Dietary Supplement Importers Will Also Be Saddled by FDA’s New Import Fees

Sep 1, 2011 | Dietary Supplements, Law & Regulatory

FDA Fees and Examinations TroubleQuestion:  What’s worse than driving a stolen car around town?

Answer: Not knowing that you’re driving a stolen car!

If you know something horrible is about to happen, you can prepare for it.  But it’s a whole different story when something bad is about to happen to you and you have no clue that it’s coming!  That’s exactly the conversation we’re having with dietary supplement importers about the coming FDA imported food fees beginning October 1st, 2011.  Much of our interaction with the press and media has revolved around conventional food imports specifically; in fact, the FDA fee changes are just for food importers. However, if you’re importing dietary supplements to the United States then you are importing food. The Federal Food, Drug, and Cosmetic Act defines a dietary supplement as a food – “… a dietary supplement shall be deemed to be a food within the meaning of this Act”. 21 U.S.C. § 201(ff) (emphasis added).

Here’s what it boils down to in relation to the fees.  If, after October 1st, you are importing into the United States a dietary supplement, dietary ingredient or a nutrient/bulk ingredient for use in manufacturing dietary supplements and if FDA has concerns over a potential safety violation in your shipment, you will be subject to the same expensive fees FDA is planning to start charging conventional food importers.  This is going to be a rude awakening for dietary supplement importers who might not think the FDA’s imported food fees apply to them; they do.

If you don’t know about the coming fee changes and how costly it could get for importers and small businesses, then please read up about the changes and consider joining FDAImports.com in submitting official comment or joining the coalition we’ve established to try to force FDA back into line with the language of the Food Safety Modernization Act.

SOURCE: FDA

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