CORVALEN

Raj Khankari
Chief Executive Officer
Bioenergy, Inc.
13840 Johnson Street NE
Ham Lake, Minnesota  55304
Dear Mr. Khankari:

On June 14, 30 and July 1, 2010, the U.S. Food and Drug Administration (FDA) conducted an inspection of your facility...  During the inspection, the investigator collected your Corvalen M® product label and an order brochure for your Corvalen®, ...and found that your Corvalen®... products are misbranded under section 403(a)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 343(a)(1)], because the products are labeled and marketed as “medical food” but do not meet the statutory definition of a medical food in the Orphan Drug Act ...Furthermore, these products are promoted for conditions that cause them to be drugs ...in that your products’ labeling is false and misleading.  Your products are labeled and marketed as medical foods for the conditions of fibromyalgia, chronic fatigue syndrome, and cardiovascular disease but do not meet the statutory definition of a medical food set forth in the Orphan Drug Act ...
Specific examples of claims in your order brochure that promote your products as drugs are as follows:

• “Corvalen, with the active ingredient ribose, can help you overcome fatigue caused by fibromyalgia, chronic fatigue, cardiovascular disease….”
• “[C]orvalen helps the body quickly restore energy levels that have been depleted by…disease.”
• “Overcome pain and fatigue associated with:

o Fibromyalgia
o Chronic Fatigue Syndrome
o Cardiovascular disease”

Your order brochure also contains disease claims in the form of personal testimonials, including:

• “The energy building benefit of ribose dramatically improved pain and quality of life in my fibromyalgia and chronic fatigue syndrome patients...
-Dr. Jacob Teitelbaum
certified internist, medical director”  

An example of claims on your Corvalen M® product label are as follows:

• “Clinically proven to improve cardiac function and restore energy diminished by fibromyalgia and chronic fatigue.”...

You should take prompt action to correct the violations described above and prevent their future recurrence.  Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].
Please notify this office, in writing, within 15 working days of the receipt of this letter, of the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur.  Include any documentation necessary to show that correction has been achieved.  If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.
Gerald J. Berg
Director
Minneapolis District
MIM/ccl

   http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm232086.htm 

-