FDA to Extend Comment Period on Use of the Term “Natural”

The Food and Drug Association (FDA) is proving once again to be responsive to the desires of consumers and trade groups, extending the comment period for use of the term “Natural.” by 90 days. Originally comments were due Feb. 10, but now will be accepted through May 10.

While the FDA has not directly acknowledged that the move was due to any one specific request, the Natural Products Association had issued a statement just a few weeks earlier asking for the extension in order to “allow sufficient stakeholder response,” said Dan Fabricant, Executive Director and CEO of NPA. “Defining ‘natural’ is a major undertaking, and NPA feels that no harm will result from FDA extending the comment period due to the interest, significance, and complexities surrounding the topic.”

The original impetus to explore regulating the term “natural” also arose from citizen demand. The agency received three Citizen Petitions asking them to define the term and another asking them to prevent products from using the term. There have also been numerous high profile court cases around products labeled “natural” which have resulted in the courts asking the FDA for guidance about usage.

The only current FDA regulations about natural were issued in the 1990s and primarily involve “nothing artificial or synthetic,” in particular, all color additives. However, in past decades, new technologies around genetically modified ingredients, preservatives, sweeteners, artificial flavors and pesticides have rapidly developed, resulting in “natural” appearing on a variety of products ranging from organic to more conventional items. The wide array of definitions by brands, combined with increased understanding by consumers about food production, has prompted consumers to ask for a more robust definition.

The current FDA comment period is only to ascertain if the FDA should regulate the term natural, and start to gather what consumers and trade groups believe the term should stand for. If the agency proceeds with the regulation, another comment period will occur once the FDA issues preliminary guidance. As a result, any federal regulation about the term likely will not go into effect for many more years to come.

To date, over 3,000 comments have already been submitted to the FDA.

The full text of the announcement can be found below:

FDA Release, December 24, 2015 

In direct response to requests from the public, the FDA has extended the comment period for the Use of the Term “Natural” on Food Labeling. The comment period will now end on May 10, 2016. Due to the complexity of this issue, the FDA is committed to providing the public with more time to submit comments. The FDA will thoroughly review all public comments and information submitted before determining its next steps.

Because of the changing landscape of food ingredients and production, and in direct response to consumers who have requested that the FDA explore the use of the term “natural,” the agency is asking the public to provide information and comments on the use of this term in the labeling of human food products.

The FDA is taking this action in part because it received three Citizen Petitions asking that the agency define the term “natural” for use in food labeling and one Citizen Petition asking that the agency prohibit the term “natural” on food labels. We also note that some Federal courts, as a result of litigation between private parties, have requested administrative determinations from the FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as “natural.”

Although the FDA has not engaged in rulemaking to establish a formal definition for the term “natural,” we do have a longstanding policy concerning the use of “natural” in human food labeling. The FDA has considered the term “natural” to mean 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 that food. However, this policy was not intended to address food production methods, such as the use of pesticides, nor did it explicitly address food processing or manufacturing methods, such as thermal technologies, pasteurization, or irradiation. The FDA also did not consider whether the term “natural” should describe any nutritional or other health benefit.

Specifically, the FDA asks for information and public comment on questions such as:

• Whether it is appropriate to define the term “natural,”
• If so, how the agency should define “natural,” and
• How the agency should determine appropriate use of the term on food labels.

The FDA is accepting public comments beginning on November 12, 2015. To electronically submit comments to the docket, visit http://www.regulations.gov and type FDA-2014-N-1207 in the search box.