FDA Regulations on International Cosmetics


Due to government-mandated ‘stay at home’ protocols the newest beauty trend in the United States now is imported skincare and cosmetics. Because mobility is restricted and access to the local Sephora is temporarily impossible, people have started to switch to online shopping and trying new products from across the globe. Influencers, especially in the United States, are pushing skincare and makeup products from everywhere. Examples of this are the Pink Sand Clay face masks from Australia or even Snail Mucus Moisturizer from Korea. Since these products are big in the American market, one can only wonder whether they need to follow American standards when it comes to regulating their ingredient content.

When considering whether imported cosmetics need to undergo the same requirements as domestic products, the FDA confirms that they do need to comply with the same laws and regulations. However, cosmetic products and ingredients are not subject to require FDA approval with the exception of any color additives. The FDA urges the manufacturers both domestic and foreign to properly label their products with the ingredient content for the consumers but it is not legally required. Legally domestically and internationally produced it is the sole responsibility of the manufacturer and company distributing the cosmetics to comply with US law, not the FDA.

Surprisingly enough, imported cosmetics do not need FDA approval before hitting the United States market. Just like domestic produced cosmetics, imported cosmetics do not need the ‘green light’ from the FDA before becoming available to consumers. Although they do not require FDA approval, the FDA just urges the manufactures to make sure the product is safe for consumption, and have proper labeling. In the same sense, the FDA does not require imported cosmetic disturbers to register with the FDA before hitting the market. If a firm is importing products to be solely cosmetics in the United States, they are not required to register with the FDA and registration numbers are not required for importing cosmetics into the country. However, the FDA does encourage both domestic and foreign companies to register their establishments and file Cosmetic Product Ingredient Statements through their Voluntary Cosmetic Registration Program, but the program and participation are voluntary, not mandatory.

Just like the United States with the FDA, other countries have their own regulation coalition and their own set of rules and regulations to follow. Many countries’ regulatory definition of drug and cosmetic differs from the FDA and United States definition. For example, some countries regulate sunscreen as a cosmetic while the United States and the FDA have entirely different regulations and see it as a drug. In the eyes of the FDA, hair restoration, skin protectant, pain relief, anti-aging effects that involve the structure or even function can be classified as a drug. Ironically sometimes the FDA defines these products as both cosmetics and drugs. In some cases, the FDA may have the same prohibited ingredients as other countries. Ingredient prohibition is put into place if the finished cosmetic product is unsafe for consumers, even if there isn’t a specific regulation prohibiting or restricting it’s use in cosmetics.

Now although the requirements for hitting the market are pretty lenient for imported cosmetics, the FDA does refuse some imported cosmetics. The United States and FDA may refuse some products because they do not comply with the United States laws and regulations. A product may be refused because the color additives may be in violation of the FDA regulations or some prohibited or restricted ingredient was included. Cosmetics are also refused when there are microbial contamination and some sort of labeling violation (ex. not in English). Or the product was labeled as a cosmetic when it’s really a drug.

Even though it is the sole responsibility of the company and the manufacturer distributing the cosmetics to properly label their products, there are some fundamental labeling requirements. When an international company is importing cosmetics to the United States, they must label all of the ingredients in English with the exception of Spanish in Puerto Rico. Some words that are considered common or usual names in the country of origin such as ‘aqua’, ‘mel’, and ‘parfum’ must be followed with the English translation ‘water’, ‘honey’ and ‘fragrance’. There is an exemption for imported cosmetic labeling. Imported bulk cosmetics do not have to comply with labeling regulations. 

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