FDA warning letter causes confusion about “natural” claims for HFCS.

  • FDA’s informal policy regarding the use of the term, “natural” is that nothing artificial (including artificial flavors) 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.  Although FDA has not codified an official definition for “natural” and does not issue determinations regarding the “natural” status of specific ingredients, the Agency issued an informal opinion letter in 2008 stating that it would not object to the use of the term “natural” on a product containing high fructose corn syrup (HFCS) where the ingredient had been produced by a specific manufacturing process that did not involve synthetic fixing agents.
  • In a recent FDA Warning Letter, the Agency caused confusion by including a paragraph alleging the impropriety of “100% Natural” and “all natural” claims where the finished product contained HFCS.  Restating its informal policy on “natural” claims, FDA concluded that the term, “‘natural’ may not be used in association with this product,” ostensibly due to the presence of HFCS.  When asked about the significance of this unusual — and seemingly self-contradictory — Warning Letter language, an FDA spokesperson confirmed that the letter would be re-posted without the section on HFCS “to avoid any confusion with the agency’s policy.”  Therefore, despite the earlier alarm, it appears that FDA did not intend to signal a new or official policy on the “natural-ness” of HFCS.
  • The food industry has grappled for years with how to apply FDA’s informal policy in practice.  Numerous class action lawsuits continue to be filed in California and in other jurisdictions challenging the propriety of “natural” or “all-natural” claims for food products that contain processed ingredients and/or genetically modified ingredients.  Although Warning Letter language is not legally binding, plaintiffs’ lawyers seize upon the Agency’s statements to support allegations of false advertising.  In the absence of an official policy on “natural” claims, the industry must remain attuned to FDA’s unofficial statements in this arena.