2015 FDA Wrap-Up and 2016 Regulatory Priorities

Happy New Year! This article will revisit and update the status of significant regulatory issues in 2015 and assess 2016 FDA priorities in the food area.

2015 Overview

• Office of Dietary Supplement Programs

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  On December 21, 2015, the FDA announced the creation of the Office of Dietary Supplement Programs (ODSP).¹ The program was formerly a division under the Office of Nutrition Labeling and Dietary Supplements, now known as the Office of Nutrition and Food Labeling. The Department of Justice brought a significant number of civil and criminal cases against the makers of dietary supplements in 2015. The creation of ODSP supports the mission of monitoring the safety of dietary supplements and taking action against entities that present a risk of harm to the consumer.

• “Natural” Label Claims

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  In 2015, the FDA received three Citizen Petitions asking that the agency define the term “natural” for use in food labeling. The term “natural” has been the subject of many food labeling lawsuits. In direct response to requests from the public, the FDA has extended the comment period on the use of the term “natural” in food labeling to May 10, 2016.² The Morgan Lewis FDA team is currently working on an analysis of the comments submitted to date. Please contact the FDA team if you are interested in submitting a comment.

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• Food Safety and Modernization Act (FSMA) Regulations

  As discussed in our November 16 post, in late 2015, the FDA published three final rules under FSMA: the Standards for Growing, Harvesting, Packing, and Holding of Produce for Human Consumption (Produce Safety rule),³ the Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP rule),⁴ and the Accreditation of Third-Party Certification Bodies to Conduct Food Safety Audits and to Issue Certifications (Accredited Third-Party Certification rule).⁵ These rules implement sections of FSMA geared toward protecting the US food supply. As discussed below, the FDA plans to take further action to implement sections of FSMA in 2016.

• Menu Labeling Requirements

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  As discussed in our post July 13, 2015, FDA released its final rule on menu labeling in restaurants on December 1, 2014, and later extended the date for compliance from December 1, 2015 to December 1, 2016. The rule will require restaurants and similar retail food establishments that (1) sell “restaurant-type food,” (2) are part of a chain of 20 or more locations, (3) do business under the same name or slight variations of each other, and (4) offer for sale substantially the same menu items as the other business locations, to disclose calorie information on menus and menu boards.

• New York Sodium Warning

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  AThe New York City Department of Health and Mental Hygiene Board of Health (Board of Health) Sodium Warning Label Rule went into effect on December 1, 2015. The Rule requires food service establishments in New York City with 15 or more locations nationwide to provide a warning for menu items that contain 2,300 mg or more of sodium. New York City is the first city in the United States to require chain restaurants to include sodium warnings on menus or menu boards. Chains with 15 or more locations have 90 days to comply with the new rule before they face a $200 fine. The rule elicited responses from the National Salt Institute and the National Restaurant Association. The National Restaurant Association filed suit against the Board of Health, claiming that it did not have the authority to require such a warning. We will monitor this lawsuit and provide updates in 2016.

2016 FDA Regulatory Publication Agenda

On December 15, 2015, the FDA released its Semiannual Regulatory Agenda.⁶ The Agenda outlines the following outstanding proposed and final rules for 2016 with respect to food:

• Food Labeling; Gluten-Free Labeling of Fermented, Hydrolyzed, or Distilled Foods:⁷

  This proposed rule was published in late 2015. It would establish requirements concerning compliance for using a ‘‘gluten-free’’ labeling claim for those foods for which there is no scientifically valid analytical method available that can reliably detect and accurately quantify the presence of 20 parts per million gluten in the food. FDA has acknowledged that it is difficult to scientifically detect gluten in fermented and hydrolyzed foods.⁸ Accordingly, the rule would require manufacturers to make and keep records to show that (1) the food meets the definition for “gluten-free” in 21 C.F.R. 101.91(a)(3), including that the food had less than 20 ppm gluten, before fermentation or hydrolysis; (2) the manufacturer adequately evaluated the processing for any potential for gluten cross-contact; and (3) where a potential for gluten cross-contact has been identified, the manufacturer has implemented measures to prevent the introduction of gluten into the food during the manufacturing process. FDA is accepting comments until February 16, 2016.

• Food Labeling: Revision of the Nutrition and Supplement Facts Labels:⁹

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  Under the Food, Drug and Cosmetic Act (FD&C Act), this final rule would amend the labeling regulations for conventional foods and dietary supplements to provide updated nutrition information on the label to assist consumers in maintaining healthy dietary practices. The rule would modernize the nutrition information found on the Nutrition Facts label, as well as the format and appearance of the label. The FDA reopened the comment period for this final rule in October 2015, and anticipates issuing a final rule in March 2016.¹⁰

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• 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 (RACCS):¹¹

  Under the Nutrition Labeling and Education Act of 1990 and the FD&C Act, this final rule would modify labeling regulations for foods to provide updated RACCs for certain food categories to assist consumers in maintaining healthy dietary practices. The rule would also amend the definition of single-serving containers; the label serving size for breath mints; and provide for dual-column labeling, which would provide nutrition information per serving and per container or unit, as appropriate. The FDA anticipates releasing the final rule in March 2016.¹²

• Focused Mitigation Strategies to Protect Food Against Intentional Adulteration:¹³

  Under FSMA, the final rule would require domestic and foreign food facilities that are required to register with the FDA to address hazards that may be intentionally introduced by acts of terrorism. Food facilities would be required to identify and implement focused mitigation strategies to significantly minimize or prevent significant vulnerabilities identified at actionable process steps in a food operation. The FDA anticipates releasing the final rule in June 2016.¹⁴

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• Sanitary Transportation of Human and Animal Food:¹⁵

  Under the 2005 Sanitary Food Transportation Act and FSMA, this final rule would establish requirements for parties and receivers engaged in the transportation of food, including food for animals, to use sanitary transportation practices to ensure that food is not transported under conditions that may render the food adulterated. The FDA anticipates publication of the final rule in April 2016.

_{¹ U.S. Food & Drug Admin., FDA Creates the Office of Dietary Supplement Programs and Announces New Nutrition Office Leadership (Dec. 21, 2015) http://www.fda.gov/Food/NewsEvents/ConstituentUpdates/ucm478303.htm.
² 80 Fed. Reg. 80178 (Dec. 28, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-12-28/pdf/2015-32471.pdf; 80 Fed. Reg. 69905 (Nov. 12, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-12/pdf/2015-28779.pdf.
³ 80 Fed. Reg. 74354 (Nov. 27, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28159.pdf.
⁴ 80 Fed. Reg. 74226 (Nov. 27, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28158.pdf.
⁵ 80 Fed. Reg. 74570 (Nov. 27, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-27/pdf/2015-28160.pdf.
⁶ 80 Fed. Reg. 77960 (Dec. 15, 2015).
⁷ Id. at 77963; 80 Fed. Reg. 71990 (Nov. 18, 2015) https://www.gpo.gov/fdsys/pkg/FR-2015-11-18/pdf/2015-29292.pdf.
⁸ 78 Fed. Reg. 47154.
⁹ 80 Fed. Reg. 77764, 77965 (Dec. 15, 2015).
¹⁰ Id. at 77764.
¹¹ 80 Fed. Reg. 77765, 77965 (Dec. 15, 2015).
¹² Id. at 77765.
¹³ Id. at 77768.
¹⁴ Id.
¹⁵ Id. at 77771.}