In a response to petitioner ACH Food Companies, FDA has approved a health claim relating to corn oil and reduced risk of heart disease.*

The available claim against which FDA will use its enforcement discretion and will not take regulatory action is:

“Very limited and preliminary scientific evidence suggests that eating about 1 tablespoon (16g) of corn oil daily may reduce the risk of heart disease due to the unsaturated fat content in corn oil. FDA concludes that there is little scientific evidence supporting this claim. To achieve this possible benefit, corn oil is to replace a similar amount of saturated fat and not increase the total number of calories you eat in a day. One serving of this product contains _ grams of corn oil."

Disqualifying levels exist for cholesterol, sodium, total fat and saturated fat.

Companies which wish to take advantage of the claim should review FDA’s “Qualified Health Claims: Letter of Enforcement Discretion—Corn Oil and Corn Oil-Containing Products and a Reduced Risk of Heart Disease.” It may be viewed at: www.cfsan.fda.gov/~dms/qhc-sum.html#corn.

Regarding Irradiation

FDA has proposed changes in its “irradiation” regulations, Docket No. 2005N-0272; April 4, 2007.

Background of the Current Regulations. In 1986, FDA published its final rule (51 Federal Register 13376) on irradiation, requiring that the labels of irradiated food products bear the “radura” logo coupled with “a radiation disclosure” statement. "Treated with radiation" or "Treated by irradiation" should appear on the labeling of irradiated food products along with the radura logo. Additional truthful information such as “treated with radiation to extend shelflife” is permitted.

 FDA’s concern, which prompted the disclosure statement, is that irradiation does not always change the appearance of the food and that consumers may not realize by visual examination alone that food has been irradiated. Therefore, failure to clearly disclose the fact of irradiation would constitute misbranding—consumers would not have a material piece of information needed to make an informed choice.

In 1997, with the passage of the FDA Modernization Act, FDA began the process of reviewing possible changes to the irradiation labeling requirements. Additionally, the Farm Security and Rural Investment Act of 2002 (FSRIA) included new criteria for the definition of “pasteurization” and established a process by which interested parties could seek new labeling alternatives for irradiated foods. Criteria established by the FSRIA defined “pasteurization” as including the use of “radioactive isotope, electronic beam or x-ray to reduce pest infestation or pathogens...”

Regulatory Options Considered by FDA

1. No change in current irradiation labeling.

2. Remove the requirement of irradiated foods labeling.

3. Keep the current disclosure but require additional labeling of purpose, i.e., “Irradiated to extend shelflife” (optional under current regulations).

4. Keep current disclosure but allow alternate terms to be used, i.e., “pasteurized” (consistent with the FSRIA).

5. Require irradiation labeling only if the food undergoes a “material” change** as a result of irradiation; require description of the purpose of treatment, i.e., “…to extend shelflife,” and permit use of alternate terms, i.e., “pasteurized.”

The Proposal. The FDA is publishing the fifth option for public comment and adoption as a regulatory requirement. The label(s) of foods which are treated with irradiation and the irradiation treatment changes the food in a way which is not apparent to the consumer at the point of purchase must include: (1) the radura logo and (2) the term “irradiated” or “pasteurized;” and the purpose statement. If a company wishes to use a term other than “irradiation” or “pasteurized,” it must petition the FDA for approval; if a company wishes to state “pasteurized,” it must notify FDA with evidence of efficacy of the process.

It is important to note that the proposal is clear that irradiation alone is not a material change in the food which must always be disclosed. If irradiation does not change the organoleptic, nutritional or functional properties of the food in a way which is not obvious to the consumer, the fact of irradiation need not be disclosed.

Comments are due July 5, 2007. For information on commenting, visit: www.cfsan.fda.gov/~lrd/fdavoice.html.

* Corn oil, vegetable oil blends, vegetable oil spreads, salad dressings, shortening and other “corn-oil containing foods;” at least 4g per reference amount customarily consumed (RACC), not including main dish or meal-type products.

** FDA proposes to define “material change” as “if irradiation changes the properties of the food in a way that is not readily apparent to the consumer at the point of purchase.  Therefore, in the absence of a material change, the fact that the food was irradiated is not considered a material fact and, therefore, no radura logo or label statement would be needed.” (Organoleptic, nutritional or functional.)