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FDA Extends NDI Draft Guidance Comment Period by 60 Days

ROCKVILLE, Md.—FDA extended the comment period for its New Dietary Ingredient (NDI) Draft Guidance by 60 days to Dec. 2, 2011. The extension came one month after five industry trade organizations requested FDA to extend the comment period by 45 days.

“It is important for the industry to use these additional 60 days prudently and continue to prepare comments that reflect the gravity this document holds for the industry, but also work toward a solution where all are satisfied," said Cara Welch, Ph.D., vice president of scientific and regulatory affairs, Natural Products Association (NPA).  “Both FDA and industry want to find that common ground where the law is upheld and this industry can continue to thrive."

NPA, along with the American Herbal Products Association (AHPA), the Consumer Healthcare Products Association (CHPA) , the Council for Responsible Nutrition (CRN) and the United Natural Products Alliance (UNPA) requested a 45-day extension for comments, asking for a deadline of Nov. 17, 2011.

“CRN appreciates that FDA has provided an extension to submit comments for the New Dietary Ingredient Draft Guidance," said Steve Mister, president and CEO, CRN. "The Draft Guidance will provide critical direction for the industry. The extension will give us the opportunity to provide a more thoughtful and comprehensive response.”

While Loren Israelson, executive director, UNPA, said the extension was not a surprise, he said it will help UNPA submit formal comments. "Remember, this is a draft guidance; you can file comments anytime you want, so this simply revises the rolling timetable for general comments," he said. "Given the scope of the issues, it is our sense there will be complementary comments going in from various parties even after the extension. I image we will file supplementary comments after the new filing date as well." He added, "There’s still a lot of road to travel on this issue."

Last week, Jarrow Formulas, a dietary supplement company,requested FDA extend the comment period by one year; however, FDA chose to extend the comment period by an additional two months. "It is probable that the request for one year by Hyman Phelps & McNamara (HPM) and Jarrow Formulas made them decide to give 15 days beyond the 45 requested by the trade associations," said Jarrow L. Rogovin, president and chariman of the board, Jarrow Formulas Inc. (JFI). "Obviously, JFI strongly disagrees and see the Draft Guidance as contrary to the public health policy enunciated in DSHEA. What we have here is a pathetic 60-day stay of execution." He said JFI has will not file comments until FDA responds to its 128 Freedom of Information Act (FOIA) requests. JFI is currrently preparing a FOIA request to FDA regarding the impact of the proposed NDI Guidance, asking about cost, enforcement, public health effect and innovation impact.

The original 90-day deadline for comments regarding FDA’s “Draft Guidance for Industry; Dietary Supplements: New Dietary Ingredient Notifications and Related Issues," was Oct. 3, 2011; the document was released in the Federal Register on July 5, 2011 (76 FR 39111).

The agency said it considered the request for a 45-day extension of the comment period and decided to extend the comment period because, “The agency believes this extension allows adequate time for interested persons to submit comments without significantly delaying action by the agency."

Welch added, “We were pleased FDA granted our extension request and even went beyond our 45 days to offer 60 days.  FDA is aware of the importance of this document and of drafting comments in response to it. The extra time FDA offered was not expected, but is welcome." She said NPA is currently working with its members and industry colleagues to compose comments that explain its issues with the Draft Guidance and also offers possible solutions in line with the Dietary Supplement Health and Education Act of 1994 (DSHEA). “The extra 60 days will be essential in providing this feedback to the agency," she said.

Comments can be submitted in writing to the Division of Dockets Management (HFA-305), Food and Drug Administration; 5630 Fishers Lane, rm. 1061; Rockville, MD 20852, or electronically ( All comments should be identified with the docket number FDA-2011-D-0376.

For a chance to ask industry experts about filing comments, be sure to attend the NDI Town Hall event at SupplySide West, set for Oct. 12 from 2 to 5 p.m. in Las Vegas.

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