Oct 27

FDA Imports: Foods and Cosmetics

Do you ever wonder how your favorite exotic cheese, foreign cookies, or champagne make it to the United States? As it turns out, importing food and cosmetics into the United States is not as simple as putting it in boxes and shipping it to the supermarket or local drug store. The U.S. Food and Drug Administration (FDA) is guided by a comprehensive statutory scheme that governs food and cosmetics produced in foreign countries and imported into the United States. Understanding the issues surrounding FDA imports, including how the importation of foods and cosmetics are affected by federal regulations, is important for timely, cost effective importation.

FDA Imports: Food Imports

All food that is imported into the United States has to meet the same requirements as food that is domestically produced, or manufactured within the United States. This means that imported food has to comply with The Federal Food, Drug, and Cosmetic Act (FD&C Act), The Fair Packaging and Labeling Act, and The Nutrition Labeling and Education Act (NLEA), which amended the FD&C Act. These requirements include ensuring all ingredients are permitted for use in foods and that the product labels comply with federal regulations. All imported foods are inspected when offered for import or entry into the United States.

Recently, food security has become a larger national priority, which has resulted in increase regulation in the area of FDA imports. In particular, Congress enacted The Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act), which requires food manufacturers and importers to: (1) register with FDA every two years and (2) submit prior notice of the imported food, which means that the importer must alert the FDA to what they are planning on importing before the shipment is offered for import. The prior notice requirement is waived a few distinct circumstances:

1. The food is brought into the United States by an individual for personal consumption;

2. Food that is imported and then exported without leaving the port of arrival;

3. Personal gifts sent from an individual in a foreign country to an individual in the United States;

4. Diplomatic gifts to an embassy in the United States, and

5. Food products that are the subject of exclusive jurisdiction of the U.S Department of Agriculture, such as meat, poultry, and eggs.

Additionally, Under the Food Safety and Modernization Act (FSMA) of 2010, if the imported food was refused entry in another country, the prior notice must also identify the other countries where the food was refused entry.

FDA Imports: Cosmetic Imports

Cosmetics imported into the United States must also comply with the same laws and regulations as those produced in the United States. Cosmetic products cannot have any prohibited ingredients and must be safe for their intended uses. Similar to foods, ingredients and labeling must be compliant with FDA regulations. Companies importing cosmetics are not required to register with the FDA but are encouraged to do so through the Voluntary Cosmetic Registration Program.

In addition to the above concerns, importers of cosmetics must be aware of other laws that could possibly govern their products. Many times, other countries have different definitions of drugs and cosmetics than the United States uses. For example, in the United States, sunscreen is regulated as a drug, while in other countries; it is regulated as a cosmetic product. Also, a product can be both a cosmetic and a drug. Importers should be aware of the different classifications and requirements for their products.

Navigating the maze of requirements for importing food products and cosmetics can be a complex task and there are several points to consider when dealing with FDA imports. If you are importing food products or cosmetics into the United States, compliance with the FDA regulations applicable to FDA imports is important. If you have any questions about compliance with the FDA import regulations and programs, please contact us at contact@giannamore-law.com.FDA Imports


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