The product research and development (R&D) process can sometimes be thought of in isolation—however, a plethora of regulatory matters come into play when creating dietary supplements or functional foods. "Your Regulatory Repertoire," a free Digital Issue from SupplySide R&D Insights, sheds light into several areas of importance, including licensing agreements, intellectual property (IP) and GMPs (good manufacturing practices).
More than ever before, the industry is seeing a marked increase in the popularity and use of proprietary ingredients to help differentiate products in the marketplace. Instrumental to the use of a licensed ingredient or product is the execution of a license agreement that clearly articulates the rights granted and contains appropriate representations, warranties and other protections for the licensee. Justin J. Prochnow and Alan N. Sutin, attorneys and shareholders of the international law firm Greenberg Traurig LLP, outline key factors to consider when one is looking to enter into a license agreement for the use of proprietary ingredients in dietary supplements.
IP can be another area of vulnerability—or it can give a business a significant advantage over its competitors. Patents, trademarks, copyrights and trade secrets all add value to a company, sometimes even becoming the organization's main source of income. As such, Rakesh M. Amin, a partner at Amin Talati LLC, and Brent Batzer, associate attorney at the firm, explain the process and importance of building and defending an IP portfolio.
Marc Ullman, a partner at the law firm Ullman, Shapiro & Ullman LLP, rounds out the Digital Issue with a look at ingredients, labels, claims and GMPs. Too many companies, he cautions, focus solely on GMP requirements as related to the process of making dietary supplements. However, FDA has repeatedly stated GMPs are about an overall quality system and compliance philosophy. Ullman reminds manufacturers not to lose sight of quality system obligations regarding the legal status of ingredients, as well as any information appearing on the label of finished goods.