Selling into the United States

Cosmetic manufacturers and processors must register their facilities with FDA and renew that registration every two years.

Registration is a standing obligation with a clock on it, not a one-time filing.

The responsible person must list each marketed cosmetic product with FDA, including its ingredients, and provide updates annually.

Every SKU you ship into the US carries a filing, and a reformulation is a filing event.

FDA can order a mandatory recall of an adulterated or misbranded cosmetic likely to cause serious harm, and can suspend a facility’s registration, after which distributing product from that facility in the United States is a prohibited act.

One suspended registration stops the whole line, not one SKU, so your manufacturer’s compliance is your commercial risk.

FDA regulates sunscreens as it does other nonprescription drug products, holding them to safety and effectiveness standards rather than treating them as cosmetics.

A Korean SPF product crosses the border as a drug, which is a different filing, a different label and a different timeline from the rest of your range.

A Federal Trade Commission rule effective 21 October 2024 prohibits the sale or purchase of fake consumer reviews and testimonials, including AI-generated ones and those from people with no actual experience of the product, and allows the FTC to seek civil penalties against knowing violators.

Seeding a US launch with reviews is no longer a growth tactic with reputational downside, it is a rule with a fine attached, and the agency named AI-generated reviews explicitly.

A Korean plant that manufactures or processes cosmetics distributed in the United States falls inside the FDA’s definition of a facility, which is written around where the product is sold rather than where the plant stands.

Contract manufacturing in Korea does not put you outside the US registration regime; it puts your manufacturer inside it.

Among United States food recalls where an undeclared allergen is named, the allergen named most often is milk, on 31% of them. In order: milk 31%, soy 17%, wheat 15%. Counted across 9,253 allergen mentions in 6,665 records; one record can name more than one allergen.

This is the label check to run before a print run, ranked by what actually gets brands pulled.

Microbiological is the reason given for 49% of United States food recalls, ahead of undeclared allergen at 31%: 12,319 of 25,042 enforcement records whose stated reason could be classified. The wording is FDA’s; the grouping is ours and is reproducible from the patterns in src/openfda.mjs.

It is the failure most likely to end a US launch, named by the agency that ends them.

44% of United States food recalls are Class I, the class FDA uses when there is a reasonable probability that the product causes serious harm or death: 12,837 of 29,273 classified enforcement records since 2012.

Class share tracks how bad the failures are, where a raw recall count mostly tracks how hard anyone looked.

Sterility or process is the reason given for 50% of United States drug recalls, ahead of potency or formulation at 18%: 8,305 of 16,739 enforcement records whose stated reason could be classified. The wording is FDA’s; the grouping is ours and is reproducible from the patterns in src/openfda.mjs.

It is the failure most likely to end a US launch, named by the agency that ends them.

10% of United States drug recalls are Class I, the class FDA uses when there is a reasonable probability that the product causes serious harm or death: 1,733 of 17,859 classified enforcement records since 2012.

Class share tracks how bad the failures are, where a raw recall count mostly tracks how hard anyone looked.

9% of United States medical device recalls are Class I, the class FDA uses when there is a reasonable probability that the product causes serious harm or death: 3,617 of 39,634 classified enforcement records since 2012.

Class share tracks how bad the failures are, where a raw recall count mostly tracks how hard anyone looked.