U.S. FDA certification full strategy: cross-border e-commerce sellers of the 7 common problems, the fourth point so that 99% people are wrong!

Three words to solve the FDA certification confusion: FDA does not have a certificate, only the registration number, must have a U.S. agent, imported cosmetics do not need to register. The legal basis of the U.S. Food and Drug Administration (FDA) is the Federal Food, Drug, and Cosmetic Act, and at the same time also enforces the Public Health Service Act, the Substance Abuse Control Act and many other laws and regulations, the scope of supervision is extremely broad, from drug testing to marketing, from cosmetics labeling to safety assessment, there are strict regulations.

The biggest problem is that many Taiwanese cross-border sellers have a misunderstanding of FDA certification. First of all, FDA registration does not issue a certificate, it only gives the applicant a response letter with the FDA Administrator's signature and a registration number. Second, the FDA does not have a so-called "Designated Certification Laboratory" and any such claim is misleading. Third, it is mandatory for Taiwan applicants to designate a U.S. citizen or company as their agent.

Did you know that the FDA works with U.S. Customs and Border Protection (CBP) to monitor imported merchandise, but not all imported cosmetics are sampled, and that the FDA issues Import Alerts to alert inspectors to specific trends in violations, such as microbial contamination, noncompliance with colorants, and other issues? Also, products that are not sampled must comply with all regulatory requirements.

For example, imported cosmetics must comply with the same regulations as domestically produced goods, and no prior FDA approval is required for ingredients other than colorants. But whatever the product, it must be safe for consumers to use and properly labeled. It is also worth noting that the definitions of "cosmetics" and "drugs" in the U.S. are different from those in many countries. For example, sunscreen products are considered drugs in the U.S., not cosmetics.

It is important for cross-border brand owners to understand the U.S. requirements for cosmetic labeling. All necessary information must be labeled in English (or Spanish in Puerto Rico), and ingredients must have "common or usual names" in English, not in other languages or INCI nomenclature. These details are critical to successful entry into the U.S. market.

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