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.

Firm/Organization: Hogan Lovells

Blogs: A Seat at the Table, Global Media and Communications Watch

Latest Articles

A Seat at the Table

FDA Issues Final Rule on Front-of-Pack Calorie Disclosures Used for Vending Machine Labeling Compliance

By Joe Levitt & Leigh Barcham

October 29, 2019

The Food and Drug Administration (FDA) issued a final rule to revise the type size requirements for front-of-pack (FOP) calorie declarations that are used to comply with the vending machine calorie labeling requirements. The final rule requires such calorie declarations to be at least 150 percent the size of the net quantity of contents statement as required under 21 C.F.R. § 101.7(i) (i.e., 1.5 x the size of the net weight). FDA proposed this change…

A Seat at the Table

FSMA Update: FDA Launches “FDA-TRACK: Food Safety Dashboard” to Track FSMA Progress

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham

October 11, 2019

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…

A Seat at the Table

FDA Public Meeting: Horizontal Approaches to Food Standards of Identity Modernization

By Elizabeth Fawell, Veronica Colas & Leigh Barcham

October 11, 2019

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…

A Seat at the Table

Lawsuit Seeks to Compel FDA to Implement FSMA’s Laboratory Accreditation Provisions

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham

August 26, 2019

Two consumer groups have sued the Food and Drug Administration (FDA) seeking to compel the agency to implement the laboratory accreditation provisions in the FDA Food Safety Modernization Act (FSMA). Specifically, the plaintiffs want FDA to meet its obligation under FSMA to establish a program for the recognition of accreditation bodies and accreditation of laboratories equipped to perform food safety testing, including developing model standards for laboratory accreditation. The lawsuit was brought in the U.S. …

A Seat at the Table

FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham

August 15, 2019

The U.S. Food and Drug Administration (FDA) recently issued the first Warning Letter addressing violations of the Foreign Supplier Verification Program (FSVP) rule, one of the seven major FDA Food Safety Modernization Act (FSMA) regulations. Under the FSVP rule, importers must take steps to verify that their foreign suppliers produce food that satisfies U.S. food safety standards. FDA issued the Warning Letter to the importer of tahini implicated in a recent Salmonella outbreak. According to…

A Seat at the Table

FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive Controls Regulations

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham

July 22, 2019

The U.S. Food and Drug Administration (FDA) recently finalized its “Guidance for Industry: Determining the Number of Employees for Purposes of the ‘Small Business’ Definition in Parts 117 and 507 (CGMP and Preventive Controls Regulations for Human and Animal Food).” The Guidance is intended to help facilities determine whether they qualify as a “small business” for the purposes of Preventive Controls for Human Food (PCHF) and Preventive Controls for Animal Food (PCAF) regulations. Qualifying as…

A Seat at the Table

Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions

By Maile Hermida, Elizabeth Fawell & Leigh Barcham

June 12, 2019

The U.S. Food and Drug Administration (FDA) reached a settlement with the two consumer groups that sued FDA in October 2018 to compel the agency to implement the traceability provisions in the FDA Food Safety Modernization Act (FSMA). The consent order, which was approved by the district court judge on June 11, 2019, establishes a timeline for FDA to publish a list of high-risk foods and engage in rulemaking setting forth additional traceability recordkeeping…

A Seat at the Table

FDA Announces Produce Safety Rule Enforcement Discretion Policy for Almonds, Pulse Crops, Wine Grapes, and Hops under FSMA

By Joe Levitt, Maile Hermida, Elizabeth Fawell & Leigh Barcham

April 3, 2019

The U.S. Food and Drug Administration (FDA) has issued Guidance detailing its intent to exercise enforcement discretion for the requirements of the Produce Safety rule as they apply to entities growing, harvesting, packing, and holding almonds, pulse crops, wine grapes, and hops. FDA received feedback from these entities that they should be exempt after it issued the final Produce Safety rule, and FDA is exercising enforcement discretion while it considers pursuing rulemaking to address the…

A Seat at the Table

FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule

By Joe Levitt, Elizabeth Fawell, Maile Hermida & Leigh Barcham

March 14, 2019

The U.S. Food and Drug Administration (FDA) has released the second of three installments of its Draft Guidance to support compliance with the Mitigation Strategies to Protect Food Against Intentional Adulteration (IA) rule. Under the IA rule, the last of the major FDA Food Safety Modernization Act (FSMA) rules to be released, food facilities must develop and implement a food defense plan that identifies their significant vulnerabilities and mitigation strategies to address those vulnerabilities, and…

A Seat at the Table

FSIS Releases Draft Guideline on Complaint Handling and Foreign Materials

By Gary Kushner, Brian Eyink & Leigh Barcham

March 12, 2019

The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) has issued a Draft Guideline detailing the Agency’s expectations of companies that identify foreign material in their meat and poultry products and more generally providing recommendations for how establishments should craft their complaint handling policies. FSIS states that it developed the document in response to an increase in the number of recalls of meat and poultry products adulterated with foreign materials, many of which…

Leigh Barcham

FDA Issues Final Rule on Front-of-Pack Calorie Disclosures Used for Vending Machine Labeling Compliance

FSMA Update: FDA Launches “FDA-TRACK: Food Safety Dashboard” to Track FSMA Progress

FDA Public Meeting: Horizontal Approaches to Food Standards of Identity Modernization

Lawsuit Seeks to Compel FDA to Implement FSMA’s Laboratory Accreditation Provisions

FDA Issues First Warning Letter for Foreign Supplier Verification Program Violations under FSMA

FDA Finalizes Guidance on How to Determine Whether a Company Meets the “Small Business” Definition under the FSMA Preventive Controls Regulations

Settlement Reached in Lawsuit to Compel FDA to Implement FSMA Traceability Provisions

FDA Announces Produce Safety Rule Enforcement Discretion Policy for Almonds, Pulse Crops, Wine Grapes, and Hops under FSMA

FDA Releases Second Installment of Draft Guidance for FSMA Intentional Adulteration Rule

FSIS Releases Draft Guideline on Complaint Handling and Foreign Materials

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