BI Nutraceuticals Educates Industry on ETO and Irradiation

BI Nutraceuticals (Long Beach, CA) has begun an education program designed to inform the dietary supplement industry about the FDA's (Rockville, MD) ban on the use of both irradiation and ethylene oxide (ETO) as a means of sterilization for raw materials.

As part of this initiative, BI has compiled a four-page consultative guide to help industry members better understand U.S. regulations surrounding the banned use of ETO and irradiation as a means for dietary supplement ingredient sterilization, as well as familiarize them with legal alternatives including steam sterilization.

"What a majority of manufacturers in the industry may not realize that the use of ETO and irradiation for the purpose of reducing or eliminating microbial loads is not permitted right now," stated George Pontiakos, president and CEO, BI Nutraceuticals. "These restrictions are not part of the new cGMPs that are being phased in over a three-year period, they are being enforced currently and companies using ETO or irradiated materials are subject to FDA penalties now."

ETO is considered a pesticide, and according to the Federal Food, Drug and Cosmetic Act, any food that bears or contains a pesticide chemical residue that is unsafe is considered adulterated.