FDA is requesting public comment on how “natural” claims should be regulated. The 90-day public comment period will open on November 12, 2015, when the FDA notice is published in the Federal Register.  In particular, FDA seeks information and public comment relating to a number of specific issues, including the following:

  • Should FDA define the meaning of “natural” through notice and comment rulemaking?
  • Should FDA prohibit “natural” claims?
  • If FDA defines the meaning of “natural” for labeling purposes, what types of foods should be allowed to qualify as “natural”?
  • Should only raw agricultural commodities qualify as natural?
  • Should multi-ingredient foods be labeled as “natural” and, if so, what types of ingredients should be disqualified?
  • Should the term account for agricultural production practices (e.g., biotechnology, pesticides, animal husbandry practices)?
  • Is there evidence that consumers associate “natural” with “organic” claims?
  • What are the public health benefits of FDA defining the term “natural”?
  • Should “natural” have some nutritional benefit associated with the food?
  • How would FDA determine whether a food labeled as “natural” complies with any criteria for the claim?

FDA has a long-standing policy for the use of the term “natural” for human foods, providing that “natural” means that nothing artificial or synthetic (including colors regardless of source) is included in, or has been added to, the product that would not normally be expected to be there. But this policy is only informal, and FDA has declined to adopt a formal regulation pertaining to the term “natural.”  As such, in Holk v. Snapple Beverage Corp., 575 F.3d 329 (3d Cir. 2009), the Third Circuit determined that the FDA policy did not preempt state law claims.  Since the Holk decision, other courts have ruled similarly.  There has been a deluge of consumer class action litigation involving legal challenges to “natural” claims in recent years.

FDA decided to invite public comment concerning the regulation of “natural” claims in food labeling, in part, because it received three citizen petitions, from the Grocery Manufacturers Association, Sara Lee Corp., and The Sugar Association, asking that the agency define the term “natural” for use in food labeling. FDA also received a citizen petition from the Consumers Union asking that the agency prohibit the term “natural” in food labeling.  In addition, several federal courts have requested administrative determinations from FDA regarding whether food products containing ingredients produced using biotechnology or foods containing high fructose corn syrup may be labeled as “natural” under the Federal Food, Drug and Cosmetic Act.

FDA announced that, during its review, it will work with the USDA’s Agricultural Marketing Service and Food Safety and Inspection Service to also examine the use of the term “natural” in meat, poultry, and egg products.

The relevant docket number is FDA-2014-N-1207. The comment period will be open for 90 days, and comments can be submitted electronically or in hard copy.