FDA Update December 6, 2024 COVID Public Health Emergency Exemption from Fees to Expire FDA Reminds OTC Hand Sanitizer Manufacturers of OMUFA Facility Fees for FY 2025 FDA is reminding companies who registered with the agency solely to manufacture hand sanitizer during the COVID-19 public health emergency that they are subject to fiscal year (FY)
FDA Update No More Free Rides As FDA Reinstates OMUFA Facility Fees as of 2025 FDA is reminding companies who registered with the agency solely to manufacture hand sanitizer during the COVID-19 public health emergency that they are subject to fiscal year (FY) 2025 OMUFA facility fees, unless they delist and deregister before 12 a.m.
Public Safety Alert: Stricter Guidelines Issued by the FDA for Alcohol-Based Hand Sanitizers Will Go Into Effect for 2022 – Pre-COVID Requirements Will Resume As we progress under the COVID rules that were put into effect as part of the EUA, the FDA is starting to rescind these EUAs as the supply shortages have been
Durisan Announces a Voluntary Recall Expansion of its Antimicrobial Hand Sanitizer With more and more companies trying to get into the hand sanitizer manufacturing business, companies need to understand that these products can become contaminated and need to be removed from the market. Here is a notice of voluntary recall expansion of a Non-Alcohol
Coronavirus (COVID-19) Update: FDA Takes Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into US to Protect U.S. Consumers The FDA has just enacted a countrywide product alert on hand sanitizers being imported from Mexico. Many of these products appear to
Since the beginning of the pandemic, the FDA has been in observation of reports of serious adverse events related to ingestion of alcohol-based hand sanitizers. The FDA has also received numerous reports of dermal toxicity associated with these products. In the Spring 2020, FDA discovered a few hand sanitizer products that were labeled to contain
As we have learned during these “EUA” times and lack of FDA oversight on new companies manufacturing and selling various products during this pandemic, there are some very serious situations of adulterated products. The FDA is trying hard to monitor this situation and address critical issues as they pop up. The FDA’s investigation of contaminated
The FDA is warning consumers about certain hand sanitizer products, including those manufactured by Harmonic Nature S de RL de MI in Mexico, that are labeled to contain ethanol or isopropyl alcohol. After testing, they have proven to be contaminated with 1-propanol contamination. 1-propanol, not to be confused with 2-propanol/isopropanol/isopropyl alcohol, is a toxic and
ALCOHOL-BASED HAND SANITIZERS Due to COVID-19 pandemic, the FDA released an announcement on April 27, 2020 about the availability of alcohol-based hand sanitizer. The FDA wants to address safety concerns related to products being sold that are not in line with the FDA’s policy and others being marketed with unproven claims. Due to the increased
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