FDA Considers Changes To Irradiation Labeling Requirements

The Food and Drug Administration (FDA) has published an advance notice of proposed rulemaking to consider changes to the current regulations for labeling of irradiated food.

The notice is in response to a congressional directive in the Conference Committee report that accompanied the Food and Drug Administration Modernization Act of 1997 (FDAMA). FDA is particularly interested in receiving comments on whether (1) the current disclosure statement required on irradiated food should be revised and (2) whether such labeling requirements should expire at a specified date in the future.

Currently, under 21 C.F.R. [sections] 179.26 of the food additive regulations, FDA requires that the label on retail packages of food treated with ionizing radiation include both the radura logo (see illustration) and a disclosure statement, such as "treated with radiation."

The logo must be placed prominently and conspicuously in conjunction with the required statement. But, as a provision of FDAMA made clear, the disclosure statement need not be any more prominent than the declaration of ingredients.

The Conference Committee report directs FDA to submit for public comment proposed changes to the current labeling regulations. In this regard, the conferees were concerned that "the required irradiation disclosure ... be of a type in character such that it would not be perceived to be a warning or give rise to inappropriate consumer anxiety."

The current labeling requirements are based upon FDA's conclusion in a 1986 rulemaking that radiation of foods is a form of processing that can produce significant changes in the organoleptic or holding properties of a food in a way not obvious to the consumer.

Therefore, the Agency decided that disclosure is required to prevent consumer deception, and that radiated food not so labeled should be considered misbranded. The Agency intended to provide this information by way of both the radura symbol and the disclosure statement, with the latter expected to be dropped once consumers became more familiar with the symbol. However, because such food products never caught on with consumers, the disclosure statement was later made permanent by the Agency.

Deadline For Comments

In examining what, if any, revisions to make to the labeling requirements, FDA raises a number of issues, most of which deal with consumer understanding and perception of the current labeling requirements and whether some other labeling provisions would better serve the purpose of informing consumers without causing "inappropriate anxiety."

The Agency is particularly interested in focus group and other consumer survey data.

Submit your comments by May 18. A list of the questions that FDA would like addressed can be found at 64 Federal Register 7834 (Feb. 17, 1999).

By George Misko, Partner, Keller & Heckman

Inquiries or comments may be sent to Mr. Misko at 1001 G St., N.W., Suite 500W, Washington, DC 20001; phone (202) 434-4100 or fax (202) 434-4646. E-mail: misko@khlaw.com

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