Are Your “Natural” Food and Supplement Ingredients Really Natural? The National Organic Program Issues Draft Guidance Concerning Definition of Natural vs. Synthetic

By Riëtte van Laack –

Under the Organic Food Production Act (“OFPA”), the National Organic Program (“NOP”) of the USDA is authorized to establish the National List of Allowed and Prohibited Substances (“National List”).  This National List contains each synthetic substance that is permitted and each natural substance that is prohibited for organic production. 

When considering whether a substance may be used in “organic” or “made with organic . . .” processed foods, two determinations must be made.  First, the substance must be classified as agricultural or nonagricultural.  (Nonagricultural substances are nonorganic).  Second, nonagricultural substances are classified as natural (nonsynthetic) or synthetic to determine their placement in the National List in section 205.605(a) (natural) or 205.605(b) (synthetic). 

Thus, the definitions of terms “agricultural,” “nonagricultural,” “natural (non-synthetic)” and “synthetic” are critical to the determination whether a substance is allowed or prohibited in organic foods, whether it needs to be included on the National List, and where on the National List it should be placed. 

How to determine whether a substance is agricultural or nonagricultural and natural or synthetic for many years has been a topic of discussion for the NOP’s advisory board, the National Organic Standards Board (“NOSB”).  A recent draft guidance (here, here, and here) announced earlier this week in the Federal register is intended to implement and clarify previous recommendations and existing practices of the NOSB.  However, the guidance likely will have a much broader reach.  The determination of whether a substance is natural or synthetic is of importance to the food industry as a whole.  In litigation regarding “natural” claims, plaintiffs have referenced the National List to support allegations that foods did not qualify for a natural claim.  Thus, manufacturers of nonorganic foods with no direct interest in organic regulations or the National List would be well advised to carefully review the draft guidance and consider the potential ramifications of this guidance being finalized.

The existing regulations are complex and appear in some aspects internally inconsistent (e.g., certain gums and high methoxy pectin are listed as agricultural substances whereas the definition of “nonagricultural substances” specifically mentions these substances as examples of nonagricultural substances).  The guidance does not address these apparent inconsistencies or clarify why, for example, vitamins and minerals are listed as synthetic substances.  The guidance further does not acknowledge the existence of FDA’s or the Food Safety and Inspection Service’s (“FSIS’s”) natural policies and it is not clear to what extent, NOP has or will take these into account in its determinations.  

Comments are due June 3, 2013.