WASHINGTON — The Food and Drug Administration on Tuesday published long-awaited guidance on new dietary ingredients in the Federal Register.
Once enacted, the guidance will establish an additional pillar of credibility to the dietary supplement industry, adding to the veracity building across the industry with the implementation of a codified, supplement-specific good manufacturing practices; the adoption of the mandatory reporting of serious adverse event reports; industry efforts to educate lawmakers and healthcare professionals around the benefits of supplementation; and an industry-sponsored initiative with the National Advertising Division of the Better Business Bureau to help the industry self-regulate inaccurate advertising claims.
Specifically, the guidance establishes a protocol around when a supplement manufacturer must file a premarket safety notification of a dietary supplement containing a new dietary ingredient. The guidance addresses in question-and-answer format what qualifies as an NDI, when an NDI notification is necessary, the procedures for submitting an NDI notification, the types of data and information that the FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing an NDI, and what should be included in an NDI notification. In addition, the guidance contains questions and answers about parts of the dietary supplement definition that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement.
“The dietary supplement industry has eagerly awaited this guidance in the hope that it will provide clarity and an appropriate framework for introducing new ingredients and products into the supplement marketplace,” Council for Responsible Nutrition president and CEO Steve Mister said. “This draft guidance ... represent[s] an important step for the dietary supplement industry — and for the agency — as it demonstrates further implementation of the requirements of the Dietary Supplement Health and Education Act and will give companies clearer understanding of [the] FDA’s expectations under the law.”
To help explain the nuances of the new guidance for the industry, the Natural Products Association will host a webinar conference on July 11. Speakers will include Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDA’s Center for Food Safety and Applied Nutrition; Scott Bass, head of the Global Life Sciences Team at Sidley Austin; Cara Welch, Natural Products Association VP scientific and regulatory affairs; and John Gay, Natural Products Association executive director and CEO. To join the call register here.
Review the draft guidance here.