NDI Draft Guidance Questions: You Asked, FDA Answered (Part II)

To see part one, which appeared Monday, please click here. Today, the rest of the answers, courtesy of Daniel Fabricant of FDA.

So, dear readers, what do we think? Post comments or start a discussion. Or you can even tell the FDA, just like CRN just did.

When will FDA start taking enforcement action against companies/products that are not in compliance as defined by this [NDI] guidance?

The agency is working hard to both develop new ideas and enhance our current capabilities with respect to enforcement, deterrence, and promoting compliance; including NDI notifications. However with that stated, this is a guidance, it does not convey any new binding authority to the agency, it only clarifies our thinking on the topic. Should there be increased enforcement/regulatory action on NDI's, it would simply be coincidental.

How open will the FDA be to making changes to the NDI guidance based on well-supported comments?

Anyone can submit comments concerning new rules, regulations, and guidance documents being considered by the Food and Drug Administration and these suggestions can, and do, influence the agency's actions. When someone sends in a comment based on sound grounds, that comment can definitely make a difference in the agency's decision-making.  It is important to remember that guidance documents represent the agency's current thinking on a particular subject and are not usually enforceable rules or requirements by themselves, but serve more to define standards or expectations. 
 

Does FDA have any suggestions as to how companies can prepare for NDI draft guidance?

Again, guidance documents represent the Agency's current thinking on a particular subject.  Another way to understand the purpose of a guidance document would be to think of it as a set of instructions to help industry understand the agency's expectations.  Guidance documents are not usually enforceable rules or requirements by themselves, but serve more to define standards and expectations and in this case it would be to more clearly communicate the new dietary ingredient requirements under Dietary Supplement Health and Education Act of 1994 (DSHEA). With this in mind, companies would be preparing by following the requirements as outlined in DSHEA where as the guidance document serves as a tool to help them meet those requirements.

Without an official "old dietary ingredient" list, how is a company new to the industry expected to be able to prove grand-fathered status of a dietary ingredient?

A comprehensive answer to that question can be found on pages 11-13 of Docket No. FDA-2005-P-0259 (formerly Docket No. 2005P-0305), (http://www.regulations.gov/#!documentDetail;D=FDA-2005-P-0259-0004;oldLink=false) the FDA response to a Petition filed by Biostratum, posted on January 12, 2009.  In general, there needs to be independent, verifiable evidence that the article itself has been offered for sale in the U.S. as a dietary supplement pre-DSHEA.  Some examples that may likely meet the evidentiary burden examples include but aren't limited to: catalogs; price lists, business records (shipping records, bills-of-lading); and advertisements.

Will the FDA really be able to handle the amount of submissions that will be coming in to them?

The goal of the NDI guidance is two-fold.  First, we want to increase compliance with the NDI requirements set forth in DSHEA which would absolutely mean more submissions coming in to the NDI review team. However, the second goal of the guidance is to enhance the quality of those submissions, so although we will be be receiving a higher volume, the increased quality of the information will reduce the amount of follow-up necessary and thus serving to offset the influx.