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U.S. Department of Health and Human Services

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Enforcement Actions

Healthy World Distributing, LLC 28-Feb-05

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

Public Health Service
Food and Drug Administration

 

Center for Biologics Evaluation and Research
1401 Rockville Pike
Rockville MD 20852-1448



FEB 28 2005

 

CBER-05-010

WARNING LETTER

CERTIFIED MAIL
RETURN RECEIPT REQUESTED

 

Mr. Mark Gustafson
Healthy World Distributing, LLC
P.O. Box 3157
Post Falls, ID 83877

Dear Mr. Gustafson:

The Food and Drug Administration (FDA) has reviewed your website at Internet address: http://www.healthyworlddistributirzg.com and has determined that your product, Dr. Horowitz's Vaccine Recovery Formula, is being promoted for conditions that cause the product to be a drug under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) (21 USC 321(g)] and/or a biological product, as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 USC 262(i)].

Dr. Horowitz's Vaccine Recovery Formula is considered a drug because the therapeutic claims shown on your website establish the product's intended use as a drug. In describing Dr. Horowitz's Vaccine Recovery Formula, your website includes the following claims:

  • "The `Prophylactic VRF" maybe used as a substitute for vaccines in `high risk' children, or as a prophylactic against vaccine related injury for children in the few states that truly require them to be vaccinated by law for school attendance."

  • The product "target[s] the principle vaccine ingredients from which children are most commonly injured."

  • "Currently showing promise in clinical trials on autistic children, this formula is provided under no risk experimental conditions using a strict 6-month protocal [sic] . . . ."

  • "For optimal effectiveness a 6 month protocol is recommended."

It appears that your Dr. Horowitz's Vaccine Recovery Formula is offered for sale to U.S. citizens because the order page of your website provides for payment and shipment to U.S. addresses. This product appears to be available to anyone who orders the product from your website.

Please be advised that in order to introduce or deliver for introduction a biological product into interstate commerce, a valid biologics license (BLA) must be in effect (42 USC 262(a)). A BLA is issued only after a showing of safety, purity, and potency for the product's intended use. While in the development stage, biological products maybe distributed for clinical use in humans only if the sponsor has on file an accepted investigational new drug application (IIVD) (21 USC 355(i); 21 CFR Part 312). Your product is not the subject of an approved BLA, or an IND. Therefore, your shipments of product represent violations of the Act and/or the PHS Act and may result in the Agency seeking such relief as provided by law. (21 USC 331).

This letter is not intended to serve as an all-inclusive review of your website and/or the products marketed by Healthy World Distributing, LLC. It is your responsibility to ensure that all products marketed on your website are in. compliance with the Act and the PHS Act and their implementing regulations. You should take prompt action to correct the violations noted above. Failure to correct these violations promptly may result in regulatory action such as seizure and/or injunction without further notice.

Please notify this office in writing within 15 working days of receipt of this letter of any steps you have taken or will take to correct the 'noted violations and to prevent their recurrence. If corrective action cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. Your response should be sent to me at the U.S. Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike, Suite 200N, Rockville, Maryland 20852-1448.

If you have any questions regarding this letter, please contact Ms. Wendy Hively at (301) 827-6201.

Sincerely,

/S/


Mary A. Malarkey
Director
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research