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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Universal Nutraceuticals, Inc. 22-Aug-05

Department of Health and Human Services' logoDepartment of Health and Human Services

Public Health Service
Food and Drug Administration

 

Baltimore District Office
Central Region
6000 Metro Drive, Suite 101
Baltimore, MD 21215
Telephone: (410) 779-5454
FAX: (410) 779-5707



FEI: 3004745479
VL Number: 05200678

August 22, 2005

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

Mr. Ashfaq H. Shah, President
Universal Nutraceuticals, Inc.
15843 Crabbs Branch Way
Rockville, Maryland 20855

Dear Mr. Shah:

The Food and Drug Administration (FDA) inspected your firm located 15843 Crabbs Branch Way, Rockville, Maryland on April 18, 2005. During that inspection, our investigators collected labeling for your product, Glucomet™. Additionally, on April 5, 2005, FDA reviewed your website at the Internet address, http://www.UniversalNutraceuticals.com. Our review of this information found that your product, Glucomet™, is in serious violation of the Federal Food, Drug and Cosmetic Act (the Act). You can find the Act and regulations on FDA's website at http://www.fda.gov.

Under section 201(g)(1)(B) of the Act [21 U.S.C 321(g)(1)(B)], articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man are drugs. Based on claims that appear in Glucomet™ labeling, FDA has determined that the product is promoted for a condition that causes it to be a drug under 201(g)(1)(B) of the Act.

Examples of such claims include:

1) Claims from http://www.universalnutraceuticals.com website:

"About us" tab: "I have been a practicing physician in the United States since 1981, and I have been very much concerned wit [sic] the near epidemic incidences of Diabetes Mellitus (Type 2) that I have witnessed particularly in the last two decades . . . . My goal in bringing Glucomet™ to market was to do all I could as a physician to help balance blood sugar levels. Glucomet™ is a highly effective and important modality that should be used in conjunction with dietary changes, proper exercise and appropriate medication. Please remember that anyone using Glucomet™ should continue taking their regular medications and to control their blood sugar under the
supervision of their primary care physician."

"Products" tab: "Developed by a renowned medical doctor, Glucomet™ is a unique combination of several unique herbs with chromium especially formulated to help the body maintain healthy blood sugar levels."

  • "Gymnema Sylvestre: [ingredient in the product] . . .used in India for centuries because of its ability to keep blood glucose level [sic] in a healthy range."

  • "Mormordica Charantia (Bitter Melon): [ingredient in the product] . . . is claimed to maintain healthy blood sugar levels."

  • " Withania Coagulans: [ingredient in the product] . . .has a reputation for maintaining healthy glucose levels . . ."

"Testimonials" tab: "My friend gave me one of your brochures on your product, Glucomet. I ordered your product over the Internet . I have used the product and my family doctor is very happy with my present reading and also told me that I can reduce the doses of my other medications, which I am taking."

"I am really thankful to you for helping me in bringing down my blood sugar. I have been a diabetic for 10 years. I have been taking Glucovance and Avandia. But my blood sugar was still between the range of 200 and 250 . After starting Glucomet it has dropped to the range of 115 to 130."

"I never believed in alternative medical treatment. I have a long history of diabetics [sic]. I am taking several medications, but still my sugar is out of control . Now my doctor wants to start insulin, but I am afraid of needles . My friend gave me the herbal supplement, Glucomet. I kept checking my blood sugar and it dropped significantly . I kept a diary and showed my doctor on next visit. He said, "I don't believe it. But whatever you are doing, continue to do it. I will put insulin on hold for now." My readings have been extremely good and I want to continue this supplement. . . "

"Glucomet has not only helped my blood sugar; all the aches and pains all over my body have disappeared as well."

"I have been diabetic for many years. I take about 6 pills a day. . . . The lady who works at my local health food store told me about your product, Glucomet. I took it . . . . I have noticed drastic changes in my blood sugar."

2) Claims from Brochures Collected During Firm Inspection:

a) "Balance Your Blood Sugar with Glucomet™" brochure

"Glucomet™ is an all new, 100% natural, completely safe, and highly effective way to treat high blood sugar levels."

"Gymnema Sylvestre (Gurmar) This is an ancient herb that has been used in India for a very long time because of its ability to keep blood glucose levels in a healthy range. Gymnema sylvestre is theorized to work on beta cells and the pancreas. Gymnema sylvestre is helpful in controlling both Type 1 and Type 2 Diabetes by decreasing the amounts of sugar that are absorbed from food and by making body cells more responsive to the insulin that is available."

"Who Should Use Glucomnet™[?] Glucomet™ is for anyone who has high blood sugar levels."

"How to Take Glucomet™ If you have high blood sugar levels : Start by taking one capsule daily after a main meal while following all directions given to you by your health care practitioner . If you have Type 2 Diabetes : Simply take one capsule after each meal and continue to monitor your blood sugar level and follow all directions given to you by your health care physician . . . ."

b) "Glucomet™ Dietary Supplement to help support your healthy blood sugar" brochure

"Glucomet™ is a totally new, 100% natural, completely safe, and highly effective way to treat high blood sugar levels ."

"Bitter Melon (Momordica charantia) . . .Bitter Melon contains a mixture of insulin-like peptoids and alkaloids, and is reputed to help control healthy blood sugar levels ."
"Gurmar (Gymnema sylvestre) . . .Gurmar may help control both Type 1 and Type 2 Diabetes by decreasing the amounts of sugar that are absorbed from foods, and by making body cells more responsive to the insulin that is available."

Because Glucomet™ is not generally recognized as safe and effective for the treatment of diabetes, it is a "new drug" under section 201(p) of the Act [21 U.S.C. 321(p)]. New drugs may not be legally marketed in the United States 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 sponsor to demonstrate that the drug is safe and effective. Further, Glucomet™ is misbranded under section
502(f)(1) of the Act [21 U.S.C. 352(f)(1)] in that the labeling of the product fails to bear adequate directions for use.

This letter is not intended to be an all inclusive review of your products and their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. You must take prompt action to correct these violations. Failure to immediately cease distribution of violative products could result in regulatory action by FDA without further notice . These actions include, but are not limited to, seizure, injunction, and prosecution.

Please notify this office in writing, within 15 working days of receipt of this letter, of the specific steps you have taken to correct the noted violations . Include all documentation of the corrective actions you have taken. If all corrective actions cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed.

Your response must be sent to Nancy L. Rose, Compliance Officer, Food and Drug Administration, 6000 Metro Drive, Suite 101, Baltimore, Maryland 21215. If you have any questions, contact Ms. Rose at (410) 779-5415.

Sincerely,
/s/

Betty Collins
Acting Director
Baltimore District