Food, Drugs and Dietary Supplements
In the area of Food, Drugs and Dietary Supplement law, attorneys at the Law Office of Arthur W. Leach represent both large and small corporations in a variety of different issues that arise out of this highly litigious field. We have handled some of the largest cases in the country involving FDA law, FTC law, and other regulatory, advertising and marketing law. Additionally, we have a long track record of successful litigation in civil trials and administrative enforcement proceedings. The Law Office of Arthur W. Leach associates with attorneys throughout the country who are experts in their field. In doing so, we strive to provide your case the best and most efficient representation possible.
Our clients include food, drug, device, and dietary supplement companies, as well as multi-level marketing companies, mail order companies and Internet-based companies. Our attorneys are particularly qualified in the area of dietary supplements governed by the Dietary Supplement Health Education act of 1994 (DSHEA). The Law Office of Arthur W. Leach counsels dietary supplement companies in a wide range of issues arising under the Dietary Supplement Health and Education Act (DSHEA), including product formulation (new dietary ingredient issues, food additive issues for non-dietary ingredients, safety issues, compliance with DSHEA and implementing regulations, etc.), GMP compliance, labeling, advertising, and promotion. We also regularly handle product and compliance-related investigations, the development of regulatory corporate compliance programs, and due diligence in financings, mergers and acquisitions.
At the Law Office of Arthur W. Leach we strive to provide our clients with sound strategic guidance to ensure compliance with complex regulations from numerous Federal Agencies, including the Food and Drug Administration, the Federal Trade Commission, and the Drug Enforcement Administration. In this regard, we have extensive experience in litigating on our clients’ behalf in connection with civil and criminal enforcement actions with the Federal Government.
Intellectual Property: Trademark and Patent Litigation
We represent clients in trademark matters in state and federal courts including the development of trademark protection strategies. The intellectual property practice of the Law Office of Arthur W. Leach combines considerable experience in the fields of patent and trademark litigation to achieve client objectives. Trademark law is part of the law of unfair competition, which also addresses trade secret protection, unfair competition and deceptive and unfair trade practices.
Products Liability and Class Action Defense
The Law Office of Arthur W. Leach represent manufacturers and distributors of consumer and industrial products in cases involving claims of loss or injury due to claimed defects or false advertising. Our trial lawyers are able to manage and try products liability cases, including personal injury and other liability cases, throughout the United States.
Companies operating in the food, beverage, and related consumer products industries face increasing and rapidly evolving challenges. These challenges have led to an explosion in consumer products liability claims, filed as class action lawsuits in light of the generally low economic damages for any individual consumer. We focus on defending class action lawsuits, consumer fraud claims, and personal injury actions allegedly stemming from the use of their products. For example, we have represented several dietary supplement manufacturers in the defense of a Deceptive and Unfair Trade Practices Act putative class action arising out of the sale and advertisement of weight loss claims that challenged the nutritional or health claims of the product.
Help when trouble Strikes.
It happens: someone challenges your product or your advertising. It could come from an individual or a class action suit. Or it could be a government agency. We have years of experience in dealing with:
- Adverse Event Reports;
- challenges before the Federal Trade Commission;
- current good manufacturing practices;
- false advertising (Lanham Act) litigation;
- food additives;
- FTC lawsuits and contempt proceedings
- FDA lawsuits and challenges to Administrative Procedures Act
- FDA import detentions;
- FDA inspections;
- FDA warning letters;
- FDA consent decrees
- patent, trademark and copyright litigation;
- state attorneys general; and
- other challenges faced by product developers and manufacturers.
- Successfully defended a dietary supplement manufacturer and retailer in several matters involving the advertising and labeling of weight loss dietary and other nutritional supplement products. Defended allegations of false advertising brought by competitors and regulators, including several investigations from the FDA and FTC.
- Served as counsel for several dietary supplement manufacturers in consumer class action lawsuits alleging false advertising, product liability, and breach of express and implied warranties concerning the packaging, promotion, and marketing of the client’s weight loss product.
- Conduct due diligence on potential acquisitions of nutritional supplement companies.
- Challenged a competitor, initiated by our client, the maker of dietary supplement products. The basis of inquiry was substantiation of establishment, performance, comparative and testimonial claims in advertising. The competitor voluntarily discontinued advertising and was advised about future efforts.
- Represented a national marketer of dietary supplements in litigation filed by the Department of Justice alleging violations of a prior FTC order.
- Counseled a producer of weight-control products on all aspects of their product advertising and marketing programs, including with respect to expert endorsements, testimonials, weight loss claims, and requirements of FDA, FTC and state consumer protection laws.
- Developed “best practices” guidance concerning the premarket review of dietary supplement product benefit claims and substantiation.
- Advised dietary supplement manufacturers and distributors concerning FDA standards governing product recalls and related communications with FDA and the public.
- Conducted regulatory due diligence to evaluate compliance of dietary supplements with FDA, FTC, and related state law requirements.
At every step, you’ll work with the Law Office of Arthur W. Leach attorneys whose experience and skills match the issues you face—from advising you in relation to FDA and FTC laws a to defending you in consumer litigation or against actions brought by the FDA or FTC. You’ll always have the support of a core group of attorneys who understand your business and know how to help you resolve the issues that come up when operating in the highly litigated field of dietary supplements.