Georgia C. Ravitz
Georgia is a partner in the firm’s Washington, DC, office. She focuses on food and drug law and regulatory policy governing the regulation of farm products (e.g., eggs, poultry, meat, dairy), pharmaceuticals (including prescription drugs, generic drugs and over-the-counter drugs), biologics, cosmetics, health and beauty aids, medical devices (both PMA and 510(k) products), dietary supplements, vitamin and mineral products, food, and other consumer goods. Georgia also focuses on the laws and regulations pertaining to consumer products generally, and those administered by the US Consumer Product Safety Commission (CPSC) and various state and local regulatory agencies responsible for consumer health and safety as well as the Federal Trade Commission (FTC).
Georgia counsels manufacturers, distributors, and retailers who manufacture and market prescription drugs, biologics, cosmetics and over-the-counter drugs, consumer products, food products, dietary supplements, and vitamin products. She has extensive experience in reviewing labeling, advertising, and packaging to ascertain compliance with applicable CPSC, Food and Drug Administration (FDA), Food Safety Inspection Service (FSIS), and Federal Trade Commission (FTC) regulations. Georgia also counsels clients on regulatory compliance and FDA/FSIS inspections, participates in agency rulemaking and adjudicatory proceedings, responds to federal and state administrative enforcement efforts, import detention matters involving FDA and the Department of Homeland Security, and advises on civil and criminal litigation relating to FDA and related regulatory matters. A central component of her practice is advising companies on the level and type of product claims substantiation that will be necessary to satisfy the National Advertising Division (NAD) and the FTC. Georgia advises FDA-regulated organizations on the need to implement stock recovery and product recalls.
Georgia represents manufacturers, distributors, importers, specialty retailers in the development of new and innovative products subject to the Federal Food, Drug, and Cosmetic Act, the Fair Packaging and Labeling Act, the Federal Hazardous Substances Act, the Consumer Product Safety Act, and the Federal Trade Commission Act and Prop 65.
Georgia’s practice also involves counseling and representing companies in connection with Made in USA claims (qualified and unqualified) in advertising and on product labeling, with particular emphasis on FTC compliance and California law, but also in connection with foreign country of origin disclosures on products. Georgia has extensive experience in American-made claims for virtually all product categories and across all industry sectors, including analyzing documentation requirements to support FTC-required substantiation for such “American-made” claims in the following industries:
- Personal care products
- Apparel and textiles
- Electronics and lighting products
- Machinery and hoses
- Components and subassemblies
The following is a sampling of Georgia’s counseling and representation experience:
Food, Drug, and Cosmetic
- Counseled clients on all aspects of food safety and the possible need for recalls and market withdrawals for FDA and FSIS regulated food products
- Preparation of responses to FDA 483 inspections
- Provided counsel to recipients of FDA Warning Letters
- Negotiated release of FDA detained food, drugs, and cosmetics
- Prepared food labeling applications for submission to FSIS for review and approval
- Counseled clients concerning compliance with FDA and state laws pertaining to labeling and advertising claims, structure/function claims, health claims, nutrition information, ingredient listings
- Reviewed product formulation and manufacturing practices (GRAS, etc.) for compliance, including direct and indirect food additives, dietary ingredients, and current good manufacturing practices (CGMP)
- Provided counseling on hazard analysis and critical control point (HAACP) systems
- Counseled food and dietary supplement firms in preparing new dietary ingredient filings with FDA
- Counseled clients in all aspects of cosmetic ingredient requirements
- Evaluated novel products to determine whether they are subject to FDA regulations
- Counseled food companies on pesticide-related issues
Consumer Product Safety
- Represented many companies before the CPSC in recall and enforcement proceedings
- Assisted in the preparation and filing of Section 15(b) defect reports with CPSC
- Negotiated and settled CPSC civil penalty investigations involving alleged failures to file a timely report
- Developed internal compliance programs and manuals for product safety and hazard reporting for mass merchandise retailers, apparel and accessory retailers, and specialty retailers
- Assisted in the creation of third-party testing and certification programs to comply with CPSIA requirements
- Counseled clients in all aspects of compliance with Consumer Product Safety Act, Federal Hazardous Substances Act, Flammable Fabrics Act, and Children’s Sleepwear Act.
- Reviewed proposed advertising copy and marketing materials, for print media, television, or social media, for regulatory compliance
- Reviewed substantiation for claims made in advertising and marketing materials
- Defended claims before the National Advertising Division (NAD) of the Council of Better Business Bureaus
- Counseled children’s product retailers in the areas of COPPA compliance
- Counseled companies with respect to green claims
- Represented major retailers in California Proposition 65 settlements involving lead content in children’s jewelry and other products
- Counseled clients on compliance with Proposition 65 settlements affecting a wide range of consumer and personal care products sold in California
- Counseled clients on compliance with REACH, FIFRA, and State Green Chemistry initiatives
- The Food and Drug Law Institute
- Association of Food and Drug Officials
- Lawyers for Children America
Publications, Presentations & Recognitions
Georgia is a frequent speaker on FDA, FTC, and CPSC product regulation. Her speaking engagements include:
- Product Recall Webinar, The Knowledge Group; June 14
- Happi Anti-Aging Conference; May 16, 2018, New York, NY.
- "Regulatory Rollback Under President Trump," Arent Fox; March 21, 2018, Webinar.
- "Medical Product Advertising & Promotion, Social Media Do’s and Don’ts," FDAnews; January 24, 2018, Webinar.
- "Regulatory Issues Impacting the Anti-Aging Category,” Happi Anti-Aging Conference; November 30, 2017, New Brunswick, NJ.
- "Organic Food Claims: How Best to Defend Against Allegations of Economic Fraud from and FDA and USDA Perspective," ANA/BAA Marketing Law Conference; November 14, 2017, Chicago, IL.
- "Navigating Key Regulatory Agencies for the Food Industry: Comprehending the Jurisdiction, Function, Organization and Interplay of the FDA, USDA, FTC and Local Health Agencies," ACI Food Law and Regulation Boot Camp; November 13, 2017, Chicago, IL.
- "The Regulation of Cosmetics," Food and Drug Law Institute (FDLI) Introduction to Food, Dietary Supplement, and Cosmetic Law and Regulation; August 15, 2017.
- "Labeling in the Context of Social Media and Omnichannel Presence," Cosmoprof; July 9, 2017, Las Vegas, NV.
- "Navigating Advertising and Labeling Requirements for Cosmetics," Cosmoprof; July 9, 2017, Las Vegas, NV.
- "Lithium Ion Batteries, Emerging Technologies, and the Reduction of Testing Burdens Under the Consumer Product Safety Act," Arent Fox; May 4, 2017, Webinar.
- "Making 'Made in USA' Claims: A Discussion with the United States Federal Trade Commission," Arent Fox; March 15, 2017, Webinar.
- "Made in USA" Presentation, BAA Marketing Law Conference; November 9, 2016, Chicago, IL.
- “Regulatory Roundtable,” Happi Anti-Aging Conference, September 21, 2016, New Brunswick, NJ.
- "Reprocessing of Reusable Devices," Food and Drug Law Institute (FDLI) Annual Conference; May 5, 2016, Washington, DC.
- "Beauty Devices vs. Medical Devices: Understanding the Differences and Minimizing Legal and Regulatory Risks,” ACI Legal, Regulatory, and Compliance Forum on Cosmetics & Personal Care Products; March 7, 2016, NY.
- “'Made in USA' Claims – FTC & California Perspectives,” BAA Marketing Law Conference; November 9, 2016, Chicago, Illinois.
- "FDA Interface", BAA Marketing Law Conference; November 9, 2015, Chicago, IL.
- “Obtaining Clarity in Chemical and Environmental Safety Issues: Developing Strategies to Ensure Ingredient Safety and Substantiate Testing Protocols,” ACI Cosmetics Conference; March 24, 2015, NY.
- "Regulatory Roundtable," Happi Anti-Aging Conference; September 11, 2015, New Brunswick, NJ.
- "FDA Overlap - Health & Wellness," BAA Marketing Law Conference; November 7, 2014, Chicago, IL.
- "Regulatory Roundtable," Happi Anti-Aging Conference; September 17, 2014, New Brunswick, NJ.
- "FDA Enforcement/Compliance: Recent Trends Related to Beauty/Personal Care Products," HBA Global Expo & Conference; June 11, 2014, New York, NY.
- "Health, Cosmetic, and Luxury Marketing Issues and Claims," BAA Marketing Law Conference; November 20, 2013, Chicago, IL.
- "Roundtable on Anti-Aging Cosmetics," Happi Anti-Aging Conference; October 30, 2013, New Brunswick, NJ.
- "Keeping Updated with the FDA: Your Ticket to Staying Out of Hot Water," HBA Global Expo & Conference; June 20, 2013, New York, NY.
- "Product Labeling: Federal, State and Beyond - California's Proposition 65," ICPHSO ABA Law Day; March 19, 2013, Orlando, FL.
- "Analysis of Recall Law & Procedures," ICPHSO ABA Law Day; February 25, 2011, Orlando, FL.
- "Properly Building Your Regulatory Business Infrastructure," Global Regulations for Cosmetics Conference; June, 2007.
- Policy-oriented speaking engagements as a featured presenter at ICPHSO, ABA and HBA; topics included product labeling, California's Proposition 65, staying up to date with FDA, and more.
In addition to her presentations and speaking engagements, Georgia is a regular contributor on FDA and FTC cosmetics and personal care products to leading trade and consumer media outlets. Her work includes:
- "Anti-Aging Products Are Not Drugs! Does the withdrawal of Import Alert 66-38 signal a change of heart at the US Food and Drug Administration?" Happi Magazine; February 6, 2018
- “Cosmeceutical Claims May Be Headed into FDA’s Radar,” The Tan Sheet; August 10, 2009 (p. 8)
- "Less Tolerant FDA May Flex Enforcement Muscles on Cosmeceuticals – Lawyer," The Rose Sheet; July 6, 2009 (p. 5)
- Articles for Happi Magazine, a well-known publication for the household, chemical, and personal products industry. Some of the articles Georgia has written include: “Here’s a Better Way to Substantiate Claims,” “Will FDA Put the Heat on Salon Suppliers?” and “Should Your AHA Cream Carry a Warning Label?”
Life Beyond the Law
Much of Georgia’s life beyond the law is spent catering to the needs of her family, as well as the veritable menagerie of animals that graze happily on her historic working farm in the Virginia countryside.