FDA Releases NDI  Draft Guidance

WASHINGTONFDA issued its updated draft guidance on new dietary ingredients (NDIs), which the agency said is intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a NDI is necessary. The guidance is also designed to help industry prepare NDI notifications.

The draft guidance is laid-out in a Q&A format and explains the definition of an NDI, when an NDI notification is necessary, the procedures for submitting a NDI notification, the types of data and information that FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing a NDI, and what should be included in a 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 document keeps the stance that an NDI is an ingredient not marketed in the United States before Oct. 15, 1994, when the Dietary Supplements Health & Education Act of 1994 (DSHEA) was enacted, and it still maintains the manufacturer or distributor of a NDI, or of the dietary supplement that contains the NDI, to submit a premarket notification to FDA at least 75 days before introducing the supplement into interstate commerce.

A few highlights of the NDI draft guidance include:

At this stage, the guidance is only for comments, and it does not update current legislation. Although FDA allows comment on the guidance at any time, to ensure the agency considers comments before it begins work on the final version of the guidance, industry members need to submit either electronic or written comments on the draft guidance within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance.

This draft guidance is required as part of the FDA Food Safety Modernization Act (FSMA), which was signed into law in January 2011.The FSMA required FDA to publish, not later than 180 days after the date of enactment.

In the document, FDA said it an estimated 55,600 dietary supplement products on the market, and FDA has received approximately 700 NDI notifications since it began reviewing NDI notifications approximately 16 years ago. Additionally, the Institute of Medicine estimated that 1,000 new dietary supplements are introduced to the market each year. These figures, coupled with recent concern by both the agency and industry regarding the presence of undeclared active ingredients in products marketed as dietary supplements, highlight the necessity for marketers of dietary supplements to submit NDI notifications as an important preventive control to ensure that the consumer is not exposed to potential unnecessary public health risks in the form of new ingredients with unknown safety profiles," according to FDA.

In response to the release the draft guidance, Steve Mister, president and CEO, Council for Responsible Nutrition (CRN), said CRN hopes it will provide clarity and an appropriate framework for introducing new ingredients and products into the supplement marketplace. As FDA has reminded us, this draft guidance document describes the agencys interpretation of the requirements for NDIsit is not a new regulation and does not create new rights or responsibilities for the industry," he said.

However, Mister said this draft guidance represents an important step for the dietary supplement industry because it gives companies clearer understanding of FDAs expectations under the law. We will now thoughtfully review the guidance which we view as FDAs best thinking on the subject and will respond with the industrys best thinking, which we trust FDA will take seriously." 

Cara Welch, vice president of scientific and regulator affairs, the Natural Products Association (NPA) , said the guidance is a game changer for the industry that answers a lot of preliminary questions. Whether it ends up being a good or negative game changer depends on the way the industry can adapt, she said. Welch said the guidance also raises concerns about its impact on the ability of Americans to get the supplements they need.

She noted two specific things that could change the market. First, is the question of when an NDI is necessary. This is adequately answered in the guidance, she said, but, Our preliminary analysis says what companies need to provide to prove an ingredient was on the market prior to DSHEA is higher than most makers are able to produce, and we wonder if that was the point of DSHEA. Second, she said safety testing requirements for NDI notifications may be at a higher level than intended by DSHEA.

NPA will host a webinar conference call, NDI Guidance: What You Need to Know," on July 11, 3:30 p.m. Eastern, with speakers including Daniel Fabricant, director of the Division of Dietary Supplement Programs at the FDAs Center for Food Safety and Applied Nutrition (CFSAN); Scott Bass, head of the Global Life Sciences Team at Sidley Austin LLP; Dr. Cara Welch, NPA vice president of scientific and regulatory affairs; and John Gay, NPA executive director and CEO. The speakers plan to discuss how the guidance clarifies when a premarket safety notification is necessary and what information is expected for NDI notifications.

Earlier this week, The American Herbal Products Association (AHPA) updated and relaunched its NDI Database and its Notifications Submissions Package in anticipation of the release FDAs guidance on NDIs. "Even though the guidance is not binding, we should all be concerned about any attempt by FDA to use this forum to change the rules and practices that have been accepted and in place for 17 years," commented Michael McGuffin, AHPA president.  AHPA will host an educational seminar, "FDA's New NDI Guidance: What You Need to Know," which will be scheduled within the next several weeks to ensure.

Other industry members are having their say on the SupplySide Community, where users can post comments on their take on the NDI draft guidance.

FDA was scheduled to release the guidance on Tuesday, July 5, but released it four days earlier.