FDA’s EMPHASIS ON NEW DIETARY INGREDIENT NOTIFICATIONS
LSRO provides expert guidance through a difficult process
Press Release
LSRO provides expert guidance through a difficult process
Be Prepared for the FDA’s Emphasis on New Dietary Ingredient Notifications
The Food and Drug Administration’s (FDA’s) newly released New Dietary Ingredient (NDI) Notification Draft Guidance1 has stirred up a hornet’s nest of commentary. Cries of “attack on DSHEA” and “perversion of congressional intent” have been answered with “take a deep breath and don’t panic” and “guidance is entirely reasonable”. While it is not clear what the final guidance will say or how it will be enforced considering the FDA’s limited resources and competing priorities, it is perfectly clear that the entire dietary supplement industry, manufacturers and distributors alike, must prepare for closer FDA scrutiny. The costs of ignoring the rules can be severe.
Are you prepared to answer all of these questions?
LSRO has an unrivalled success rate in guiding our clients through this overwhelming and difficult process.
Call on LSRO to help you:
LSRO’s staff has experienced doctoral-level scientists with the necessary expertise to make your process successful. Moreover, LSRO draws on the expertise of scientific professional organizations and thousands of experts. Plus, LSRO provides exceptional service that is reliable, respected, credible, fair, independent, and responsive to client needs. When you think LSRO, think value added and cost-effective.
The depth of our experience with the FDA, coupled with our excellent service and verified track record, make LSRO the most trusted scientific experts for the food and dietary supplement industry.
For more information visit our website at www.LSRO.org;
or contact Michael Falk • 301-634-7030 • Fax 301-634-7876 • FALKM@LSRO.ORG
1FDA Draft Guidence Document
The Food and Drug Administration’s (FDA’s) newly released New Dietary Ingredient (NDI) Notification Draft Guidance1 has stirred up a hornet’s nest of commentary. Cries of “attack on DSHEA” and “perversion of congressional intent” have been answered with “take a deep breath and don’t panic” and “guidance is entirely reasonable”. While it is not clear what the final guidance will say or how it will be enforced considering the FDA’s limited resources and competing priorities, it is perfectly clear that the entire dietary supplement industry, manufacturers and distributors alike, must prepare for closer FDA scrutiny. The costs of ignoring the rules can be severe.
Are you prepared to answer all of these questions?
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What kinds of changes in extraction technique/formulation/condition of use will trigger the need for a fresh NDI notification? |
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What kinds of studies, if any, will be required to demonstrate safety? |
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Can you use safety data from an approved product to justify safety of a related product? |
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Who should submit the NDI notification, supplement manufacturers or ingredient suppliers? |
LSRO has an unrivalled success rate in guiding our clients through this overwhelming and difficult process.
Call on LSRO to help you:
|
Evaluate your ingredient/supplement and advise you as to whether NDI notification is necessary |
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Critically review the literature and safety data of your supplement or ingredient |
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Determine your data needs |
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Specify and set priorities for your safety study needs |
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Prepare a NDI notification dossier for submission to FDA |
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Guide you through the entire process |
LSRO’s staff has experienced doctoral-level scientists with the necessary expertise to make your process successful. Moreover, LSRO draws on the expertise of scientific professional organizations and thousands of experts. Plus, LSRO provides exceptional service that is reliable, respected, credible, fair, independent, and responsive to client needs. When you think LSRO, think value added and cost-effective.
The depth of our experience with the FDA, coupled with our excellent service and verified track record, make LSRO the most trusted scientific experts for the food and dietary supplement industry.
For more information visit our website at www.LSRO.org;
or contact Michael Falk • 301-634-7030 • Fax 301-634-7876 • FALKM@LSRO.ORG
1FDA Draft Guidence Document
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For nearly half a century, the Life Sciences Research Office (LSRO) has provided expert, objective scientific opinions and evaluations to governmental agencies and leading corporations in the food, health and bioscience sectors. A non-profit organization originally established in 1962, LSRO provides independent science-based analysis and advice that has proven integral to the development of sound policies and regulations on the national and international level.
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