Inspections, Compliance, Enforcement, and Criminal Investigations
Bioenergy, Inc 11/1/10
Department of Health and Human Services
|Public Health Service|
Food and Drug Administration
|Minneapolis District Office|
250 Marquette Avenue, Suite 600
Minneapolis, MN 55401
Telephone: (612) 758-7185
FAX: (612) 334-4142
November 1, 2010
RETURN RECEIPT REQUESTED
Refer to MIN 11 – 04
Chief Executive Officer
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 located at 13840 Johnson Street NE, Ham Lake, Minnesota. During the inspection, the investigator collected your Corvalen M® product label and an order brochure for your Corvalen®, Corvalen® Chewable Wafers, and Corvalen M® products. FDA has reviewed the Corvalen M® product label and order brochure and found that your Corvalen®, Corvalen® Chewable Wafers, and Corvalen M® 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 [21 U.S.C. § 360ee(b)(3)] or the criteria set forth in Title 21, Code of Federal Regulations (21 CFR), 101.9(j)(8). The Corvalen M® product is also misbranded under section 403(q) of the Act [21 U.S.C. § 343(q)] in that it does not bear all of the required nutrition information. Furthermore, these products are promoted for conditions that cause them to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. You can find the Act and its implementing regulations on FDA’s website at http://www.fda.gov.
Your Corvalen®, Corvalen® Chewable Wafers, and Corvalen M® products are misbranded within the meaning of section 403(a)(1) [21 U.S.C. § 343(a)(1)] 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 [21 U.S.C. § 360ee(b)(3)].
The Orphan Drug Act defines “medical food” as “a food which is formulated to be consumed or administered enterally under the supervision of a physician and which is intended for the specific dietary management of a disease or condition for which distinctive nutritional requirements, based on recognized scientific principles, are established by medical evaluation.” The regulation in 21 CFR 101.9(j)(8) sets forth criteria to clarify the statutory definition of a medical food. Specifically, this regulation provides that a food is a medical food only if:
i. It is a specially formulated and processed product (as opposed to a naturally occurring foodstuff used in its natural state) for the partial or exclusive feeding of a patient by means of oral intake or enteral feeding tube;
ii. It is intended for the dietary management of a patient who, because of therapeutic or chronic medical needs, has limited or impaired capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or who has other special medically determined nutrient requirements, the dietary management of which cannot be achieved by the modification of the normal diet alone;
iii. It provides nutritional support specifically modified for the management of the unique nutrient needs that result from the specific disease or condition, as determined by medical evaluation;
iv. It is intended to be used under medical supervision; and
v. It is intended only for a patient receiving active and ongoing medical supervision wherein the patient requires medical care on a recurring basis for, among other things, instructions on the use of the medical food.
FDA considers the statutory definition of “medical food” to narrowly constrain the types of products that fit within this category. 1 In addition to other criteria, medical foods must be for the dietary management of a specific disorder, disease, or condition for which there are distinctive nutritional requirements and must be intended to be used under medical supervision. 2 Patients with such a disorder, disease, or condition must have a limited capacity to ingest, digest, absorb, or metabolize ordinary foodstuffs or certain nutrients, or have other special, medically determined nutrient requirements which cannot be managed by the modification of the normal diet alone.3 Medical foods are not those simply recommended by a physician as part of an overall diet to reduce the risk of a disease or condition. 4 No established distinctive nutritional requirement exists for the conditions for which your products are promoted as medical foods, and your products therefore do not meet the statutory or regulatory definition of a medical food.
Your Corvalen M® product is also misbranded within the meaning of section 403(q) of the Act [21 U.S.C. § 343(q)] in that it does not bear all the required nutrition information. Your products must declare all nutrition information in accordance with FDA’s food labeling requirements under 21 CFR 101.9. For example, your products must declare: the number of servings per container [21 CFR 101.9(d)(3)(ii)]; the calories from fat [21 CFR 101.9(c)(1)(ii)]; the total fat content [21 CFR 101.9(c)(2)]; the saturated fat content [21 CFR 101.9(c)(2)(i)]; the trans fat content [21 CFR 101.9(c)(2)(ii)]; the cholesterol content [21 CFR 101.9(c)(3)]; the sodium content [21 CFR 101.9(c)(4)]; the protein content [21 CFR 101.9(c)(7)]; the vitamins and minerals [21 CFR 101.9(c)(8)(iii)]. Your food products must also include a footnote that states “Percent Daily Values are based on a 2,000 calorie diet. Your daily values may be higher or lower depending on your calorie needs…” [21 CFR 101.9(d)(9)].
Additionally, your Corvalen products are promoted for conditions that cause the products to be drugs under section 201(g)(1)(B) of the Act [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your product labeling establish that your Corvalen®, Corvalen® Chewable Wafers, and Corvalen M® products are drugs because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violates the 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 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.”
Your products are not generally recognized as safe and effective for the above referenced uses and therefore the products are “new drugs” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.
The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your product labels and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.
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.
Your response should be directed to Melissa I. Michurski, Compliance Officer, at the address listed above. You can contact Ms. Michurski at (612) 758-7185 with any questions regarding this letter.
Gerald J. Berg
1 See 56 Fed. Reg. 60366, 60377 (Nov. 27, 1991); see also Guidance for Industry: Frequently Asked Questions About Medical Foods, May 2007.
2 See 21 U.S.C. § 360ee(b)(3); see also 56 Fed. Reg. at 60377.
3 See 21 CFR 101.9(j)(8)(ii); see also 56 Fed. Reg. at 60377.
4 See 56 Fed. Reg. at 60377.