Department of Health and Human Services' logo Department of Health and Human Services

Public Health Service
Food and Drug Administration
Center for Biologics Evaluation and Research
Office of Compliance and Biologics Quality

 

1401 Rockville Pike #200N, HFM-600
Rockville, MD 20852-1448

June 2, 2005
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Linda K. Craig, RN, BSN
Immunity Today, LLC
10925 Antioch #101
Overland Park, KS 66210

Ref. No. 05-011

Dear Ms Craig:

The Food and Drug Administration (FDA) has reviewed your website at Internet address: www.immunitytoday.com and has determined that your "transfer factor" products, derived from bovine colostrum, are being promoted for conditions that cause the products to be drugs under section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 USC 321(g)] and/or biological products, as defined in section 351(i) of the Public Health Service Act (PHS Act) [42 USC 262(i)].

Your transfer factor products, including Immune Care 64, PAP-TF, LY-TF, Immune Care RTF, Formula 560, Formula 540, Formula 530, and Formula 512, are considered drugs and/or biological products because the therapeutic claims, as shown on your website, establish their intended use as such. In describing your transfer factor products, your website includes the following claims:

Your website contains numerous personal testimonials that constitute therapeutic claims. These testimonials include, but are not limited to, the following:

It appears that your transfer factor products, including Immune Care 64, PAP-TF, LY-TF, Immune Care RTF, Formula 560, Formula 540, Formula 530, and Formula 512, are offered for sale to US citizens because the order page of your website provides for payment and shipment to US addresses. Furthermore, the website testimonials are from persons residing in the United States. These products appear to be available to anyone who orders the products from your website.

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

In addition, we note that your transfer factor products appear to be the same as products for which Animune, Inc. was criminally convicted of marketing without a license. Specifically, the Internet websites www.animune.com and www.tomorrowsfoods.com indicate that you obtain your transfer factor products from Tomorrow's Foods, Ltd and that Tomorrow's Foods, Ltd manufactures those transfer factor products using a patented process developed by Animune, Inc involving the isolation of transfer factors from the colostrum of cattle that have been injected with human viruses. In 2004, Animune, Inc. was prosecuted by the federal government for using that patented process to manufacture transfer factor products like yours that were unapproved new drugs and unlicensed biological products, and for distributing those products into interstate commerce without a biologics license in effect. Please be advised that the company pled guilty to violation of Title 18 USC, section 371 (conspiracy) and was ordered to pay fines; euthanize the injected cattle, and abandon all colostrum previously seized by the FDA.

This letter is not intended to serve as an all-inclusive review of your website and/or the products marketed by Immunity Today, 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 US Food and Drug Administration, Center for Biologics Evaluation and Research, HFM-600, 1401 Rockville Pike #200N, Rockville, MD 20852-1448.

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

Sincerely,
/s/
Mary A. Malarkey
Office Director

This page was posted on March 28, 2006.

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