Late last month, the American Herbal Products Association sent a letter to the U.S. Food and Drug Administration requesting the denial of a petition to allow the use of ionizing irradiation on dietary supplements and dietary ingredients.
AHPA only recently become aware of the food additive petition, which was filed in 2003 by Steris Corp., when it was referenced in the June 2007 preamble to the FDA's final rule on current good manufacturing practice for dietary supplements. The petition asks the FDA to allow ionizing irradiation up to a dose of 30 kiloGray for controlling microbial contamination of dietary ingredients.
The FDA already allows this type of radiation to preserve and kill bacteria in some meats and produce, but the dosage is regulated and only dry spices and frozen meats for NASA are allowed a dose as high as 30 kiloGray. The limits on all other food types are significantly less. For example, fresh pork is allowed a maximum dose of 1 kiloGray and poultry is allowed a maximum dosage of 3 kiloGray.
AHPA President Michael McGuffin, who signed the letter, says he is not an expert on irradiation, nor does he know what — if any — harm the process might cause dietary supplements and herbs. The issue, he says, is that Steris Corp. has the burden to prove that the irradiation at the dosage it's asking for won't cause harm, and the company has not done so. "This is a bad petition because the petition process requires petitioners to be knowledgeable," McGuffin says.
In addition to the trade association's members, he says the letter was written with consumers in mind. "We think we know our customers, the people who use herbs and vitamins," he says. "Customers assume those are natural products. We think they'd prefer not to have irradiated products."
The letter states that there is no need for ionizing radiation to treat this class of goods because "current good manufacturing practice is usually sufficient to ensure that dietary supplements are not subject to microbial contamination that presents any risk to the health of consumers."
McGuffin also writes that the petition, should it be approved, could allow the United States to become a dumping ground for poor quality herbal ingredients from around the world, as irradiation of herbal ingredients is not permitted in many countries.
Should the FDA choose to allow irradiation of dietary ingredients, AHPA says the requested dosage is unacceptable. "Steris Corp. has proposed that only astronauts would be able to obtain foods treated with higher limits of ionizing radiation than dietary supplements, and has apparently ignored the fact that, while spices are used in small amounts, dietary supplements may be consumed in quantities of several grams per day."
Steve Norton, a spokesman for Steris Corp., says the petition regarding irradiation of dietary supplements is one the company is no longer pursuing with the FDA. It was filed back in 2003 on behalf of a customer who manufactured dietary supplements as a means of seeking clarification on irradiation. That company is no longer a client. The maximum dose in the petition was based on spices because of their similar composition.
Norton adds that there is no law currently prohibiting irradiation of dietary supplements. "There seems to be a misconception that food becomes radioactive," he says. "It's a process that's in use for a broad range of food products to eliminate bacteria and mold."