On April 2, 2013, USDA released Draft Guidance here, here, and here addressing an issue that has plagued the National Organic Standards Board (NOSB”) for years: how to determine whether a substance is agricultural or non-agricultural and synthetic or non-synthetic. These determinations are paramount when considering whether a substance may be used in “organic” or “made with organic…” processed foods, as only specifically listed natural or synthetic nonagricultural substances that are included in the National List may be used. 7 C.F.R. § 205.606. According to the Draft Guidance, “natural” is a synonym for “non-synthetic.”

While the term “natural” has not been defined by FDA and FTC, USDA’s Draft Guidance explicitly details processes that create non-synthetic or natural substances. Agricultural materials that are chemically changed due to allowed agricultural processing methods (e.g., cooking, baking, etc.) do not result in classification of the processed agricultural product as synthetic, nor do products of naturally occurring biological processes, such as fermentation and composting. Moreover, heating or burning of biological matter (e.g., plant or animal material) is also a natural process that does not result in classification of ash as synthetic. On the other hand, heating or burning of non-biological matter (e.g., minerals) to cause a chemical reaction triggers the synthetic substance definition.

Additionally, materials produced by separation techniques are classified as natural or non-synthetic if the extract results in a material that meets three criteria. First, at the end of the process, the material must not be transformed into a different substance via a chemical change. Second, the material may not be altered into a form that does not occur in nature. Finally, any synthetic materials used to separate, isolate or extract the substance must be removed from the final substance (e.g., evaporation, distillation, precipitation, etc.) such that they have no technical or function effect in the final product.

As we have previously noted, “natural” food and dietary supplement claims litigation has exploded in popularity over the past year. Because FDA and FTC have made it clear that they have no plans to establish a definition of the term “natural” any time soon, this Draft Guidance is likely to have a broad effect on the entire food industry, not just USDA-regulated products. The National List has already been referenced by plaintiffs to support accusations that certain foods do not qualify for natural claims, and this Draft Guidance targeted at defining synthetic versus non-synthetic substances is just another weapon in their arsenal. Comments on the Draft Guidance are due by June 3, 2013.