Benfotiamine is a lipid-soluble form of thiamine (vitamin B-1). It was developed in Japan in the early 1960's to treat alcoholic neuritis. It is the most effective metabolic precursor of active thiamine, or vitamin B1, available.

Though benfotiamine is lipid-soluble, it metabolizes quickly, producing high levels of thiamine pyrophosphate (TPP, the active form of thiamine), which then continues to metabolize in the body as usual. Benfotiamine itself does not accumulate in the body. The original patent filed in the United States on benfotiamine included data from LD-50 tests on lab mice (Table III) indicating that benfotiamine is significantly less toxic than common vitamin B-1 (typically, thiamine hydrochloride).

Yes, in the past couple of years interest in this compound has grown significantly.

Benfotiamine has no known negative interactions with any medications. In fact, the use of some medications may cause a thiamine deficiency which benfotiamine would likely correct.

While the recent clinical trials have concentrated on conditions such as neuropathy, retinopathy and nephropathy, there is an expectation among those studying this compound that its beneficial effects may be far more wide-ranging, to include: sciatica, vascular health, general nerve health, improved blood pressure, general cellular protection, anti-aging, fibromyalgia, prevention of lactic acidosis, and treatment for Alzheimer’s disease.

Though the body cannot use more than about 10mg. of common, water-soluble vitamin B-1 per day, benfotiamine is lipid-soluble and can safely be used at much higher levels than common vitamin B-1.

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).

Though attempts were made by the Japanese pharmaceutical manufacturer Sankyo to market benfotiamine in the U.S. decades ago, there was little interest until the recent article published in the U.S. by Dr. Brownlee. Since that time, interest in benfotiamine has increased dramatically. I have heard some speculation that since the patent on benfotiamine expired years ago, no large company is interested in investing in its promotion. I personally remain mystified as to why this very beneficial compound has languished in obscurity in this country until now.

“Pharmaceutical grade” means that the product has been manufactured under GMP conditions and is safe, pure and effective. Under GMP (Good Manufacturing Practices) every step of the process is documented by using established SOPs (Standard Operating Procedures). This includes training, equipment, raw materials, facilities, and final release criteria. Everything can be traced back to the date, time, person, lot number, and piece of equipment used.


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