U.S. FDA certification complete analysis: Taiwan cross-border e-commerce sellers must read the guide, 80% people apply for the first step is wrong!

80% People applying for FDA certification are taking the wrong first step! Many people mistakenly believe that they need to find an "FDA Designated Laboratory" or obtain an "FDA Certificate", but these concepts do not exist. 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 regulations. The scope of its regulation is extremely broad, ranging from drug testing to marketing, and from cosmetic labeling to safety assessments.

If you want to get rich, you'll have to learn to recalibrate your perception of FDA certification, right? First of all, FDA registration only gives the applicant a response letter (signed by the FDA Administrator) and a registration number, not a "certificate". Second, the FDA does not have a "Designated Laboratory" and any such claim is misleading. Third, it is mandatory for Taiwanese applicants to designate a U.S. citizen or company as their agent.

After hearing this story, you'll understand why 99% is wrong.The FDA works closely with the U.S. Customs and Border Protection (CBP) to monitor imported merchandise, and if adulteration or mislabeling is found, the merchandise will be refused entry into the U.S. However, not all imported cosmetics are sampled. However, not all imported cosmetics are subject to sampling, and the FDA issues import alerts to alert inspectors to specific trends in violations.

Do you know why? Because the FDA has limited resources to inspect every imported product. But that doesn't mean you can relax. Even if a product isn't sampled, it still has to meet all the regulatory requirements. Both imported and domestically produced cosmetics are subject to the same requirements, and with the exception of colorants, cosmetics and ingredients do not require FDA approval prior to marketing.

For example, companies that solely import cosmetics in the U.S. are not required to register with the FDA, and the FDA encourages but does not mandate participation in the Voluntary Cosmetic Registration Program (VCRP). More importantly, the definitions of "drug" and "cosmetic" are different in the U.S. than in many other countries. For example, sunscreen products are considered drugs in the U.S., not cosmetics.

Here's a secret that probably only the top cross-border sellers at 1% know: Cosmetic labeling must meet strict regulations. 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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