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Public Health Service
Food and Drug Administration
  College Park, Maryland 20740

CERTIFIED MAIL
RECEIPT REQUESTED

FEB 07 2008

Som Pruthi
International Pharmaceutical Corporation
Pilex Corporation
202 Marisol Way
Monterey, CA 93940-7639

WARNING LETTER
Re: CFSAN-OC-08-03

Dear Som Pruthi:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web sites at the Internet addresses: http://www.malaria.me.uk, www.arthritis.bz, www.hepatitis.bz, www.pilex.com, and www.hernorrhoids.com and has determined that the products Malariam, Arthritan, Hepatan, and Pilex are promoted for conditions that cause the product 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 web sites 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 violates the Act.

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

www.malaria.me.uk - MALARIAM

Also, these claims are supplemented by the metatags used to bring consumers to your website. The metatags include "malaria prevention," "malaria treatment," and "malaria cure."

www.arthritis.bz - ARTHRITAN

Examples of some of the claims on your web site in the form of testimonials include:

www.henatitis.bz - HEPATAN

Your web site also contains disease claims in the form of personal testimonials, including:

before HEPATAN

after HEPATAN 2 weeks

acceptable

AST (units/L) 66

37

7-27

ALT (units/L) 102

52

1-21

www.pilex.com, www.hemorrhoid.com and www.hemorrhoids.com - PILEX

Your web site also contains disease claims in the form of personal testimonials, including:

Also, these claims are supplemented by the metatags used to bring consumers to your websites, www.pilex.com, www.hemorrhoid.com and www.hemhorrhoids.com. The metatags include "hemorrhoids treatment" and "hemorrhoids bleeding."

Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 20l(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 products "Malariam," "Arthritan," "Hepatan," and "Pilex" are also misbranded within the meaning of section 502(f)(1) of the Act in that labeling for these drugs fail 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. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We urge you to review your websites, 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. §§ 332and 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.

Your response should be directed to Felicia B . Williams at Food and Drug Administration, Center for Food Safety and Applied Nutrition, Office of Compliance, HFS-608, 5100 Paint Branch Parkway, College Park, MD 20740. If you have any questions, you may contact Ms. Williams at (301) 436-2566.

Sincerely,

/S/

Joseph Baca
Director, Office of Compliance
Center for Food Safety and Applied Nutrition

This page was posted on July 19, 2010.

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