How to Know if Your Company Needs Legal Counsel Regarding Dietary Supplements
In today’s regulatory environment, it’s more critical than ever that companies follow all FDA and FTC regulations and comply with the laws surrounding dietary supplements. If you have any questions at all about your responsibilities under the law, including label claim issues, labeling requirements, advertising reviews, Good Manufacturing Practices (GMPs), preparing for FDA inspections and how to avoid potential GMP failures, having the right legal counsel to guide you can make all of the difference.
In deciding whether your company can benefit from legal counsel experienced 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 or an 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 for dietary supplements?
- Are you recording and reporting adverse events in accordance with the Adverse Event Reporting (AER) requirements 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 Supplement Counsel 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.
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 CGM&B, 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 protected].