FDAnews Drug Daily Bulletin


Aug. 25, 2006

The operator of a health supplement website drew a warning letter from the FDA for product labeling that the agency said classified it as a new drug.

According to the Aug. 1 warning letter, the website advertised Immune Assist 24/7 as an "Adjunct Therapy in HIV," said that it is "presently being tested in human trials for use in HIV infections and for Hepatitis C" and asked "Bird Flu -- Are You Ready?" The website also made several claims for the product ingredients, which are listed as an extract of green tea and six kinds of mushrooms. It said, for example, that shitake mushrooms are used medically for any and all "diseases involving depressed immune function including cancer, AIDS, environmental allergies, yeast infections, frequent flu and colds."

These claims mean the FDA considers the product a drug, which cannot be marketed without an approved new drug application, the warning letter said. It directed Anthony Peters, the recipient of the warning letter, to correct the violations or face seizure of the product.

When DID accessed the website www.immuneassist247.com (http://www.immuneassist247.com) , the claims cited in the warning letter appeared to have been removed. The website also bore the following disclaimer: "The information on this website is intended for educational purposes only. The products offered on this website have not been evaluated by the Food and Drug Administration and are not intended to diagnose, treat, prevent or cure any disease." However, the website, which lists its company name as Birkdale Medicinals, advertised Immune Assist 24/7 as "clinically proven to enhance immune function 24 hours a day, 7 days a week" and said that "it increases the number and activity of the T-cells, B-cells, natural killer cells and many others."

"I just complied with what they said I have to do," Anthony Peters, the recipient of the warning letter, said. "How can you fight them? Even if you say the truth and they disagree, what can you do? You just have to comply."

The letter can be seen at www.fda.gov/foi/warning_letters/g5970d.pdf (http://www.fda.gov/foi/warning_letters/g5970d.pdf).