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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Circle of Health, Inc, www.ayurveda-herbs.com 6/12/09

   

HHS Logo with hyperlink to HHS.govDepartment 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:


Shilajit Churna Rasayana 17


• "Precautions: This product is not meant to replace insulin treatment, it is a
dietary supplement for diabetics."


In addition, on the page dedicated to this product, "blood sugar reduction" appears in a
list of terms related to the product, directly above a header that states the name of the
product. The word "diabetes" also appears after the description of this product's
suggested effects, preparation instructions, and the "precautions" statement above.

Somalata Rasayana 21


On the page dedicated to this product, "obesity" appears in a list of terms related to the
product, directly above a header that states the name of the product.


Kapikachu Rasayana 22


On the page dedicated to this product, "Viagra Herbal Alternatives," "Impotence
Remedy," "Impotence Cure," and "Erectile Dysfunction" appear in a list of terms related
to this product, directly above a header that states the name of the product.
Additionally, a list of terms related to this product at the bottom of this page includes
"male infertility."


Arjuna Rasayana 4


• "Arjuna is useful as an anti-ischemic and cardioprotective herb for hypertension
and ischemic heart disease, especially in irregular cardiac rhythm, angina or
myocardial infarction. The bark possesses diuretic and tonic effects for cases of
cirrhosis of the liver ...."


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