“Using the portal helps you understand what information is required by the agency. I think it could be very helpful because having looked through all the NDIs from day one I have seen many that were rejected because they did not comply with the basic form,” Alex Schauss, senior director of AIBMR, told NutraIngredients-USA. AIBMR is a Seattle-based scientific and regulatory consultancy that has helped a number of dietary supplement companies with GRAS and NDI submissions.
Although the industry is becoming more sophisticated as experience with the NDI submission process accrues, companies still make basic mistakes. Schauss, who has given the online portal a test drive, said using the tool will prompt companies to have the correct data in the correct order, and will alert users when things are missing.
“Using the portal will force people to take a much more careful look at how complete the information they are submitting is,” Schauss said.
Comprehensiveness, not convenience
Having the process online doesn’t mean is will be easy, Schauss said. While the process might be somewhat more convenient than submitting all the information on paper through the mail (which is still an option), convenience is not the primary goal; the goal is to make sure the information is complete.
“People who have experience may be able to get through the process fairly quickly. For others, I think it will take a number of hours to complete,” he said.
“Form FDA 3880 prompts a submitter to input the elements of a new dietary ingredient notification (NDIN) in a standard format and helps the submitter organize its NDIN to focus on the information needed for FDA’s safety review. Safety information will be submitted via a supplemental form entitled “New Dietary Ingredient Safety Information.” This form provides a standard format to describe the history of use or other evidence of safety on which the manufacturer or distributor bases its conclusion that the new dietary ingredient will be reasonably expected to be safe,” the agency said in the statement announcing the new system and the opening of the public comment period.
Schauss said even with the prompting that will be provided by the new portal, companies going to the time and expense of a submission would be well advised to spend a little more to get competent help.
“It pays to come to a company that has experience in the process. There are individuals who have come to us and have said they think there has been 4,000 years of exposure to the ingredient and that is why they believe it is safe. We explain to them all the kinds of data that would substantiate that claim. Sometimes, based on the composition of the ingredient, we might recommend test beyond what they normally might expect for a dietary supplement ingredient. The real work is done before you ever get to the online portal,” Schauss said.
NDI notifications are required on any potential new supplement ingredient that cannot be shown to have been on the market as an article of food at the time of the grandfather date set up in DSHEA of Oct. 15, 1994. While interpretations of what that means varies, FDA has taken lately to reiterating its position that new extracts of trace chemicals that can found in botanical sources but are now being presented in concentrated form mostly likely would need an NDI notification. (The recent case of anatabine citrate, found in small amounts in various fruits and vegetables, is an example. Star Scientific, now doing business as Rock Creek Pharmaceutical, received a warning based in part on the missing NDIN.)
A revised NDI Draft Guidance that is expected to clarify this and some other issues surrounding the process is expected to be released sometime soon. The guidance has had a meandering journey, having first been released in 2010 to a storm of industry criticism. In early 2011 FDA agreed to revise the guidance to take into account industry feedback, and after a series of high level meetings with industry stakeholders the matter has hung fire, perhaps held up by vacancies at top positions within FDA.