FDA Releases Guide for Industry to Meet New Nutritional Labeling Final Rule Providing Clarification on Compliance Timelines

February 15, 2017 By

January 2017 FDA has released a guide to aid industry comply with the new nutritional labeling requirements as per the final rule.

Service(s) Related to Post: Nutritional Labeling

Following the FDA’s final rule for Food Labeling: Revision of the Nutrition and Supplement Facts released May 27, 2016, the FDA has provided a guide to assist manufacturers of conventional foods and dietary supplements to comply with this final rule. This guide provides questions on answers on the final rule, including guidance on added sugars, formatting of lines and leading for the Nutrition Facts label. The guide provides answers to commonly received questions on the final rule by the FDA, and importantly clarifies the compliance timelines for manufactures.

While the FDA had originally indicated that there would be two compliance timelines based on a company’s sales, there were many questions regarding the interpretation of the timeline and how to determine annual sales, and thus when labels must be in compliance. This guide clarifies that for a company that has greater than $10 million dollars in sales any food product that is labeled on or after July 26, 2018 must bear the nutritional labeling, while companies with less than $10 million in sales are provided with an extra year, until July 26, 2019, to have compliantly labeled products.

There are two key points to consider here, the first is that the FDA has indicated that they will not consider the location of the product in the distribution chain when determining the compliance date, rather they consider the compliance date to be “at the time of labeling”. This means that if a company has shipped a product in bulk before the compliance date to be further packaged and labeled at another location, after the compliance date, it is at the time the label is applied when the product must be in compliance with the new nutritional labeling requirements. In short, when the company labels the product, this is when the compliance timeline needs to be taken into consideration. Secondly, the FDA has further clarified their position regarding how a company determines their annual sales. The annual sales are based only on the company’s food sales (i.e. conventional foods and/or dietary supplements), sold in the last three years and it would be based on both domestic and international food sales. The FDA will give companies the option to take either the average of the last three years of food sales, or the smallest sales volumes from the previous three years, when determining annual sales.

The compliance dates above are the final time by which a company’s products must comply with the final nutritional labeling rule, however a company can choose to voluntarily comply in advance of their required timeline. Additionally, FDA permits conventional foods and dietary supplements to be over-labeled with the new nutritional labeling requirement, provided the label is durable and does not cover any mandatory information required on the label.

dicentra is a professional consulting firm that specializes in addressing all matters related to safety, quality and compliance for all product categories in the health sciences and food industries. We evaluate, implement, and provide all the necessary support for your products and operations to gain market access and build confidence in your brand. Contact dicentra at 1-866-647-3279 or visit www.dicentra.com to learn more about us and our services in Nutritional Labeling.