By James Roza, Cn?????????????????? I applaud Botanicals International?s (BI) proactive stance in dealing with the issue of unapproved sterilization methods as reported in NPI?s recent press release, ?BI Nutraceuticals Commences Education Program Surrounding FDA Approved Raw Material Sterilization Methods?. Their program to enlighten the industry about the FDA ban on the use of ethylene oxide (ETO) and gamma rays (irradiation) to sterilize dietary ingredients is a bold step forward in addressing a sensitive issue that has been part and parcel of this industry for a long time.

For those new to the industry, this ban is not a prohibition that just recently took effect, it has been around for quite a while but it has not been discussed with the transparency that BI is planning to provide. The use of ETO and irradiation for the sterilization of herbs and other nutraceuticals such as shark?s cartilage has been in use for many years. Until the advent of steam, ozone and hydrogen peroxide sterilization, many companies had no other means to reduce microbial loads but through ETO and irradiation. While these methods are allowed for certain spices and approved foods, many companies either willingly or unknowingly purchased ingredients of this ilk for the manufacturing of their dietary supplements.

Luckily the industry has not had to bare the brunt of an ETO incident as it has with the issue of heavy metals and Proposition 65 or steroids masquerading as dietary supplements, but it is an accident that is ready to happen if we don?t take charge of it ourselves. The more transparent and rational discussion we as an industry can give to these issues bodes well for our success in the future.