FDA's proposal to revise labeling regulations for irradiated dietary supplements and food products could ease label requirements, but how the regulation would measure "material change" from radiation leaves the possibility for a bigger burden, trade groups say.

In the April 4 Federal Register, FDA proposes changing its regulation so the radura logo and the term "irradiated," or a derivative of it, is required only for products in which irradiation "causes a material change in the food, or a material change in the consequences that may result from the use of the food."

FDA says the ¹ proposed change will provide consumers with more useful information than the current regulation and comes in response to the Farm Security and Rural Investment Act of 2002 (² Also see "FDA Ginseng Labeling Enforcement Stressed In House Ag Approps Bill" - Pink Sheet, 15 July, 2002., p.15).

The deadline for comments is July 3, FDA said.

The Council for Responsible Nutrition and the Natural Products Association tell "The Tan Sheet" the proposed change for how material change will be measured causes some concern. Otherwise, the proposal appears positive for the industry.

"On an initial review, I would think that this would be seen at least as somewhat favorable by members of the dietary supplement industry," said Andrew Shao, Ph.D., CRN vice president for scientific and regulatory affairs.

Daniel Fabricant, Ph.D., NPA's vice president of scientific affairs said, "To the effect that this is going to really change things up for supplement manufacturers, it doesn't seem that it is going to have too significant an impact."

"However, we need to deal with our membership on that and really do some research into the issue and see what the impact will be in fact," Fabricant added.

A particularly positive component of the proposal is allowing firms to use "pasteurized" on labels instead of some form of the term radiation if the irradiation process they use meets criteria in the Federal Food, Drug and Cosmetic Act and the agency does not object.

FDA regulations currently allow no alternatives to some form of the term radiation on labels for products required to indicate exposure to ionizing radiation. However, firms can include the specific type of radiation process they use, according to FDA.

Despite the enhanced safety from the irradiation process killing insects, molds and bacterium present in some products or ingredients, some consumers balk at buying products with radiation noted on labels, Shao said. It is a "term that seems to stigmatize products in the minds or the eyes of many consumers," he said.

Pasteurized "is a little bit more consumer friendly" and using it instead of irradiated on labels could help firms draw more customers to their products, Shao said.

"I think they identify that as meaning it's done to ensure the stability, the shelf life and the safety of the products, but don't see it as something dangerous or something reducing the quality of the product the way they may view something like radiation."

"The point is that there is the opportunity to use more consumer-friendly language. The FDA opening the door for that, which I think overall is going to be a good thing for the industry and consumers."

However, it is not clear whether the proposal's reference to material change will be good for industry because criteria are not set for measuring changes in a product's shelf life, smell, taste or texture.

"There doesn't seem to be a real iron-clad system of measurement with respect to material change," Fabricant said.

In its comments on the proposal, NPA will ask FDA to establish "some pretty stringent guidelines, or least something where there's some kind of scientific oversight that makes sense in this area," he said.

"Are they going to go around to everyone and look at every product that's out there and say a radiation of this herb constitutes a material change? We don't know what the mechanism of that is, so obviously we need to feel that out a little bit and see what else is there," Fabricant added.

Material change from irradiation of dietary supplement products is most commonly seen in their color or other elements of their appearance, Shao said.

However, more substantive changes from irradiation can happen with botanical products. "It could affect the taste, but I would suspect there are few instances where there is actually a material change," Shao said.

- Malcolm Spicer (m.spicer@elsevier.com)

FDA Radiation Label Change Positive, But “Material Change” Issue Troubling

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