FDA extends NDI comment period
which to send their comments to the FDA regarding the premarket
notification program for new dietary ingredients (NDIs).
The FDA has agreed, according to the American Herbal Products Association, to extend the comment period for a further 60 days.
The government body originally published a notice on 20 October to solicit comments on numerous issues related to NDIs and set a 45-day comment period, which ended on 3 December. The AHPA, along with four other trade assoiations, submitted a request for the extension that means comments will now be due in early February.
The FDA tried to give the debate more prominence by holding a public meeting on 16 November, giving industry and consumers the chance to discuss the premarket notification program for NDIs.
Industry bodies such as the National Nutritional Foods Association (NNFA), the Council for Responsible Nutrition (CRN) and the AHPA all voiced their opinions at the meeting.
"What everyone in the industry needs is clear guidance," said David Seckman CEO of the NNFA. "Specifically, the NNFA believes that section 413 [the clause of DSHEA that deals with NDIs] is unclear as to when a NDI notification is required and the type of information to be included if a premarket notification is filed."
While he was insistent on the need for clarity, Seckman also noted the desire for flexibility in any new regulations, for example, in the type of evidence required for a NDI.
The CRN's opinion was put forward by the body's president Annette Dickinson. Her speech too focused on the joint necessity of having NDI guidelines that were clear, but at the same time not overly rigid.
As noted by Peter Barton Hutt, a lawyer at Covington & Burling, who spoke at the meeting at the request of the CRN and the Consumer Healthcare Products Association, the new standards should be "practical and real world" not "unrealistic and impractical".
"The FDA has the opportunity to establish a less rigid and more practical system that will nonetheless adequately protect the public," said Barton Hutt.
A NDI is defined as one that was not marketed prior to the passage of the Dietary Supplement Health and Education Act (DSHEA) of 1994. Before such ingredients can be marketed, safety data must be reviewed and accepted by the FDA.
