The Sports Nutrition industry is constantly pushing the envelope of innovation. With innovation comes the need to protect it, and ensure that it is compliant with applicable Federal laws and regulations.
One of the threshold issues that sports nutrition companies face when bringing a new and innovative product to market is protecting their intellectual property and being careful to avoid infringing the intellectual property of others, namely patents, trademarks and copyrights. Keeping abreast of changes in legislation and the issuance of Final Rules is critical both for new and experienced companies in the sports nutrition industry. They affect the ingredients you can import, the supplements you can sell and claims you can make about them.
Collins Gann McCloskey & Barry PLLC offers many services to our clients in the Sports Nutrition industry ranging from general business advice to advice on regulatory compliance. Issues of particular concern to sports nutrition companies are marketing products that contain New Dietary Ingredients in compliance with the Dietary Supplement Health and Education Act (DSHEA), ensuring substantiation of the claims made about those products, and recording and reporting serious adverse events in accordance with an Adverse Event Reporting (AER) system.
Some of the many services Collins Gann McCloskey & Barry PLLC offers to our clients include:
- Review of labels and advertising from a FD&C Act and FTC stand-point (FDA enforces the FDCA with respect to the safe and legal marketing of food and dietary supplement products; FTC regulations deal with truthful advertising that is not misleading);
- Provide advice and consultation on drafting accurate and compliant supplement fact panels
- Provide advice and consultation on drafting appropriate warnings for dietary supplement products
- 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
- Review, negotiate and draft supply and manufacturing agreements
- Review and draft employment, endorsement and licensing agreements
- Provide consultation on quality control and current Good Manufacturing Practices (cGMPs)
- Advise and consult on various intellectual property matters including assisting clients in trademark and copyright registrations
- 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 such as warning letters, detention of imports, and product recalls
- Coordinate the defense against criminal investigations or FDA, DEA or other enforcement actions initiated by regulatory agencies
Contact us for more information about our dietary nutritional supplements practice.