The dietary supplement industry has undergone significant changes over the past 20 years. As science and technology converge, the U.S. Food and Drug Administration (FDA) and Federal Trade Commission (FTC) are more aggressive than ever with 483 inspections, investigations and recalls. It has even been noted in recent press releases that the likelihood of criminal prosecutions is on the rise as well. Now more than ever, having a skilled dietary supplement attorney on your side is absolutely critical. If you have received a warning letter, or anticipate an FDA issue, you need legal representation since navigating the highly regulated nutritional supplement industry can be overwhelming for even the most experienced business owner acting alone. At McFarlin LLP, our dietary supplement attorneys have worked with some of the key players in the industry. We help our clients avoid FDA and FTC issues with skillfully detailed responses and strategic remedial measures. We will work hard to ensure the longevity and profitability of your operation.
Dietary Supplement Industry Challenges
Operating a dietary supplement or nutritional supplement company may feel like a constant battle with regulators, competitors, and even consumers themselves, but it can be extremely fulfilling as well. Producing a nutritional supplement that genuinely improves and enhances consumers’ lives can be tremendously gratifying from both a personal and financial perspective. On the road to fulfillment however, many issues can arise, but these issues need not be much more than a “bump in the road” with the right legal representation. Legal and Administrative issues can include:
- Regulatory Compliance (FDA and FTC)
- Gaining GRAS (Generally Recognized as Safe) Status
- Intellectual Property and Trademark Challenges (shutting down imposters)
- Supplement Label Compliance Review
- Manufacturing and Licensing Agreements
- Defense of FDA 483 Inspections and Investigations
- Product Recalls
- Advertising Claims Review (Data to Support Claims)
- New Ingredient Introduction (DSHEA Compliance)
- Sales and Distribution Contracts
- Administrative Hearing Representation
- Dietary Supplement Litigation (Class Action Defense)
- Grand Jury Subpoena Defense
FDA Inspection Defense
For dietary supplement manufactures or distributors, an FDA inspection can be highly stressful and potentially devastating. However, even when potentially serious allegations are made, managing the investigation process properly can make a huge difference in the outcome. Oftentimes immediate remedial measures or prompt compliance can relieve the situation. Other times, standing firm on advertising claims may be more appropriate. In either case, an immediate response from an experienced dietary supplement attorney is essential. Responding, or even interacting with the FDA, without legal counsel can often make the situation much worse. Regulators must be replied to in an appropriate manner and typically on a fast time frame. If your company is facing an inspection or are in receipt of an FDA Form 483 Inspection Observation Report, call us today; you likely only have 15 days to respond. Our FDA Dietary Supplement attorneys will guide you through the process to the best possible solution.
Dietary Supplement Attorneys
At McFarlin LLP, our dietary and nutritional supplement attorneys represent clients in every phase of product development, distribution, regulation, and litigation. Our firm focuses on providing cost-effective legal services to the dietary supplement industry. A skilled and experienced nutritional supplement attorney can be affordable. Call us today for a free case evaluation and analysis at: (888) 728-0044.