Elle Jimenez

Elle Jimenez

Associate
About

Elle Jimenez is an associate attorney in DLA Piper's FDA Regulatory Group. She advises national and international clients on regulatory compliance matters across the lifecycle of FDA-regulated products, including foods, beverages, dietary supplements, and cosmetics.

Elle also counsels clients on navigating overlapping regulatory frameworks enforced by other agencies, including the Alcohol and Tobacco Tax and Trade Bureau (TTB), U.S. Department of Agriculture (USDA), and the Consumer Product Safety Commission (CPSC). Her practice includes advising on labelling, packaging, and product claims, and guiding clients on ongoing regulatory compliance across a wide range of consumer goods. She also manages cross-border recalls, coordinating regulatory strategy and stakeholder communications across multiple jurisdictions.

Elle regularly supports M&A transactions involving FDA-, TTB-, and USDA-regulated businesses. She conducts regulatory due diligence, including assessments of a company's compliance, permits, certifications, inspection and audit history, and prepares change of ownership and change of control permit analyses to facilitate smooth regulatory transitions and mitigate transactional risk.

Bar admissionsDistrict of Columbia

EXPERIENCE

Alcohol
  • Serve as lead alcohol regulatory associate on a tequila acquisition, advising on federal (TTB) and 50-state change-of-control requirements and coordinating regulatory strategy across jurisdictions
  • Conduct label reviews and classification assessments for non-alcoholic malt beverages and canned cocktails, including FDA vs. TTB jurisdictional assessments
  • Advise on tied-house compliance
  • Assess regulatory procedures for international alcohol companies establishing U.S. operations
Foods, Beverages, and Dietary Supplements
  • Coordinate with consultants, laboratories, and internal stakeholders to evaluate product safety issues and advise on recall strategy and classification 
  • Analyze international standards for heavy metal content in food ingredients 
  • Provide regulatory counsel and risk assessment for food and dietary supplement labeling, including claim evaluation, ingredient disclosures, and overall compliance
  • Advise restaurant chains on menu labeling laws, allergen warning statements, and related compliance strategies
  • Draft and negotiate food regulatory provisions in transaction documents (including purchase agreements and disclosure schedules), prepare diligence memoranda assessing regulatory risk to buyers, and advise on TSAs and post-closing allocation of regulatory responsibilities
  • Conduct regulatory due diligence for transactions involving FDA-regulated products, including assessment of compliance, permits, certifications, and audit history
  • Advise foreign pork and chicken producers on U.S. considerations for vertical operations integration
Cosmetics
  • Conduct ingredient and label risk assessments for 30+ products for an international cosmetics company entering the U.S. market, including classification, claim substantiation, and compliance with U.S. labeling requirements
  • Advise on structure/function claims and related risk assessments
Cannabis
  • Perform state-by-state comparative analysis of synthetic cannabinoid laws and evaluate permissibility of hemp-derived CBD in food and beverage products under varying state frameworks
Consumer Products
  • Serve as lead associate managing a multi-country product recall spanning 9 countries, managing regulatory strategy, cross-border compliance considerations, and stakeholder communication
  • Advise on CPSC recall matters involving foreign-based companies, including coordination of regulatory submissions and agency communications 
  • Advise on packaging and labeling requirements under the Fair Packaging and Labeling Act and Uniform Packaging and Labeling Regulations
  • Counsel on maintaining brand distinction between flagship and fighter brands, outlining structural strategies for compliant labeling
 

Pro Bono

Elle is actively engaged in pro bono and community service initiatives. She has successfully represented an individual in appealing multiple denials of Social Security Disability Insurance before an Administrative Law Judge, resulting in a favorable judgment. She was part of a team representing a class of individuals challenging government agency deficiencies in the administration of Supplemental Nutrition Assistance Program (SNAP) benefits and collaborated with an Alaskan nonprofit organization to support residents experiencing significant delays in receiving SNAP benefits—personally contacting affected individuals to help advance their cases within the system. In addition, Elle presents pro bono webinars to small business owners, advises startups on product classification and labeling requirements, and volunteers at local food banks to help combat food insecurity.

Education
  • J.D., Georgetown University Law Center
    Senior Online Editor, The Georgetown Law Journal
  • B.A., University of Michigan
    Phi Beta Kappa

Memberships and Affiliations

  • Food and Drug Law Institute

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