Mary Grywatch
Senior Associate Global Regulatory
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Overview
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Experience
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Credentials
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Insights and events
Mary Grywatch provides practical guidance on complex FDA, USDA, and FTC regulatory issues to help food and beverage companies in all segments of the industry achieve their business goals. Mary also advises consumer products companies on compliance with CPSC consumer safety regulations, including Section 15(b) reporting.
Mary counsels clients on Food and Drug Administration (FDA) and United States Department of Agriculture (USDA) compliance with current good manufacturing practice (cGMP), advertising and labeling compliance, and food safety issues that arise throughout the entire food supply chain. She helps companies navigate enforcement actions at various levels of FDA enforcement, including responses to Warning Letters and Form FDA 483s, as well as Consent Decree advising. Mary drafts comments on proposed regulations and agency guidance.
In addition, Mary has experience with matters in front of the Federal Trade Commission's Bureau of Consumer Protection on food advertising and also consumer product advertising such as "Made in USA" claims. Mary also has extensive experience navigating consumer product safety issues regulated by the Consumer Product Safety Commission (CPSC), includingc ompliance with mandatory federal safety standards, Section 15(b) reporting obligations, and CPSC recalls.
Prior to law school, Mary was a legal assistant at a Washington, D.C. law firm, where she assisted lawyers in white-collar investigations, pharmaceutical class action litigations, and federal habeas petitions for death row inmates.
Representative experience
Counseled food manufacturer on responding to an FDA Inspectional Observations Form 483 and avoiding further enforcement action.
Advising major food companies on compliance with FSMA preventive controls and supply chain requirements.
Advised several companies on CPSC reporting requirements, avoiding a recall in multiple instances, and navigating recall in others.
Advising company on consumer product regulatory due diligence in connection with ~$2bn acquisition of electronics company.
Advising private equity firm on food regulatory due diligence in connection with ~$1bn aquisition of major food manufacturer.
Advising major food company on food regulatory due diligence in connection with ~$280m acquisition to expand portfolio offerings.
Credentials
- J.D., Columbia Law School, James Kent Scholar, 2018
- B.A., Hamilton College, 2012
- District of Columbia
- Maryland