FDA Extends Comment Period on 'Natural' and Revokes Packaging Food Additive Approval

FDA extends comment period on use of the term "natural" on food labeling and revokes food additive approval for long-chain perfluorinated compounds in food packaging.


FDA Extends Comment Period on Use of the Term "Natural" on Food Labeling. 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.

As stated in its original announcement on, FDA is requesting comment on the use of the term natural in the labeling of human food products because of the changing landscape of food ingredients and production, and in direct response to consumers who have requested that FDA explore the use of the term.

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. The agency also notes that some federal courts, as a result of litigation between private parties, have requested administrative determinations from FDA regarding whether food products containing ingredients produced using genetic engineering or foods containing high fructose corn syrup may be labeled as “natural.”

Although FDA has not engaged in rulemaking to establish a formal definition for the term “natural,” it does have a long-standing policy concerning the use of “natural” in human food labeling, considering it 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. FDA also did not consider whether the term “natural” should describe any nutritional or other health benefit. 

Specifically, 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.

To electronically submit comments to the docket, visit http://www.regulations.gov and type FDA-2014-N-1207 in the search box.  

 

FDA Revokes Food Additive Approval for Long-Chain Perfluorinated Compounds in Food Packaging. On December 31, 2015, FDA revoked its food additive regulation for use of three long-chain perfluorinated compounds (PFCs) in response to a Food Additive Petition filed by the Natural Resources Defense Council, the Center for Food Safety, the Breast Cancer Fund, the Center for Environmental Health, Clean Water Action, the Center for Science in the Public Interest, the Children’s Environmental Working Group, and Improving Kids’ Environment.

Although it appears that manufacturers generally have stopped using these products, FDA’s action means that any continued use of the PFCs covered by the regulation is no longer permitted.  Any use of these substances would need to be authorized through the Food Contact Notification Process, which would need to address FDA’s safety concerns. 

FDA had authorized the use of several long-chain PFCs as grease-proofing agents before safety concerns came to light.  These authorizations include the food additive regulation for long-chain PFCs authorized prior to 2000 (which is being revoked by this action), and Food Contact Notifications (FCNs) that became effective after 2000.

In 2010, the FDA identified safety concerns through a comprehensive review of the available literature.  The FDA then worked with industry to stop distribution of the long-chain PFCs most commonly used in food packaging at that time: those subject to FCNs. By October 1, 2011, these manufacturers had voluntarily stopped distributing these long-chain PFCs. 

Upon publication of the final rule, the food additive petition process includes a 30-day period to file objections by any person adversely affected. For more information or to submit objections, visit http://www.regulations.gov; search for docket number FDA-2015-F-0714

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