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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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International Pharmaceutical Corporation 07-Feb-08

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

Public Health Service
Food and Drug Administration

 

College Park, Maryland 20740


WARNING LETTER

CERTIFIED MAIL
RECEIPT REQUESTED

FEB 07 2008

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

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

• "[M]ay help prevent malaria without side effects"

• "MALARIAM capsule is good and safe in prevention and treatment of malaria fever without side effect."

• "The MALARIAM capsule is very effective in prevention of malaria fever in endemic areas."

The product name "MALARIAM" and URL address for your website both contain the word "malaria." The use of "malaria" in the name of your product and in the URL for the website where you sell the product suggests that "MALARIAM" is intended for use in treating or preventing malaria.

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

• "2 capsules a day of ARTHRITAN for 2-4 weeks may significantly reduce pains due to arthritis, gout, lumbago or sprain without side effects."

• "For advanced stage bone or cartilage damage, I capsule a day may be needed for maintenance after initial 8 weeks treatment"

The URL address for your website contains the word "arthritis." The use of "arthritis" in the URL for the website where you sell the Product suggests that "ARTHRITAN" is intended for use in treating or preventing arthritis.

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

• "I have taken the herbal. .(Arthritan) for 2 weeks and experienced the following:
1. My back pain has been substantially reduced (from level 7 to 2).
2. I am immediately able to walk erect and not tilted-because of back pain....
4. I was surprised at the substantial relief in a relatively short time."

www.henatitis.bz - HEPATAN

• "Hepatitis Virus C Therapy"

• "Breakthrough Hepatitis Therapy & Prevention"

• "May significantly reduce liver inflammation in 2-4 weeks"

• "2 studies of 10 & 350 have shown promising results of reducing serum bilirubin from high of 9-16 to the normal range of 0.2-0.8 mg/dl and S.G.P.T reduction from the high of 500-900 to the normal range of 5-35 units/ml."

• "I feel that the Hepatan capsule is having miraculous properties for curing jaundice - Dr. S. Pruthy".

The URL address for your website contains the word "hepatitis." The use of "hepatitis" in the URL for the website where you sell the product suggests that "HEPATAN" is intended for use in treating or Preventing hepatitis.

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

• "While I was initially skeptical when I placed my first order, after three weeks of using Hepatan, there has been a noticeable improvement in the way I feel and in my sleeping pattern. Hepatan has diminished the swelling in my liver, improved my quality of life and restored my hope that recovery is possible."

before HEPATAN

after HEPATAN 2 weeks

acceptable

AST (units/L) 66

37

7-27

ALT (units/L) 102

52

1-21

My swelling and pain has gone down considerably. I feel better and my appetite has improved."

• "After useing (sic) Hepatan for 7 weeks, taking it twice a day for 2 weeks, then once a day for the next 5 weeks, my results were:

Viral Load before. . . . . . . . . . . . . 14,850,000
Viral Load after HEPATAN . . . . . . 6,080,000.
I feel good. Hepatan is working for me..."

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

• "BREAKTHROUGH TREATMENT for HEMORRHOIDS"

• "Proper usage of Pilex helps stop pain, itching, burning and rectal bleeding by shrinking the inflamed area of discomfort."

• "No longer do you have to worry about messy hemorrhoid ointments or expensive hemorrhoid surgery with extensive recovery time associated with other rectal bleeding and external hemorrhoids treatments."

• "helps stop hemorrhoidal bleeding"

• "up to 6 months relief within I treatment"

• "thousands of satisfied users No reported side affects" [sic]

The URL addresses for your websites www.hemorrhoid.com and www.hemorrhoids.com, contain the words "hemorrhoid" or "hemorrhoids," respectively. The uses of "hemorrhoid" and "hemorrhoids" in the URLs for the websites where you sell the product suggest that "PILEX" is intended for use in treating or preventing hemorrhoids.

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

• "[W]ithin the 3rd day, the bleeding had stopped. It is truly a remarkable product. I am another very satisfied and happy customer."

• "I bought one order of Pilex 1 1/2 years ago. The hemorrhoids immediately disappeared for 1 yr & 3 mo."

• "[G]reat alternative to going under the knife and having surgery!!!"

• "Pilex is the miracle that has saved me. I have had bouts of rectal bleeding, hemorrhoids and polyps for years. The bleeding stopped within 2 days along with itching. . . Thanks Pilex."

•"Surgery was my only option. . . my bleeding has ceased. . .I can say that PILEX works . . .Sincere gratitude to you."

Also, these claims are supplemented by the metatags used to bring consumers to your websites, www.pilex.com, www.hemorrhoid.com and www.henlorrhoids.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