Before you export any hand sanitizer to the United States, register your establishment with the U.S. Food and Drug Administration (U.S. FDA), to avoid the detention of your shipment.
The global hand sanitizer market size valued at $2.7 billion and is expected to grow at a compound annual growth rate (CAGR) of 22.6% until 2027.
Your hand sanitizer must be manufactured in compliance with an FDA Monograph.
- Alcohol (ethanol) that is not less than 94.9% ethanol by volume or United States Pharmacopeia (USP grade) Isopropyl Alcohol
- Glycerin (glycerol) USP or Food Chemical Codex (FCC) (also known as “food grade”)
- Hydrogen peroxide
- Sterile water (by boiling, distillation, or other process that results in water that meets the specifications for Purified Water USP). Water should be used as quickly as possible after it is rendered sterile or purified.
▪ The alcohol (ethanol) is denatured either by the alcohol producer or at the point of production of the finished hand sanitizer product.
▪ The hand sanitizer is manufactured according to the formula consistent with World Health Organization (WHO) recommendations.
▪ The ethanol or isopropyl alcohol is used as active ingredient in the correct amount.
FDA test results show certain hand sanitizers have low levels of ethyl alcohol or isopropyl alcohol, which are active ingredients in these products.
The agency expanded its list of hand sanitizers consumers should not use, to include subpotent hand sanitizers, in addition to hand sanitizers that are or may be contaminated with methanol, also known as wood alcohol. Substantial methanol exposure can result in nausea, vomiting, headache, blurred vision, permanent blindness, seizures, coma, permanent damage to the nervous system or death.
Click here for the Spanish version: La FDA advierte a los consumidores sobre los riesgos de contaminación por metanol en algunos desinfectantes para las manos.
Because hand sanitizer is regulated by the FDA as an over-the-counter (OTC) drug product, your company will need a Drug Establishment Registration.
Such registration requires a DUNS (Data Universal Numbering System, abbreviated as DUNS or D-U-N-S) Number assigned by Dun & Bradstreet Inc. DUNS Number is free. Obtaining it in less than 30 days is possible for a fee.
A foreign company or registrant must provide the name, address, and phone number of the foreign registrant’s U.S. Agent, such as ITB HOLDINGS LLC.
The U.S. Food and Drug Administration will not confirm a registration, provide an FDA Establishment Identification (FEI) number, or provide confirmation of a registration renewal until ITB HOLDINGS LLC confirms it has agreed to serve as U.S. Agent.
All sanitizers must have a standard Drug Facts label.
Manufacturers, exporters, importers and distributors should be aware that the FDA will take action when:
- Certain hand sanitizers may not contain a sufficient amount of ethyl alcohol or isopropyl alcohol.
- Hand sanitizers are sold or offered for sale with false and misleading, unproven claims that they can prevent the spread of viruses such as COVID-19, including claims that they can provide prolonged protection (up to 24-hours).
- Products are fraudulently marketed as FDA-approved, since there are no hand sanitizers approved by FDA.
- Products are packaged to appear as drinks, candy or liquor bottles, because their appearance could result in accidental ingestion or encourage ingestion. Children are particularly at risk with these products, since ingesting only a small amount of hand sanitizer may be lethal in a young child.
- Products are labeled with harmful or poisonous ingredients, such as methanol.
Label Review or Update is available, when requested.
When your methods, facilities, or controls for manufacturing, processing, packing, or holding do not conform to CGMP, your product will be considered adulterated within the meaning of section 501(a)(2)(B) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. 351(a)(2)(B).
- Company Registration.
- Product Listing.
- U.S. Agent Service.
Manufacturers of Hand Sanitizers and Alcohol Wipes are no longer exempt from FDA User Fees, paid to the U.S. Treasury, every year. These fees tend to increase substantially.
Monograph Drug Facility (MDF) Facility Fee: $26,153.
Contract Manufacturing Organization (CMO) Facility Fee: $17,435.