New Dietary Ingredient Notification Draft Guidance Must Be Withdrawn – CRN and CHPA

FDA should replace the current new dietary ingredient notification draft guidance with one that better aligns with the Dietary Supplement Health and Education Act, the Council for Responsible Nutrition and Consumer Healthcare Products Association say.

In Dec. 2 joint comments, the trade groups ask FDA to withdraw the existing NDI notification draft, a stronger stance than the one taken by the Natural Products Association, which suggests FDA substantially rewrite the draft.

CRN and CHPA also are concerned about FDA publishing and taking comments on the draft guidance so close to a presidential election.

Council for Responsible Nutrition President and CEO Steve Mister said federal agencies tend to go quiet during election years to avoid creating controversy that might hurt the sitting administration. But if FDA does nothing after receiving the comments and the current guidance remains in draft form, industry faces a long period of uncertainty.

“We’re worse off than before we had a guidance, because now we have something we really think is unworkable but we don’t have clarity that FDA’s not going to enforce it,” Mister said in an interview.

Even if FDA does not decide to write a guidance that compromises with industry’s concerns, the agency should at least say it will scrap the current draft, he added.

“Then as the election year goes along, at least we have some clarity as to the status. To not do that leaves the industry worse off.”

Should FDA not withdraw the guidance, industry may work with its allies in Congress to pressure the agency. Work on the draft guidance “doesn’t end on Dec. 2,” the deadline for comments, Mister added.

Members of Congress have introduced legislation to clarify FDA’s rulemaking and guidance authorities, and stakeholders in other FDA-regulated industries are touting legislation that “would tend to fence in FDA a little bit to keep it from going out of bounds,” Mister said.

Moreover, the anti-regulation message of those bills is encouraging to CRN. “We think that our message that FDA has gone too far … plays well in that environment,” Mister said.

The guidance represents only FDA’s thinking on compliance with the NDI notification requirement, so industry cannot sue to stop the agency from processing the draft into a final guidance until FDA takes enforcement action because no harm has been done, Mister said.

“We are concerned that what they’re doing exceeds their authority under DSHEA. That would argue that if they try to enforce it, that we should protect those rights,” he said.

The industry wants a strong NDI policy that is enforced robustly, Mister said. “We all know that there are ingredients out there that are clearly NDIs that don’t have a notification and should,” he said. “We’d like to see the FDA deal with those things that are clearly out of bounds.”

The Ingredient, Not The Supplement

CRN and CHPA’s comments focus on five common themes in industry discussion following the release of the draft guidance in July.

First, the groups emphasize that DSHEA and FDA policy support filing NDI notifications only for a new ingredient rather than any supplement containing that ingredient.

The agency’s acknowledgements of ingredient-focused notifications without objection “demonstrate its open endorsement” of the approach and FDA’s 1997 NDI notification final rule says the agency expects no more than 12 notifications per year, the groups point out.

FDA also states in its estimate of industry’s burden for compliance with the NDI notification regulation that a total of 55 are submitted annually (Also see "FDA “Undercuts” NDI Guidance Opposition With Compliance Cost Estimate – CRN" - Pink Sheet, 21 Nov, 2011.).

However, following publication of the draft guidance, an FDA official said the number of notifications should be higher because while the agency receives only 50 NDI notifications each year, more than 1,000 new supplement products reach the market annually (Also see "NDI Guidance Protects Public Health And Allows Innovation – FDA's Fabricant" - Pink Sheet, 11 Jul, 2011.).

“The agency cannot now argue that thousands of necessary NDI notifications are ‘missing’ when its own estimates of the appropriate number of NDI notifications were quite low and clearly were linked to the number of dietary ingredients,” CRN and CHPA say.

Additionally, FDA is not equipped to handle the number of notifications it would receive if the draft guidance is finalized, the groups add. The number of notifications that would be required “would cripple the agency.”

The agency has not publicly identified “even one” instance where the ingredient-based approach resulted in a safety problem with a finished product containing the related ingredient, CRN and CHPA note. The groups request that FDA permit ingredient suppliers to submit notifications and delete the proposal to require duplicative submissions by every manufacturer for each product containing an NDI.

“No Evidence” To Use Chemical Alteration List

FDA also should change its stance on chemical alteration, the groups say. The agency’s stance seems to arise from a “mistaken, and overly narrow,” reading of DSHEA’s legislative history.

There is “simply no evidence” in the legislative history that Congress intended FDA to adopt a static definition of the processes included and courts previously ruled similar lists as “exemplary, not exclusive,” the groups note.

FDA should retain a “flexible, science-based approach that permits case-by-case determinations of whether the end result of a given process is chemically identical to the material present in the food supply,” the groups urge. “This is what the statute, sound science and agency precedent require.”

“Unreasonable Barrier” In Grandfather-Status Burden

CRN and CHPA, like NPA, argue DSHEA does not require firms to prove an ingredient was on the market before Oct. 15, 1994, when DSHEA was passed, but rather requires FDA to prove the ingredient’s status. Similarly, standard rules of evidence would place the burden of proof on the agency, the groups add. “This policy lacks any legal or rational justification.”

The draft guidance’s prohibition on the use of affidavits to prove an ingredient’s grandfather status would be illegal, burdensome and particularly disadvantageous to firms that more recently entered the market, the groups argue.

The policy contradicts DSHEA’s “express directive” that federal agencies not impose “unreasonable regulatory barriers limiting or slowing the flow of safe products” to consumers, CRN and CHPA add.

It may be impossible for newer firms to access contemporaneous evidence of pre-DSHEA marketing, the groups note. “Affidavits are routinely admitted as evidence in courts of law, and there is no rational basis for FDA to refuse to admit them for this purpose,” they add.

Synthetic Botanicals Allowed

The draft guidance provision that seems to disqualify synthetic botanicals as dietary ingredients contravenes both DSHEA and standing FDA policy, according to the comments.

DSHEA permits ingredients that are dietary substances “for use by man to supplement the diet by increasing the total dietary intake,” a “catch-all” provision that includes synthetic botanicals, CRN and CHPA say. The agency has stated that a substance like CoQ10, which is completely synthetic, “falls within the broad range of dietary ingredients that Congress contemplated,” they add.

FDA also has approved generally recognized as safe status for natural and synthetic riboflavin, vitamin A and vitamin D, and should “explicitly acknowledge” that synthetic botanicals are valid dietary ingredients that may be marketed under DSHEA, the groups say.

Food Additives “An Approval Standard”

The agency should not propose for NDI filings a level of safety comparable to that required for food additives, the groups add.

There is “absolutely no question that Congress intended to remove dietary supplements from the food additive category, as evinced by the section of DSHEA entitled ‘Exclusion from Definition of Food Additive,’” the groups note.

The draft guidance contains several references to the Redbook, the official FDA manual for evaluating food additives. These standards would be “completely inappropriate” for the evaluation of NDIs, the groups say. All references to the Redbook must be removed from the guidance “and replaced with a set of safety principles that are appropriate for the intended use and meet the DSHEA standard of a reasonable expectation of safety.”

When filing an NDI notification, firms receive a letter that specifies that the acknowledgement is not an acceptance of the safety of the product but FDA deems a food additive safe when it accepts the additive, Mister noted.

“They’re still calling it an NDI, but they’re holding us to an approval standard without giving us the approval,” he said.