Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
  Seattle District
Pacific Region
22201 23rd Drive SE
Bothell, WA 98021-4421
Telephone: 425-486-8788
FAX: 425-483-4996

June 12, 2009

VIA CERTIFIED MAIL
RETURN RECEIPT REQUESTED

In reply refer to Warning Letter SEA 09-19

Circle of Health, Inc.
P.O. Box 399
Eugene, Oregon 97405

WARNING LETTER

Dear Sir or Madam:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website at the Internet address www.ayurveda-herbs.com and has determined that your products "Kapikachu Rasayana 22," "Somalata Rasayana 21," "Shilajit Churna Rasayana 17," and "Arjuna Rasayana 4" are promoted for conditions that cause them to be drugs under section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321 (g)(1)(B)]. The therapeutic claims on your website establish that these products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of these products with these claims violate the Act.

Examples of some of the claims observed on your web site include:

These claims are supplemented by metatags used to bring consumers to your website through Internet searches. Examples of these metatags include "Viagra Herbal Alternatives," "Impotence Remedy," "Impotence Herbs Cure," "Diabetes Alternative Medicine," "Obesity," "High Cholesterol Herbs," and "Heart Disease Cure."

Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, they 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. Your "Shilajit Churna Rasayana 17," "Somalata Rasayana 21," "Kapikachu Rasayana 22," and "Arjuna Rasayana 4" products are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fails to bear adequate directions for use [21 U.S.C. § 352(f)(1)].

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, 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.

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 §§ U.S.C. 332 and 334]. You should take prompt action to correct these deviations and prevent their future recurrence. Failure to do so may result in enforcement action without further notice.

Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to 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.

Please send your reply to the Food and Drug Administration, Attention: Lisa M. Elrand, Compliance Officer, 22201 23rd Drive SE, Bothell, Washington 98021-4421. Your response should be directed to Ms. Elrand at the above address.

Sincerely,

/S/

Charles M. Breen
District Director

cc:
Associate Director
Division of Advertising Practices
Federal Trade Commission
600 Pennsylvania Avenue, N.W.
Washington, D.C. 20580

This page was posted on January 31, 2010.

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