Brief Guide to Safely Export Cosmetics to the US

The regulatory aspects to consider before starting export activities


Planning Internationalisation SME United States of America Export markets International marketing International marketing

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This article was written in collaboration with ExportUSA.

The United States is one of the largest import market for cosmetics and perfumes. US demand for beauty and personal care products has experienced a very strong growth in recent years: the value of imports of beauty products has doubled compared to 2010, becoming one of the primary target markets for cosmetic companies, as we wrote in the previous article Beauty Boom: US Market on the Rise.
At this point, it is of primary interest to understand which regulatory aspects must be considered before starting to export to the US.

Product labeling

The regulation of the cosmetic sector in the USA is under responsibility of the US Food and Drug Administration (FDA). There are two main regulations for cosmetic products in US: Food Drugs Cosmetic Act (FDCA) and the Fair Packaging and Labeling Act (FP&L), in addition to all FDA guidelines. Furthermore, the State of California has a specific discipline: Proposition 65 provides a list of banned chemicals that are prohibited from being placed on the market.

According to the law, special attention should be given to ingredients and product labeling. Correct labeling must inform consumers about the use of the product and related warnings, as well as clearly indicate the composition, place of production and distribution. Here are some basic elements that must be adapted to US guidelines:

  • Name
  • Unit of measure
  • Use direction
  • Warnings
  • Indication of the ingredients

It is of fundamental importance that the communication and use of specific terms are clear, effective and not misleading. Each label must exclusively declare the effective cosmetic action, safeguard the truthfulness and correctness of the information in order to protect the consumer. The same prohibition extends to advertising and reference websites of the product.
In compliance with the principle of truthfulness, it is also advisable to pay particular attention to the use of the terms natural and organic on labels. The Food and Drug Administration has not established a regulation in the cosmetic field for the term natural. The U.S. Department of Agriculture, on the other hand, has regulated the organic term only in organic food labeling.
Despite this, Federal Trade Commission (FTC) has established that a misleading use in the presence of artificial components is a deceptive behavior, and exposes the exporting company to penalties that can reach up to $16,000 for each individual infringement (consider that every single sale of the product is a separate violation).

Finally, it is always advisable to check the mandatory contents in labeling. For example, in Europe the inclusion of the PAO (symbol of the Period After Opening) is mandatory, while in the United States its inclusion is absolutely optional.

FDA registration for cosmetic products

Once the product has been brought into compliance with current regulations, it is ready for export and, thereafter, it will be possible to decide whether to register with the FDA (Voluntary Registration). Cosmetic products are in fact the only sector that is not subject to mandatory FDA registration, with the exception of cosmetic products for professional use, such as products used in beauty salons, wellness centers, skin care clinics and hotels. Furthermore, it does not apply to products considered "pharmaceutical" such as sunscreens, skin whitening treatments and acne creams.

However, the voluntary FDA registration for cosmetic products for final end does not imply a streamlining of the procedures, since there are no preventive controls and the adapting process is entirely under the responsability of exporting companies. Before exporting, the company must verify that the products destined to the market can be considered in compliance with the law: only on arrival at customs, FDA staff will carry out checks for the sale in the United States.
Several export consultancies therefore help exporters to follow a procedure of controls to prevent shipments being blocked at customs.