On May 4, 2018, the FDA issued its final rule extending the compliance date for the updated nutrition information on the labels of most conventional foods and dietary supplements. The final rule is consistent with FDA’s October 2, 2017 proposed rule, and implements a 1.5 year (approximate) compliance date extension:
The compliance date extension proposal applies to FDA’s May 2016 rulemaking on Revision of the Nutrition and Supplement Facts Labels, and Serving Sizes. FDA received more than 50,000 comments in response to its compliance date extension proposal, some of which opposed the extension and others suggested a longer extension. In response to comments, FDA noted, in relevant part, the following:
Ultimately, the compliance date extension means that those covered by the final rules may either voluntarily comply with the updated requirements or continue to use labels compliant with the old requirements until the applicable 2020 or 2021 compliance date. As a reminder, FDA’s January 2017 Q&A Guidance on nutrition labels specifies that the compliance date is tied to the date when the food is labeled, and not to the location of the food, i.e. when the product is purchased or distributed:
To determine the compliance date for a particular food product, we would not consider the location of a food in the distribution chain. For example, the food product, whether labeled before or after the compliance date, may be at the manufacturing facility awaiting distribution, at a warehouse awaiting further distribution, in transit to the United States to be offered for import, or on the store shelf of a U.S. retail establishment. We consider the date the food product was labeled for purposes of determining the compliance date.
Q&A Guidance at Q&A No. 1. Accordingly, it seems that a manufacturer that anticipates having product labeled under the old rule in inventory or distribution after the compliance date should ensure that records are available that document the date of when such inventory was labeled. Such documentation will be critical if FDA has questions related to the compliance date.