{"id":19123,"date":"2026-01-01T18:05:52","date_gmt":"2026-01-01T10:05:52","guid":{"rendered":"https:\/\/greenoo.tw\/?p=19123"},"modified":"2026-01-01T18:05:52","modified_gmt":"2026-01-01T10:05:52","slug":"taiwan-seller-fda-cosmetic-compliance-guide","status":"publish","type":"post","link":"https:\/\/greenoo.tw\/en\/taiwan-seller-fda-cosmetic-compliance-guide\/","title":{"rendered":"Taiwan Sellers and Foreign Trade Factories Exporting to the U.S. FDA Cosmetics Compliance Guide (2026 Update)"},"content":{"rendered":"

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Taiwan sellers and foreign trade factories wishing to export cosmetic products to the U.S. market must complete product registration and facility registration in accordance with FDA regulations and confirm whether the products are OTC drugs, as well as clarify responsible entity attribution and labeling compliance requirements.<\/p>\n

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This chart organizes the four major judgmental aspects of FDA cosmetics compliance to help Taiwan sellers and foreign trade factories establish a correct understanding of the framework.<\/p>\n

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The logic of the FDA's categorization of cosmetics and OTC drugs.<\/h2>\n

The U.S. FDA's classification of cosmetics and OTC drugs is not based on the name of the product or the part of the body where it is to be used, but rather on the core criteria of \"claimed function\" and \"mechanism of action\".<\/p>\n

Products claiming to treat or prevent diseases or alter the structure of the human body (e.g., sunscreen, whitening, anti-acne), even if they appear to be in cosmetic form, may still be categorized as OTC drugs and are subject to more stringent review and registration procedures.<\/p>\n

On the other hand, if the product is only claimed to clean, beautify, or modify the appearance of the product and does not involve pharmacological effects, it is considered a cosmetic product and is subject to MoCRA (Modernization of Cosmetics Regulation Act of 2022).<\/p>\n

The logic of this judgment directly affects the subsequent registration process, ingredient review, labeling requirements and responsibility, Taiwan sellers and foreign trade factories should be correctly categorized at the product design stage.<\/p>\n

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Taiwan sellers and foreign trade factories to determine the responsibility<\/h3>\n

Under the FDA's cosmetic compliance framework, the determination of who is responsible is based on \"who controls the formulation and labeling of the product,\" not simply \"who makes it\" or \"who ships it.<\/p>\n

If a Taiwan-based foreign trade factory only produces OEM products according to a formula specified by the customer and does not participate in the formula design or labeling decisions, the factory is the \"Manufacturer\" and the customer is the \"Responsible Person\".<\/p>\n

If a Taiwanese brand designs its own formula, decides on the labeling content, and commissions a factory to manufacture the product on its behalf, the brand is the responsible party and must complete FDA registration and facility registration.<\/p>\n

If a Taiwan factory also has the ability to develop formulas and export to the U.S. under its own brand name or at its own discretion, the factory is the responsible party and must complete all compliance procedures on its own.<\/p>\n

This logic of judgment may be different from the logic of responsibility attribution in Taiwan domestic sales or other markets, and should be clearly defined at the contract stage to avoid subsequent disputes.<\/p>\n

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FDA Cosmetic Registration and Facility Registration Process<\/h2>\n

After MoCRA 2022, all cosmetic products marketed in the U.S. will be required to complete FDA registration and enrollment for both the responsible party and the manufacturing facility.<\/p>\n

The registration process consists of two major components: Facility Registration and Product Listing, both of which must be completed through the FDA's electronic system.<\/p>\n

Facility registration should be submitted by the manufacturing plant or responsible party, containing basic information such as facility address, contact information, type of manufacturing (e.g., formulation, filling, packaging), etc. Upon completion of the registration, a Facility Registration Number (FRN) will be obtained.<\/p>\n

Product listings will be submitted by the Responsible Party and will list all products sold in the U.S. by name, type, list of ingredients, and method of use, and a Product Listing Number (PLN) will be obtained for each product.<\/p>\n

If there is a change in product formulation or labeling, the product list must be updated within 60 days of the change; if there is a change in facility address or type of manufacturing, the facility registration must be updated within 60 days of the change.<\/p>\n

Taiwan sellers and foreign trade factories should complete the registration before the first export of their products and set up a regular update mechanism to avoid compliance risks due to outdated information.<\/p>\n

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\ud83d\udcca Form Instructions<\/strong>: Comparison of FDA Cosmetic Registration and Facility Registration Items (Compendium: [Cross-Border Safety Judgment - Green Circle])<\/h2>\n
\n\n\n\n\n\n\n\n\n\n
Project<\/th>\nFacility Registration<\/th>\nProduct Listing<\/th>\n<\/tr>\n<\/thead>\n
Submission of the main body<\/strong><\/td>\nManufacturer or Responsible Party<\/td>\nresponsible party<\/td>\n<\/tr>\n
Submit Content<\/strong><\/td>\nFacility Address, Contact Information, Type of Manufacturing<\/td>\nProduct Name, Category, Ingredients List, How to Use<\/td>\n<\/tr>\n
Obtaining a serial number<\/strong><\/td>\nFacility Registration Number (FRN)<\/td>\nProduct Listing Number (PLN)<\/td>\n<\/tr>\n
Update Frequency<\/strong><\/td>\nWithin 60 days of change<\/td>\nWithin 60 days of change<\/td>\n<\/tr>\n
Applicable scenarios<\/strong><\/td>\nAll manufacturing facilities<\/td>\nAll products sold in the U.S.<\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<\/div>\n

Text description (placed below the form)<\/strong>::
\nThis form organizes the two core items of FDA cosmetics registration to help Taiwan sellers and manufacturers quickly determine the subject of submission and the timing of updates.<\/p>\n

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Ingredient Review and Labeling Compliance Requirements<\/h3>\n

The FDA adopts a parallel system of \"List of Prohibited Ingredients\" and \"List of Restricted Ingredients\" rather than a case-by-case approval system for the review of cosmetic ingredients.<\/p>\n

Products containing ingredients specifically banned by the FDA (e.g., chloroform, mercury compounds, certain colors) cannot legally enter the U.S. market, and products containing limited-use ingredients (e.g., certain preservatives, hair dyes) must comply with concentration limits and specific labeling requirements.<\/p>\n

Labeling compliance requirements include: product name, net weight, manufacturer or responsible party information, a list of ingredients (in descending order of content), and a warning message (if applicable), etc., which must be labeled in English on the product packaging.<\/p>\n

If the product is both a cosmetic and an OTC drug (e.g., foundation containing sunscreen ingredients), it must comply with both cosmetic and OTC drug labeling specifications, including the Drug Facts panel and active ingredient labeling.<\/p>\n

Taiwan sellers and foreign trade factories should conduct ingredient compliance checks at the product design stage and commission professional organizations to conduct labeling audits to avoid products being refused entry or taken off the shelves due to mislabeling.<\/p>\n

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\"FDA<\/p>\n

This chart compares the differences in labeling requirements for cosmetics and OTC pharmaceuticals to assist Taiwan sellers and manufacturers in determining the focus of compliance for dual nature products.<\/p>\n

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Common Misconceptions and Key Points of Practical Judgment<\/h3>\n

Common misconceptions among Taiwanese sellers and foreign trade factories when it comes to FDA cosmetics compliance include:<\/p>\n

Misunderstanding 1<\/strong>: It is considered that as long as the product looks like a cosmetic, it is directly applicable to the cosmetic regulation and ignoring the claimed function may result in the product being classified as an OTC drug.<\/p>\n

Misunderstanding 2<\/strong>: It is believed that with FDA registration, one is free to make any claim for efficacy, ignoring the fact that the claim must be consistent with the classification of the product and must not involve an unapproved drug use.<\/p>\n

Misunderstanding 3<\/strong>: The OEM is not considered to have any compliance obligations, ignoring the fact that the factory still has to complete the facility registration and may be recognized as a responsible party if it is involved in the formulation or labeling decisions.<\/p>\n

Misunderstanding 4<\/strong>: It is assumed that as long as an ingredient is legal in Taiwan, it can be used directly in the U.S. market, ignoring the fact that the FDA's list of banned and restricted ingredients is not exactly the same as Taiwan's regulations.<\/p>\n

In practice, Taiwan sellers and foreign trade factories should carry out classification judgment, responsibility attribution confirmation, ingredient compliance check and labeling audit at the product development stage, and establish a regular update mechanism to reduce subsequent implementation and market risks.<\/p>\n

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[Application Notes<\/h2>\n

The content of this article is based on currently available official information, the actual application of the latest announcements of the competent authorities and the actual implementation shall prevail.<\/p>\n

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[Official Supporting Documents<\/h2>\n

According to the U.S. FDA, the classification of cosmetics and OTC drugs is based on the claimed function of the product, not the form or site of use, and the responsible party is required to complete the registration and compliance process according to the actual claims of the product.<\/p>\n

Official source:<\/strong><\/p>\n