Washington, D.C., December 17, 2007 – American Herbal Products Association (AHPA) in opposing a petition filed with the Food and Drug Administration (FDA) to allow the use of ionizing radiation for the control of microbial contamination on dietary supplements and dietary ingredients.
Dear Lane A. Highbarger, Ph.D.
I join American Herbal Products Association (AHPA) in opposition to a petition by the FDA referenced in the preamble to FDA’s final rule on current good manufacturing practice for dietary supplement on June 25, 2007. I support AHPA’s opposition to this petition on the following grounds:
- Proper handling of dietary supplements under current good manufacturing practice is usually sufficient to ensure that they are not subject to microbial contamination that presents any risk to the health of consumers of these products
- If approved, the use of ionizing irradiation on herbal dietary ingredients will mask one of the factors that is currently relevant to the determination of ingredient quality, since information about microbial levels and the presence of pathogens or yeasts and molds at any time during the handling of a treated ingredient would be lost. Of particular concern are pathogens, since even if pathogenic organisms are eliminated through irradiation, pathogenic by-products such as endotoxins or exotoxins may remain in the material
- Irradiation is currently allowed in the United States for eleven food categories, and in proposing that the limitation of ionizing radiation for dietary supplements be established at 30 kGy, the petition is suggesting that this limit be from 3 to 30 times higher that is currently allowed for all but two food categories. Dietary supplements may be consumed in quantities of several grams per day. Thus, dietary supplement consumers will be exposed to much higher levels of any material changes that occur in a supplement’s or ingredient’s characteristics or in its consequences of use, if any, as a result of the irradiation.
I look forward to your response to this letter,
Please print and send your copy of this letter today and just say “No” to the irradiation of dietary supplements!
Send your letter to:
Lane A. Highbarger, Ph.D.
Food and Drug Administration
Center for Food Safety and Applied Nutrition (HFS-255)
Office of Food Additive Safety
5100 Paint Branch Parkway
College Park, MD 20740