The U.S. Food and Drug Administration (FDA) has issued a proposed rule (“Proposed Rule”)[1] that updates the definition of the “healthy” nutrient content claim under 21 C.F.R. § 101.65(d) for the first time since its issuance in 1994. The Proposed Rule, published on September 29, 2022, notes that “nutrition science has evolved since the 1990s” and that the proposed changes are intended to make the regulation “consistent with current nutrition science and Federal dietary guidance.”[2]
FDA is accepting comments until December 28, 2022. Stakeholders should note that the proposed amendments may require companies to remove “healthy” claims from current labels and may make new products eligible to bear “healthy” claims. The comment period affords impacted companies the opportunity to provide FDA with input that could modify the current Proposed Rule. K&L Gates’ FDA team can assist clients with submitting comments and with assessing the impact of the Proposed Rule.
Highlights of the Proposed Rule
The changes in the Proposed Rule align with the FDA’s 2016 changes to the nutrition labeling regulation at 21 C.F.R. § 101.9,[3] primarily by refocusing the attention from limiting fat to limiting sugar intake. The proposal also addresses several areas to make the regulation more consistent with current nutrition guidelines; for example, the Proposed Regulation would permit water, avocados, nuts, and seeds to bear the “healthy” claim, whereas products such as highly sweetened cereals would not be eligible for the claim.[4]
Under the existing regulation,[5] a “healthy” food must meet certain criteria, including limits on total fat, saturated fat, cholesterol, and sodium, and minimum amounts (at least 10 percent of the Daily Value) of favorable nutrients (e.g., vitamin A, vitamin C, calcium, iron, protein, and dietary fiber).[6] In contrast, while continuing to place limits on the presence of certain nutrients (e.g., added sugar, sodium, saturated fat), the Proposed Rule’s updated “healthy” criteria take a very different approach to promoting the consumption of certain foods, consistent with the 2020-2025 Dietary Guidelines for Americans, through the new concept of “food group equivalents.” Specifically, to meet the proposed “healthy” claim criteria, a food would need to contain minimum amounts of one or more of the following food groups or subgroups: fruit, vegetables, grains, dairy, and protein foods. FDA’s proposed table of “food group equivalents” is reproduced below:
FDA Proposed Rule – Food Group Equivalents
| Food Group | Food Group Equivalent
|
Examples |
| Vegetable | 1/2 cup equivalent vegetable | 1/2 cup cooked green beans; 1 cup raw spinach |
| Fruit | 1/2 cup equivalent fruit | 1/2 cup strawberries; 1/2 cup 100% orange juice; 1/4 cup raisins |
| Grains | No less than 3/4 oz. equivalent whole grain | 1 slide of bread; 1/2 cup cooked brown rice |
| Dairy | 3/4 cup equivalent dairy | 6 oz. fat free yogurt; 1 1/8 oz. nonfat cheese |
| Protein foods | 1 1/2 equivalent game meat, 1 oz. equivalent seafood, 1 oz. equivalent egg, 1 oz. equivalent beans, peas, or soy products, or 1 oz. equivalent nuts and seeds | 1 1/2 oz. venison; 1 oz. tuna; 1 large egg; 1/4 cup black beans; 1/2 oz. walnuts |
In a change from the current “healthy” regulation, the Proposed Rule distinguishes between undesirable fat (i.e., saturated fat) and desirable fats (i.e., monounsaturated and polyunsaturated fats) in the diet. In this regard, the Proposed Rule reflects the impact of the 2015 citizen petition submitted by KIND LLC (Docket No. FDA-2015-P-4564[7]), a manufacturer of sweetened nut snack bars, which requested that FDA accommodate “healthy” claims for products containing monounsaturated and polyunsaturated fats but that are not “low fat” as defined under 21 C.F.R. § 101.62(b)(2). KIND filed its petition after receiving a warning letter from FDA in 2015, requesting that they remove the “healthy” claim from products due to disqualifying levels of fat from nut ingredients (e.g., almonds, peanuts). In a press release issued with submission of its petition, KIND highlighted that the current “healthy” regulation permits products like fat-free chocolate pudding, sweetened cereals, and toaster pastries to qualify as “healthy,” whereas foods like almonds, avocados, and salmon were ineligible due to their fat content.[8] In response to KIND’s petition, FDA had been exercising enforcement discretion since September 2016 for certain products not low in fat but that contain predominantly mono and polyunsaturated fats.[9]
Under the Proposed Rule, FDA has eliminated total fat and cholesterol from consideration for “healthy” claims. Also, while a food product must adhere to limits for added sugars, saturated fat, and sodium, limits on unfavorable nutrients are no longer keyed to compliance with other nutrient content claim regulations (e.g., meeting the definition of “low saturated fat” under 21 C.F.R. § 101.62(c)(2)). The Proposed Rule expresses disqualifying levels for unfavorable nutrients as percentages of daily values under 21 C.F.R. § 101.9.
FDA summarizes the criteria for “healthy” claims by product type below. Unlike the current regulation, the Proposed Rule would specifically allow all raw whole fruits and vegetables to qualify for the “healthy” claim because of their positive contribution to an overall healthy diet, as well as to allow water to bear the “healthy” claim:
FDA Proposed Rule – Eligible Products for “Healthy” Nutrient Content Claim
| Product | Criteria for bearing “healthy” claim |
| Raw, whole fruits and vegetables | No additional criteria; all raw, whole fruits and vegetables may bear the claim. |
| Individual food products | At least 1 food group equivalent per RACC from 1 food group, and Nutrients to limit. |
| Mixed products | At least 1/2 food group equivalent each from at least 2 different food groups, and Nutrients to limit. |
| Main dish as defined at 21 CFR 101.13(m) | At least 1 food group equivalent each from at least 2 different food groups, and Nutrients to limit. |
| Meal as defined at 21 CFR 101.13(l) | At least 1 food group equivalent each from at least 3 different food groups, and Nutrients to limit. |
| Water | Plain water and plain, carbonated water may bear the claim. |
This proposed rule is likely the first of many that will bring FDA’s nutrient content claim regulations in line with its 2016 revisions to the nutrition labeling regulation. The comment period for the Proposed Rule closes on December 28, 2022; comments can be submitted at https://www.federalregister.gov/documents/2022/09/29/2022-20975/food-labeling-nutrient-content-claims-definition-of-term-healthy#open-comment.
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FOOTNOTES
[1] 87 Fed. Reg. 59168 (Sept. 29, 2022), https://www.federalregister.gov/d/2022-20975.
[2] Id. at 59174.
[3] For more information, see FDA, Changes to the Nutrition Facts Label, https://www.fda.gov/food/food-labeling-nutrition/changes-nutrition-facts-label.
[4] Id.
[5] 21 C.F.R. 101.65(d).
[6] 87 FR 59168, at pg. 59172, https://www.federalregister.gov/d/2022-20975/p-57.
[7] The petition is available at https://s3.amazonaws.com/kind-docs/citizen-petition.pdf.
[8] See KIND, Seven Years After KIND’s Citizen Petition, FDA Proposes New Definition of “Healthy,“ Press Release, https://www.kindsnacks.com/media-center/press-releases/KIND+Citizen+Petition+FDA+proposes+new+definition+of+healthy.html
[9] FDA, Guidance for Industry: Use of the Term “Healthy” in the Labeling of Human Food Products, https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-industry-use-term-healthy-labeling-human-food-products