Exporting Dietary Supplements to US

All dietary supplements, also known as nutraceuticals, must comply with US regulations prior to export to US. These regulations include labeling, ingredients, manufacturing, and registration. Failure to comply with the regulations may result in the supplements being denied entry into the US. 

Prior to importation be sure the importing company is registered with FDA under the Bioterrorism Act and that the manufacturer is also registered. Also, be sure that the manufacturing was conducted under good manufacturing practices for dietary supplements as identified in the Code of Federal Regulations. In addition, all ingredients in a dietary supplement must be generally recognized as safe through being in a supplement prior to the regulation's implementation or that a new dietary ingredient application has been submitted and reviewed by FDA. All labeling must be compliant with FDA regulations as well. This includes ensure the dietary supplement has a Supplement Facts panel, statement of identity, country of origin, net contents, directions for use, appropriate warnings and designation of manufacturer or distributor. 

Marketing material that accompanies a product or that is located at the point of sale will be deemed labeling and must also comply with FDA regulations. It is important that any websites associated with the product do not make impermissible claims. FDA has been known to review websites when products are seeking entry into the US. 


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