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Tip of the Week: Technical Amendments Released by FDA that You Need to Know
Tip of the Week: Technical Amendments Released by FDA that You Need to Know

The Food and Drug Administration released a technical amendment effective December 21, 2018, that amends Section 21 of the Code of Federal Regulations (CFR) by correcting errors in labeling examples, restoring missing information, updating cross-references and revising Appendix B of part 101.

1. The Serving Size Final Rule revised 101.9(b)(2)(i) by removing paragraph (b)(2)(i)(E) and adjusting the designation of paragraphs (b)(2)(i)(F) through (I) accordingly. However, a cross-reference in 101.9(b)(5)(vi) for using “ounce” as a household measure was not updated to match the new regulations, so it has been changed from “101.9(b)(2)(i)(G)” to “101.9(b)(2)(i)(F)”.

2. The Nutrition Facts Label Final Rule did not change the regulations that define saturated fat, trans fat, polyunsaturated fat, or monounsaturated fat but these sections were inadvertently omitted from the CFR when it was updated with the new regulations. This technical amendment restores sections 101.9(c)(2)(i) through (iv) which contain these fatty acids.

3. Section 101.9(c)(6)(i), which covers dietary fiber, contained a cross-reference to 101.81(c)(2)(ii)(A)(6) that has been corrected to 101.81(c)(2)(ii)(B)(1). This reference describes psyllium husk for the purposes of declaring it as dietary fiber.

4. 101.9(c)(6)(iii) states that if the Added Sugars content is not required, because the amount is 0 and no claims are made, and it is not declared on the Nutrition Facts panel then the statement “Not a significant source of Added Sugars” must be placed as a footnote. The regulation did not include the provision that allowed this statement to be omitted if the Simplified Format can be used per the requirements in 101.9(f) so the statement “Except as provided for in paragraph (f) of this section,” has been added.

5. In the preamble of the Proposed Rule to revise the Nutrition Facts and Supplement Facts Labels, it stated the quantitative amounts for all mandatory and voluntary vitamins and minerals would be required, but there would be an exception for “Small Packages”. Since this was omitted from the Final Rule, 101.9(c)(8)(ii) has been amended to include the exception.

6. Section 101.9(c)(8)(iv) includes a table of the vitamins and minerals but the order of these vitamins and minerals was not updated for the new regulations. This table has been updated to match the required order of vitamins and minerals. Due to the reordering of the nutrients in the table, some of the footnotes at the bottom of the table needed to be renumbered. The Vitamin A RAE footnote has been renumbered and amended to match the wording in the preamble of the Nutrition Facts Label Final Rule, however, there appears to be an extra mention of “dietary” in the technical correction

7. 101.9(d)(1)(iii) omitted the requirement from the preamble of the Nutrition Facts Label Final Rule that the minimum font size would be 6 point for “Amount per serving” and “%Daily Value”, which are 101.9(d)(4) and (6) respectively so the technical amendment adds that requirement.

8. The sample labels in 101.9(e)(5) and (6) are updated to correct errors in the graphics.

  • These graphics were updated to extend the line under Saturated Fat further left and to change the rounding of Potassium to the nearest 10mg.
  • The designation “Per Serving and Per Container” was added to the title of the first example in 101.9(e)(6).
  • Servings per container and serving size were added to the second example in (e)(6).
  • The Tabular Dual Column Display example has been updated with a clearer graphic.

9. 101.9(j)(13)(i) covers the requirements for packages with less than 12 square inches of available labeling space. The regulations omitted the sections (j)(13)(i)(A) and (j)(13)(i)(B) that cover the use of a phone number or address in place of nutrition information and the minimum font size in the nutrition panel if one is included.

10. A reference in 101.9(g)(13)(i)(B) was corrected to 101.2(c)(2) because the regulation that was referenced, 101.2(c)(5), does not exist.  This reference pertains to special exemptions for small food service packages that are individual serving size packages.

11. Appendix B of 21 CFR 101 which provides an example of graphic enhancements used for the nutrition panel was updated to match the new regulations.

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