Biologics Firm Receives FDA Warning Letter

Envita Natural Centers of America (Scottsdale, AZ, www.behealthyamerica.com) received a warning letter from the FDA on June 14 that states that the firm’s manufacturing process violates the Public Health Service Act and the Federal Food, Drug, and Cosmetic Act.

Envita produces cancer treatments by extracting cells from cancer patients and manipulating them to increase the T-cell count, with the aim of enabling the body to kill off tumor cells. Based on an inspection conducted March 1, 2006, FDA concluded that the company’s process rises above the agency’s threshold of “minimum manipulation” of cells.

According to the warning letter, Envita’s treated cell cultures are both a biological product and a drug, for which the company must have a valid biologics license (BLA) or new drug application (NDA) in effect before commercial distribution. Prior to approval, biological and drug products may be distributed for clinical use in humans only if the sponsor has an investigational new drug (IND) application in effect. Envita does not have an IND in effect for this product, and neither a BLA nor an NDA has been filed.

The agency says that the company’s treated cell cultures do not meet the definition of human cells, tissues, and cellular- and tissue-based products (HCT/Ps). Under 21 CFR Part 1271, HCT/Ps are not subject to license or IND requirements if certain criteria are met. In this case, says the agency, those conditions are not met because the cells are more than minimally manipulated.

The warning letter also says Envita violated regulations governing the proper conduct of clinical studies by failing to submit an IND and to meet the general requirements of an IND.

In addition, FDA says Envita’s product appears to be misbranded within the parameters set by the Food, Drug & Cosmetic Act because the labeling fails to clearly state adequate directions for the drug’s intended use.