March and April were very busy months for the Federal Trade Commission’s Office of Consumer Protection staff who focus on “Made in USA” enforcement. Indeed, FTC issued seven “closing letters” to companies during a three-week period, in which FTC closed out its investigations involving allegations that each company “overstated the extent to which” the products in each case were made in the United States. In each case, the FTC closed out the investigation based on the company’s agreement to implement a remedial action plan, including but not limited to such actions as removing unqualified US-origin claims from websites and social media and providing corrected qualified claims to third-party resellers and distributors. This flurry of activity began on March 14, 2017 and ended on April 5, 2017, as follows:
Georgia C. Ravitz
Georgia Ravitz is a partner in the firm’s Washington, DC, office and leads the Consumer Product Safety practice, and is a senior partner in the firm’s Food & Drug (FDA) and Advertising practices. She focuses on food and drug law and regulatory policy governing 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), and Federal Trade Commission (FTC) regulations. Georgia also counsels clients on regulatory compliance and FDA 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. 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
- Preparation of responses to FDA 483 inspections
- Provided counsel to recipients of FDA Warning Letters
- Negotiated release of FDA detained food, drugs, and cosmetics
- 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, 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 and Recognitions
In addition to presentations and speaking engagements on FDA/FTC/CPSC product regulation, Georgia is a regular contributor on FDA and FTC cosmetics and personal care products to leading trade and consumer media outlets. Her work includes:
- 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?”
- 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.
- Marketing and consumer-oriented presentations for industry organizations including Brand Activation Association (BAA) on advertising and marketing within highly regulated industries.
Blog Posts by Georgia C. Ravitz
What’s the News?
Walgreens recently settled with the state of New York over allegations that the drug retail chain misled consumers with its pricing, including value and clearance prices. According to the New York attorney general’s office, an undercover investigation showed that Walgreens was overcharging customers compared to the prices displayed in print advertising and on-shelf tags. Walgreens agreed to pay $500,000 to settle the dispute and has agreed to review and correct the allegedly misleading pricing practices. This should serve as a reminder to retailers in all industries of the need to exercise care in product pricing, as this area has become a common target for regulators and the plaintiff’s bar.
The Federal Trade Commission announced on April 12 that it reached settlement agreements with four companies that market skin care products, shampoos, and sunscreens online over charges that they falsely claimed that their products are “ALL NATURAL” or “100% NATURAL,” despite the fact that they contain synthetic ingredients.
The Commission voted unanimously to issue each administrative complaint and to accept the four proposed settlement agreements. The Commission has also issued a complaint against a fifth company, California Naturel, for making similar claims. A copy of the FTC’s press release announcing the settlement agreements can be found here.
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