- 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.
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.