On March 1, 2018, Food and Drug Administration (FDA or the agency) Commissioner Dr. Scott Gottlieb, M.D., announced new efforts to advance implementation of the new consumer Nutrition Facts label for foods, and with it a plethora of guidance documents on dietary fiber, Reference Amounts Customarily Consumed (RACCs) for product categories, declaration of added sugars on honey and similar products, and proper labeling of honey and honey products. We briefly discuss each of the following guidance documents further below:

  • Final Guidance for Industry: Reference Amounts Customarily Consumed: List of Products for Each Product Category
  • 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; Small Entity Compliance Guide
  • Final Guidance for Industry: Scientific Evaluation of the Evidence on the Beneficial Physiological Effects of Isolated or Synthetic Non-digestible Carbohydrates Submitted as a Citizen Petition (21 CFR 10.30)
  • Draft Guidance for Industry: Declaration of Added Sugars on Honey, Maple Syrup, and Certain Cranberry Products
  • Final Guidance for Industry: Proper Labeling of Honey and Honey Products

The deadline for submitting comments on the Draft Guidance concerning the declaration of added sugars for honey, maple syrup, and certain cranberry products is May 1, 2018. Comments should be submitted to Docket No. FDA-2018-D-0075. The other documents are Final Guidance, on which comments can be submitted at any time.

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Photo of Elizabeth Fawell Elizabeth Fawell

Partner, Washington, DC

Elizabeth Fawell navigates the detailed, and often complex, regulatory issues confronting food companies and helps them understand both the rules and various risks involved so that they can make informed business decisions. Elizabeth works with every segment of the food industry, including manufacturers, distributors, retailers, restaurants, and food service operators; and their trade associations.  Elizabeth’s work on behalf of food industry clients with the Food Safety Modernization Act (FSMA) since its inception and her understanding of Hazard Analysis Critical Control Point (HACCP) systems provides her with the experience and perspective needed as she counsels clients on how to comply with new requirements under the law. Elizabeth is a Preventive Controls Qualified Individual (PCQI) and has completed the FSPCA PCQI training.

Elizabeth knows how laws, regulations, and guidance documents are developed, interpreted, and enforced. Her extensive knowledge enables clients to prevent and respond to enforcement actions such as Warning Letters, Import Alerts, and agency investigations. She helps clients in determining whether an RFR is necessary and whether a recall is warranted. If so, she helps manage the recall to minimize business impacts. Elizabeth provides real-time advice during factory inspections, helps clients prepare 483 responses, and drafts inspection manuals. She also assists clients in lawfully and creatively promoting their products; such as the development of labels, claims, and website and promotional campaigns. Elizabeth also supports clients in advertising disputes and with responses to FTC and Attorney General investigations.

Elizabeth helps clients stay informed of and ahead of public policy issues and develops strategies for effective advocacy before regulators. She also counsels clients on compliance with Consumer Product Safety Commission (CPSC) safety standards, testing and certification requirements, and reporting obligations.

Elizabeth is a member of the Food and Dietary Supplements Committee of the Food and Drug Law Institute.

Photo of Leigh Barcham Leigh Barcham

Associate, Washington, DC

Leigh Barcham provides business-oriented legal and policy solutions to food and agriculture companies and trade associations. She advises clients on state and federal regulatory issues that may arise throughout the entire food production line from farm to table. Leigh also guides clients in consumer products industries as they navigate federal advertising laws and regulations.
When she joined Hogan Lovells, Leigh brought with her more than five years of public policy experience. A part-time student by night and a law clerk by day, Leigh worked throughout law school at a firm in Washington, D.C., focusing on legislation and federal regulation affecting the energy industry. Before law school she served as a policy analyst for international affairs and climate change at the White House Council on Environmental Quality.

Photo of Christine Forgues Christine Forgues

Associate, Washington, DC

Chris Forgues provides business-oriented legal and scientific solutions to food and agriculture companies and trade associations.
She advises clients on state and federal regulatory issues that arise throughout the entire food supply chain and production line, ranging from USDA and FDA enforcement actions and federal investigations to regulatory compliance, import and export issues, litigation support, comment preparation, advertising disputes, and labeling issues.

Chris’s background in life science (chemistry and pharmacology) assists her in her science-based food law practice. Chris’s unique educational background and regulatory scientist experience provides valuable context to complex scientific issues as they relate to the governing regulatory requirements.

When she joined Hogan Lovells, Chris brought with her more than nine years of regulatory consulting experience. A part-time student by night and a regulatory scientist by day, Chris worked throughout law school at a firm in Washington, D.C., focusing on product review, development, and post-marketing in the life sciences sphere, with experience handling matters under the Food and Drug Administration (FDA), the Department of Agriculture (USDA), and the Environmental Protection Agency (EPA), the Federal Trade Commission (FTC), the National Advertising Division (NAD), the Consumer Product Safety Commission (CPSC), as well as state regulatory bodies.