The first port of call is the FDA’s less than comprehensive 1993 advice (outlined here on p2407) that natural means that “nothing artificial or synthetic (including all color additives regardless of source) has been included in, or has been added to, a food that would not normally be expected to be in the food”.
However, this doesn’t specifically address the use of organic solvents such as hexane for extracting natural ingredients, GMOs, high fructose corn syrup, partially hydrogenated vegetable oils, or a host of other allegedly ‘un-natural’ substances cited in lawsuits filed against food manufacturers in recent years.
It also fails to clarify what processing methods, if any, might render a natural ingredient, un-natural.
The USDA, meanwhile, has come up with some guidance - but it only applies to meat and poultry: "A product containing no artificial ingredient or added color and is only minimally processed."
The NOP National List is frequently cited in civil litigation to support allegations that certain foods do not qualify for ‘natural’ claims
Another port of call for manufacturers - and plaintiffs’ lawyers - looking for guidance on what is natural is USDA’s National Organic Program (NOP) ‘National List’ of Allowed and Prohibited Substances for organic production.
While it was certainly not intended for this purpose, the list is frequently cited in civil litigation to support allegations that certain ingredients are not ‘natural’, notes Hyman, Phelps & McNamara attorney Riëtte van Laack.
And as a result, all firms - whether they are involved in organic foods or not - should look at new draft guidance and decision trees (here and here) just published in the federal register, in which the NOP eplains how it decides what goes on these lists, and which substances are natural ( ‘nonsynthetic’ ) and which are not.
All food and beverage manufacturers are well advised to carefully review the draft guidance …
The document is “intended to implement and clarify previous recommendations and existing practices of the National Organic Standards Board”, says van Laack, writing in the FDA law blog on last week. “However, it 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.”
Substance is still classified as natural if the material extracted from the natural source ‘has not been transformed into a different substance via chemical change’
In the draft guidance, the NOP says a food substance may be classified as nonsynthetic (natural) if the extraction or separation technique results in a material that meets the following criteria:
• At the end of the extraction process, the material has not been transformed into a different substance via chemical change;
• The material has not been altered into a form that does not occur in nature; and
• Any synthetic materials used to separate, isolate, or extract the substance have been removed from the final substance via evaporation, distillation, precipitation, or other mean, such that they have no technical or functional effect in the final product.
Is citric acid natural? The NOP thinks so
Meanwhile, products of “naturally occurring biological processes” such as fermentation, composting, manure production, enzymatic processes, and anaerobic digestion are also considered natural. Examples include vinegar, citric acid (which plaintiffs in several class action lawsuits argue is not ‘natural’), compost, gibberellic acid, and spinosad.
The NOP says it is also “aware that there may have been some inconsistency in theclassification of a small number of materials used in organic crop production” and is issuing the new draft guidance “in an effort to clarify the status of these materials”.
Comments - due by June 3 - are specifically requested on the classification of bagasse, biochar, corn steep liquor, fatty acids, glycerin, molasses, vegetable protein hydrolysate, vinasse, and xanthan gum. Click here for details.