Update September 29, 2017: FDA announced extension of the compliance dates for the Nutrition Facts and Supplement Facts label final rule and the Serving Size final rule to January 1, 2020, for manufacturers with $10 million or more in annual sales. The new date for manufacturers with less than $10 million in annual sales would is January 1, 2021.
Original post: In June of this year FDA announced that there would be a delay in enforcement of the new food and dietary supplement labeling regulations that were to be enforced beginning July 26, 2018. Unfortunately, they did not announce a new enforcement date or say much more about it, except that “FDA will provide details of the extension through a Federal Register Notice at a later time.” While there still has not been a Federal Register notice, on September 14th FDA Commissioner, Scott Gottlieb tweeted:
This tweet suggests that the new labeling rules will not be enforced until 2020, giving FDA plenty of time to write guidance documents to clarify several vague aspects of the regulations and to publish technical amendments to correct discrepancies in the published final rule.
In a previous post I speculated that enforcement of the new facts box labeling regulations would be delayed. I based this on FDA’s delay of the restaurant menu labeling requirements. That delay was a result of presidential orders to review all new regulations for “unnecessary regulatory burdens placed on the American people.” I am going to speculate again and propose that FDA will revisit the new rules on declaration of added sugars and the new definition of fiber and reopen the comment period. This prediction is based on what FDA did with the restaurant menu labeling requirements—they reopened the comment period for portions of the regulations that caused a great deal of confusion that the agency was unable to clear up for industry. You may read about my reasoning here.
The new definition of fiber and the requirement to declare added sugars in the nutrition facts box are the two most difficult and controversial changes to the regulations. In June the Natural Products Association petitioned FDA to stay enforcement of the new labeling regulations and to reconsider the fiber and added sugar rules. The petition lists the grounds for the request as follows:
- Implementation of the Final Rule is Inconsistent with the Administration’s Regulatory Agenda and Directives;
- The Food Labeling Final Rule Presents Serious Issues with Respect to First Amendment Protections for Commercial Speech;
- Inclusion of a Daily Value (DV) for Added Sugar in the Final Rule but Not in the Proposed Rule was an Example of Impulsive Behavior to Hastily Circumvent the Public Rulemaking Process;
- FDA’s Own Consumer Studies Do Not Support the Addition of Added Sugars to the Nutrition Facts and Supplement Facts Labels;
- Eye-Tracking Studies Do Not Support FDA’s Position to Include Added Sugars as a New Declaration in Nutrition Facts and Supplement Facts Labels;
- The Food Labeling Final Rule’s Change in How Dietary Fibers are Declared is Unjustified, Unduly Burdensome, and Does Nothing to Advance Consumer Health; and
- FDA failed to submit an economic impact analysis with this guidance to the Office of Management and Budget (OMB), regarding this new cost burden to the food and supplement industries.and supplement industries.
You may read the entire petition here.
Other groups have also petitioned FDA for delay of enforcement for various reasons, one of which is to coordinate with USDA on the compliance date for new (and as yet unpublished) rules for ‘non-GMO’ labeling, which is set by Congress for 2020.
In the meantime, let me know what questions you have about new or old FDA regulations.