Fees: New Dietary Ingredient Pre-Market Notification Submission
The fee for a New Dietary Ingredient Pre-Market Notification Submission is $1495. This service addresses a challenge facing companies producing or distributing dietary supplements containing new dietary ingredients for retail sale in the U.S. If a dietary supplement contains a dietary ingredient that has not been present in the food supply or used in dietary supplements before 1994, the FDA requires you to provide documentation as to why you believe the consumption of the dietary ingredient can be reasonably expected to be safe at least 75 days before introducing the product to the US market. Registrar Corp assistance with submission provides the following benefits:
A team of Regulatory Specialists who examine each element of your documentation in relation to the FDA's requirements for submissions of New Dietary Ingredient Notifications.
Guidance as to formatting requirements and concise presentation to allow FDA officials to quickly and efficiently complete their review.
Multilingual assistance throughout the submission process; if the FDA requests additional information or clarification of materials, Registrar Corp will work with you to complete these supplemental submissions at no extra cost to you.
Registrar Corp assists businesses with U.S. FDA compliance. Certificates of Registration issued by Registrar Corp provide confirmation to industry that you are fulfilling U.S. FDA registration requirements. U.S. FDA does not issue or recognize Certificates of Registration. Registrar Corp is not affiliated with the U.S. Food and Drug Administration.
