In the ever-changing landscape of the health, fitness and nutritional supplement industries, you need to stay ahead of the curve. Could you survive an investigation of your products, your labels, your advertising copy, your facility? How do you navigate the maze of new regulations and run your business at the same time? With FDA policies actively evolving, how can you bring a new product to market in compliance with the Dietary Supplement Health and Education Act (DSHEA)? How can you ensure your advertising complies with FDA and FTC regulations? How can you substantiate your claims or determine what claims are appropriate? What must you do in order to comply with the newly established Good Manufacturing Practices (GMP’s) for dietary supplements? Are you recording and reporting adverse events in accordance with the recently enacted Adverse Event Reporting (AER) system for dietary supplements? How are you handling your trade names and brands?

Collins, McDonald, & Gann, P.C. (CMG), is a law firm dedicated to helping clients in the health, fitness and dietary supplement communities. With recognized authorities in sports performance supplements and regulatory, advertising and marketing law, CMG offers a powerful bi-coastal team providing a variety of legal services to a whole range of companies from start-ups to long-established members of industry. CMG offers in-depth experience and personalized attention you can trust to get you the answers you need ... when you need them. The partners of CMG have been formally rated by the professional legal community as practicing at the highest levels of skill and ethical integrity (AV-rated in Martindale-Hubbell). Los Angeles lawyer Alan Feldstein, Of Counsel to the firm, brings with him years of experience serving the dietary supplement industry. CMG can help you stay ahead of the curve by providing the following services:

• Review labels and advertising from an FDC and FTC standpoint (FDA laws deal with the safe and legal marketing of food and dietary supplement products; FTC regulations deal with truthful advertising that is not misleading);
• Review, negotiate and draft supply, manufacturing, employment and licensing agreements;
• Provide consultation on quality control and good manufacturing practices;
• Provide general business advice;
• Advise and consult on various intellectual property issues including assisting clients in trademark and copyright registrations;
• Advise clients regarding DSHEA compliance of New Dietary Ingredients;
• Provide consultation on drafting accurate and compliant supplement fact panels;
• Assist in coordinating review of products and/or ingredients through our scientific consulting team of chemists, toxicologists, research scientists and other outside experts regarding different aspects of manufacturing, labeling and marketing of products, such as assembling substantiation and safety data;
• Coordinate and manage outside defense counsel and provide strategy on civil litigation including ERSP claims, product liability claims and class action lawsuits;
• Manage and counsel on defense against State or Federal regulatory actions;
• Coordinate the defense against criminal investigations or FDA, DEA or other enforcement actions initiated by regulatory agencies;
• Provide a “legal health checkup” of company’s advertising, labels and other marketing materials to help avoid running afoul of FDA, FTC or Federal regulatory laws. The best time to ensure compliance with the law is up-front, before there’s a problem.

CMG is positioned at the forefront of sports supplement issues. Read our latest issue as well as archived issues by clicking on any of the links below.

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When FDA pronounced last year that dietary supplement products containing androstenedione were adulterated new dietary ingredients under DSHEA, CMG analyzed the legal grounds and standards upon which FDA acted in an article published in the Sports Nutrition Review Journal, 1(1):52-60, 2004. The article, entitled "'Adulterated' androstenedione: What FDA's action against Andro means for industry," was authored by CMG lawyers Rick Collins and Alan Feldstein and suggests what might be done to ameliorate the escalating problem of lack of communication and cooperation between FDA and industry. Mr. Collins also presented on "The Future of Sports Nutrition after Ephedra and the Steroid Scandal" at the FitExpo in Pasadena, CA, in 2004, and gave an "Insider's Update on the Regulatory Issues Surrounding Sports Supplements" at the International Society of Sports Nutrition (ISSN) 2004 Annual Conference in Las Vegas. Rick Collins and Alan Feldstein also recently co-authored "Comments on FDA's Pre-market Notification for New Dietary Ingredients" which Mr. Feldstein presented to the Food and Drug Administration in Washington, DC. Most recently, Mr. Collins gave a presentation entitled ?Ephedra, Prohormones ... What's Next? -- How the Federal Government Regulates the Dietary Supplement Industry" at the 2nd Annual ISSN Conference in New Orleans.

The new decision on ephedra has many industry insiders debating its implications. "Ephedra: Interpreting the New Court Ruling" offers some basic considerations. (Feel free to contact CMG for specific advice.)

Call 516-294-0300 or email info@cmgesq.com to discuss how the legal team at CMG can help your business stay safely ahead of the curve.