Ethylene Oxide/Sterigenics Updates

Articles Tagged with FDA

Breast_implants_in_hand_01-300x200The FDA recently issued a safety communication warning about a link between breast implants and certain cancers that can develop in the scar tissue around implants.

This new agency warning does not include Breast Implant-Associated Anaplastic Large Cell Lymphoma which has previously been linked to certain Allergan textured breast implants. Those textured implants were recalled after being linked to 600 illnesses and 33 deaths.

New Cancer Link to Breast Implants

baby-2423896_1920-1-300x200Beech-Nut Nutrition is voluntarily recalling an infant rice cereal due to high levels of arsenic. The cereal impacted is the Single Grain Rice baby cereal with an expiration date of May 1, 2022. The reason for the recall is that the cereal exceeds the FDA’s limit of 100 parts per billion of arsenic.

In addition, the company announced that it will no longer market Single Grain Rice Baby Cereal, citing their commitment to infant safety and doubt about being able to consistently obtain rice flour below the FDA guidance level for inorganic arsenic as reasons for the decision. This is good news for parents who have been concerned about the recent reports of toxic heavy metals–including arsenic–in the baby food they feed their infants, but it is not enough. It’s critical that the other major baby food companies make the health and safety of children a priority as well.

The scrutiny of heavy metals in baby food is long overdue. Last year, a subcommittee of the U.S. House of Representatives Committee on Oversight and Reform, which had been investigating the presence of arsenic and other toxic metals in baby food, issued their final report. The report revealed that all of the major companies that responded to the agency’s request for internal testing documentation had arsenic in their baby food. Beech-Nut was not the only company with this problem; Gerber, Hain, and Nurture also had the same issue. Three other baby food companies—Walmart, Sprout Organic, and Campbell’s–did not cooperate with the investigation.

baby-food-1-300x300Baby food has been facing some much-needed scrutiny lately. A recently released Congressional report disclosed that many top baby foods, both organic and non-organic, are contaminated with dangerous levels of heavy metals such as arsenic, cadmium, lead, and mercury. This is especially concerning since both the World Health Organization and the FDA have concluded that these heavy metals pose a danger to human health, and to babies and children in particular.

The findings are the result of a year-long investigation by the House Committee on Oversight and Reform into heavy metals in baby food. Launched after a 2019 study by Healthy Babies Bright Futures found toxic metals in 95% of the baby food they tested, the Congressional investigation asked top baby food companies to voluntarily produce information about their testing policies and test results. Four companies responded to this request: Gerber, Beech-Nut, Hain, and Nurture. The Hain products are labeled as ‘Earth’s Best Organic’ and the Nurture products are labeled as ‘HappyBABY’. Three other companies—Walmart, Sprout Organic, and Campbell–did not cooperate, according to the Congressional report.

The responses to the Congressional inquiry revealed a major problem: all of the companies had used ingredients containing heavy metals in their baby food. Not only that, but the companies had routinely ignored their own standards for toxic metals, continuing to sell tainted baby food to families. And most of the companies had failed to test their finished baby food products for toxic metals, despite an industry admission that testing only the ingredients might underestimate the amount of heavy metals in the finished product. Below are the some of the results included in the Congressional report. (Keep in mind that these numbers are from the companies’ own test results, not results from an independent lab.)

Hand-sanitizer-225x300Washing your hands with soap and water is always the best option for keeping your hands clean, but we don’t always have access to soap and water. That’s where hand sanitizer comes in. Hand sanitizers have never been as popular or necessary as they are right now. Unfortunately, the increase in demand for hand sanitizers has led to some dangerous products being on the shelves. There has been a dramatic increase in hand sanitizers containing methanol, also referred to as wood alcohol. Methanol has no place in hand sanitizers given that it can be toxic when absorbed through the skin or ingested. To make matters worse, the methanol found in hand sanitizers is not being labeled as an ingredient on the product itself, meaning we have to be extremely careful about what products we are buying and using during this time.

What is Methanol?

 Methanol is a volatile, flammable liquid that is commonly used in antifreeze and fuel production. Exposure to methanol can cause agitation, headaches, dizziness, nausea, amnesia, seizures, and comas. If hand sanitizer containing methanol is ingested, blindness or death can occur. Under no circumstances should methanol be used in hand sanitizers.

It sometimes seems these days as if taking an herbal supplement is akin to gambling…you never know what you are going to get.

Just last week, the FDA issued its first mandatory recall of kratom products after Triangle Pharmaceuticals refused to comply with a March 30th agency request for a voluntary recall. That earlier action came after 87 people in 35 states became sick with salmonella after ingesting kratom supplements. Of those 87 people, 27 were sick enough to require hospitalization. Multiple companies that market kratom products conducted recalls, but Triangle Pharmaceuticals, despite having samples of their kratom products test positive for salmonella, refused to cooperate, forcing the FDA to issue the mandatory recall.

The recalled products include supplements such as Raw Form Organics Maeng Da Kratom Emerald Green, Raw Form Organics Maeng Da Kratom Ivory White, and Raw Form Organics Maeng Da Kratom Ruby Red.

crying-1315546_1920.jpgIf you are a parent who has been giving Miralax to your child thinking that it is a safe way to help with constipation, you may want to wait until the investigation of Miralax at the Children’s Hospital of Philadelphia is finished.

According to Philly Voice, the Children’s Hospital has been given an FDA grant to study parent reports of disturbing and scary side effects possibly caused by this over the counter medication. 1 This is in response to 167 reports of adverse side effects-including neurological and psychiatric events–in children who took Miralax, received by the FDA before 2012. Moreover, the ABC 6 Action News team found more than 5 times that many adverse reports in the FDA’s records up through 2016. Those documents show that the families of 950 children have reported adverse events to the FDA after their child took Miralax, ranging from mouth ulcers to suicidal thoughts, mood swings, aggression, and seizures. 2

None of this should come as a surprise to the FDA, which added Miralax to its Adverse Event Reporting System in connection with “neuropsychiatric events” such as autism, dementia, depression, schizophrenia, multiple sclerosis, Alzheimer’s and Parkinson’s disease, back in 2011. 3

Co-authored by Jacob Exline of The Collins Law Firm, P.C.

On August 24, the U.S. Food and Drug Administration (FDA) reported a recall of 13 different dietary supplements produced by Novacare, LLC due to an undeclared ingredient, salicylic acid, which is harmful to consumers if swallowed. The FDA performed a sample analysis, found the salicylic acid, and subsequently marked the products as unapproved new drugs. The Novacare products are used to aid in weight loss and are taken orally in capsule form. While the products have not yet been reported to have caused any injuries, they should be immediately returned to the Utah-based company.

Salicylic acid is a drug used to treat skin problems such as pimples. However, if swallowed, it is toxic and harmful to consumers. Salicylic acid can cause nausea, vomiting, gastrointestinal irritation, loss of hearing, and sweating as well as severe reactions of blurred vision, mental confusion, cerebral edema and cardiorespiratory arrest (which could be life-threatening). The FDA states that those who are allergic, elderly, have a history of stomach problems, or consume three or more alcoholic drinks a day have a higher risk of toxicity.

Co-authored by Gregory Zimmer of The Collins Law Firm, P.C.

The Food and Drug Administration is hard at work. The first half of this month has already had 3 recalls of nuts tainted with Salmonella and 2 recalls of pet food due to Listeria contamination.1 These recalls follow the highly publicized multistate Listeria outbreak from affected Blue Bell ice cream products which resulted in 10 hospitalizations and 3 deaths.2 While the FDA catches many issues before they are widespread, you may still be at risk. How do you know if you are one of the unlucky few who are affected, and what do you do next?

Foodborne illness typically present symptoms hours or days after contaminated food is consumed, but people can sometimes develop illnesses up to 2 months later.3 You can check here4 for recent and ongoing food recalls.

The U.S. Food and Drug Administration (FDA), the Centers for Disease Control and Prevention (CDC) and state and local health officials investigated an outbreak of Salmonella Bredeney infections linked to Trader Joe’s Valencia Creamy Salted Peanut Butter, with SKU # 97111, made by Sunland Inc. of Portales, New Mexico. On November 30, 2012, the CDC issued a final update reporting that this outbreak appeared to be over after a total of 42 people from 20 states (including Illinois) were infected. Other affected states include Arizona, California, Connecticut, Louisiana, Massachusetts, West Virginia, Maryland, Michigan, Minnesota, Missouri, New Jersey, New Mexico, New York, Nevada, North Carolina, Pennsylvania, Rhode Island, Texas, and Virginia. Most people injured by the contaminated food were infected with Salmonella and developed diarrhea, fever, and abdominal cramps 12 to 72 hours after infection. The illness usually lasts from four days to a week. In some people, the diarrhea may be so severe that the patient needs to be hospitalized. In these patients, the Salmonella infection may spread from the intestines to the bloodstream, and then to other body sites and can cause death unless the person is treated promptly with antibiotics. Young children, the elderly, and those with compromised immune systems are the most likely to have severe infections. It is estimated that Approx. 400 persons die every year with acute salmonellosis. The FDA found that between June 2009 and August 2012, Sunland Inc. had distributed, or cleared for distribution, peanut, and almond butter after testing identified the presence of at least one of nine different Salmonella types in those lots. Two of these lots showed the presence of the outbreak strain of Salmonella Bredeney. Further, during the inspection of the processing plant in 2012, the FDA found the presence of Salmonella in numerous environmental samples, including Salmonella Bredney. Investigators found that employees improperly handled equipment used to hold and store food. There were no handwashing sinks in the peanut processing building production or packaging areas and employees had bare-handed contact with ready-to-package peanuts. This is in addition to numerous other problems with the handling and storage of equipment, and products, both raw and cooked. On November 26, 2012, the FDA suspended the “food facility” registration of Sunland, Inc. which is required for a facility that manufactures, processes, or holds food in the United States. This was the FDA’s first use of its suspension authority under the Food Safety Modernization Act. On December 21, 2012, U.S. District Judge William P. Johnson signed a consent decree imposing requirements on Sunland keep potentially harmful products from entering the market. Based on the requirements of the decree, the FDA reinstated Sunland’s food facility registration. However, the company cannot process or distribute food from its peanut butter plant or peanut mill plant until it has complied with the consent decree’s requirements to the FDA’s satisfaction. The consent decree requires actions including that Sunland retain an independent sanitation expert to develop a sanitation control program that the company must then implement, and, the company must conduct environmental monitoring and testing to ensure that disease-causing organisms are not present in its facility or in its food products. Hopefully, all these steps will go a long way toward preventing any future injuries due to food poisoning or other foodborne illnesses. More information on the situation can be found by clicking here.

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