Under section 403(a) of the Federal Food, Drug, and Cosmetic Act, a food is deemed "misbranded" if its labeling is "false or misleading in any particular." A misbranded product cannot legally be shipped in interstate commerce and is subject to seizure by the FDA. Thus, any description of a food or food ingredient as "natural" must not be false or misleading within the meaning of section 403(a). But what does "natural" mean in the legal sense?
FDA has not formally defined the term "natural," but has offered informal interpretations. Most notably, FDA discussed natural claims in the preamble to the 1993 rule establishing nutrient content claim regulations, defining "natural" as meaning "nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food."
At that time, FDA specifically considered the degree of processing (whether a food or ingredient that has undergone more than minimal processing should be permitted to bear a "natural" claim), but never added that criterion to its policy.
FDA's definition of "color additive" provides that "where a food substance such as beet juice is deliberately used as a color, as in pink lemonade, it is a color additive." 21 CFR §70.3(f). And Compliance Policy Guide No. 7127.01 states, "since all added colors result in an artificially colored food, we would object to the declaration of any added color as … "natural."
FDA declined to change the policy in 2005, denying a citizen petition that pointed to misleading claims and consumer confusion as a result the current situation. The petition requested modification of the "natural" policy with respect to the degree of processing permitted and the clarification of other terms. However, depending on the facts, qualified claims such as "all ingredients from natural sources" may be appropriate.
Although FDA has not adopted a regulation on use of the term "natural" in general, there is a regulation at 21 C.F.R. § 101.22(a)(3) defining "natural flavor." Under that provision, processing steps that physically purify or isolate a flavor substance, without changing its chemical composition, are permitted.
The USDA adopted a policy in 1982 regarding natural claims for meat and poultry products. The USDA definition covers products that do not contain any artificial or synthetic ingredients, and are not more than minimally processed. USDA also requires "natural" claims be accompanied by a brief statement explaining what is meant by the term. In 2005, USDA revised the definition to allow sugar, sodium lactate from a corn source and natural flavorings from oleoresins or extractives. Due to controversy within industry, USDA initiated a "rulemaking" to resolve the issues.
FDA has not been active in challenging "natural" claims for foods, although "warning" letters have been sent to manufacturers, particularly for the use of color additives in products bearing "natural" claims. Of course, this does not preclude a challenge from a competitor or a consumer group. A competitor might challenge a claim before the National Advertising Division of the Council of Better Business Bureaus. Consumer groups might sue.
A recent example is a class action lawsuit backed by the Center for Science in the Public Interest (CSPI) against Kraft, under Florida's Deceptive and Unfair Trade Practices Act, alleging the labeling for Capri Sun beverages is misleading. Capri Sun, sweetened with high fructose corn syrup, claims on its packaging to be "natural." According to CSPI, high-fructose corn syrup is not natural because it "isn't something you could cook up from a bushel of corn in your kitchen." Kraft responded that it had previously decided to phase in new packaging that omits the "natural" claim, switching instead "no artificial colors, flavors or preservatives."
Last May, CSPI threatened to sue Cadbury-Schweppes regarding the introduction of a "natural" label and marketing campaign for 7UP. The basis for the challenge was, again, the use of high-fructose corn syrup in the product. In January, Cadbury-Schweppes announced plans to drop the "natural" claims and emphasize the ingredients in 7UP "for which there is no debate" over their "natural" status.
Leslie T. Krasny is a partner at the law firm of Keller and Heckman LLP, San Francisco office specializing in food and drug law with emphasis on food safety, food labeling, ingredient evaluation, organics, biotechnology and advertising. She is a member of the California Bar and holds a master's degree in cell and molecular biology.