U.S. Food and Drug (FDA)

Our goal is to serve as trusted advisors to our clients. We not only assist our clients with laws and regulations, we also support them in building their corporate reputation as well as providing valuable access to regulators, the Administration and Congress. Our clients depend on our attorneys to understand agency decisions and policies and assist them in responding to changes in regulations and policies. More importantly, we help our clients in their dialogues with federal agencies and encourage proactive efforts to shape regulations and legislation. regulatory and public policy changes. We have deep experience in developing coalitions in conjunction with trade associations in working on key legislative and regulatory initiatives.

Our attorneys have decades of experience in biologic, medical device, housewares, food, cosmetics, dietary supplement regulation as well as in the use of these products in digital health and the flow of data and information through the interconnected internet of medical things. We represent our clients throughout the product life cycle, from initial efforts through clinical trials, premarket review and post-market regulation, including licensing agreements, product clearance, approval and registration, notifications and recalls, inspections, audits and Warning Letters. Proactively, we draft citizen petitions, manage civil and criminal investigations and litigation, as well as oversight by Congress. We advise on how to operationalize the use of these products using cutting edge technologies and while complying with complex regulatory and statutory laws.

Practus’ FDA team is fully integrated with our other firm practice areas, such as intellectual property, corporate, product liability and other litigation, advertising, product safety and other pertinent areas of practice. We strive to provide the best solutions for the challenges that confront our clients, while helping them plan for the future.

Practus team represents our clients in securing approvals, complying with post-market requirements, enforcement actions, recalls and other regulatory issues. Our team responds to citizen petitions, planning and preparation for agency meetings and appeals, as well as drafting agreements with vendors. We also assist with FDA with international inspections of products and ingredients.

We assist clients with establishment registration, labeling, and listing requirements. Our experience includes litigation in competitor lawsuits and in cases brought under the Administrative Procedures Act (APA).

We represent our clients in every aspect of production and marketing of medical devices. Practus’ attorneys know the industry and the regulatory and policy environment, allowing us to work with clients toward the choice and implementation of the best regulatory pathway.

Our team has deep experience working with a wide range of medical devices, including clearances of and approvals for 510(k)s, de novo submissions and Premarket Approvals (PMAs), as well as Humanitarian Device Exemptions (HOE). We work closely with diagnostic companies to shape regulations and policies governing breakthrough genetic and molecular diagnostic tests. We also help manage post-market compliance, including post-market surveillance, supplementation, establishment registration, product listing, inspections, reporting and recalls.

Practus’s attorneys have broad experience in all aspects of food and dietary supplement regulation, including product development, product safety, labeling, Generally Regarded as Safe (GRAS) standards, product and facility inspections, promotion, and advertising. enforcement, recalls, and citizen petitions. Our team has the requisite experience to assist our clients with the complex world of food regulation and policy. Practus’ team has represented the food industry in most of the major recall events of the past two decades. In addition, we have strong experience assisting clients in the development of global regulation and policy. We provide advice to clients in the food and dietary supplement industries, as well as medical food, food additives, food ingredients, and pet food industries. We are very well versed in advising on Dietary Supplement Health Education Act (DSHEA), Food Safety Modernization Act (FSMA), Fair Packaging and Labeling Act (FPLA), and the Bioterrorism Act. We formulate strategies to promote clients’ positions in the areas of rulemaking and legislation that affects the food and dietary supplement industries. In addition, we represent clients in advertising matters before the Federal Trade Commission (FTC), the National Advertising Division (NAD) of the Council of Better Business Bureaus (BBB), and in state and Federal courts.

Our attorneys are well-versed in the jurisdictional boundaries and concurrent jurisdiction with other agencies, including the US Consumer Product Safety Commission (CPSC). There are times when food contact issues and consumer product safety intersect such as with housewares and promotional products. Our attorneys help clients navigate jurisdictional waters, guiding them through compliance and crisis management issues.

We advise clients in the cosmetics industry and in the over the counter (OTC) drug industry for monographed OTC drugs on general FDA compliance, product packaging, labeling and advertising, safety issues. We represent clients in all areas of cosmetics and OTC drug regulation, including claims regarding cosmetics and OTC drugs, Good Manufacturing Practices (GMPs), Good Laboratory Practices (GLPs) and in marketing of monographed OTC drugs, as well as approval of color additives.

We help our clients manage enforcement actions, including customs detentions, responses to warning letters, factory inspections responding to 483 and market withdrawals, when necessary. We also have extensive experience managing public relations issues arising from negative social media and consumer product reviews as well as counterfeiting Issues for both cosmetics and OTC drug products, in conjunction with our Intellectual Property colleagues. . We also assist in obtaining registration and listings for OTC manufacturing facilities and products.

Our team counsels clients in advertising, marketing and promotion, claim substantiation, as well as compliance with the Federal Trade Commission Act and state false advertising statutes and regulations. We represent clients in advertising challenges before the FTC, National Advertising Division (NAD), and in consumer class actions.

Our team has experience serving as senior in-house attorneys in pharmaceutical, medical device, and cosmetic companies in several major international corporations. We have successfully defended clients in regulatory proceedings before the FDA and FTC, as well as in advertising challenges before the National Advertising Division (NAD), Electronic Retailing Self-Regulation Program (ERSP), and the FTC. We assist clients in structuring business transactions including corporate acquisitions and divestitures, public offerings, joint ventures, and distribution agreements.

We assist our clients in complying with veterinary drug regulations. We have managed.  New Animal Drug Applications (NADA), Conditional Approvals (CA), Green Book listings, as well as recalls. We also represent clients in advertising matters before the FTC, and the NAD.

Practus’ TEAM   represents clients before the USDA, including the Animal and Plant Health Inspection Service (APHIS), Food and Nutrition Service (FNS), Food Safety and Inspection Service (FSIS), and the National Organic Program (NOP). We deal with compliance issues, administrative proceedings, and litigation, as well as advertising issues involving FTC. We work on issues involving labeling, meat and poultry safety and labeling perishable products, animal feed, organic agriculture, transgenic crops, plant pests, animal welfare, permitting and product recalls.

We provide guidance navigating FDA, the Drug Enforcement Administration (DEA) as well as most states for the advertising, distribution, and sale of cannabis and cannabis-containing products. This includes regulatory issues involving the manufacture, sale, use and advertising claims for cannabis and its derivatives, as well as product that contains cannabis or its derivatives, such as cannabidiol (CBD), which in turn may be a derivative of the industrial hemp cultivar of cannabis, which is no longer covered by the Controlled Substances Act under the Farm Bill of 2018.

Digital health sits at the intersection of medical devices, technology, and healthcare. It spans a wide array of technologies and services, such as wearable medical devices, mobile health apps, robotics, remote patient monitoring, direct-to-consumer devices, machine learning and AI, software as a medical device, and telehealth.

Our digital health attorneys have extensive experience in counselling clients in all areas of digital health technologies, including determining whether a technology is a regulated medical device; negotiating ownership, licensing, distribution, and other arrangements for the delivery of digital health; assessing the flow of data and information through interconnected technologies; drafting licenses, terms of use and privacy policies; and advising on governing laws, including technology, privacy, and other laws that impact digital technology.  We also represent clients on the protection and use of trademarks in digital health, including the development of their brand.