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U.S. Department of Health and Human Services

Inspections, Compliance, Enforcement, and Criminal Investigations

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Enforcement Actions

Alternative Health Approaches 24-Sep-07

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

Public Health Service
Food and Drug Administration

 

Los Angeles District
19701 Fairchild
Irvine, California 92612-2506
Telephone (949) 608-2900


 

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

W/L 18-07

September 24, 2007

Alternative Health Approaches
1628 E. Southern Avenue
Suite #9, PMB-122
Tempe, AZ 85282

Dear Sir/Madam:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your web site at the Internet address http ://www.virupel.org and www.shop.alternativehealthapproaches.com and has determined that the product "Virupel®" is promoted for conditions that cause the product to be a drug under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)). The therapeutic claims on your web site establish that the product is a drug because it is intended for use in the cure, mitigation, treatment, or prevention of disease. The marketing of this product with these claims violates the Act.

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

Virunel®. 135 count

"Supports the immune system for viruses and bacteria."

"This report is being released as preliminary information about and exploration .of some of the prevailing understandings regarding avian ("bird") flu, viral infections involving the respiratory system in general, and the potential for Virupel® to prevent, mitigate, or cure related infections."

"LIKELY ACTION OF VIRUPEL® ON VIRUSES AND POSSIBLY H5N1
Through its components Virupel® exercises antiviral, antibiotic, and generally anti-infectious properties in mammals, birds, and humans. Virupel® is likely to be both preventative at lower doses and curative at higher to maximum dosages for respiratory viral infections, and is especially designed to deal with the most dangerous and potentially fatal symptoms of the H5NI influenza. Virupel® is likely to be equally effective against other influenzas as well as against many cold viruses."

For greatest effectiveness against H5N1 or other serious flus, Virupel® should be taken early in the illness-when symptoms first appear or at least within the first 24 hours, and not later than the second day of symptoms."

"Virupel® may be very effective at limiting the potential for hemorrhaging in the lungs, while significantly reducing fluid buildup that could lead to pneumonia. Virupel's® antibiotic properties may help reduce the chance of secondary bacterial infections."

Claims In the Form of Testimonials:

"ALLERGY RELIEF, . . . : I started taking the Virupel and my allergy symptoms went away as well as the last of the vaginal discharge I was dealing with. "

"MY SORE THROAT AND COLD/FLU SYMPTOMS WERE GONE: I have been able to get rid of 3 sore throats and the resulting cold/flu symptoms that always follow by taking Virupel."

"PINK EYE, STREP THROAT GONE: I developed a case of conjunctivitis (pink eye) and tried Virupel, not really expecting it to work . I was amazed when all my symptoms were gone within in less than a day. On another occasion I had a case of strep throat and instead of taking antibiotics I tried Virupel. All symptoms were gone in less than two days."

"VIRUPEL WORKED WHEN ANTIBIOTICS DID NOT"

Furthermore, these claims are supplemented by the use of metatags you use to bring consumers to your website. The metatags include: "nutraceutical line incredibly supports the body in such varied areas as colds and flus including bird flu, blood pressure, allergies, bird flu, avian flu, bird flu pandemic, avian flu pandemic, bird flu virus, avian flu virus, spanish flu, virus, pandemic, cure, symptom, vaccine, tamiflu, natural, help for bird flu pandemic, preventative bird flu, preventative avian flu, antiviral, antibiotic, immune illness, used to treat anemia,
neutropenia, Myasthenia Gravis, Lupus."

Furthermore, your product is not generally recognized as safe and effective for the above referenced conditions and therefore, the product is also 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 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.

The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products. 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 td 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: Compliance, 19701 Fairchild, Irvine, California, 92612. If you have any questions regarding any issue in this letter, please contact Barbara Rincon, Compliance Officer, at telephone number 949-608-4439.


Sincerely,

/S/

Alonza E. Cruse
District Director