December 19, 2018

Today the FDA filed a technical amendment to their new nutrition labeling regulations titled Food Labeling; Revision of the Nutrition and Supplement Facts Labels; Technical Amendments . The amendment is scheduled to be published in the Federal Register on December 21, when they will immediately go into effect .

The amendments:
  • updated Appendix B to Part 101- Graphic Enhancements Used by the FDA,
  • corrected graphic errors that were made in labeling examples,
  • restored incorrect deletions,
  • added new clarifications,
  • corrected the edition of a reference cited in the rule, and
  • corrected cross-references to other regulations.

Since the FDA published the two final rules in the Federal Register in 2016, Prime Label and others have shared feedback with the agency on several inconsistencies and omissions, mostly non-substantive in nature. For example, there was mis-alignment between the Nutrition Facts Label final rule’s requirements and sample label graphics. Also, preexisting parts of the old rule were removed, even though the FDA did not intend to remove those provisions. This amendment restores the inadvertent removal of four paragraphs detailing saturated fat, trans fat, polyunsaturated fat, and monounsaturated fat from the Code of Federal Regulations, as well as some references to the minimum type size of 6 points and the limited exception to use an address or telephone number for consumers to obtain nutrition information. 

Farm Bill Exempts "Added Sugar" Declaration                               
 In another development, the Agriculture Improvement Act of 2018, or Farm Bill, is expected to be signed by the President tomorrow. The final Bill will specifically exempt "any single-ingredient sugar, honey, agave, or syrup, including maple syrup" packaged food from bearing the declaration "Includes Xg Added Sugars" in the nutrition label. When used as ingredients in other food or beverage products however, these ingredients will still qualify as Added Sugars. Manufacturers and distributors of these single ingredient products will want to watch for execution tomorrow and consider an implementation timeline to follow. 

Next Steps:
Prime Label recommends that food and supplement companies make sure that their labeling software and graphic design templates reflect the modifications detailed in the newly revised Appendix B and this corrected technical amendment. Prime Label has been corresponding with the FDA frequently about these errors over the last couple of years, so PLC's EZform software already includes most of the corrections apart from those that will be published in our December software release.
Stay Tuned fo r Bioengineered Labeling D evelopments ...
Prime Label is anticipating publication of the final National Bioengineered (BE) Food Disclosure Standard ("the GMO labeling law") any day now. It left the White House review at the end of November and is undergoing final processing as we speak. Both of these laws and their updates - for BE and Nutrition Label Reform - will be thoroughly covered at PLC's Food Label Conference in April, and we will continue to monitor developments with our contacts at the USDA and FDA for late-breaking news. Stay tuned - we'll notify our Label Alert subscribers as soon as new information is available!

Jesse Zuehlke, PhD
Prime Label Consultants has been host to the nation's premier food labeling conference since 1989. As food marketers and manufacturers are faced with one of their greatest challenges in two decades - to adjust to sweeping new nutrition and BE rules for packaged products - the Food Label Conference remains in high demand as the place to learn the latest about food labeling compliance. This year boasts an unprecedented range of educational opportunities with more than 35 different breakouts in addition to 9 optional Add-On Trainings. For more details on the Food Label Conference held on April 15-16, 2019, click below:
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