Applicants must submit evidence to support a claim they wish to make associated with the product, with NHPD allowing therapeutic claims, risk reduction claims and structure-function claims, in addition to non-specific claims.
Any products with an identified health risk are an immediate priority for NHPD enforcement activity.
The process of acquiring an NPN involves submitting a product license application to NHPD along with safety and efficacy information to support the claim.
NHPD has posted numerous monographs, so if a company wishes to make a simple monograph claim, they need only refer to the monograph and a shorter turnaround time theoretically applies.
It quickly became apparent under the new regulations that the NHPD would be unable to deliver the quick turnaround times it originally predicted and that a backlog of product submissions would evolve.
One challenge to this system is that the ingredient files are not reviewed for completion by NHPD until they are actually referenced in an NPN submission.
In an April presentation to industry, NHPD admitted that because of the current backlog in product approvals, a system redesign would be required for a long-term solution.
On the positive side, NHPD has eliminated its backlog in logging and analysis of submissions, allowing it to focus on evaluation.
Other recent communications from NHPD involve marketing and enforcement strategies.
And when you use the information line set up by NHPD, a response is rare.
Wojewnik highlighted the monthly and quarterly communications issued by NHPD as providing excellent general information about the status of NHPD, as well as compliance and enforcement.