The Complete Guide to FDA Accreditation: A Must-Read for Cross-Border Entrepreneurs! Can you believe how important point 5 is?

With these three tricks, successful FDA approval is not a dream! First, understand the real legal authority of the FDA, then grasp the cooperation mechanism between the FDA and CBP, and finally familiarize yourself with the special requirements for importing and exporting cosmetics. U.S. Food and Drug Administration (FDA) to implement the main law is the "Federal Food, Drug and Cosmetic Act," that is, Title 21 of the United States Code, but also responsible for the implementation of the Public Health Service Act and other regulations, the scope of supervision is extremely broad.

Taiwan cross-border sellers must be clear that the FDA certificate does not exist! The FDA will only give the applicant a response letter (with the FDA administrator's signature) and registration number after registration, not the so-called "certificate". More importantly, the FDA does not have a so-called "Designated Laboratory", and any organization claiming to be an FDA-designated certification laboratory is misleading consumers.

Not all ingredients require FDA approval, but it is important to note that Taiwan applicants must designate a U.S. citizen (company/association) as an agent for FDA registration, which is mandatory.The FDA works closely with the U.S. Customs and Border Protection (CBP) to monitor imported merchandise, and if adulteration or inaccurate labeling is found, it will be refused entry into the United States.

The best part is that not all imported cosmetics are subject to sampling! The FDA issues Import Alerts to alert inspectors to specific trends in violations. Even if a product is not sampled, it must still meet all regulatory requirements. For cross-border exporters, it is important to understand that imported and domestically produced cosmetics are subject to the same requirements.

Did you know that companies that solely import cosmetics in the U.S. are not required to register with the FDA, and that the FDA encourages, but does not mandate, participation in the Voluntary Cosmetic Registration Program (VCRP)? In addition, the definitions of "drug" and "cosmetic" in the U.S. are different from those in many countries. For example, sunscreen products are considered drugs in the U.S., not cosmetics.

Strongly, and somewhat frighteningly, cosmetic labeling must meet strict requirements. All necessary information must be labeled 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 the product being refused entry.

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