Imports-- Helping you comply with U.S. regulations

Import of Unapproved Articles

If you are importing foods, drugs, cosmetics, or dietary supplements into the United States we can help you with the following:

 

 

 

Determine if your products can be legally sold in the United States

We will review the ingredients, the dosage form, and the intended use, and help you classify the products as foods, drugs, cosmetics, dietary supplements, or some other category, then let you know what needs to be done to legally distribute these products in the US.

 

Make sure your products are properly labeled

The labeling regulations for foods, drugs, cosmetics, and dietary supplements are quite specific, very complex, in some ways very similar but, in a lot of ways, very different from one another. We know and understand the applicable regulations and we are very experienced at label preparation and review.

 

Register your facilities and list your products with the FDA

Drug, conventional food, and dietary supplement establishments are required to be registered with the FDA. Drug products are required to be listed.

 

Comply with U.S. regulations that pertain to your product

Most of these products are required to be manufactured in accordance with good manufacturing practices. All of them have specific regulations that must be complied with.

 

Resolve problems if your product has been detained

We will interface with FDA and/or Customs to help resolve the problem. We have a lot of experience in this area. We have been successful at getting many products released from detention either by resolving issues with FDA or by recommending appropriate rework of the product.

Upon the submission of a statement to the FDA, an importer may ship certain otherwise unapproved articles into the United States for use in products intended exclusively for export. These articles include drug components that are ready or suitable for use for health-related purposes, food additives, color additives, or dietary supplements, including products in bulk form, that are intended to be incorporated by the initial owner or consignee into a drug, biological product, food, food additive, color additive, or dietary supplement to be exported from the U.S.