The new dietary ingredient notification draft guidance sets a higher standard for evidence needed to support NDI notifications, similar to that required for food additives approvals, a food and drug attorney says.

If the draft guidance is adopted in its current form, it “will, in effect, impose the very system [the Dietary Supplement Health and Education Act of 1994] was intended to stop,” said Scott Bass, an attorney with Sidley Austin.

Scott Bass

The proposed system, which in some cases could require human or animal testing or other evidence not previously required, “essentially blocks entry because of [these] perceived high barriers,” Bass added.

When lawmakers and industry crafted DSHEA, Rep. Henry Waxman, D-Calif., proposed a system that would subject non-grandfathered NDIs to a food additive-style pre-market approval system, Bass said July 11 during a Natural Products Association webinar on the guidance.

Supplement industry champions Sens. Tom Harkin, D-Iowa, and Orrin Hatch, R-Utah, “joined industry in saying that was an unacceptable system,” he added.

Instead, the DSHEA system, which grandfathered all ingredients in commerce before October 1994, required that firms notify FDA of any new dietary ingredients. The agency does not approve NDIs, but rather acknowledges the notification or deems it incomplete and asks the firm for more information.

FDA must achieve two policy priorities with the guidance, protecting public safety and preventing impossible safety burdens, Bass acknowledged.

“Industry perception is this document would, in effect, impose too much of a burden and revert to a quasi-food additive type system,” he said.

Industry immediately raised concerns after FDA published a draft of the long-awaited document in the July 5 Federal Register, meeting a deadline set by the Food Safety Modernization Act (Also see "Synthetics Stance In NDI Guidance Raises Red Flag For Industry" - Pink Sheet, 11 July, 2011.).

“I understand fully that this is a draft guidance and even as a final guidance does not operate as law,” Bass said. “But we all know that the practical effect could be sufficient to chill entry.”

There has been poor compliance with the NDI regulatory scheme, he said. “But the incentive to get the industry to do it isn’t to make the requirements so strict that there’s no point in starting in the first place if they think it’s too expensive or too onerous.”

Daniel Fabricant, director of FDA’s Division of Dietary Supplement Programs, reiterated that the agency’s docket shows how firms prove the safety of their ingredients.

Records show “a number of firms of all sizes and all business models and from very sophisticated ingredients to less sophisticated ingredients” have “met the bar” and proved ingredient safety, he said during the NPA program.

“I think it’s very clear from some of the examples in the docket what we’ve been doing and how the agency views the issue on a wide range of ingredients,” he added.

Although DSHEA specifically exempted supplements from food additive and GRAS regulations, dietary supplements are foods, Fabricant noted.

“Elements of how a food is determined to be safe are certainly appropriate for dietary supplements,” he said.

“A Condemnation of Pre ’94 Products”

Bass also expressed concern that FDA would examine products considered grandfathered.

“I think industry is surprised that what they thought were acceptable products for 15 or 20 years may now be on the block,” he said.

“Everyone was scrambling around looking for adequate sources of documentation” to prove the products were on the market but there “wasn’t a treasure trove” of proof available, he noted.

Bass encouraged FDA to focus on potentially spiked products or those with changed manufacturing methods rather than undertake a “condemnation of the pre-’94 products.”

Guidance Should Not Surprise

Fabricant said he was “surprised that people said they were surprised” about documenting how long products have been on the market.

FDA will require “independent and verifiable evidence” rather than “an article of faith” to prove the product was on the market, he noted.

Indeed, an industry lawyer speaking at a Food and Drug Law Institute conference in January warned that the agency looks for “concrete evidence” of pre-October 1994 sale of dietary ingredients (Also see "NDI Needed In Absence Of "Concrete Evidence" Of Prior Sale – Attorney" - Pink Sheet, 7 February, 2011.).

Bass noted that trade associations compiled lists of acceptable products and “there was some implicit understanding with the agency that the inclusion on those lists was acceptable.”

NDI notifications are “the only preventive control we have to keep the public health safe when it comes to this particular category of goods.” – FDA’s Fabricant

However, Fabricant said FDA has made clear the agency does not consider the lists to be sufficient proof an ingredient was grandfathered.

“I think what’s been consistent all along is that the lists aren’t authoritative,” he said. “They don’t meet the standard that’s in play there.”

Indeed, the draft guidance includes this question and answer:

“Is there an authoritative list of dietary ingredients that were marketed prior to October 15, 1994 (a so-called "grandfathered list" or "old dietary ingredient list")?
“No. Each supplement manufacturer or distributor is responsible for establishing that the dietary ingredients in its dietary supplements comply with the NDI notification requirements. While some trade associations and other industry groups have published lists of "'old dietary ingredients,’ these lists have not been verified by FDA and are not backed by evidence that the ingredients listed were actually marketed” prior to DSHEA’s passage.

Fabricant also disputed the assertion that the agency is condemning all grandfathered products.

“We have a provision here that’s largely been unused,” he said. “It’s the only preventive control we have to keep the public health safe when it comes to this particular category of goods. I think that’s an important consideration.”

By Carolyn B. Phenicie

NDI Safety Data Guidance Sets Evidence Bar Too High, Attorney Says

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