The USDA’s National Organic Program (“NOP”) recently issued draft guidance (herehere, and here) that organic and nonorganic food manufacturers alike should be aware of. In addressing what is required to certify a product as “organic,” the NOP has offered its own definition of “natural” (or “nonsynthetic”), which is “a substance that is derived from mineral, plant, or animal matter and does not undergo a synthetic process as defined [in the Act] (7 U.S.C. 6502(21)).” In turn, the NOP defines “synthetic” as “a substance that is formulated or manufactured by a chemical process or by a process that chemically changes a substance extracted from naturally occurring plant, animal, or mineral sources, except that such term shall not apply to substances created by naturally occurring biological processes.” (See Draft Guidance § 6.1.)

The Organic Food Production Act vests authority in the NOP to establish a “National List of Allowed and Prohibited Substances” (“National List”) with regard to “organic” or “made with organic…” products. To determine whether a substance is allowed or prohibited, it must first be determined whether the substance is “natural (nonsynthetic)” or “synthetic.” How these terms are defined is thus critical to determining whether a substance is included on the National List, and where on the National List it should be placed.

As a result, the National Organic Standards Board (“NOSB”) (the NOP’s advisory board) has focused a great deal of time and energy over the years on determining what qualifies as “natural” and what does not. These efforts recently led the NOSB to issue the above-cited draft guidance, which is intended to implement and clarify previous recommendations and existing practices of the NOSB. In addition to offering their own definitions of “natural” and “synthetic” in the “organic” context, the NOP’s guidance includes a “Decision Tree for Classification of Materials as Synthetic or [Natural] Nonsynthetic.” This draft guidance (and any resulting final guidance) should therefore be carefully reviewed by organic and nonorganic food producers alike—especially those who make “natural” claims on their labels.

Comments on the draft guidance are due by June 3, 2013. Yet to be seen is whether the NOP will address some apparent confusion in the draft guidance (for example, why certain minerals are classified as synthetic simply because they undergo a chemical change caused by heating the mineral) or the existence of the FDA’s and the Food Safety and Inspection Service’s “natural” policies.