Inspections, Compliance, Enforcement, and Criminal Investigations
Peters, Anthony 01-Aug-06
Department of Health and Human Services
Public Health Service
RETURN RECEIPT REQUESTED
August 1, 2006
250 N Newman Road
Lake Orion, MI 48362
Dear Mr. Peters:
The Food and Drug Administration (FDA) has reviewed your web site at the Internet address http://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: http://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 U.S.C. 321(g)(1)(B)]. The Internet labeling of your product bears the following claims:
"Adjunct Therapy in HIV"
"Immune-Assist 247™ is presently being tested in human trials for use in HIV infections and for Hepatitis C. The results have been amazingly positive in each one of these studies."
"Bird Flu - Are You Ready?"
In addition the Internet labeling for your product bears the following claims for the listed ingredients:
EGCG (Green Tea Extract): "EGCG protects against . . .respiratory infections, helps to block the cancer promoting actions of carcinogens, protects against high total and LDL cholesterol level. . .."
Reishi : "Recently Reishi has been touted as a remedy for cancer, HIV, Hepatitis B, herpes,. . . high blood pressure and diabetes."
Shitake: "Shitake is used medically for any all diseases involving depressed immune function including cancer, AIDS, environmental allergies, yeast infections, frequent flu and colds."
Cordyceps Sinenssis: "Cordyceps in widely employed to treat upper respiratory problems, impotence, weakened immune systems . . . . It is used in China to treat a number of bronchial problems such as bronchitis, pneumonia, pulmonary emphysema and tuberculosis . . . ."
Agaricus blazei : "Agaricus blazei mushroom can  prevent viruses. . . ; This mushroom has an anti tumor and anti cancer effect, and is particularly effective in preventing cancer of the uterus . Agaricus blazei . . . reduces the effects of arteriosclerosis."
Coriolus : "It is . . .used to treat pulmonary infections . . ."
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 U.S.C. 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 U.S.C. 321(p)]. Under section 505 of the Act [21 U.S.C. 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 U.S.C. 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.
Joann M. Givens
Detroit District Office