Food exports to the U.S. must see! FDA certification complete guide, 10 minutes to make you from novice to expert!

80% Taiwanese cross-border sellers applying for FDA certification are getting the first step wrong! Whether you are planning to export powder, tea bags, masks or serums, this 10-minute quick guide will help you avoid all the common pitfalls and pass FDA certification smoothly.

Food, cosmetics, health care products and even medical and healthcare products have always been the strengths of Taiwanese companies. Over the past decade, countless Taiwanese brands have been recognized through theCross-border e-commerce platformsIt's been an amazing success in the U.S. market, but did you know? But did you know there's one thing in common behind all of these successes: they're all properly understood and FDA-cleared!

The FDA is the U.S. Food and Drug Administration, and its core function is to ensure that products on the U.S. market meet safety standards. The biggest problem is that the FDA requirements for different product categories vary greatly, which is something that many Taiwanese cross-border exporters tend to overlook.

For example, when cosmetic masks are sold to the United States, FDA requirements vary depending on the product claims. If the product claims to have a cosmetic effect (e.g., moisturizing, cleansing skin), it only needs to comply with basic FDA regulations. However, if it claims to have a therapeutic effect (e.g., removing acne, anti-bacterial), it is considered a pharmaceutical cosmetic and requires more stringent FDA approvals.

It is really worth noting that although pearl milk tea packets, as ordinary food products, do not require prior approval, their labeling requirements are extremely stringent! It must contain the product name, ingredient list, nutritional labeling, and other information, all of which must be labeled in English. Tea and tea bags also do not require FDA pre-certification, but production facilities must be registered with the FDA, which is often overlooked by Taiwanese manufacturers.

Even more surprising is the difference in FDA registrations between Taiwan companies and U.S. companies. A Taiwan company needs an agent in the US to assist with FDA matters, while a US company can complete product registration more easily. It's no wonder that more and more cross-border brand owners are choosing to set up their companies in the United States!

FDA certification may seem complicated, but with the right knowledge and process, any Taiwanese cross-border seller can handle it with ease. Compliance is not just a legal requirement, it is the key to winning the trust of U.S. consumers.

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