On April 2, 2013, USDA released Draft Guidance here, here, and here addressing an issue that has plagued the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 According to the Draft
Guidance, "natural" is a synonym for
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and FTC, USDA's Draft Guidance explicitly details processes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time soon, this Draft Guidance is likely to have a broad effect on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.
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