Today, FDA published notice of the availability of a final guidance for industry, entitled: The Declaration of Added Sugars on Honey, Maple Syrup, Other Single-Ingredient Sugars and Syrups, and Certain Cranberry Products (June 2019). The final guidance provides industry with some rational relief from the added sugars nutrition labeling requirements that predated it. That relief derived from the Agriculture Improvement Act of 2018 (Pub. L. 115-334), commonly known as the “Farm Bill.” FDA has provided until July 1, 2021 for these products to come into compliance with the Farm Bill and final guidance.
Every five years, HHS and USDA must jointly publish a report -- the Dietary Guidelines for Americans. The 2015-2020 Dietary Guidelines includes (p. 28) a recommendation for healthy eating patterns that limits added sugars (including honey, syrups, and other caloric sweeteners) to less than 10% of calories per day. This recommendation influenced FDA’s revision of its nutrition labeling regulations to include requirements on “added sugars.”
In the Federal Register of May 27, 2016, FDA issued final rules updating the Nutrition Facts label and Serving Sizes for packaged foods. The Nutrition Facts label final rule established a 50g daily value (DV) for added sugars (21 C.F.R. § 101.9(c)(9)) and required that added sugars be included in the Nutrition Facts panel (NFP) (21 C.F.R. § 101.9(c)(6)(iii)). “Added Sugars” was defined, in pertinent part:
Added sugars are either added during the processing of foods, or are packaged as such, and include sugars (free, mono- and disaccharides), sugars from syrups and honey….
Id. The Nutrition Facts label final rule required added sugars to be declared on the food label by stating “Includes Xg Added Sugars,” indented directly below “Total Sugars.” Id. Thereafter, In the Federal Register of March 2, 2018, FDA published notice of the availability of a draft guidance for industry, entitled, “The Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products; Draft Guidance for Industry; Availability,” which essentially mirrored its regulatory requirements, and asked interested parties to submit comments.
Section 12516 of the 2018 Farm Bill, enacted in December 2018, provided that the food labeling requirements under section 403(q) of the FD&C Act may not require that the Nutrition Facts label of any single-ingredient sugar, honey, agave, or syrup, including maple syrup, which is packaged and offered for sale as a single-ingredient food, bear the declaration “Includes Xg Added Sugars.” However, at the same time, the Farm Bill did not change the requirement under the Nutrition Facts label final rule that the %DV, indicating the contribution of added sugars from these products to the diet, be declared.
The final guidance does not change the requirements of FDA’s Nutrition Facts label final rule, as codified at 21 C.F.R. § 101.9(c)(6)(iii) and (c)(9). Rather, it advises that FDA will exercise enforcement discretion for noncompliance with § 101.9 in the following instances:
It does not appear that FDA has consumer-tested the suggested obelus symbol or explanation. Importantly, FDA advised: “The symbol and footnote are not a requirement, but FDA encourages manufacturers to use them as a way to provide useful information to consumers” (emphasis added).
FDA advises manufacturers of single-ingredient packages and/or containers of pure honey, pure maple syrup, and other pure sugars and syrups, as well as the cranberry products discussed in the final guidance, of its intent to exercise enforcement discretion until July 1, 2021 for complying with the Farm Bill and the final guidance.
Overall, the final guidance seems to provide consumers with information as to how consumption of these products may be accommodated within the recommendations of the Dietary Guidelines. As Rep. Chellie Pingree (D-Maine) put it during a 2018 hearing with then FDA Commissioner Scott Gottlieb: “I think it’s misleading for a jar of 100% pure honey or maple syrup to label its sugars under the ‘added sugar’ category when nothing has been added to those products.”