Importers continue to look into bringing more hand sanitizes to fulfill market demands

Updated: Jun 9, 2020



Hand sanitizer gel has been around for a long time. It was invented in 1966 by a student nurse. You can use hand sanitizer to reduce the number of microbes on your hands. To be effective, hand sanitizer needs to contain at least 60% -75% isopropyl alcohol. As today’s economic and health climate continues into uncertainty, many medical supplies goods are still in huge demand including hand sanitizers.


To import hand sanitizer into the USA, you have to first think of its relevant FDA requirement. Hand Sanitizer is always considered a drug by FDA standards if it contains an active ingredient. Typically hand sanitizer contains alcohol (ethanol or ethyl alcohol), isopropyl alcohol, and benzalkonium chloride – which are all considered to be active ingredients.

The following information must be reported to the FDA for products categorized as drugs:

  1. FDA Actual Manufacturer

  2. Drug Listing Number (Formerly NDC Number)

  3. Drug Registration Number (DUNS Number)


How to check a hand sanitizer brand's NDC code


https://www.accessdata.fda.gov/scripts/cder/ndc/index.cfm



I typed the property name PURELL, it gives me a full list of PURELL hand sanitizer that is approved by the FDA to be sold in the market



Although the NDC code is not required to appear on the drug labels itself it is required information as part of customs clearance


Duty rate of Hand Sanitizer


The applicable subheading for the HandSanitizer 3824.99.9297, HTSUS, which provides for Prepared binders for foundry molds or cores; chemical products and preparations of the chemical or allied industries (including those consisting of mixtures of natural products), not elsewhere specified or included: Other: Other: Other: Other: Other: Other. The rate of duty will be 5%. If the hand sanitizer is imported from China, the US-China trade war list 3 still applies with an additional 25% duty rate using 9903.8803 HTSUS.


Recent Warning from FDA office


Recently, The Food and Drug Administration states that it has recently become aware that some entries of hand sanitizers have been disclaimed to the FDA and the full message set was not filed for FDA review. Additionally, some entries of hand sanitizers have been transmitted as cosmetics instead of drugs. This is a big NO-NO


FDA is taking some firm actions toward these shipments. Penalty or CF28 Notice of action is on the way to these importers. So please remember hand sanitizers are drugs regulated by FDA agency. As such, you never instruct your broker to simply disclaim FDA or clear as cosmetics instead of OTC.



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