WHAT IS THE FDA POSITION ON BENFOTIAMINE?
At first I was curious as to whether benfotiamine is considered a drug or a supplement. I have established to my satisfaction (and based on the expert opinion of others in the industry) that benfotiamine, a synthetic derivative of vitamin B-1, is a dietary supplement under the Dietary Supplement Health and Education Act (DSHEA) of 1994. During 2003 I have successfully imported to the U.S. both bottled tablets as well as bulk benfotiamine, with full disclosure and full FDA and U.S. Customs review and approval at the respective U.S. ports of entry. Let me emphasize that. The FDA did a hands-on review and inspection of my imported benfotiamine, with full disclosure as to contents by both name and chemical formula, and approved all items for import. Benfotiamine may be imported under Tariff Number: 2936.22.00.00, (thiamine and its derivatives). For those curious as to the current FDA stance on dietary supplements, I offer the following quote from their website: Under DSHEA, a firm is respo
