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:
- From July 26, 2018, to January 1, 2020 for manufacturers with $10 million or more in annual food sales; and
- From July 26, 2019, to January 1, 2021 for manufacturers with less than $10 million in annual food sales.
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:
- Some manufacturers will need to change different parts of their labels depending on the products they make. This serves as a useful reminder to all manufacturers that, when implementing the updated Nutrition Facts, it is critical to review all product labeling. Changes to the Reference Amounts Customarily Consumed (“RACC”), coupled with changes to the Reference Daily Intakes for vitamins and minerals and Daily Reference Values for macronutrients will affect the percent Daily Values. The change in Daily Values may result in modifications to Nutrient Content Claims, and other claims on the food labels.
- FDA also rejected, with little rationale, comments requesting that FDA align the compliance date with USDA’s implementation of the National Bioengineered Food Disclosure rules. Although FDA indicated that it works with USDA to align compliance dates of regulations that require changes in food labeling, the agency simply stated that it does not agree that it “need[s] to ensure the alignment of compliance dates for other regulatory initiatives with those for the Nutrition Facts Label and Serving Size Final Rules.”
- A large part of FDA’s rationale for extending the compliance date is to ensure that all manufacturers covered by the final rules have guidance from FDA to address certain technical questions received after publication of the final rules, and that they have sufficient time to complete and print updated Nutrition Facts labels for their products before they are expected to be in compliance with the final rules. Comments supportive of the extension mentioned that guidance is needed on issues such as dietary fiber, added sugars, serving sizes, and small package labeling before relabeling certain products. To date, FDA has issued guidance on a number of Nutrition Facts-related issues.
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.