The U.S. Food and Drug Administration (FDA) has launched two new online dashboards that track key metrics reflecting the impacts from the FDA Food Safety Modernization Act (FSMA) regulations. The dashboards are part of FDA-TRACK, an agency-wide performance management program. There are separate dashboards for: (1) Preventive Controls and Current Good Manufacturing Practice (CGMP) Measures, and (2) Imported Food Safety Measures.

The release of these new data dashboards is consistent with one of FDA’s longstanding goals for FSMA implementation: to establish and analyze metrics to track the outcomes for the FSMA regulations. FDA’s intends to eventually release data tracking compliance with all seven major FSMA rules. This memorandum provides an overview of the information included in the two new dashboards and identifies some of the key takeaways from the data currently available.

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On September 27, 2019 the U.S. Food and Drug Administration (FDA) hosted a public meeting to gather information from stakeholders on changes the agency could make to existing standards of identity (SOIs), particularly changes that could be made across categories of standardized foods (i.e., “horizontal” changes), to provide flexibility for the development of healthier foods and facilitate innovation. Though FDA primarily was in listening mode during the meeting, comments by agency representatives suggested FDA’s commitment to SOI modernization. In particular, the agency encouraged stakeholder comments to the docket, indicating interest in highly-detailed proposals for establishing horizontal approaches to SOIs that eliminate barriers to improvements in product nutrition profiles, spur innovation, and provide flexibility to allow emerging technology to reach consumers while ensuring sufficient transparency. Written comments are due by November 12, 2019, and can be submitted to FDA docket number FDA-2018-N-2381-1371. This memorandum provides a high-level summary of the agency statements and stakeholder comments made during the meeting.

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On September 26, 2019, the Federal Trade Commission’s (FTC’s or the Commission’s) Bureau of Consumer Protection (BCP) held a public workshop on “Made in USA” and similar U.S.-origin claims for consumer goods sold in the United States. This is the first time the Commission has sought public input on its approach to such claims since issuing its 1997 Enforcement Policy Statement. The FTC is considering revising the Policy Statement or issuing formal rulemaking, and is seeking comments on consumer perception of “Made in USA” claims, the workability of the current standard, the value of a bright-line rule for the amount of permissible foreign content (e.g., a specific percentage), and its approach to enforcement, which currently emphasizes counseling compliance over prosecuting violations.

The workshop featured panelists representing members of industry, consumer advocacy groups, and FTC attorneys who are principally responsible for enforcing the Commission’s policy on “made in USA” claims. There were three discussion segments: (1) Consumer Perception – How Do Consumers Interpret Made in USA Claims; (2) Doing Business Under the Current Policy – What Are the Compliance or Policy Challenges Under the Current Framework; and (3) Enforcement Approaches – Should the Commission Reexamine Its Current Approach to Addressing Deceptive Made in USA Claims. Members of the public were not invited to speak during the workshop, but are encouraged to submit comments to the FTC docket. The FTC is requesting comments on 15 specific questions, attached in Appendix A.

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The U.S. Food and Drug Administration (“FDA”) recently released Chapter 14 of its Draft Guidance for Industry, “Hazard Analysis and Risk-Based Preventive Controls for Human Food” (“Draft Guidance”). Entitled “Recall Plans,” the chapter explains how food facilities subject to the Current Good Manufacturing Practice, Hazard Analysis, and Risk-Based Preventive Controls for Human Food Rule (“PCHF Rule”) can establish and implement a written recall plan. This memorandum provides a brief overview of the Draft Guidance. Comments on the Draft Guidance should be submitted by February 4, 2020.

Background

Facilities covered by the PCHF Rule are required to have a written recall plan if they have any foods with a “hazard requiring a preventive control,” as determined based on their hazard analysis. The regulations require the recall plan to include procedures that describe the steps to be taken, and assign responsibility for taking those steps, for the following actions, as appropriate to the facility:

  1. Directly notify the direct consignees of the food being recalled, including how to return or dispose of the affected food;
  2. Notify the public about any hazard presented by the food when appropriate to protect public health;
  3. Conduct effectiveness checks to verify that the recall is carried out; and
  4. Appropriately dispose of recalled food—e.g., through reprocessing, reworking, diverting to a use that does not present a safety concern, or destroying the food.

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On October 7th, 2019, the Regulatory Impact Analysis and the draft amendment of the Official Mexican Standard NOM-051-SCFI/SSA1-2010 – “General Labelling Specifications for Pre-packaged Foods and Non-Alcoholic Beverages – Commercial and Health Information” were published in the portal of the National Commission on Regulatory Improvement. The foregoing was the result of the proposal for amendment of the General Health Law in terms of the front labeling warnings, submitted by the Health Commission of the House of Representatives.

Below please find some of the main modifications included in the aforementioned draft amendment:

i. It introduces new applicable terms and definitions, such as sugar added and sugar-free, natural or artificial sweetener, front labeling system; supplementary nutrition facts, children, critical nutrients, genuine and substitute products, warning stamp, among others.

ii. It now forbids the use of legends which refer to recommendations or endorsements by professional companies or associations.

iii. The use of characters, drawings, celebrities, gifts, offers, toys or contests is now forbidden for certain product categories.

iv. Likewise, the new draft amendment now limits the advertising of certain product categories in social media.

v. New rules apply for the use and declaration of the denomination of foods, mainly in terms of genuine and substitute products.

vi. Furthermore, the draft amendment sets out new guidelines for the declaration of ingredients, among which the following stand out:

  • Declaration of sugars, their categories, and quantities.
  • Declarations of allergens and ingredients which may cause hypersensitivity and/or intolerance, including new categories thereof (e.g. syrups).
  • Tighter regulations for additives.

vii. Draft amendments introduce the obligation to declare added sugars and trans-fats, as part of the Nutritional Declaration of products.

viii. It now broadens the supplementary nutritional facts chapter.

ix. Adopts the Front Labeling System, the purpose of which is to warn and inform the consumer regarding nutrients which, according to the provisions of the Official Mexican Standards (NOM), constitute a health risk. For example:

  • The use of warning stamps in connection with nutrients (for example: “Excess Calories”).
  • The use of warning stamps in connection with sweeteners (for example: “It contains sweeteners, should be avoided for children”).
  • Precautionary legends (for example: “It contains caffeine, should be avoided in children”).
  1. Finally, the draft amendment provides for a Conformity Assessment Procedure, and now introduces the obligation to obtain a compliance opinion.

The Hogan Lovells Global Regulatory team is ready to assist you and clarify any questions you have on this matter.

The U.S. Food and Drug Administration (FDA) recently published a list of the records that importers are required to develop and maintain under the Foreign Supplier Verification Program (FSVP) regulation. [1] The thirteen-page document contains detailed checklists of the required records,, though not every record on the list will be applicable to every importer.  These records need to be made available to FDA during an FSVP inspection. [2]

As background, the FSVP regulation requires importers to verify that the food they are importing into the United States has been produced in a manner that meets applicable U.S. food safety standards.  To do this, importers are required to develop, implement, and maintain an FSVP that includes documentation of verification activities for each imported food from each foreign supplier. [3]  The FSVP regulation itself does not include a list of the specific records that are required to be maintained.  (In contrast, the supply-chain program component of the Preventive Controls for Human Food (PCHF) regulation does include a list of required records.)

The new list issued by FDA is highly-detailed and should be a useful tool for importers.  Likewise, this list could become a roadmap, of sorts, for FDA investigators during inspections.  FDA is actively enforcing the FSVP regulation and routinely requests that importers provide copies of all FSVP records related to the import entry that is the focus of the inspection.  Accordingly, importers may want to consider using this list to guide an internal inspection-readiness audit, or to assist with the development of their FSVP if they do not already have one.

[1]/         FDA Publishes List of Records Required Under FSVP (October 7, 2019) (FDA Constituent Update), https://www.fda.gov/food/cfsan-constituent-updates/fda-publishes-list-records-required-under-fsvp.
[2]/         Foreign Supplier Verification Programs for Importers of Food for Humans and Animals (FSVP) Regulation Records Requirements, https://www.fda.gov/media/131229/download.
[3]/         21 CFR § 1.500 et seq.

A lawsuit filed yesterday by the California Chamber of Commerce challenges the legality of Proposition 65 warnings on foods that contain acrylamide. The Complaint, which named the Attorney General of the State of California as the Defendant and was filed in the United States District Court (Eastern District of California), is seeking declaratory relief asking the court to rule that Proposition 65 warning requirements for cancer as applied to acrylamide in food products violate the First Amendment, and injunctive relief prohibiting the Defendant and private bounty hunters from enforcing Proposition 65 warning requirement for cancer with respect to acrylamide in food products.

Acrylamide is not intentionally added to food products. Rather, the chemical is formed naturally in many types of food during cooking or processing through the Maillard reaction. According to the Complaint, common sources of acrylamide in the human diet include, among others, breakfast cereals, crackers, bread crusts, coffee, grilled or roasted asparagus, French fries, potato chips and other fried and baked snack foods, canned sweet potatoes, canned black olives, prune juice, roasted nuts, and toast. Acrylamide was listed under Proposition 65 in 1990 pursuant to the Authoritative Bodies listing mechanism, based on EPA’s determination that acrylamide was a “probable” human carcinogen and IARC’s classification of acrylamide as Group 2B (“possibly carcinogenic to humans”).

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Please join us on Wednesday, November 6 for the launch of a new webinar series featuring updates on the latest news and trends in the food and beverage industry. Our first webinar will focus on updates regarding CBD, FSMA, and the FTC. Please see below for the program agenda:

Navigating the regulatory landscape for CBD: What the hemp is going on?

Although the 2018 Farm Bill created new legal distinctions between cannabis that is “marijuana” and cannabis that is “hemp,” hemp-derived ingredients, including cannabidiol (CBD), remain subject to regulation by FDA, USDA, and the states. Samantha Dietle will provide an update on the current regulatory landscape for hemp-derived products, including how FDA, USDA, and states are approaching regulation and enforcement.

FDA’s escalation of FSMA enforcement

Maile Hermida and Elizabeth Fawell will discuss recent inspection and enforcement trends related to FSMA implementation. They will review frequent inspection citations and what companies should be focusing to ensure compliance and prevent the issuance of a FDA Form 483, as well as some lessons from recent FSMA related Warning Letters.

Recent FTC enforcement involving social media

Social media platforms provide unparalleled ways for marketers to interact with consumers. The concurrent complex legal responsibilities are evident from recent enforcement and other activities of the Federal Trade Commission. Steve Steinborn will analyze recent FTC actions. You will come away with a short-list of key areas to put on the agenda of your next internal social media compliance meeting and gain insight on best practices and practical tips.

Register: A Seat at the Table – What’s new in food law

This activity has been approved for MCLE credit by the State Bar of California in the amount of 1 hour, all of which will apply to general credit. No hours will apply to legal ethics, to substance abuse/competence issues, or to recognition and elimination of bias credit. Hogan Lovells certifies that this activity conforms to the standards for approved education activities prescribed by the rules and regulations of the State Bar of California governing minimum continuing legal education.
 
This course has been approved in accordance with the requirements of the New York State Continuing Legal Education Board for a maximum of 1 credit hour, of which 1 credit hour can be applied toward the Professional Practice requirement.

This course has been approved for Minimum Continuing Legal Education credit by the State Bar of Texas Committee on MCLE in the amount of 1 credit hour, of which 0 credit hours will apply to legal ethics/professional responsibility credit.
 
Attendees licensed in other states will receive uniform certificates of attendance, which they may use to request individual credit from their respective state bars. Approval guidelines and credit hours vary by state.

The Food and Drug Administration (FDA) recently announced the launch of an updated version of the Food Defense Plan Builder Version 2.0 (FDPB) to help companies meet the requirements of the final rule “Mitigation Strategies to Protect Food Against Intentional Adulteration” (IA Rule) under the FDA Food Safety Modernization Act (FSMA). The FDPB is a voluntary tool intended to aid entities subject to the IA Rule in preparing customized food defense plans.

FDA is hosting a webinar to demonstrate how to download, install, implement, and use the FDPB, as well as to answer questions about how to use the system. This webinar will be held on October 10, 2019, at 1 pm ET.

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The Food and Drug Administration (FDA) recently announced it will hold a full-day public meeting on October 21, 2019, regarding “A New Era of Smarter Food Safety.” As explained in more detail in this memorandum, as part of FDA’s ongoing implementation of the FDA Food Safety Modernization Act (FSMA), the agency is exploring new and emerging technology to assess risks and prioritize resources, while creating a more digital, traceable, and safer system. The agency’s initial focus areas are traceability, smarter tools, and approaches for prevention, the challenges of new business models and retail food safety, and support for the development of food safety cultures. The meeting will be held in Rockville, Maryland, and also will be webcast.

FDA also is opening a docket to receive comments related to this issue, including on several questions set out in the Federal Register notice announcing the meeting. The docket will be open through November 20, 2019.

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