The Council for Responsible Nutrition has called upon the Food and Drug Administration to withdraw its draft guidance on New Dietary Ingredients, saying it “far exceeds the permissible scope of a guidance document, proposing substantive requirements that must be the subject of notice-and-comment rulemaking.”
It is the second time in the past few days that a major industry group has asked FDA to start over on the NDI draft guidance. On Nov. 30, the Natural Products Association filed comments to the Federal docket asking for a substantial rewrite of the document. Dec. 2 ends the comment submission period for NDIs.
“Many of the basic premises of the draft guidance simply exceed FDA’s authority under the law. So whether you call it a rewrite or a withdrawal or whatever, the same thing needs to happen,” said Steve Mister, president and CEO of CRN.
“The industry needs some clarity in the short term so that they understand that this document is not going to be the basis for enforcement.”
In its comments filed this morning, CRN lays out five major areas in which the guidance should be rewritten to conform to the “letter and spirit of DSHEA.”
The comments, in which CRN was joined by the Consumer Healthcare Products Association, unequivocally assert that the draft guidance violates the provisions of the Dietary Supplements Health and Education Act (DSHEA). CRN said the guidance as it stands “would bring a return to the pre-DSHEA regime” and “would convert the NDI notification process into a requirement of premarket proof of safety indistinguishable from the food additive requirement.” Industry observers have long maintained that precluding a system of premarket approval was one of the primary objectives of DSHEA when it was passed in 1994.
CRN takes serious issue with NDI draft guidance on whether the NDI process should be ingredient- or product-specific, and comes down strongly on the ingredient side. “We strongly urge FDA to delete its proposal to require duplicative data submissions by every single manufacturer,” the comments state.
Improper use of food additive standards
CRN also criticizes the draft guidance in its references to the "Redbook," the official FDA manual for assessing food additives. DSHEA made a specific distinction between dietary supplements and food additives, CRN states, and the draft guidance in its present form undoes this. In so doing, it requires a level of safety data to meet the food additive bar, which is a “reasonable certainty of no harm,” not the dietary supplement standard in DSHEA of a “reasonable expectation of safety.”
The comments also urge FDA to reverse its stance on synthetic botanicals. Take the example of lycopene. The draft guidance says lycopene that is derived from chemical synthesis cannot be a dietary ingredient, whereas lycopene that comes from a tomato is good to go, even if the molecule is identical in both cases. CRN rejects this notion, and says synthetic botanicals should be allowed to be sold (in fact, large quantities of synthetic botanicals are on the market now). The trade group also takes issue with FDA shifting to manufacturers the burden for proving whether an ingredient fits into the Old Dietary Ingredients category or should be the subject of a NDI notification. And the comments say that FDA got it wrong on the subject of chemical alteration, and that the draft guidance would improperly place many ingredients whose manufacturing processes have evolved over time into the NDI category.
Even though the comments document is 38 pages long, it doesn’t include everything that industry considers problematical in the NDI draft guidance. It says nothing about probiotics, fish oil or enzymes, for instance.
Mister said CRN was under the impression that a group of probiotics companies was planning to comment on the portions of guidance that pertain to their products. Similarly, he said enzyme manufacturers were planning to file comments (the deadline for which is today) specific to their concerns. And GOED, the group representing omega-3s companies, has already filed comments.
“We felt we needed to address those umbrella issues that are across the board. We felt it better to let individual groups or companies address specific things. Otherwise we could have had a 100-page document,” Mister said.
In the end, CRN says the NDI draft guidance “contradicts DSHEA, Congressional intent and 17 years of agency policy, while having no basis in either sound science or public health policy.”