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The law required FDA to provide NDI guidance, but no concrete hint of such guidance had come. Until now.
When I feel stressed, friends will attest, one of my favorite remedies is watching the 1982 movie “Poltergeist.” Not to force an analogy, but the dietary supplements industry is about to come face to face with a ghost from the past: New Dietary Ingredients guidance.
We’ve been anticipating FDA’s release of some kind of NDI guidance for years, since 1994 and the passage of the Dietary Supplement Health and Education Act (DSHEA). The law required FDA to provide NDI guidance, but no concrete hint of such guidance had come. Until now.
Unrealized by many, between such mandates as food facility registrations and FDA-powered recalls, the Food Safety Modernization Act (FSMA), effective in January, gave FDA a firm deadline for publishing NDI guidance. The Act states: “Not later than 180 days after the date of enactment of this Act, the Secretary shall publish guidance that clarifies when a dietary supplement ingredient is a new dietary ingredient, when the manufacturer or distributor of a dietary ingredient or dietary supplement should provide the Secretary with information as described in section 413(a)(2) of the Federal Food, Drug, and Cosmetic Act, the evidence needed to document the safety of new dietary ingredients, and appropriate methods for establishing the identity of a new dietary ingredient.”
Day 180, FDA’s deadline, is July 3. What might the guidance entail? A poster presented by FDA’s NDI review team in April, at the 10th annual International Conference on the Science of Botanicals, in Oxford, MI, provided a glimpse of what could be contained in FDA’s official guidance come July.
In effect, the poster shared examples, sort of a “Dos and Don’ts,” of why FDA has turned down NDI notifications in the past. (Thus far, notifications have had a high failure rate of 78%, says Loren Israelsen, founder of the United Natural Products Alliance/UNPA). Industry should take heed of the poster’s lessons now. Once FDA makes its expectations official through guidance, it’s possible the agency may crack down on ingredients that should have NDIs.
Some of the reasons cited for failure, unsurprisingly, include not correctly or sufficiently identifying botanical ingredients, inadequate descriptions of processing, unreliable safety studies, or inadequately provided history of use.
Two other issues cited, however, were surprising to me. First, FDA objected to a synthetically derived ingredient, stating it was not considered a dietary ingredient under CFR 201(ff)(1). Second, FDA declined one notification because the “safety of a combination of ingredients was not addressed.” These issues could have larger implications for nature-identical synthetic ingredients and product-specific versus ingredient-specific notifications, respectively.
But going back to the rejections overall, these notification failures may stem from a lack of understanding of what FDA is actually looking for in NDI notifications. If the guidance looks similar to FDA’s poster, it should provide some direction on this.
It’s also clear that companies in both the dietary supplements and food industries need a clearer understanding of NDIs-including who needs to file one. As Israelsen and Harry Rice, UNPA’s vice president of regulatory and scientific affairs, point out, many companies aren’t clear on whether they need NDI or Generally Recognized as Safe (GRAS) status, or both. They say these distinctions are now even more complicated thanks to how the FSMA subjects ingredients to food GMPs and hazard analysis and risk-based preventive controls, until the ingredients are incorporated in a dietary supplement. From that point, they are subject to dietary supplement GMPs.
“People don’t understand the differences, and now they’re going to have to make a conscious set of choices, depending on whether they plan on their ingredients going into dietary supplements, functional foods, or both,” says Israelsen. “There will be different sets of safety standards for each, and it’s going to get really confusing.” To help clear up the confusion, UNPA will host an intensive, two-day seminar on July 26-27 in Salt Lake City, with more details to come.
And back to the impending NDI guidance: “It’s really going to change things,” says Israelsen. Also, “It answers the one primary criticism of DSHEA and our industry: that it’s unregulated. When they say that word unregulated, this is what they’re talking about-this NDI process. If we do this well and show that we have some discipline and understanding of the process, it will go a great distance to getting rid of that last, final ‘unregulated industry’ mantra.”