Collins Gann McCloskey & Barry PLLC (CGMB), is a law firm dedicated to providing experienced counsel in dietary supplement law to clients in the health, fitness and dietary supplement communities. With recognized authorities in sports performance supplements and FDA law, FTC law, and other regulatory, advertising and marketing law, CGMB offers a powerful bi-coastal team providing a variety of legal services to a whole range of dietary supplement companies from start-ups to long-established members of industry.
What We Do … and our Leadership in Dietary Supplement Law
In the ever-changing landscape of dietary supplement law, as well as the law surrounding the functional foods and sports nutrition industries, you need to stay ahead of the curve. Now, more than ever, it is critical for companies to ensure that they are following all protocol when it comes to FDA compliance in the supplement industry, as well as be aware of FDA enforcement issues and the importance of 483 Inspection and 483 Response in potentially avoiding FDA warning letters for supplement companies.
Whether you are seeking to take proactive steps to ensure dietary supplement FDA compliance, or are concerned about the potential of a dietary supplement recall based on a 483 Inspection or FDA warning letter, you need dietary supplement lawyers experienced in the issues facing today’s supplement companies. You need a dietary supplement lawyer familiar with FDA issues … and experienced FDA counsel that can help ensure that your products meet all current, and future, FDA requirements for dietary supplements. Our dietary supplement lawyers can help you navigate your company through today’s most critical issues in dietary supplement law and FDA/FTC compliance requirements. In deciding whether your firm can benefit from legal counsel in dietary supplement law, ask yourself the following questions:
- Are all your product names and other company intellectual property protected by trademarks?
- Can you fend off a challenge to any of your existing trademarks from a competitor?
- Have your dietary supplement product labels been reviewed by legal counsel?
- Do you have proper licensing and manufacturing agreements in place?
- Are you covered by adequate indemnification agreements?
- Could you survive a 483 inspection of a FDA investigation of your facility? Or an FDA investigation of your products, your labels or your advertising copy?
- How do you navigate the maze of new dietary supplement FDA and FTC regulations and run your business at the same time?
- With FDA policies actively evolving, how can you bring a New Dietary Ingredient to market in compliance with the Dietary Supplement Health and Education Act (DSHEA)?
- How can you ensure your dietary supplement advertising complies with FDA and FTC regulations?
- How can you substantiate your claims or determine what claims are appropriate?
- Do you have sufficient studies and research to back up your claims?
- What must you, as a manufacturer, do in order to come into compliance with all current 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 do you handle risk management; do you have proper insurance coverage and procedures to deal with customer complaints?
- Have you been contacted by a District Attorney, State Attorney General, Better Business Bureau, Consumer Affairs department or the National Advertising Division (NAD) regarding substantiation of your claims?
- Have you received a Civil Investigative Demand from the FTC?
- Have you received a federal Grand Jury subpoena?
- Have you been served with a Class Action suit?
Dietary Supplement Lawyers Recognized as Leading Legal Authorities in Health, Fitness and Nutritional Supplements
CGMB offers in-depth experience in dietary supplement law and personalized attention you can trust to get you the answers you need … when you need them.
The partners and dietary supplement attorneys of CGMB 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 in dietary supplement law serving the dietary supplement industry. Our dietary supplement lawyers in New York and Los Angeles can help you stay ahead of the curve and ensure FDA compliance in the supplement industry – allowing you to concentrate on growing your supplement business while we ensure that all of your products are following current guidelines for supplements.
Areas of Practice:
- Dietary Supplements
- Functional Foods
- Sports Nutrition
- FDA Investigations
- Other Supplement Emergencies
If you have a legal matter or question surrounding dietary supplement law/FDA Law, or are faced with an FDA Warning Letter or possible supplement recall, you need experienced counsel, straight answers and prompt attention. Call the dietary supplement lawyers of CGMB, at 516-294-0300 today to discuss how we can help in all aspects of dietary supplement law. We may be reached via facsimile at 516-294-0477 or by email at email@example.com.