Attorneys | Rick D. Quinn, Esq.
PARTNER, Benjamin L. England & Associates, LLC
principal, fdaimports.com, LLC
Contact Mr. Quinn:
(949) 224-3879, Irvine, California Office
(410) 220-2800, Maryland, Corporate Headquarters
Mr. Quinn’s practice focuses on providing business-centered solutions for exporters, importers, manufacturers, distributors, wholesalers, and retailers of regulated products involving Food and Drug Administration (FDA), Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), Federal Trade Commission (FTC) and the Consumer Product Safety Commission (CPSC). He routinely counsels start-ups, mid-sized and large-sized privately-held firms, and public companies on mitigating risks associated with regulatory enforcement and private litigation, developing comprehensive compliance programs, and structuring business models and transactions to manage regulatory compliance and risk unique to FDA-regulated products. Mr. Quinn also manages the firm’s Qingdao, China office.
As a California lawyer, Mr. Quinn routinely advises companies concerning:
• California Department of Public Health actions
• California Safe Cosmetics Program compliance.
• California Proposition 65 compliance and enforcement.
• California Business & Professions Code §17200 and §17500 & California Legal Remedies Act matters involving FDA-regulated products.
Mr. Quinn focuses his federal practice on the following representative areas:
• Asset Protection: Developing strategic asset-protection solutions for businesses operating in regulated commodities.
• Petitioning U.S. Customs and Border Protection for relief from Liquidated Damages claims related to FDA-imported products; resolving seizure actions.
• Evaluating business plans, models, and contracts to mitigate and manage legal risks uniquely associated with FDA and FTC regulated products.
• Resolving administrative holds, detentions, refusals of FDA-regulated articles at the ports of entry, and problems related to U.S. Customs and Border Protection and U.S. Department of Agriculture examinations and detentions.
• Legal and regulatory counsel concerning Import-for-Export procedures and for obtaining various FDA Export Certificates for foods, dietary supplements, cosmetics, drugs and medical devices.
• Responding to FDA Form 483s related to facility inspections of manufacturers, distributors, and retailers of foods, dietary supplements, medical devices, cosmetics.
• Reviewing product labeling and website & advertising for legal and regulatory compliance of conventional foods, medical foods, dietary supplements, cosmetics, drugs (OTC, HPUS, Rx), medical devices and tobacco products.
• Regulatory Reviews for foods, dietary supplements, drugs (including APIs), cosmetics, and tobacco products.
• Pre-Market Notifications, New Dietary Ingredient regulatory counsel and notification filings; Generally-Recognized-As-Safe regulatory counsel and notifications; Structure / Function Notification letters; and 905(j) Substantial Equivalence Tobacco Product Reports.
• Responding to FDA recall requests of foods, drugs, dietary supplements, cosmetics, and medical devices.
• Regulatory Counsel: Interpretation and application of FDA, FTC, USDA, TTB and CBP regulations, guidance, and procedures.
• Labeling; Health Product Submissions, Rotational Warning Plan development and recordkeeping counsel; and TTB permits for tobacco products.
• Responding to FDA Warning Letters for all FDA-regulated products.
• Reviewing product and marketing claims for FDA and Federal Trade Commission enforcement and compliance on internet marketing materials, including testimonials, social media, and endorsements, etc.
• Resolving U.S. Department of Agriculture entry holds and exams, obtaining APHIS permits.
• U.S. Tax and Trade Bureau Label reviews, obtaining Federal Basic Permits, Formulation Approvals, and Certificate of Label Approvals (COLAs) and COLA waivers; state-based Alcohol Beverage Control permitting, including alcohol labeling, permitting, ingredient and formulation review and analysis.
Rick Quinn and Ben England, The Color of Controversy: Current Perspectives in FDA Policy on Artificial Colors and Hyperactivity in Children, Institute of Food Technologies (October, 2011).
Rick Quinn and John Johnson III, Imported Orange Juice Gets the Squeeze: FDA's Illegal Treatment of Brazilian Orange Juice During the Carbendazim Incident, FDLI Update 14 (May/June 2012).
Rick Quinn and John Johnson III, U.S. Law & Regulation for OTC Drugs: Basics of Compliance and Importation, New York Health Forum Magazine (June 2012).
Mr. Quinn received his Juris Doctor degree from Loyola Law School, Los Angeles, CA. During law school was an Editor of the Loyola of Los Angeles International and Comparative Law Review. He also was an Extern to The Honorable Consuelo B. Marshall, Chief Judge, United States District Court for the Central District of California, and was a clerk in the Office of the District Attorney, Los Angeles County California, in its Major Fraud Prosecution Unit. He received a Bachelor of Arts degree from Covenant College in Interdisciplinary Studies (History, Philosophy, and Sociology). He also holds a Master of Arts degree in Religion from Pittsburgh Theological Seminary.
State Bar of California
District of Columbia Bar