Columbia, MD 9.7.2011

According to Benjamin England, Founder and CEO of FDAImports.com, many dietary supplement importers are not aware that new FDA food inspection and re-examination fees will apply to them beginning October 1st, 2011.  The new FDA fee structure is clearly oriented toward food imports; however, FDA considers dietary supplements a food when it comes to import regulations.  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).1

Mr. England commented that, “dietary supplement importers might not be conscious of the fact that FDA will impose the new fees, when applicable, to imported dietary supplement and dietary ingredient shipments because they might forget that FDA regulates these products as special types of foods.  Losing sight of that legal fact would be a very costly oversight.”  Benjamin England and his team at consulting firm FDAImports.com, have launched a coalition to fight the FDA’s food import fees and have been urging dietary supplement importers and manufacturers to consider themselves as affected parties. Mr. England states:

“If, after October 1st, you are importing into the United States a dietary supplement, dietary ingredient or nutrient/bulk ingredient for use in manufacturing dietary supplements and if FDA has concerns over the safety of the product, you will be subject to the same expensive fees that FDA is planning to start charging conventional food importers.  This could be a rude awakening for dietary supplement importers who may not think that FDA’s imported food fees apply to them; they do.”

FDAImports.com is urging all food and dietary supplement manufacturers and importers to familiarize themselves with the little-publicized fee structure that goes into effect October 1st, 2011.  Benjamin England has just released a video explaining the impact that this fee structure could have on small businesses and has been speaking with various importers about how this new structure could create a domino effect of increased costs for consumers and importers.

SOURCES: 

1. FDA: http://www.fda.gov/RegulatoryInformation/Legislation/FederalFoodDrugandCosmeticActFDCAct/FDCActChaptersIandIIShortTitleandDefinitions/ucm086297.htm

2. FDAImports.com:  http://www.fdaimports.com/coalition

Benjamin L. England is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs.  Currently he is founder and CEO ofFDAImports.com, LLC, a firm of consultants and affiliated attorneys routinely seeking removal of foreign manufacturers from FDA import alerts.

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For more information contact Benjamin L. England and the FDAImports.com team athttp://www.fdaimports.com, call (410) 740-3403 or contact Jon Barnes at jrbarnes@fdaimports.com.