New year…new regulatory requirements…here’s a roadmap
As the New Year gets underway, along with yearly goals and plans for the future, it’s important to realize and understand that the FDA regulatory landscape is changing. And while regulations are always evolving, they rarely hit every player in the dietary supplement industry all at once—until now.
Regarding product labeling
In 2016, the FDA published its final rules for updating food and dietary supplement labels. While some portions of the rule did not apply to dietary supplements, the new rule did include changes to what types of nutrients must or can be declared on supplement labels as well as the Daily Values associated with these nutrients. Nearly every nutrient possessing a Daily Value was impacted in some way by these rule changes. The FDA has given a deadline of July 26, 2018 for compliance of these new regulations. Find out how NEC can help you navigate through the changes here.
Regarding New Dietary Ingredient (NDI) notifications
Also in 2016, the FDA published a draft guidance, which advised the following:
Any dietary supplement marketed in the U.S. after DSHEA must file an NDI notification with the FDA to demonstrate evidence of product safety to lawfully be marketed.
The requirement to file an NDI boils down to whether the supplement was on the market before DSHEA or if the key ingredient can be found in conventional food or drinks. Find out more here.
Regarding the Council for Responsible Nutrition’s (CRN) product registry—OWL (Online Wellness Library)
Designed as a self-regulating initiative, CRN is looking to separate the legitimate manufacturers that comply with all federal regulations from the “fly-by-nighters” selling quick fixes and illegal drugs marketed as supplements. The largest component of this initiative is to require all CRN members to submit their finished dietary supplement labels to UL, a global independent safety science company, starting July 1, 2017. “We’re moving in a deliberate, step-wise fashion and layering initiatives that, when combined, will address transparency, ingredient verification and GMP compliance,” said Steve Mister, CRN President and CEO.
NEC will provide label files to individual companies, marketers and distributers to submit their supplement product labels as necessary to maintain their respective membership with CRN. Find out more here.
The big picture
With many changes in a short space of time, it may seem daunting to navigate these new requirements and successfully market your products in full compliance—that’s where a knowledgeable and experienced contract manufacturer can be your best asset. NEC has an industry-recognized, regulatory department that ensures every product label meets all applicable regulations. This is our REGSAFE guarantee, which means we are personally committed to adhering to the highest industry standards and regulatory compliance. And here’s the best part—we’ve been providing this valuable service to our customers all along. We’ve been there for our customers for many years, and we will continue to help each customer stay compliant and be confident of what they put on the shelves. If you haven’t already, experience the NEC difference today!