The Natural Products Association has called on the U.S. Food and Drug Administration to substantially revise the New Dietary Ingredients (NDI) draft guidance document. In comments on the guidance submitted on the Federal docket, NPA requested that FDA rewrite the guidance to reflect that the NDI process should be about ingredients, not finished products. It also called for a revision of the status of Old Dietary Ingredients (ODIs) as well as calling for eight other specific revisions.
“In this draft guidance, the FDA significantly oversteps the authority given to it by Congress in DSHEA,” said NPA Executive Director and CEO John Gay in a statement to the media. “Therefore, a substantial rewrite of the guidance is necessary.”
“The draft guidance sets up a de facto food additive safety standard, which directly contravenes the intent of Congress in DSHEA,” said Cara Welch, NPA vice president for scientific and regulatory affairs.
The NPA comments state that the guidance document improperly shifts the burden of proof of what qualifies as an ODI (i.e., an ingredient that was on the market prior to the October 1994 grandfather date) onto industry. The association states that FDA should be obligated to prove that an ingredient is unsafe and to then request history of use.
NPA also takes issue with FDA’s position in the guidance that the several extant industry lists of ODI ingredients are of no value. “FDA should accept the submitted industry lists as a rebuttable presumption of pre-DSHEA status,” the comments state.
NPA also specifically rejects the notion that new finished products containing a NDI should be required to file a full-blown safety notification before going to market. “DSHEA places the burden on FDA to prove that dietary supplements are unsafe,” the comments state. As an alternative, NPA recommends a clarification of an “administrative” filing, suggesting a finished product manufacturer could merely reference safety information pertaining to the NDI that would already have been submitted by the ingredient manufacturer. NPA also wants clarification of whether identical finished products each need their own filing, which is what seems to be called for in the draft guidance.
Science for supplements, not food additives
In other portions of the comments, NPA takes issue with the standard of proof that the guidance seems to call for. DSHEA specifically states that dietary supplements are not to be regulated as foods, NPA stated, and the level of safety data specified in the draft guidance goes well beyond that needed to conclude that a dietary ingredient will “reasonable by expected to be safe.”
NPA also called for specific revisions on portions of the guidance pertaining to probiotics and synthetic botanicals, and wants FDA to expand the definition of what does not constitute chemical alternation. Stated another way, the NPA wants to shorten the list of new manufacturing processes that would take an ODI into NDI territory.
“Through DSHEA, Congress envisioned a system that would allow products already on the market to remain available to the consumer while creating a reasonable mechanism for new ingredients to enter the market,” Gay said. “The draft guidance does neither. Rather, it proposes an NDI process that would result in dampened innovation, more expensive and fewer products, and excessive paperwork, robbing the industry and FDA of scarce resources.
“The industry needs clarity for the rules governing the NDI process, but those rules must be consistent with DSHEA,” he said.