Covington & Burling LLP | Stephanie Resnik

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Stephanie Resnik

Associate

Washington +1 202 662 5945 sresnik@cov.com Download V-card

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Stephanie Resnik is an associate in the firm’s Washington, DC office, where she is a member of the Food, Drug, and Device practice group. She advises food, pharmaceutical, biotechnology, and tobacco companies on a variety of regulatory and compliance issues.

Ms. Resnik advises major food companies on a broad range of U.S. regulatory and compliance issues, including labeling, advertising, facility registration, ingredient status, CGMP compliance, and reporting requirements. This advice also includes strategies for minimizing the risk of consumer fraud or class action litigation.

Ms. Resnik also provides regulatory advice and due diligence to support the corporate transactions of the firm’s life sciences practice.

Advised food companies on the labeling and advertising of food products, including nutrition facts labeling requirements.
Reviewed and analyzed food labels for compliance with federal requirements.
Advised companies on the ingredient status of food and dietary supplements.
Counseled tobacco companies on the impact of the Deeming Rule on previously unregulated tobacco products, including registration and listing requirements, health warning requirements, and requirements for FDA approval of regulated products.
Provided regulatory advice and due diligence to company for acquisition of a food and dietary supplement manufacturer.

Advised nonprofit organization on legal issues relating to Washington, DC’s status as a Sanctuary City.
Advised nonprofit organization on the authority of the Centers for Disease Control and Prevention (CDC) to research the causes and prevention of gun violence.

FDA Issues Draft Guidances on Nutrition Labeling

Yesterday, FDA issued a long-anticipated draft guidance intended to help industry comply with the agency’s May 2016 final rules modernizing nutrition labeling. Presented in a question-and-answer format, the draft guidance (Q&A Draft Guidance) provides information related to the compliance date, labeling of added sugars, rounding of the declaration of ...

FDA Releases Draft Guidance on “Disclosure Statement” Provisions of Four FSMA Rules

Last week, FDA released a draft guidance1 clarifying requirements for the “disclosure statement” provisions of its four major Food Safety Modernization Act (FSMA) rules. Entities subject to these provisions must disclose, in documents accompanying the food, that certain hazards have not been controlled. The draft guidance provides insight into the circumstances ...

FDA Releases Long-Awaited Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food

Earlier this week, FDA released five chapters of a multi-chapter draft guidance on hazard analysis and risk-based preventive controls for human food. The long-awaited draft guidance is intended to help industry comply with certain requirements of the agency’s final rule for preventive controls for human food (PC rule) under the Food Safety Modernization Act ...

FDA Issues Final Rule for Registration of Food Facilities

On July 14, 2016, FDA published its amended final regulations for registration of domestic and foreign food facilities under the Food Safety Modernization Act (FSMA). Registration is required for such facilities that manufacture/process, pack, or hold food for human or animal consumption. The final rule codifies a number of provisions that were mandated by FSMA ...

Both Houses of Congress Pass S.764 Establishing the National Bioengineering Food Disclosure Standard, Which Would Immediately Preempt Key Parts of the Vermont GMO Labeling Law

Yesterday, the United States House of Representatives passed Bill S.764 (“Joint Bill”), which will amend the Agricultural Marketing Act of 1946 to add Subtitle E: “National Bioengineered Food Disclosure Standard,” and Subtitle F: “Labeling of Certain Food.” The United States Senate passed the same bill last week on July 7, 2016. The Joint Bill, if signed into ...

FDA Issues Final Rule to Protect Food from Intentional Adulteration

On May 27, 2016, FDA finalized its seventh and final food safety rule under the Food Safety Modernization Act (FSMA), which will become new 21 C.F.R. Part 121. The Intentional Adulteration rule establishes requirements to help protect food against adulteration from acts intended to cause wide-scale harm to public health, including acts of terrorism. For the ...

FDA Issues Final Rules on Changes to Nutrition Labels

On Friday, May 20, 2016, FDA issued two final rules to revise the nutrition labeling requirements for conventional foods and dietary supplements—the first major revisions to the nutrition labels since they were originally required over 20 years ago. Recognizing a shift in the average American’s consumption habits and understanding of the Nutrition Facts label, ...

Representative Matters

Pro Bono

News and Insights (Showing 5 of 9) (Showing 9 of 9)

FDA Issues Draft Guidances on Nutrition Labeling

FDA Releases Draft Guidance on “Disclosure Statement” Provisions of Four FSMA Rules

FDA Releases Long-Awaited Draft Guidance on Hazard Analysis and Risk-Based Preventive Controls for Human Food

FDA Issues Final Rule for Registration of Food Facilities

Both Houses of Congress Pass S.764 Establishing the National Bioengineering Food Disclosure Standard, Which Would Immediately Preempt Key Parts of the Vermont GMO Labeling Law

FDA Issues Final Rule to Protect Food from Intentional Adulteration

FDA Issues Final Rules on Changes to Nutrition Labels

Will Evaporated Cane Juice Be Sweet for Class-Action Plaintiffs?

Labeling Genetically Modified Foods

Practices

Industries

Education

The George Washington University Law School, J.D., 2012

University of Minnesota, M.F.A., 2007

University of Wisconsin, B.A., 2003

Bar Admissions