A Product-Specific NDI Rule Could Flood FDA with 16,000 Backlogged Notifications to Process, Say CRN and CHPA

December 2, 2011

The two associations today submitted their comments on the NDI draft guidance to FDA, whose comment deadline is today.

If FDA were to require product-specific new dietary ingredient (NDI) notifications rather than just ingredient-specific notifications, as the agency has indicated in its recent NDI draft guidance, the result could be a backlog of 16,000 additional NDI notifications FDA would have to process for products launched over the past 17 years, say the Council for Responsible Nutrition (CRN; Washington, DC) and the Consumer Healthcare Products Association (CHPA; Washington, DC). The two associations today submitted their comments on the NDI draft guidance to FDA, whose comment deadline is today. (For a full version of the comments, click here.)

According to FDA’s own estimates, the agency has thus far received only 700 NDI notifications submitted by industry in the past 17 years since the requirement for NDI notifications was published in the Dietary Supplement Health and Education Act (DSHEA) in 1994. However, CRN has argued that this number is far lower than the number of new dietary supplement products, and not ingredients alone, that have entered the market in those years. Thus, those notifications likely were ingredient-specific and not product-specific.

In their comments, CRN and CHPA point out that the DSHEA regulations themselves only refer to new dietary ingredients, and not finished products, and thus FDA’s draft guidance is instituting a new requirement for product-specific notifications that wasn’t authorized by DSHEA.

CRN and CHPA state that if FDA in fact seeks to establish a product-specific regulation, requiring any new product formulations or combinations of products containing an NDI ingredient-even those products with slight formula alterations that include additional ingredients that aren’t NDIs-it would greatly drive up the number of new notifications the agency will have to process, a number that “would cripple the agency.”

“Using estimates from the Draft Guidance, there are 1000 new dietary supplements introduced to the market each year, but there have been only 700 NDI notifications since the agency began reviewing them. The backlog of NDI notifications that FDA now appears to be requesting-more than 16,000 (1,000 NDIs per year for 17 years minus the 700 NDI notifications actually submitted)-would cripple the agency,” stated CRN and CHPA in their comments.

Moreover, they added, “The magnitude of this FDA-projected backlog is reminiscent of what caused the breakdown of the GRAS affirmation petition process. The NDI notification avalanche would precipitate an even greater failure.” (Generally Recognized as Safe, or GRAS, affirmation reviews were originally all handled by FDA, but due to more reviews than the agency could handle, it then also instituted a self-affirmed process by which companies could have their GRAS reviews conducted by independent third parties.)

Other objections to the guidance-and conflicts with the original regulations of DSHEA-that CRN/CHPA’s comments address include:

 

Chemical Alteration

FDA should not restrict the chemical alteration processes allowed for ingredients not deemed as NDIs to only those on the short list provided in the current draft guidance.

“Neither DSHEA nor its legislative history requires or permits FDA to restrict the processes that do not result in chemical alteration to this very short list…A wide variety of manufacturing processes are permissible under the statute, as long as the resulting compounds are identical to those found in the food supply.”

 

Synthetic Ingredients

Moreover, the associations point out how chemical alteration relates to synethetic nature-identical ingredients.

“Even complete synthesis of nature-identical ingredients in the food supply does not constitute chemical alteration. If the final product is chemically identical, as confirmed by analytical methods, to the ingredient found in nature, there is simply no basis in the statute to assert that the manufacturing method triggers an NDI notification. Scientific policy does not support the existence of a pre-specified list of processes that do or do not result in chemical alteration. The only inquiry under the statue is whether the material generated at the conclusion of a process is chemically identical to the material found in the food supply.” They point out that FDA itself seems to have taken this stance by allowing genetically engineered foods in the food supply.

Moreover, “The broad language of DSHEA includes in the definition of a dietary ingredient both synthetic ingredients that are identical to ingredients found in nature and those that had not previously been intended for use in supplementing the diet. Synthetic ingredients clearly may be marketed under Section 201(ff)(1)(E) of the FDCA, the ‘catch-all’ provision that encompasses dietary substances ‘for use by man to supplement the diet by increasing the total dietary intake.’ This category is limitless. Its only prerequisite for a dietary ingredient-presuming that the ingredient meets other provisions of the statute-is the labeled intent that the dietary ingredient is for use to supplement the diet.”

The associations state the FDA itself has affirmed GRAS both natural and synthetic versions of several nutrients and has acknowledged NDI notifications for nature-identical botanical ingredients in the past, without objection.

Moreover, they point out, “Manufacturers typically have more control over synthetic processes than over natural extraction process, and this can yield tangible safety and quality benefits for consumers.”

 

Burden of Proof

FDA, and not industry, bears the burden of proving that a dietary ingredient is an NDI, although the draft guidance seems to state otherwise. “If FDA were to allege that a dietary supplement is being illegally marketed without an NDI notification for a dietary ingredient in the product, under standard rules of evidence it would bear the burden of proof to demonstrate the NDI status of that ingredient. In the Draft Guidance, FDA would not only reverse this burden and place the burden of proof on the industry, but it would require parties to produce contemporaneously created written documentation to prove non-NDI status. This policy lacks any legal or rational justification.”

 

Duplicitous Notifications

Once NDI status is established for a specific ingredient, industry should be able to rely on that notification, without requiring other companies to subsequently file NDIs for that ingredient, as the draft guidance seems to require.

 

Evidence of Safety

The associations state the guidance proposes safety requirements equivalent to the strict food-additive safety requirements-something DSHEA prohibited-including references in the NDI guidance to The Redbook, FDA’s manual for evaluating food additives. “Congress deliberately removed dietary supplements from the food additive regulatory regime in DSHEA, but the Draft Guidance would ignore the statute by adopting the same safety standards as those that apply to food additives.”

 

Conclusion

The associations summarize: “The agency’s attempt to redefine the NDI notification process in the Draft Guidance contradicts the letter and spirit of DSHEA….It far exceeds the permissible scope of a guidance document, proposing substantive requirements that must be the subject of notice-and-comment rulemaking. If FDA were to implement the Draft Guidance in its current form, it would reduce consumer access to safe and beneficial dietary supplements, reduce innovation and growth in the industry, and increase barriers to market entry for new companies and products. For these reasons, we request that FDA withdraw the Draft Guidance, give careful consideration to these comments, and begin the process anew with a Draft Guidance that reflects the statutory language and legislative intent of DSHEA.”

The argument that in its guidance, FDA has unlawfully made drastic changes to the original regulation, was also made by attorney Marc Ullman recently.

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