U.S. FDA certification 7 key issues: Taiwan manufacturers must read the guide, this really may be off the shelves!

Can you believe it? Many Taiwanese cross-border sellers have had their products rejected by the U.S. Customs because of a misunderstanding of FDA certification! The U.S. Food and Drug Administration (FDA) enforces the Federal Food, Drug, and Cosmetic Act, and is also responsible for enforcing the Public Health Service Act and other laws and regulations. The scope of its regulation is extremely broad, ranging from drug testing to marketing, and from cosmetic labeling to safety assessment.

These are seven questions about FDA registration that you may not have heard out there. First, the FDA does not issue certificates of registration, it only gives the applicant a response letter and a registration number. Second, the FDA does not have a so-called "Designated Laboratory" and any such claims are misleading. Third, it is mandatory for Taiwan applicants to designate a U.S. citizen or company as their agent.

Most surprisingly, the FDA works closely with the U.S. Customs and Border Protection (CBP) to monitor imported goods, but not all imported cosmetics are sampled.The FDA issues import alerts to alert inspectors to specific trends in violations, such as microbial contamination, failure to comply with colorant regulations, and other issues.

What I'm about to say may change your mind. Companies that simply import cosmetics in the United States are not required to register with the FDA! The FDA encourages, but does not mandate, participation in the Voluntary Cosmetic Registration Program (VCRP). The FDA encourages, but does not mandate, participation in the VCRP. Furthermore, with the exception of colorants, cosmetics and ingredients do not require FDA approval before they can be marketed, but they do need to be safe for consumers to use and properly labeled.

What will really help you avoid having your products rejected is to understand the difference in the definitions of "drug" and "cosmetic" in the United States. The U.S. definition is different from many other countries. For example, sunscreen products are considered drugs in the U.S., not cosmetics. Products that have hair growth, skin protection, pain relief, anti-aging effects, etc. may be considered drugs or both.

A strong man never confuses facts and opinions, but a weak man can't distinguish between the two. Cosmetic labeling must meet strict requirements, and all necessary information must be in English (or Spanish in Puerto Rico). Ingredients must have "common or usual names" in English, not just INCI nomenclature or other languages. Failure to comply with these requirements may result in denial of entry of the product.

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