FDA Warns Manufacter of Drugs Claims in Herbal Formula

The FDA has sent a warning letter to Two Feathers, a nutraceutical company that produces Two Feathers Healing Formula, also known as Compound X.

The letter charges that the company's Healing Formula should be classified as a drug and is also misbranded.

According to the company's website, Two Feathers sells Healing Formula as a treatment and cure for cancer, tumors, venereal diseases, and internal malignancies, the warning letter states. Based on the company's claims, the FDA has taken the position that Healing Formula is classified as a drug. Moreover, according to the FDA, Healing Formula is considered a new drug because there is no evidence that it is generally recognized as safe and effective for these claimed uses. The warning letter also asserts the product is misbranded because its labeling does not contain sufficient directions for its claimed uses.

Two Feathers declined to comment on the issue.

To view the warning letter, go to http://www.fda.gov/foi/warning_letters/g5322d.pdf.