Inspections, Compliance, Enforcement, and Criminal Investigations
Immunity Today, LLC 02-Jun-05
Department of Health and Human Services
Public Health Service
Center for Biologics Evaluation and Research
June 2, 2005
RETURN RECEIPT REQUESTED
Linda K. Craig, RN, BSN
Immunity Today, LLC
10925 Antioch, Suite 101
Overland Park, KS 66210
Dear Ms. Craig:
The Food and Drug Administration (FDA) has reviewed your website at Internet address: http://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:
"Transfer factor has consistently been effective in the prevention and treatment of viral infections."
"For acute onset of symptoms [from Herpes Simplex Virus and Varicella-Zoster Virus], one can expect an immediate response ."
"The end product contains the important immune-supporting activities from a number of transfer factors including those for HHV-6, Epstein Barr Virus (EBV), Cytomegalovirus (CMV), Herpes Simplex Virus (HSV), and Herpes Zoster Virus (HZV)."
"Patients with a variety of conditions have tried our products, including chronic fatigue syndrome (CFS), fibromyalgia (FM), Gulf War syndrome, patients with post-Lyme symptoms (CFS or FM symptoms after Lyme disease), multiple sclerosis (MS), cancer, fever blisters/genital herpes, shingles, and other neurologic conditions and HIV patients."
"A number of patients that had noted substantial improvement in their symptoms while taking enhanced transfer factor products experienced deterioration in symptoms when they discontinued it. . . . It may be necessary for patients to take it indefinitely."
"The good news however is some insurers are recognizing the use of transfer factor (TF) as a viable treatment for immune disorders and provide reimbursement for all or a portion of the product cost."
"Transfer factor appears to be very safe."
Your website contains numerous personal testimonials that constitute therapeutic claims . These testimonials include, but are not limited to, the following:"
Gilbretta" from Missouri is quoted as stating: "My life has definitely been changed by this product and I highly recommend it to anyone seeking relief from diseases such as Multiple Sclerosis/Chronic Fatigue Syndrome or HHV-6."
"Rebecca" from Kansas, is quoted as stating: "Since starting a therapeutic dose of Formula 560,1 have noticed a significant improvement in my overall health. I have been HHV6 negative for three months, and my natural killer cell function count is up to 61."
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 U.S. citizens because the order page of your website provides for payment and shipment to U.S. 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 http://www.animune.com and http://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 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.
Mary A. Malarkey
Office of Compliance and Biologics Quality
Center for Biologics Evaluation and Research