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Should the FDA Reconsider Defining ‘Natural,’ ‘All Natural’ and ‘100% Natural’?

7 Oct, 2014 By: John Waller, Blank Rome LLP, Jeffrey Richter


In 1993, the Food and Drug Administration (FDA) reluctantly chose not to define what “natural” should mean in the context of food advertising and labeling. It did so at that time not because it believed that “natural” was adequately defined, but rather because it believed that it lacked the resources to undertake the rulemaking process required to define “natural” – and because it had other priorities at that time.

While its decision did not create significant problems for food and supplement manufacturers and marketers at the time, the growing use of the terms “natural,” “all natural” and “100% natural” to market food and supplements to increasingly health-conscious consumers, and the realization by an expanding cadre of attorneys that substantial money can be made in prosecuting manufacturers and marketers who use such terms to describe products that contain minute amounts of artificial or synthetically produced substances – even when those artificial or synthetically produced substances are typically found in the food and supplement products or are approved for inclusion in products labeled “organic” – should cause the FDA to reconsider its prior decision not to define those terms. This is especially true as the courts that are presented with these cases to review and decide have been inconsistent in their handling of such litigation and, consequently, manufacturers and marketers of food and supplements are needlessly being subjected to the risks and expense of litigation if they want to describe their products using one of these terms.

By way of illustration, courts have recently differed over whether the use or inclusion of artificial or synthetic substances approved to be used or included in food products properly labeled as “organic” under the National Organic Program permits the products to also be labeled as “natural,” “all natural” or “100% natural.” Some courts have found that consumers generally equate “natural” and “organic” or consider “organic” to be a more stringent standard than “natural.”

As a consequence, they have found it to be implausible that a reasonable consumer would believe that ingredients permitted in properly labeled “organic” products would not be permitted in products labeled “natural” and have summarily dismissed the false advertising/mislabeling lawsuits challenging the inclusion of such substances in products labeled as “natural,” “all natural” or “100% natural.” Other courts that have been presented with comparable facts have concluded that the fact that a product is properly labeled “organic” is not determinative as to whether it is also properly labeled “natural,” “all natural” or “100% natural,” and that summary disposition of that issue is therefore unavailable and that the issues must be decided at a later stage of the case, perhaps at trial by a jury. Much of this litigation and much of such inconsistency could be readily avoided if the FDA would define “natural,” “all natural” and “100% natural.”

The precise parameters that the FDA may adopt for “natural,” “all natural” or “100% natural” is less of a concern than having established definitions for those terms. The FDA can choose to include or exclude genetically modified organisms from its definitions. It can similarly choose to include or exclude the same substances approved for use in or on products labeled “organic” under the National Organic Program.

It can also choose to include or exclude minute quantities of leavening agents and other artificial or synthetic substances from its definitions. What is important for both consumers and manufacturers and marketers of food and supplement products is that they can all know what the rules are when a product is labeled “natural,” “all natural” and “100% natural.”

Jeffrey Richter and John Waller are attorneys at Blank Rome LLP. They can be reached at (424) 239-3400 or via E-mail at jrichter@blankrome.com and jwaller@blankrome.com.


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