Amaru Sánchez

Food and Dietary Supplements

• Advised companies in emerging food categories, including alternative proteins utilizing plant, microbial, and animal cell-based technologies (cell-cultivated meat), organic products, and bioengineered ingredients.
• Assisted food companies and trade associations in maintaining an active role in the development of domestic and global governmental regulations, policies, and industry guidance by preparing food and food-ingredient-related filings, organizing agency meetings, and drafting and submitting comments in response to regulatory actions.
• Provided comprehensive counsel clients on regulations and policies throughout the product lifecycle, from formulation and manufacturing facilities to supply chain, labeling, compliance claims, regulatory marketing strategy, and advertising.
• Provided due diligence on mergers and acquisitions of food and dietary supplement business.
• Advised food manufacturers on food safety obligations under the Food Safety Modernization Act, including preparing food safety plans for compliance with hazard analysis and risk-based preventive controls requirements.
• Represented major food manufacturers and distributors to obtain release of detained products held by FDA and USDA at import.
• Assisted companies on federal regulatory matters involving the U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS), as well as other USDA agencies such as the Agricultural Marketing Service (AMS) and the Animal and Plant Health Inspection Service (APHIS).

Cosmetics and Drugs

• Assisted cosmetics companies on developing marketing claims to minimize regulatory and litigation risk and advising on the regulatory status of ingredients.
• Assisted a cosmetic company to develop an internal regulatory compliance system concerning color additives permitted for use in cosmetics.
• Advised manufacturers on compliance with OTC monograph requirements.
• Managed the preparation and submission of the New Drug Application for a publicly traded global pharmaceutical company and assisted with ongoing communication with the FDA.
• Served on the Medical Legal Review committee for a global pharmaceutical company.

Amaru Sánchez focuses his practice on matters involving products regulated by the FDA, the USDA, and other regulatory agencies. He has experience advising companies through FDA requirements for expedited development and review programs. He also regularly guides clients through information requests and enforcement actions, including warning letters, recalls, import detentions, and alerts.

Amaru advises clients in food and beverage litigation matters concerning regulatory compliance, enforcement issues, and public policy. He is a sought-after speaker, lecturer, and panelist, recognized for his insights on legal and policy developments, navigating regulatory hurdles in food innovation, and developing product labeling and compliance programs.

Before joining the firm, Amaru was in private practice at another law firm where he assisted clients producing FDA and USDA-regulated products with bringing their products to market and advised on post-market issues. He also served as executive director to a pharmaceutical company, providing legal, regulatory, and strategic advice, and was a project manager for the National Quality Forum. His previous roles also include working as a health policy research analyst and as the acting committee director in the Massachusetts state legislature.

Languages

• Spanish

Bar Admissions

• District of Columbia

Education

• The Catholic University of America (J.D., 2017)
• Boston University (M.P.H., 2009)
• University of Florida (B.S, 2006)

Memberships