can map motor and language brain activity, as well as epileptic discharges, by producing panoramic videos of brain waves over 10 square centimeters of the brain’s cortex while maintaining resolution at a microscopic level. Currently, Dayeh’s research group holds the world record of recording brain activity from a single cortical grid with 2,048 channels on the surface of the human brain published in Science Translational Medicine in 2022. The device was used in the operating room of Dr. Ahmed Raslan of the OHSU. Since then, the team has increased the number of recording channels to 4,096 and continues to work on increasing the number of channels in the grid to monitor brain activity in even higher resolution. Pending success of this staged trial, the team will transition to the next crucial step of making the PtNRGrid available for commercial use at scale. Demonstrating that ECoG grids with sensors in the thousands of channels record brain activity with high fidelity also opens new opportunities in neuroscience for uncovering a deeper understanding of how the human brain functions. Basic science advances, in turn, could lead to improved treatments grounded in enhanced understanding of brain function. “Our goal is to provide a new atlas for understanding and treating neurological disorders, working with a network of highly experienced clinical collaborators at UC San Diego, MGH, and OHSU,” Dayeh said. Dayeh’s work toward the FDA approval is supported by an NIH BRAIN® Initiative award # UG3NS123723. To read the original article click here.

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Evidence That Endocrine Disrupting Chemicals Are a Major Health Threat

AHA Publisher — Wed, 20 Apr 2022 07:00:53 +0000

Al Sears, MD, CNS – The autocrats at the CDC, EPA, and FDA continue to deny you’re in danger from the daily deluge of hormone-disrupting chemicals they’ve allowed into your environment. They have to know it’s a ridiculous lie. Each passing day brings more evidence these endocrine disrupting chemicals (EDCs) are a major threat. Synthetic chemicals like the bisphenol A (BPA) from plastics latch onto cellular receptors, increase estrogen production, reduce male fertility, and alter human metabolism. This sets the stage for massive chronic disease. You see, excess estrogen can destroy your health. It can even send you to an early grave. I’ve been blowing the whistle on endocrine disruptors for over two decades now, and at last the research community is beginning to wake up. Dr. Shanna H. Swan is a Mount Sinai medical center expert who initially accepted the EPA’s propaganda about EDCs… until her research validated a shocking global decline in human fertility. Now she’s crusading to alert the world to this massive threat. BPA Nosedive: Fertility and Health Fall Off a Cliff Together Among the stunning trends Dr. Swan documents: Plummeting masculinity: The sperm counts of men in the Western world dropped by over 59% from 1973 to 2011. She based her findings on 183 studies involving 42,935 men. Dr. Swan blames BPAs and other EDC toxins. Fading testosterone: The average male sex hormone level in men is dropping at about 1% a year. And there’s no sign the decline is leveling off. Crashing fertility: By 2045, Dr. Swan predicts that most couples who want to conceive will need artificial means such as IVF to have children… they simply won’t have enough reproductive capacity. Life-threatening consequences: One study showed women struggling with infertility had a 32% higher risk of dying.1 It’s even worse for men – those with abnormal sperm, or low sperm counts, had a 230% higher risk of dying.2 These are grim statistics… and I want to make sure that you don’t become one of them. Your Gameplan to Beat EDCs EDC Defense Protocol No. 1: Reduce Exposure – Start with the basics: Buy certified-organic fruits and veggies whenever possible. Use glass food containers not plastic, and never heat food in a plastic container unless you want a side helping of BPA with every meal. And do whatever you can to avoid fast food. It’s laced with EDCs… fast-food lovers have 40% higher BPA and phthalate blood levels.3 EDC Defense Protocol No. 2: Glutathione – Glutathione is a “seek and destroy” detoxifier that neutralizes environmental toxins and free radicals. Several studies indicate those who reach 100 are more likely to have higher levels of glutathione.4 More glutathione triggers better stem cell function.5 I recommend liposomal glutathione… it’s more absorbable. It can double immune-function biomarkers in a single week, including T cells and B cells.6 Start with a gram a day of liposomal glutathione… and gradually increase to 1 gram twice daily. EDC Defense Protocol No. 3: The Estrogen-Buster From Bali – Eugenol blocks estrogen imitators from locking onto cellular receptors, limiting the ability of EDCs to disrupt normal hormone levels. You’ll find clove oil and eugenol extract online and at your local supplement store. EDC Defense Protocol No. 4: Get Plenty of I3C and DIM – Indole-3 carbinol (I3C) is a special compound found in cruciferous vegetables such as brussels sprouts, broccoli, and cauliflower. Your body converts I3C into diindolylmethane (DIM). The I3C/DIM combo converts estrogen into harmless compounds your body easily excretes. I recommend 100 mg a day of I3C and DIM to protect you from EDCs. To Your Good Health, Al Sears, MD, CNS References: 1. Murugappan, Gayathree, et al. “Association between Infertility and All-Cause Mortality: Analysis of US Claims Data.” American Journal of Obstetrics and Gynecology, vol. 225, no. 1, 1 July 2021, pp. 57.e1–57.e11, NIH.gov website. 2. Eisenberg, M. L., et al. “Semen Quality, Infertility and Mortality in the USA.” Human Reproduction, vol. 29, no. 7, 15 May 2014, pp. 1567–1574, NIH.gov website. 3. Zota, Ami R, et al. “Recent Fast Food Consumption and Bisphenol a and Phthalates Exposures among the U.S. Population in NHANES, 2003-2010.” Environmental Health Perspectives, vol. 124, no. 10, 2016, pp. 1521–1528, NIH.gov website. 4. Andersen, H. R., Jeune, B., Nybo, H., Nielsen, J. B., Andersen-Ranberg, K., & Grandjean, P. (1998). Low activity of superoxide dismutase and high activity of glutathione reductase in erythrocytes from centenarians. Age and Ageing, 27(5), 643–648. 5. Jeong, E. M., Yoon, J.-H., Lim, J., Shin, J.-W., Cho, A. Y., Heo, J., … Kim, I.-G. (2018). Real-Time Monitoring of Glutathione in Living Cells Reveals that High Glutathione Levels Are Required to Maintain Stem Cell Function. Stem Cell Reports, 10(2), 600–614. 6. Sinha, R., Sinha, I., Calcagnotto, A., Trushin, N., Haley, J. S., Schell, T. D., & Richie, J. P. (2018). Oral supplementation with liposomal glutathione elevates body stores of glutathione and markers of immune function. European Journal of Clinical Nutrition, 72(1), 105–111.

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FDA Allows Emergency use of Antibody Drug President Trump Received

AHA Publisher — Mon, 23 Nov 2020 08:00:26 +0000

Associated Press via CBN News – U.S. health officials Saturday agreed to allow emergency use of a second antibody drug to help the immune system fight COVID-19, an experimental medicine that President Donald Trump was given when he was sickened last month. The Food and Drug Administration authorized use of the Regeneron Pharmaceuticals Inc. drug to try to prevent hospitalization and worsening disease from developing in patients with mild-to-moderate symptoms. The drug is given as a one-time treatment through an IV. The FDA allowed its use in adults and children 12 and over who weigh at least 88 pounds (40 kilograms) and who are at high risk of severe illness from COVID-19 because of age or certain other medical conditions. Emergency authorization allows use of the drug to start while studies are continuing to establish safety and effectiveness. Early results suggest the drug may reduce COVID-19-related hospitalization or emergency room visits in patients at high risk for disease progression, the FDA said. Regeneron said that initial doses will be made available to roughly 300,000 patients through a federal government allocation program. Those patients will not be charged for the drug but may have to pay part of the cost of giving the IV. Initial supplies will likely be vastly outstripped by demand as the U.S. has surged past 12 million reported cases, with the country facing what health experts say will be a dark winter due to the uncontrolled spread of the virus. Antibodies are proteins the body makes to target and help eliminate viruses, but it can take weeks for the best ones to form after an infection occurs. The drugs are concentrated versions of ones that proved best able to do this in lab and animal tests, and in theory, help the body start to fight the virus right away. The Regeneron drug is a combo of two antibodies to enhance the chances it will prove effective. Earlier this month, the FDA gave emergency authorization to a single-antibody drug from Eli Lilly that also is still being studied. There’s no way to know whether the Regeneron drug helped Trump recover; he received a host of treatments and most COVID-19 patients recover on their own. FDA regulators authorized the Regeneron drug using their emergency powers to quickly speed the availability of experimental drugs and other medical products during public health crises. In normal times the FDA requires “substantial evidence” to show that a drug is safe and effective, usually through one or more large, rigorously controlled patient studies. But during public health emergencies, the agency can lower those standards and require only that an experimental treatment’s potential benefits outweigh its risks. The emergency authorization functions like a temporary approval for the duration of the COVID-19 pandemic. To win full approval, Regeneron will have to submit additional research to fully define the drug’s safety and benefit for patients. The White House cast the decision as a victory for Trump’s efforts “to deliver cutting-edge treatments with highly promising results to protect the health and safety of the most vulnerable Americans,” according to a statement from spokesman Michael Bars. To read the original article click here. For more articles from CBN News click here.

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COVID Report Raises Questions About Fatality Rate, and Studies Show Sugar Puts You at Risk

AHA Publisher — Wed, 02 Sep 2020 07:00:05 +0000

News Staff via CBN News – New numbers from the CDC reveal 94 percent of Americans who have died from COVID-19 already had underlying health problems. This reinforces what doctors have been telling us all along, that the weakest among us are the ones who are most susceptible to the virus. CBN News Medical Reporter Lorie Johnson explains, “The data does not suggest that these people with underlying conditions would have died anyway from that condition if they had not been infected with coronavirus. It should not be interpreted to mean that the only ‘real’ coronavirus deaths are the ones where the patient had no underlying conditions.” Since God created us with immune systems to fight disease, Johnson points out we should work on improving our health to make us less vulnerable to serious complications from viruses like COVID. “We need to stay as healthy as possible, because that way our body is better able to fight off the virus if it enters our body,” she explained on CBN Newswatch. “Believe it or not, doctors recommend eating less sugar because new research shows too much sugar can blunt our body’s ability to fight off the virus.” Johnson spoke with Dr. Michael Goran, a sugar researcher at USC who said since COVID could be with us for a while, now is a good time to give up sugar. “Clearly a high sugar diet in the long term is going to contribute to longer-term increases in your blood glucose levels,” he began. “And what these studies are showing is that when you have a higher blood glucose level in general it contributes to this kind of broad, across-the-body, low-grade state of inflammation that comes along with that high blood glucose.” “And so what these studies are showing is that when you have that low-grade inflammation across the body, when you actually get an infection, like from COVID-19, the response becomes a little abnormal and the body responds to the low-grade inflammation throughout the body instead of just attacking the COVID. So it’s not a good thing to have broad-scale inflammation in the body when your immune system needs to fight COVID-19.” “The combination is not very good and you have a greater amount of complications to the infection because the thinking is that the immune system is attacking other parts of the body instead of the COVID 19,” he explained. Dr. Goran just wrote a book called Sugarproof that comes out on September 1, and it’s all about how sugar harms children. The book offers practical advice about how to get them off the sweet stuff and even includes recipes. Childhood obesity is a known problem in America, but even skinny kids often eat too much sugar which can adversely affect their development. It can cause attention problems, anxiety and inflammatory conditions such as asthma and acne. And beware that even if you’re buying organic cereal and goat milk yogurt don’t think they are low in sugar. Meanwhile, the head of the Food and Drug Administration says he’s open to fast-tracking a COVID-19 vaccine before clinic trials are completed. Dr. Stephen Hahn told the Financial Times that, under the right circumstances, an emergency authorization could be approved while stage three trials are still underway. Dr. Hahn said the drug company would have to request emergency authorization before the FDA makes the decision. He stressed that pressure from the White House would not influence the decision. To read the original article click here. For more articles by CBN News click here.

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FDA Urges Consumers to Avoid Certain Brands of Toxic Hand Sanitizers That May Contain Methanol

AHA Publisher — Wed, 05 Aug 2020 07:00:07 +0000

Andrea Morris via CBN News – The use of hand sanitizer has become a standard practice after the WHO declared COVID-19 a pandemic back in March. The announcement sparked fear among millions, triggering them to panic purchase hand sanitizer which led to a national shortage. Production of the product ramped up and new brands hit store shelves, but the Food and Drug Associationbecame concerned over some sanitizers that potentially contained the dangerous ingredient methanol. Now, the FDA is taking action to alert consumers of the hazards associated with methanol and which products to avoid using. In a report from July 2, the FDA said it is “warning consumers and health care providers that the agency has seen a sharp increase in hand sanitizer products that are labeled to contain ethanol (also known as ethyl alcohol) but that have tested positive for methanol contamination. Methanol, or wood alcohol, is a substance that can be toxic when absorbed through the skin or ingested and can be life-threatening when ingested.” The agency announced that adults and children who ingested certain hand sanitizers tainted with methanol experienced “nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.” According to an “import alert” issued by the FDA on July 31, many of the hand sanitizers appear to have been manufactured in Mexico and should be avoided due to their potential health hazards. And the organization says it’s working to keep dangerous products out of the United States. “We remain extremely concerned about the potential serious risks of alcohol-based hand sanitizers containing methanol,” FDA Commissioner Stephen M. Hahn said in a statement. “Producing, importing, and distributing toxic hand sanitizers poses a serious threat to the public and will not be tolerated.” The Centers for Disease Control and Prevention (CDC) describe methanol as toxic alcohol that is colorless and watery. It is used as a solvent and pesticide which can be absorbed into the body by inhalation, ingestion, skin contact, or through eye contact. Find FDA information on contaminated hand sanitizers and the product code at the agency’s web site here. To read the original article click here. For more articles from CBN News click here.

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