Degree Of Difficulty Could Climb For Industry's NDI Investments To Continue
"Can we maybe as an industry, and I guess the FDA, agree not to overcomplicate the NDI process in the sense that it's actually pretty easy to navigate the process and understand what you have," says Frank Jaksch, Chromadex co-founder and executive chairman. "I want to encourage companies to do the right thing," says Mark LeDoux, founder, CEO and chairman of Natural Alternatives Internationa. "Our firm spent millions of dollars and went through the front door of the FDA. … This is not a difficult process to do the right thing."
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Consumer Healthcare Products Association, Council for Responsible Nutrition and United Natural Products Alliance model proposed NDI-master file framework on US Drug Master File FDA has accepted for decades. System would not be administered by FDA, but the agency’s support is critical for helping manufacturers protect their investments in research for information supporting NDI notifications.
Since Council of Better Business Bureaus investigators in May 2018 asked about claims for Tru Niagen, ChromaDex pulled the ads while reaching milestones in product distribution and ingredient licensing.
"I think dietary supplement is a pathway where the agency can get data to protect public health and folks in the industry that have spent time and treasure on CBD will get a chance to try and market it," says Bob Durkin, former FDA ODSP deputy director. NDI notifications for CBD ingredients should focus on safety in the formulation of a particular product, not about the substance generally, he says.