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FDA serial warning! More than 100 kinds of hand sanitizers with insufficient alcohol content are blacklisted.
Release time:
2020-08-19 17:33
In June, the FDA just issued a warning to several hand sanitizers containing formaldehyde. Now, the FDA has issued another warning about hand sanitizers with insufficient alcohol content. Judging from the FDA's recent regulatory efforts, hand sanitizer products, which have seen a significant increase in sales during the epidemic, have become a key regulatory target for the FDA, and both product compliance and product labeling and product quality need to be taken seriously by exporters.
"FDA test results show that some hand sanitizers have low ethanol or isopropanol content, which are the active ingredients in hand sanitizer products." The agency said in an updated warning on July 31.
"The agency urges consumers not to use these products that are not effective enough, except for hand sanitizers that have been or may be contaminated with methanol, and their scope has been expanded to include hand sanitizers that are not effective enough."
In the United States, hand sanitizer is an over-the-Counter (OTC) for local disinfection. Like anti-dandruff shampoo, fluoride toothpaste, sunscreen and other products, it is regulated by FDA.
Any OTC product already on the market must meet certain conditions, otherwise it will be treated as an NDA. Drugs containing these active ingredients can directly apply for NDC and sell them on the OTC market without applying for NDA. At present, there are hundreds of active ingredients permitted by the US FDA to be used in OTC. The US FDA's management and identification of OTC ingredients are all published in the Federal Register. The relevant provisions amount to tens of volumes and hundreds of thousands of pages. Studying the management methods of US OTC is the professional work of professional lawyers and consultants. The NDC number applying for OTC must be seated accordingly.
New Anrun Consulting can provide export enterprises with all kinds of epidemic prevention materials exported to the United States FDA services:
For OTC products under the US FDA, the following services can be provided:
• apply for a Dun & Bradstreet number;
• Site registration;
• Apply for NDC;
• FDA product filings;
• Product label review.
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