Our Website Uses Cookies 


We and the third parties that provide content, functionality, or business services on our website may use cookies to collect information about your browsing activities in order to provide you with more relevant content and promotional materials, on and off the website, and help us understand your interests and improve the website.


For more information, please contact us or consult our Privacy Notice.

Your binder contains too many pages, the maximum is 40.

We are unable to add this page to your binder, please try again later.

This page has been added to your binder.

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

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 medical device, pharmaceutical, biotechnology, food, and tobacco companies on a variety of regulatory and compliance issues, including labeling, advertising, facility registration, CGMP compliance, and reporting requirements.

Ms. Resnik has experience counseling clients on interactions with federal and state regulatory agencies, including the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Federal Trade Commission (FTC), and state Boards of Pharmacy, as well as interactions with the Better Business Bureaus' (BBB) National Advertising Division (NAD). She has extensive experience working with state regulators and navigating complex state laws and regulations to determine the appropriate licenses or permits required to operate in such states.

  • Advise device company regarding risks of promoting device products for specific indications under a 510(k) clearance with a general indication.
  • Prepare public comments to FDA on behalf of tobacco companies urging FDA to modify its interpretation and implementation of the Substantial Equivalence pathway for tobacco products.
  • Advise e-cigarette companies on risks of making claims on marketing materials under the Tobacco Control Act's modified risk provisions.
  • Draft guidelines for cosmetic company regarding "Made in USA" claims under the FTC's and state of California's standards.
  • Navigate the various federal and state licensing/permitting requirements for food manufacturer's facilities.
  • Advise food companies on the labeling and advertising of food products, including nutrition facts labeling requirements.
  • Counsel 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 obtaining marketing orders.
  • Prepare public comments to USDA on behalf of food manufacturer regarding National Bioengineered Food Disclosure Standard proposed rule.
  • Provide regulatory advice and due diligence to company regarding acquisition of a food and dietary supplement manufacturer.

Pro Bono

  • 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.