In comments submitted to FDA dated October 13, 2011, Herbalife states it “supports the need for more and better NDI submissions that over time will safeguard consumers and make it harder for irresponsible marketers to remain in business”.
The company’s six specific ways to improve the functionality of the guidance are:
• Permit NDI Master Files and Allow for Follow-On Simplified Notifications,
• Protect Intellectual Property,
• Provide greater clarity for “Grandfathered” Lists of Dietary Ingredients,
• Resolve Discrepancies between Treatment of Synthetically Derived Botanicals and Metabolites,
• Bring Transparency to a Formalized NDI Process in which FDA defines the criteria to ensure a consistent approach by its NDI reviewers, and
• Clarify the exceptions to notification requirements for certain NDIs with a history of use in conventional foods.
In an email to NutraIngredients-USA, John Venardos, senior VP, worldwide regulatory, government and industry affairs at Herbalife, confirmed that the comments have been shared with CRN, AHPA, NPA and UNPA.
IP
The company expressed “concern” in ensuring confidentiality associated with intellectual property. As such the company has asked FDA to revise the NDI guidance to include a numbering protocol and for FDA to respect the intellectual property of filers.
“It is important that FDA identify which sections of NDI filings will be considered as commercial trade secrets.
“It is recommended that Dockets write to the entity submitting the NDI to confirm which pages of each NDI submission will be considered as business confidential and accordingly redacted.”
Transparency
The Los Angeles-based company has also called for procedural transparency to provide FDA, industry, and observers – including Congress, the public, and other interest groups – with an easy way of following the progress of a pending NDI filing, and also to plan product development.
Such transparency could be achieved in five simple steps, said the company:
1. FDA would open a master file with a submission number upon receipt of a NDI notification;
2. The agency would then conduct a review of the documents to ensure all the necessary elements are present – the quality of the information would not be reviewed at this stage;
3. An accept-or-reject notice would then be published, and, if accepted, the 75-day review period would start;
4. FDA has 75 days to conduct its substantive review;
5. Finally, FDA would publish its decision.
Notification demands
In an exclusive interview with NutraIngredients-USA this week, Daniel Fabricant, PhD, director of the division of dietary supplement programs at the FDA reiterated that comments submitted to the agency led to the conclusion that the average time to compile notifications for an NDI was 20 hours.
This view has been challenged by industry stakeholders. Herbalife’s Venardos told Nutraingredients-USA that the company thinks “the time to properly prepare an NDI submission is closer to 80-100 hours”.