Contract Research Organizations are becoming a staple in the dietary supplement and functional food markets, where products backed by solid research will be sure to prevail in the new regulatory environment.
As FDA ramps up enforcement in food and dietary supplements, companies need to know what claims can be made for their products based on their level of substantiation.
FDA's final rule on cGMPs could be the best thing to happen to dietary supplements since the passing of DSHEA if companies approach these new regulations in a practical, balanced manner.
Designing and implementing a scientific and organizational quality system for the botanical and dietary supplement industry will be a necessary requirement for those companies that want to be successful in the future.