FDA's perceived failure to act aggressively on NDI enforcement has given companies in the supplement industry little incentive to follow the rules, according to several sources interviewed in recent months.
At a recent conference, the leader of a dietary supplement trade group suggested FDA has “a credibility gap.”
The Sept. 16 remarks by Steve Mister of the Council for Responsible Nutrition (CRN) followed a speech from earlier that day by Steven Tave, an FDA official who identified a “regulatory gap,” that he described as the chasm between requirements in the law and what can be “realistically” achieved through enforcement.
That “gap,” Mister suggested during the Dietary Supplements Regulatory Summit, “is way too broad and it’s created a bigger problem from FDA, not an enforcement gap but what I would call a credibility gap or even a threatability gap.”
FDA has not enforced the new dietary ingredient notification (NDIN) requirement of the Dietary Supplement Health and Education Act of 1994 (DSHEA) since its enactment, “and therefore, there’s no perceived threat from FDA for noncompliant companies,” according to Mister, president and CEO of CRN.
The referenced provision is a crucial one in the law: Subject to an exemption related to an ingredient previously in the conventional food supply in a form not chemically modified, before marketing an NDI, a manufacturer or distributor must first provide FDA evidence to establish its safety in a supplement. FDA has received less than 1,200 NDINs since the law was signed by former President Bill Clinton—leaving industry observers and FDA officials to conclude that many companies have failed to meet the statutory requirement.
“And the lack of [NDI] filings may very well be directly related to the fact that there are no incentives to comply and no threat of enforcement if you don’t,” Mister added during the virtual summit.
Setting the ‘record straight’
His comments caught the attention of Tave, who directs the Office of Dietary Supplement Programs (ODSP). In a Q&A during the event, Tave said he “respectfully” disagreed with Mister’s conclusions.