NDIs discussed at FDA led public meeting
meeting, as announced last month, giving industry and consumers the
chance to discuss the government body's premarket notification
program for new dietary ingredients (NDIs).
Industry bodies such as the National Nutritional Foods Association (NNFA) and the Council for Responsible Nutrition (CRN) expresed their gratitude at having been given this opportunity to contribute to resolving the problems surrounding NDIs, before expressing their wishes for the future.
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.
"What everyone in the industry needs is clear guidance," said David Seckman CEO of the NNFA testifying at the public meeting. "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 focussed on the joint necessity of having NDI guidelines that were clear, but at the same time not overally 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.
The FDA noted that yesterday's meeting had been prompted by the receipt of a "number of omissions and other problems" in notifications sent in by various players to comply with the NDI legislation.
More specifically the FDA said that certain companies had failed to "adequately describe the identity and composition of the NDI", to provide enough information proving that the substance was an NDI or to put forward comprehensive safety information.
