James R. Ravitz
Jamie Ravitz is practice group leader for Arent Fox's FDA Practice (Food & Drug). He also is a member in the life sciences and advertising groups, with a well-rounded practice focused on food and drug law, healthcare, consumer product safety, and advertising. Jamie serves as vice chair of the firm’s consumer product safety committee. Jamie's FDA practice assists clients in navigating regulatory requirements impacting medical device combination products and medical technologies. He also helps clients through all regulatory phases of the approval, manufacture, marketing and retail process.
Jamie represents manufacturers and distributors in obtaining approval to market medical devices, drugs, biologics, food, dietary supplements, and cosmetic products. Additionally, he counsels on all aspects of the marketing of such products, including labeling, advertising, manufacturing, and distribution. Jamie’s Food and Drug Administration (FDA) practice focuses on assisting companies with the development of FDA regulatory pathways for novel medical technologies and device combination products (device/drug and device/biologic). In addition, he assists clients with the preparation of marketing applications (PMA and 510(k)), requests for designation, and pre-Investigational Device Exemption (IDE) applications. He further counsels on post-approval/clearance issues such as product advertising, adverse event reporting, recalls, and QSR compliance. He also advises clients on matters related to Medicare reimbursement of products regulated by the FDA.
Jamie further counsels clients on their advertising, marketing, and promotional efforts. He reviews corporate advertising and marketing initiatives for federal and state legal compliance and to minimize potential liability. Jamie has represented clients in advertising disputes before the National Advertising Division of the Better Business Bureau.
Jamie also advises national retailers and manufacturers with consumer product safety issues. He counsels clients before the Consumer Product Safety Commission on compliance issues and product recalls, and he has participated in numerous product recalls. He frequently advises clients on US and international labeling and other regulatory requirements. Jamie has extensive experience advising clients on labeling and advertising for products that are subject to FDA and/or Federal Trade Commission (FTC) jurisdiction.
See Jamie's full bio here.
Blog Posts by James R. 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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