News | September 8, 2000

FDA explores changes to ‘fresh' labeling rule

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Current fresh regulations
Industry definitions of ‘fresh'
Economic impact
Looking ahead

Manufacturers using new nonthermal processing technologies to control pathogens and increase shelf life have asked the FDA to allow their products to bear "fresh" labeling — which is viewed as attractive to consumers — sparking debate with manufacturers of products traditionally labeled as fresh.

At issue in the "fresh" controversy is consumers' perception of the term, whether consumers would accept and understand an expansion of fresh to include foods processed with new technologies — including chemical treatment of fruit, high-pressure processing, high-pressure CO2, irradiation, mild thermal treatment, post-electric field infiltration and ultraviolet light processing — and the economic impact such a change would have on manufacturers using traditional processing methods.

As the FDA decides whether to initiate a rulemaking to amend its current definition of fresh, it asked industry for input on these and other questions at a July 21 public meeting in Chicago. Christine Lewis, director of the Office of Nutritional Product Labeling and Dietary Supplements at the FDA's Center for Food Safety and Applied Nutrition (CFSAN), emphasized that the agency currently is in "listening mode," gathering comments from industry on whether the use of the term fresh is "truthful and not misleading" when used on products processed with alternative nonthermal technologies and what type of criteria the agency should use when considering the term's use with future technologies.

Current fresh regulations(Back to Top)
According to a January 6, 1993, final rule, the FDA's definition of fresh includes products in their raw state or finished form that have not been frozen or subjected to any form of thermal processing or any other form of preservation (58 FR 2302). Products for which use of the term "does not suggest or imply that a food is unprocessed or unpreserved" — such as pasteurized milk — are exempt from this qualification.

Additionally, the regulation allows foods that have undergone certain processes to bear the fresh label, including:
• the addition of approved waxes or coatings.
• the post-harvest use of approved pesticides.
• the application of a mild chlorine wash or mild acid wash on produce.
• the treatment of raw foods with ionizing radiation not to exceed the maximum dose of 1kiloGray (21 CFR §101.95).

Industry definitions of ‘fresh'(Back to Top)
In defining fresh, manufacturers that use nonthermal technologies other than those exempted by the final rule focus on physical characteristics. According to Dennis Olson, spokesman for Titan SureBeam Corp., which uses ionizing electrons or X-rays to treat its products, consumers use physical properties to distinguish between raw and processed food.

"Nonthermal processes that don't change the physical characteristics of raw products should qualify for using the term fresh," said Olson.

Indeed, the National Food Processors Association (NFPA) argued that some new technologies might preserve food qualities viewed as essential to the use of the label term fresh, such as color, aroma and moisture. NFPA recommended that the FDA propose amendments to §101.95 to accommodate those technologies that help retain product characteristics associated with fresh.

Sevuga Palanippan, manager of technology innovation of juice manufacturer Minute Maid, contended that nonthermal processes do not alter food characteristics in a drastically different way from the raw state and, therefore, should qualify for the term fresh. For instance, according to Palanippan, juice that has undergone nonthermal processes, but has not been frozen, heated or chemically preserved should be allowed to use the term fresh.

"[I]t's not different from untreated juice in terms of physical, bio-chemical, nutritional and organoleptic properties," said Palanippan.

Manufacturers opposed to expanding the definition of fresh to include new technologies also focused on consumer perceptions, although in this case they focused on consumers' current use and understanding of the term. According to these groups, consumers depend on the term to distinguish between those foods that have been processed and those that have not.

"[T]he term fresh to consumers means washed, extracted, bottled and refrigerated," said John Martinelli, assistant CEO of Orchid Island Juice Co. "To apply the word fresh to a post-extracted treated product would be misleading to consumers."

Leslie Zinn, owner of the fresh juice company Ardeu's Garden, anticipates that debate over defining fresh may become as controversial as the current debate over organic labeling. The FDA has received numerous comments in response to the lowering of organic labeling standards, and Zinn noted that consumers might respond similarly to changes in the definition of fresh.

Despite the discord surrounding these issues, participants at the public meeting agreed that establishing quantifiable parameters for measuring the effects of these new technologies would be difficult. In addition, the FDA would have to enforce these parameters, increasing costs for both the agency and industry.

Adhering to such parameters also could lead to increased costs in manufacturing nutritious foods, according to Donald Quass, president of the consulting firm Imbroglio Cures Inc. and a supporter of a broader definition of fresh. In Quass' opinion, competition and consumer perceptions would determine the thresholds for the term fresh more effectively.

Peter Chaires, spokesman for the American Fruit Juice Council, which opposes expansion of fresh to include new technologies, agreed that quantifiable parameters would be difficult to enforce. "This would indeed be a slippery slope for the agency," he said. "Such an approach would leave the definition of fresh flexible and at the mercy of political winds, economic clout and process innovations."

In contrast, International Fresh Cut Produce Association technical director Jim Gorny said that common laboratory tests can determine whether a product respires, leading him to recommend that the FDA set only one quantifiable parameter for freshness: "Is it alive?"

Economic impact(Back to Top)
Expanding the fresh definition also could adversely affect those manufacturers using traditional production methods. If the term is changed, small businesses likely would struggle to compete with larger firms that have the resources to implement these new technologies that can increase shelf life. According to Chaires, small businesses would be unable to compete with large firms if foods improved through these technologies were labeled as fresh. "The economic damage to the current fresh juice industry could be catastrophic," said Chaires.

Harriet Adams, vice president of marketing for Juice Tree Inc., elaborated on Chaires' comment. "Allowing the term fresh on foods processed with technologies places small firms not able to use technologies at a great economic disadvantage. In fact, I think it threatens their survival," she said.

Looking ahead(Back to Top)
CFSAN's Lewis stressed at the close of the meeting that the FDA has not yet made any decisions regarding the use of the term fresh for foods processed with new technologies. She noted that whether or not a decision is made in the near future depends on the level of priority given to the issue when the Center develops its Program Priorities plan for fiscal year 2001, which is due out this fall.

For more information: <%=company%>, 1725 K. Street NW, Washington, D.C. 20006, Tel: 202-872-4000, Fax: 202-296-1091.

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