Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition - FDA.gov

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According to the FDA:

"The U.S. Food and Drug Administration (FDA) recommends that parents and caregivers do not use infant head shaping pillows intended to change an infant’s head shape or symmetry or claim to prevent or treat any medical condition. The FDA is not aware of any demonstrated benefit with the use of infant head shaping pillows for any medical purpose. The use of head shaping pillows can create an unsafe sleep environment for infants and may contribute to the risk of suffocation and death.

Infant head shaping pillows are not FDA-approved. The safety and effectiveness of these products have not been established ... "

Source: 

Do Not Use Infant Head Shaping Pillows to Prevent or Treat Any Medical Condition: FDA Safety Communication - FDA.gov

Do Not Use Baby Neck Floats Due to the Risk of Death or Injury - FDA.gov

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According to the safety communication:

"The U.S. Food and Drug Administration (FDA) is warning parents, caregivers, and health care providers not to use neck floats with babies for water therapy interventions, especially with babies who have developmental delays or special needs, such as spina bifida, spinal muscular atrophy (SMA) type 1, Down syndrome, or cerebral palsy. The use of these products can lead to death or serious injury."

Read the full safety communication:  Do Not Use Baby Neck Floats Due to the Risk of Death or Injury: FDA Safety Communication - FDA.gov

Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe - FDA.gov

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According to the FDA:

"Consumers need to beware of products to lighten or whiten their complexion. These products, which include both injectable skin whitening and skin bleaching products, are potentially unsafe and ineffective, and might contain unknown harmful ingredients or contaminants.

Injectable skin whitening products are marketed for injection into a vein or muscle or under the skin. They are sold online and in some retail outlets and health spas. They often promise to lighten the skin, correct uneven skin tone, and reduce blemishes. Some products even claim to treat conditions such as liver disorders and Parkinson’s disease.

Although the average consumer might not assume so, these products are unapproved new drugs whose sales are not condoned by the U.S. Food and Drug Administration (FDA). The FDA has not approved any injectable drugs for skin whitening or lightening."

Source:  Injectable Skin Lightening and Skin Bleaching Products May Be Unsafe - FDA.gov

Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses

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Halloween Safety Tips: Costumes, Candy, and Colored Contact Lenses - FDA.gov

According to the FDA: 

"Enjoy a safe and happy Halloween by following these guidelines.

Halloween is fast approaching, and you and your kids may be celebrating it a bit differently this year. Whatever form your celebration takes, make sure it includes safe hygiene practices such as covering your mouth and nose with a cloth face covering or mask when around others, maintaining social distance and frequent hand washing.  The Centers for Disease Control also have tips for protecting yourself and others.

Whether you’re a ghost or zombie, vampire or witch, poor costume choices—including decorative (colored) contact lenses and flammable costumes—and face paint allergies can cause injuries that haunt you long after Halloween.

Enjoy a safe and happy Halloween by following these guidelines from FDA, the Consumer Product Safety Commission, and the Centers for Disease Control and Prevention:" ...

Millions of Americans receive drugs by mail. But are they safe? - NBC News

 According to the article:

"Millions of Americans receive their medications by mail but many, like Becker, find themselves forced to do so by their insurance plans or face the prospect of paying exorbitant amounts for the same drugs. 

An NBC News investigation found the growth of mail-order pharmacies has caused many people to feel trapped in a system that has left them with crushed pills, damaged vials and lifesaving drugs exposed to extreme weather.  ...

Interviews with more than 65 mail-order pharmacy customers across the nation revealed deep worries over how their medication is delivered — and no affordable alternatives. Many reported receiving drugs in flimsy packaging without temperature indicators, which can cost as little as a dollar per package. Others have had to plead with pharmacies to send them replacement drugs after receiving medication they thought arrived too warm or cold."

Read the full source article:  Millions of Americans receive drugs by mail. But are they safe? - NBC News

Americans Took Prevagen for Years—as the FDA Questioned Its Safety - WIRED

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Read the full source article:  Americans Took Prevagen for Years—as the FDA Questioned Its Safety - WIRED

According to the article:

"Commercials for Prevagen have insisted that “it’s safe and effective,” an assurance Quincy echoed to regulators. But an investigation by WIRED now shows that for years officials at the FDA questioned the basis for the company’s claims. Multiple FDA inspections, most of which have not been reported before, found significant issues with Quincy’s manufacturing processes, complaint handling, and the quality control testing that was supposed to ensure its products were safe.

And thousands of Americans have reported experiencing “adverse events” while taking Prevagen, including seizures, strokes, heart arrhythmias, chest pain, and dizziness. While the existence of adverse event reports alone don’t prove a product is the cause, the nature and pattern of complaints about Prevagen worried FDA officials, according to agency records. One internal report from 2015 stated that the “numerous adverse events reported” indicated “a serious safety hazard.” "

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Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication - FDA.org

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Updated April 11, 2024

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Dental Amalgam Fillings - FDA.gov

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Read the full FDA Safety Communication:  

Recommendations About the Use of Dental Amalgam in Certain High-Risk Populations: FDA Safety Communication - FDA.org

According to the communication:

"The U.S. Food and Drug Administration (FDA) is providing recommendations about the use of dental amalgam in certain groups of people who may be at greater risk to the potential adverse health effects of mercury exposure, to include:

• Pregnant women and their developing fetuses;
• Women who are planning to become pregnant;
• Nursing women and their newborns and infants;
• Children, especially those younger than six years of age;
• People with pre-existing neurological disease;
• People with impaired kidney function; and
• People with known heightened sensitivity (allergy) to mercury or other components of dental amalgam."

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FDA warns 15 companies for illegally selling various products containing CBD - FDA.gov

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FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns - FDA.gov

Violations include marketing unapproved new human and animal drugs, selling CBD products as dietary supplements, and adding CBD to human, animal foods

According to the FDA news release:

"Today, the U.S. Food and Drug Administration issued warning letters to 15 companies for illegally selling products containing cannabidiol (CBD) in ways that violate the Federal Food, Drug, and Cosmetic Act (FD&C Act). The FDA also published a revised Consumer Update detailing safety concerns about CBD products more broadly. Based on the lack of scientific information supporting the safety of CBD in food, the FDA is also indicating today that it cannot conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food."

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Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys - FDA.gov

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Read the full article:  Statement on FDA’s scientific work to understand per- and polyfluoroalkyl substances (PFAS) in food, and findings from recent FDA surveys - FDA.gov

"PFAS are a family of human-made chemicals that are found in a wide range of products used by consumers and industry. There are nearly 5,000 types of PFAS, some of which have been more widely used and studied than others. Many PFAS are impermeable to grease, water and oil. For this reason, beginning in the 1940s, PFAS have been used for many different applications including in stain- and water-resistant fabrics and carpeting, cleaning products, paints and fire-fighting foams, as well as in limited, authorized uses in cookware and food packaging and processing, referred to as food contact substances."

" ... the FDA has been working to develop new methods to quantify certain per- and polyfluoroalkyl substances (PFAS) in foods. We have employed these new methods to test samples of foods Americans typically consume for certain types of PFAS, and today we are making available recently analyzed data from these initial testing initiatives.

Overall, our findings did not detect PFAS in the vast majority of the foods tested. In addition, based on the best available current science, the FDA does not have any indication that these substances are a human health concern, in other words a food safety risk in human food, at the levels found in this limited sampling. These data give our scientists a benchmark to use as we continue our critical work studying this emerging area of science."

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What six things a Food Safety Lawyer does not eat | Food Poison Journal

You've got to view the 6 things: What six things a Food Safety Lawyer does not eat | Food Poison Journal:

"What six things a Food Safety Lawyer does not eat"

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Destroying the FDA to save it? No, more like just destroying it. – Respectful Insolence

Look into this crystal ball:  Destroying the FDA to save it? No, more like just destroying it. – Respectful Insolence:

"First the 21st Century Cures Act passes, weakening the FDA. Next, we’ll very likely end up with either a batshit nutty libertarian who doesn’t believe the FDA should require evidence of efficacy before approving drugs or a real, honest-to-goodness pharma shill as the next commissioner of the FDA. It’s going to be a long four years."

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Making Progress in Protecting Consumers from Unsafe Supplements | FDA Voice

Read Dr. Ostroff's (FDA) full comments: Making Progress in Protecting Consumers from Unsafe Supplements | FDA Voice:

"We want to expand our use of criminal investigation and enforcement tools to address serious safety-related violations and cases of intentional fraud; and further build strategic investigatory and enforcement collaborations with the Federal Trade Commission, Department of Justice, and state governments, including state health departments and attorneys general.

Ultimately our top priority is to protect the consumers who want to improve, not damage, their health and have a right to expect that dietary supplements will be safe for them and their families."

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The F.D.A.’s Medical Device Problem - The New York Times

Read the full op-ed: The F.D.A.’s Medical Device Problem - The New York Times:

"The 21st Century Cures Act would subject millions of Americans to unsafe or untested medical devices. We urge the Senate, as it takes up the bill, to avoid these dangerous provisions. Unlike medical drugs, which can readily be discontinued if problems are found, many medical devices are permanently implanted and cannot easily be removed if found to be defective. Stricter evidence standards and increased federal funding of the F.D.A. are needed to ensure that innovative medical devices lead to better health."

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#FDA #GMP #training #cGMP

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Hurricane Safety Checklist - FDA Public Health Focus

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Updated September 4, 2024:

The original link broke.

You can still read about the same topic here, on FDA.org:

https://www.fda.gov/consumers/consumer-updates/hurricane-season-be-prepared

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View the entire checklist: Public Health Focus > Hurricane Safety Checklist:

"The FDA reminds consumers to take precautions for storing water and ensuring the safety of their food and medical supplies for themselves, their families, and their pets during and after any hurricane-related rain, possible flooding and power outages.

The agency also reminds consumers that it is important to have a plan in place for emergency medication and medical supplies for both people and animals. This is especially true for those with health concerns, particularly if the power goes out.

In general, FDA encourages consumers to:" . . .

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FDA seeks more data on safety of hospital hand cleaners - Yahoo News

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Updated October 6, 2021

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FDA seeks more data on safety of hospital hand cleaners - Medical Xpress

Safely Using Hand Sanitizer - FDA.gov

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Read the full article: FDA seeks more data on safety of hospital hand cleaners - Yahoo News:

"Federal health officials say more information is needed to establish the safety and effectiveness of common hand cleaners used in hospitals, doctors' offices and nursing homes to kill germs and prevent infections.

The Food and Drug Administration is asking manufacturers to submit additional data about medical hand washes and sanitizers, including the long-term effects of their daily use on the skin."

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FDA Safety Communications > Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication

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Updated October 15, 2022

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Use Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication - FDA.gov

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The FDA is Recommending Transition to Duodenoscopes with Innovative Designs to Enhance Safety: FDA Safety Communication - FDA.gov

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Read the entire communication: Safety Communications > Design of Endoscopic Retrograde Cholangiopancreatography (ERCP) Duodenoscopes May Impede Effective Cleaning: FDA Safety Communication - FDA.gov:

"The FDA wants to raise awareness among health care professionals, including those working in reprocessing units in health care facilities, that the complex design of ERCP endoscopes (also called duodenoscopes) may impede effective reprocessing. Reprocessing is a detailed, multistep process to clean and disinfect or sterilize reusable devices. Recent medical publications and adverse event reports associate multidrug-resistant bacterial infections in patients who have undergone ERCP with reprocessed duodenoscopes, even when manufacturer reprocessing instructions are followed correctly. Meticulously cleaning duodenoscopes prior to high-level disinfection should reduce the risk of transmitting infection, but may not entirely eliminate it."

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Food additives on the rise as FDA scrutiny wanes - The Washington Post

Read the full article: Food additives on the rise as FDA scrutiny wanes - The Washington Post:

"The explosion of new food additives coupled with an easing of oversight requirements is allowing manufacturers to avoid the scrutiny of the Food and Drug Administration, which is responsible for ensuring the safety of chemicals streaming into the food supply.

And in hundreds of cases, the FDA doesn’t even know of the existence of new additives, which can include chemical preservatives, flavorings and thickening agents, records and interviews show.

“We simply do not have the information to vouch for the safety of many of these chemicals,” said Michael Taylor, the FDA’s deputy commissioner for food."

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Put Medicines Up and Away For Child Safety

The FDA emphasizes that it's National Safety Month.

View the website of: Up and Away:

"Any kind of medicine or vitamin can cause harm if taken in the wrong way, even medicine you can buy without a prescription. Walk around your house and find a storage place too high for a child to reach or see."

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FDA - Consumer Updates > Temporary Tattoos May Put You at Risk

Consumer Updates > Temporary Tattoos May Put You at Risk - FDA:

"However, "just because a tattoo is temporary it doesn't mean that it is risk free," says Linda Katz, M.D., M.P.H., director of FDA's Office of Cosmetics and Colors. Some consumers report reactions that may be severe and long outlast the temporary tattoos themselves."

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More from the FDA:

• Tattoos & Permanent Makeup
• Cosmetics
• Inked and Regretful: Removing Tattoos
• Think Before You Ink: Are Tattoos Safe?
• Tattoo Inks Pose Health Risks
• Five Tips for a Safer Spring Break

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Is the mythical "five-second rule" actually real? - CBS News

Is the mythical "five-second rule" actually real? - CBS News:

"New research finds that there is some truth to the so-called "five-second rule" -- the belief that food is safe to eat if picked up from the floor in under five seconds.

Researchers at Aston University in Birmingham, U.K. studied the rate of bacteria transfer in food items dropped on the floor and picked up within three to 30 seconds. They found that the amount of time an item spent on the floor was directly related to bacteria levels."

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