FDA emergency stop methanol hand sanitizer export!

Release time:

2020-06-23 17:26

Recently, the US FDA issued a notice advising consumers not to use any hand sanitizer made by Eskbiochem SA de CV (Mexico) because of the possible presence of methanol. Methanol is a toxic substance that can be absorbed through the skin or ingested. The FDA tested samples of two of these products-Lavar Gel and CleanCare No Germ. CleanCare No Germ contains 28%(v / v) of methanol. Methanol is not an acceptable component of hand sanitizer and should not be used due to its toxic effects.

Consumers who have been exposed to methanol-containing hand sanitizers should seek immediate treatment, which is essential to potentially reverse the toxicity of methanol poisoning. High exposure to methanol can cause nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent neurological damage, or death. Although everyone who uses these products on their hands is at risk, young children who accidentally ingest these products, as well as adolescents and adults who consume these products in the form of alcohol (ethanol) substitutes, are most at risk of methanol poisoning.

The FDA reminds consumers to wash their hands often with soap and water for at least 20 seconds, especially after going to the bathroom; before eating; after coughing or sneezing. If soap and water are not available, the Centers for Disease Control and Prevention (CDC) recommends that consumers use alcohol-based hand sanitizers that contain at least 60 percent ethanol.

What is the FDA (US Food and Drug Administration)?

The Food and Drug Administration (FDA) is one of the executive agencies set up by the U.S. government in the Department of Health and Human Services (DHHS) and the Department of Public Health (PHS). This institution is closely related to the life of every American citizen. Internationally, the FDA is recognized as one of the world's largest food and drug regulatory agencies. Many other countries promote and monitor the safety of their products by seeking and receiving FDA assistance.

Beginning on March 31, 2019, the FDA began implementing an institutional restructuring. The FDA's reorganization reflects the agency's commitment to modernizing its structure to advance its mission of protecting and promoting public health and to address the challenges of rapid innovation in the industry FDA regulates. Food and Drug Administration (FDA) supervisor: supervision and inspection of food, drugs (including veterinary drugs), medical devices, food additives, cosmetics, animal food and drugs, wine beverages with alcohol content less than 7%, and electronic products; also includes cosmetics, Radiated products, combination products and other electronic products and medical products related to personal health and safety. Testing, inspection and certification of items that affect human health and safety by ionic and non-ionic radiation generated during the use or consumption of products.

According to the regulations, the above products must be tested by FDA to prove their safety before they can be sold on the market. The FDA has the right to inspect manufacturers and to prosecute violators.

FDA Hand Sanitizer Registration Notice

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.

According to Article 201 under Volume 21 of the United States Code of Federal Regulations (CFR) of 1938 and the provisions on "Grandfather Clause" in Regulation 107(C) amending Volume 21 of the United States Code of Federal Regulations of 1962, drugs that have been listed before the implementation of these regulations are not managed as new drugs, but their active ingredients are required to be re-recognized by FDA and are considered as "Generally Recognized as Safe and Effective and Not Misbranded". Recognized ingredients are published by the FDA with dosage ranges and attending functions.

Any OTC product already on the market must meet the above conditions, otherwise it will be processed according to 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 epidemic prevention materials exported to the United States FDA services:

For US OTC products, the following services are available:

Apply for a Dun & Bradstreet number;

Apply for FDA product filing;

Product label review, etc.

K-REACH joint registration, the South Korea government urges you to move!

"Special Control of Hazardous Chemicals Catalogue" is coming. Methanol and ethanol are all in the catalogue!

K-REACH joint registration, the South Korea government urges you to move!

"Special Control of Hazardous Chemicals Catalogue" is coming. Methanol and ethanol are all in the catalogue!

Latest developments

Key Illustration of Railway Transportation Regulations for Consumer Lithium Battery Cargo

Recently, the Ministry of Industry and Information Technology of the National Railway Administration China National Railway Group Co., Ltd. announced the guidance on the railway transportation of consumer lithium battery goods. For details, please refer to our public article. Official