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ACI, CHPA Urge FDA: Withdraw Allowance for Emergency Sanitizer Production


ACI, CHPA Urge FDA: Withdraw Allowance for Emergency Sanitizer Production
April 30, 2021
Contact Author Rachel Grabenhofer
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In an appeal to the U.S. Food and Drug Administration (FDA), the American Cleaning Institute (ACI) and Consumer Healthcare Products Association (CHPA) urged the agency to withdraw its emergency guidance allowing non-traditional manufacturers to produce hand sanitizers, citing safety concerns.
The ACI and CHPA wrote, In the early days of the COVID-19 pandemic, FDA issued its Guidance for Industry: Temporary Policy for Preparation of Certain Alcohol-Based Hand Sanitizer Products During the Public Health Emergency (COVID-19), to help meet unprecedented demand, allowing non-traditional sanitizer companies to manufacture these FDA-regulated products. While FDA’s temporary guidance provides instructions for developing hand sanitizers, the newer manufacturers were not required to meet FDA’s typical manufacturi ....

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FDA Issues More Sanitizer Warnings, Posts Microbe-related Recalls


FDA Issues More Sanitizer Warnings, Posts Microbe-related Recalls
February 25, 2021
Contact Author Rachel Grabenhofer
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In the past few weeks, the U.S. Food and Drug Administration (FDA) has issued a warning letter and added five entries to its do not use sanitizer list over product sub-potency. It also flagged four foaming hand soaps recalled for possible microbe contamination.
Warning Letter: Insufficient (58%) Ethanol Content
A warning letter issued on Feb. 18, 2021, to Absaea Cosmetics, of Emiliano Zapata, Mexico, the FDA states, Following an attempt to import Fragrance Free Vlanc + Plur Hand Sanitizer Rinse Free Formulated with 70% of Alcohol with Aloe Vera & Glycerin into the United States, it was detained and refused admission at the border. The results of the FDA laboratory testing of a batch of this product detained at the border demonstrate that this drug product labeled as manufactured at your facility is adulter ....

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900+ Hand Sanitizer Poisonings, Mexican Imports Put on FDA Alert


900+ Hand Sanitizer Poisonings, Mexican Imports Put on FDA Alert
February 8, 2021
Contact Author Rachel Grabenhofer
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CBS News, the increased use of hand sanitizers has led to a surge in accidental poisonings, most involving children. The National Poison Data System registered 938 hand-sanitizer exposure cases from 55 different U.S. Poison Control Centers during the 10 day period alone of Jan. 1 to Jan. 10, 2021. This marks a 57% increase from the year prior and of those cases, nearly 600 involved children ages five and younger.
The U.S. Food and Drug Administration (FDA) has been issuing product alerts for several months now, warning consumers and continulally updating its do not use list of sanitizers for those found to contain, or suspected of containing, methanol; in addition to subpotent products. As  ....

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Methanol Content and How to Test for it: FDA Guidance


Methanol Content and How to Test for it: FDA Guidance
January 22, 2021
Contact Author Rachel Grabenhofer
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Since relaxing the rules last March to quickly fulfill a desperate hand sanitizer need, the U.S. Food and Drug Administration (FDA) has been watching products flood the market and flagging those tested or suspected to contain dangerous methanol in its do not use list.
Now, the agency has released a guidance policy for manufacturers to test for this contaminant in alcohol (ethanol) and ispropyl alcohol supplies before they are used for hand sanitizer production.
According to the policy:
In response to the demand for alcohol-based hand sanitizers during the COVID-19 public health emergency, FDA issued temporary policies for the manufacture of alcohol-based hand sanitizer products and ethanol for use in alcohol-based hand sanitizer. The temporary policies explain that FDA does not intend to take action against firms w ....

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FDAs Sanitizer Hotlist Cites Nevada Distributor, Calls Out Subpotency and Methanol


FDA s Sanitizer Hotlist Cites Nevada Distributor, Calls Out Subpotency and Methanol
January 13, 2021
Contact Author Rachel Grabenhofer
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not use.
As previously noted, the FDA s list flags hand sanitizer products implicated or known for methanol and 1-propanol content or subpotent efficacy, among other complaints. Last quarter (October 2020), several products were added from China. This quarter includes more additions from China and Mexico, along with one Nevada, USA distributor.
The following companies and products appeared on the FDA s list between Nov. 10, 2020, and Jan. 11, 2021. For the complete list, see the FDA website.
Simex Logistics SA de CV (Mexico), for its Health & Hand Gel Hand Sanitizer, which was FDA-tested and found to contain subpotent ethanol alcohol levels. The FDA recommended a company recall on Nov. 10, 2020, and added the firm to an import alert to stop its products from entering the U.S. on Nov. 17 ....

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