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

Public Health Service
Food and Drug Administration
Detroit District

 

300 River Pl #5900
Detroit, MI 48207
Telephone: 313-393-8100
FAX: 313-393-8139

August 1, 2006
WARNING LETTER
VIA CERTIFIED MAIL, RETURN RECEIPT REQUESTED

Anthony Peters
250 N Newman Rd
Lake Orion, MI 48362

Ref. No. 2006-DT-24

Dear Mr Peters:

The Food and Drug Administration (FDA) has reviewed your website at the Internet address www.immuneassist247.com. The review shows serious violations of the Federal Food, Drug, and Cosmetic Act (the Act) in the labeling of your product "Immune-Assist 247™". You can find the Act and implementing regulations through links on FDA's Internet home page: www.fda.gov.

Under the Act, articles intended for use in the diagnosis, cure, mitigation, treatment or prevention of disease in man are drugs [Section 201(g)(1)(B) of the Act, 21 USC 321(g)(1)(B)]. The Internet labeling of your product bears the following claims:

In addition the Internet labeling for your product bears the following claims for the listed ingredients:

The list of claims is not intended to be all-inclusive, but represents, the types of claims found in your product labeling.

These claims cause your product to be a drug, as defined in section 201(g)(1)(B) of the Act [21 USC 321(g)(1)(B)], because they establish that this product is intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Because ;this product is not generally recognized as safe and effective when used as labeled, it is also a new drug as defined in section 201(p) of the Act [21 USC 321(p)]. Under section 505 of the Act [21 USC 355], anew drug may not be legally marketed in the United States without an approved New Drug Application (NDA). 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 above violations are not meant to be an all-inclusive list of deficiencies in your products or their labeling. It is your responsibility to ensure that all products marketed by your firm comply with the Act and its implementing regulations.

You must immediately correct these violations. If you do not immediately correct them, you may be subject to enforcement action without further notice. The Act provides for seizure of illegal products and for injunctions against the manufacturers and distributors of illegal products [21 USC 332 and 334].

Please advise this office, in writing and 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 ensure that similar violations do not occur. 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 reply should be directed to Judith A. Putz, Compliance Officer at the above address.

Sincerely,
/s/
Joann M. Givens
District Director

This page was posted on February 12, 2008.

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