Source: https://www.arnoldporter.com/en/perspectives/publications/2018/05/fda-and-usda-action-implements-us-nutrition
Timestamp: 2019-02-17 04:17:49
Document Index: 599018476

Matched Legal Cases: ['§ 101', '§ 66', '§ 66', '§ 66', '§ 66', '§ 101', '§ 66', '§ 66', '§ 66', '§ 66', '§ 66']

FDA and USDA Action Implements US Nutrition Action Plan and Federal Food Labeling Policy Agenda | Publications and Presentations | Arnold & Porter
In January, FDA issued its Strategic Policy Roadmap, entitled "Healthy Innovations, Safer Families," which highlighted a goal to "empower consumers to make better and more informed decisions about their diets and health; and expand the opportunities to use nutrition to reduce morbidity and mortality from disease." 1 Consistent with FDA's Strategic Policy Roadmap, the first half of 2018 has included significant regulatory actions, including:
In response to stakeholder concerns about the time-intensive and burdensome nature of overhauling their labels to comply with the new food labeling requirements, FDA has once again delayed the compliance date for two final rules that affect the Nutrition Facts Label: (1) Food Labeling: Revision of the Nutrition and Supplement Facts Labels (the Nutrition Facts Label Final Rule) and (2) Food Labeling: Serving Sizes of Foods That Can Reasonably Be Consumed At One Eating Occasion; Dual-Column Labeling; Updating, Modifying, and Establishing Certain Reference Amounts Customarily Consumed; Serving Size for Breath Mints; and Technical Amendments (the Serving Size Final Rule). For an overview of the final rules, which were published on May 27, 2016, please read our firm's Advisory.
The Nutrition Facts Label and Serving Size final rules originally required compliance by July 26, 2018 (manufacturers with annual food sales of less than US $10 had an additional year to comply). After receiving over 50,000 comments on a proposed rule extending the compliance deadlines by 1.5 years, on May 4, 2018, FDA issued a final rule extending the deadlines.7 Now, manufacturers with $10 million or more in annual food sales must comply starting on January 1, 2020, while manufacturers with less than $10 million in annual food sales must comply by January 1, 2021.
In deciding to extend this deadline, the Agency noted the importance of giving manufacturers time to use FDA guidance to address technical questions raised after issuance of the final rules, such as questions pertaining to fiber, on which FDA issued guidance in March 2018. In fact, since January, FDA has issued six guidance documents in addition to menu labeling (discussed above) related to compliant labeling, including the following:
Draft Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products (February 2018). The guidance advises food manufacturers of the Agency's intent to exercise enforcement discretion regarding use of the symbol "†" in the Nutrition Facts label to direct consumers to truthful and non-misleading statements on the package outside of the Nutrition Facts label. The symbol "†" immediately follows the added sugars percent Daily Value information on single ingredient packages and/or containers of pure honey or pure maple syrup and on certain dried cranberry and cranberry juice products that are sweetened with added sugars and that contain total sugars at levels no greater than comparable products with endogenous (inherent) sugars, but no added sugars. Comments on the guidance are due by June 15, 2018.
(1) The most predominant ingredient of the food would independently be subject to the FD&C Act's labeling requirements, or
(2) The most predominant ingredient of the food is broth, stock, water, or a similar solution, and the second most predominant ingredient of the food would independently be subject to the FD&C Act's labeling requirements.17
(1) Text Disclosure.21 The list on which a BE food is included–either "highly" or "not highly adopted"–governs the disclosure statement that may be conveyed about the food. The proper textual disclosure for a "highly adopted" BE food or BE food ingredient is, "bioengineered food" or "contains a bioengineered food ingredient". The phrase, "bioengineered food", applies to raw agricultural products (e.g., corn) and processed products that only contain BE food ingredients (e.g., cornmeal). "Contains a bioengineered food ingredient" applies to all other foods.
For a "not highly adopted" BE food, entities may use the following statements: "bioengineered food", "may be bioengineered food", "contains a bioengineered food ingredient", or "may contain a bioengineered food ingredient." AMS has requested comments on the proposed text disclosures, including with regard to the use of "may be" or "may contain" disclosures.
(2) Symbol Disclosure.22 AMS has proposed, and requests comments on, three alternatives for the symbols that may be used to indicate the BE status of a food.
Alternative 2-C
(3) Electronic or Digital Link Disclosure.23 Regulated entities may also disclose the BE status of a food through electronic mechanisms such as scanning a code with a smartphone or other device. In this case, regulated entities must also include the statement, "scan here for more information" or similar language reflecting the technology used to access the information, and provide at telephone number with instructions to "call for more information."
Advancing guidance on dietary sodium reduction targets is another key component of the Agency's Nutrition Innovation Strategy. As we previously discussed here, on June 2, 2016, FDA released draft guidance for industry on the Agency’s effort to work with food companies and restaurants to gradually reduce sodium levels in food. Once finalized, the draft guidance document will provide short-term (two years) and long-term (ten years) voluntary mean and upper-bound targets for sodium concentrations in categories of commercially processed, packaged, and prepared foods.
Healthy Innovation, Safer Families: FDA's 2018 Strategic Policy Roadmap, Jan. 2018, at 15.
FDA Extends Menu Labeling Compliance Date to 2018, May 1, 2017. See 21 CFR § 101.11.
FDA, PowerPoint Presentation on Menu Labeling.
FDA Guidance for Industry, Menu Labeling: Supplemental Guidance for Industry, May 2018, at 4.
Statement from FDA Commissioner Scott Gottlieb, M.D., on the public health benefits from enactment of menu labeling, May 7, 2018.
National Bioengineered Food Disclosure Standard, 83 Fed. Reg. 19860, (May 4, 2018).
National Bioengineered Food Disclosure Standard, Pub. L. 114-216 (July 29, 2016).
Proposed 21 CFR § 66.1, definition of a bioengineered food.
Proposed 21 CFR § 66.5(c), Alternative 1-A.
Id., Alternative 1-B.
Id., Alternative 1-C.
83 Fed. Reg. 19860, 19869.
Proposed 21 CFR § 66.5(a)-(b), (d)-(e).
Proposed 21 CFR § 66.3(b)(2). Note that predominance refers to the position of an ingredient on a list of ingredients, and is determined by the weight of the ingredient in the product, per 21 CFR § 101.4(a)(1).
83 Fed. Reg. 19860, 19871.
Proposed 21 CFR § 66.100(a).
See proposed 21 CFR § 66.102.
See proposed 21 CFR § 66.104.
See Proposed 21 CFR § 66.106.
Proposed 21 CFR § 66.114.
See Guidance for Industry: Use of the Term "Healthy" in the Labeling of Human Food Products, Sept. 2016.
Reducing the Burden of Chronic Disease, Remarks by Scott Gottlieb, M.D., Commissioner of Food and Drugs, National Food Policy Conference, Washington DC, Mar. 29, 2018.
"Natural" on Food Labeling, FDA.
Reducing the Burden of Chronic Disease, Remarks by Scott Gottlieb, M.D., Commissioner of Food and Drugs, National Food Policy Conference, Washington DC, Mar. 29, 2018 ;Id.
FDA's Nutrition Innovation Strategy, available at https://www.fda.gov/Food/LabelingNutrition/ucm602651.htm (updated Mar. 29, 2018); Reducing the Burden of Chronic Disease, Remarks by Scott Gottlieb, M.D., Commissioner of Food and Drugs, National Food Policy Conference, Washington DC, Mar. 29, 2018, available at https://www.fda.gov/NewsEvents/Speeches/ucm603057.htm.
FDA Acknowledges Qualified Health Claim Linking Early Peanut Introduction and Reduced Risk of Developing Peanut Allergy, Sept. 7, 2017, available at https://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm575001.htm.
Reducing the Burden of Chronic Disease, Remarks by Scott Gottlieb, M.D., Commissioner of Food and Drugs, National Food Policy Conference, Washington DC, Mar. 29, 2018, available at https://www.fda.gov/NewsEvents/Speeches/ucm603057.htm.
FDA's Nutrition Innovation Strategy, available at https://www.fda.gov/Food/LabelingNutrition/ucm602651.htm (updated Mar. 29, 2018).
IDFA's 24 Priority Issues for FDA CFSAN Regulatory Reform, Feb. 2, 2018.