urges FDA to reinstate GRAS self affirmation exemption in NDI guidance

By Hank Schultz

- Last updated on GMT

Related tags Ndi notification Draft guidance Gras Fda urges FDA to reinstate GRAS self affirmation exemption in NDI guidance
Dietary supplement retailer has asked the FDA to reaffirm the exemption that self-affirmed GRAS ingredients have from the NDI notification provision. The company has also suggested changes to the NDI master file idea and has asked the agency to instate a formal process to create a list of Old Dietary Ingredients.

The e-commerce retailer filed comments this week on the agency’s revised draft guidance on New Dietary Ingredients. In addition to the above concerns, the company addressed issues with FDA’s proposal for NDI master files, with its position on synthetic botanicals, and with its position on the ways in which an ODI could be transformed into an NDI via manufacturing changes that amount to chemical alternation. The company also called on FDA to publish an annual summary of serious adverse events and called for stepped up enforcement to weed out bad actors in the industry.

Standing up for self-affirmation

On the GRAS issue, the company’s comments, issued under the name of John Venardos, vice president of global product regulatory compliance, urged FDA to clarify its position on the status of self-affirmed GRAS ingredients.  Ingredients that have gone through this process are in something of a limbo; under the first draft guidance, issued in 2011, they were specifically exempted from the need to file a NDI notification, while in the most recent version this language has been omitted. Ingredients that have obtained a GRAS no objection letter from FDA are specifically mentioned in both versions of the draft guidance.

“Oddly, however – and in contrast with the 2011 version of the Draft Guidance – FDA omits mention of GRAS “self-affirmations” (or “independent conclusions” of GRAS status) from the Section IV.B.2 question and response. No explanation is given for this change, and we strongly urge FDA to correct the omission,”​ the comments said. 

The company stated that in its recent guidance on GRAS submissions FDA has already concluded “that the GRAS standards applicable to GRAS notifications apply to independent conclusions of GRAS status as well.” ​ The comments went on to say, “There is simply no basis in law for FDA to categorically exclude GRAS self-affirmations.”

The company also asked FDA to extend this exemption for the need to file a further NDI notification to those ingredients that have been rejected in an NDI filing but which subsequently went through the self affirmed GRAS process.

NDI master files

The company applauded FDA for including the concept of master files into the revised draft guidance.  Under this proposal, the original developer of an ingredient could designate portions of its filing to remain confidential, and this information could be used by other companies in subsequent filings at the discretion of the original filer. This system could protect the trade secrets and investment made by the original filer, preventing the manufacturers of me-too products from relying on NDI notification work done by another company.  But noted that the draft guidance is not consistent in laying out this proposal, giving rise to potential confusion about which portions of a NDI filing could remain confidential and which portions would be made public. 

The comments urge FDA to alter the proposed process so that only a sufficiently detailed description of the ingredient and the number designation of the filing would be made public. The comments also urge that FDA to specifically state that safety information on an ingredient would be treated as a trade secret.

“Properly executed, use of NDI Master Files can eliminate duplicative filings, provide an efficient path to compliance for responsible companies and, significantly, also protect the intellectual property of those investing in costly safety studies and interpretive reports,” ​the comments stated.

The comments also reject FDA’s assertion that every new product that contains an NDI needs to file a new notification.

“We do not, however, support FDA’s attempted expansion of the NDI notification requirement to every combination of already-notified NDIs. Such a requirement is not required by the statute, is burdensome and provides minimal added safety information,”​ the comments said.

ODI list

As it was with the master files concept, the company was similarly supportive of FDA’s willingness to consider compiling an authoritative list of ODIs.  But the comments asked FDA to put into place a formal process to make that happen, or the fear is that this concept will languish.  The company asks FDA to reconvene a version of the industry stakeholder panel that tackled the issue in 2013.  The company suggests a maximum 20-month process in which potential ODIs could be vetted on the following criteria:

  • Slam dunks: Those ingredients that are well known to have been on the market prior to Oct. 15, 1994
  • Ingredients that should be subject to enforcement discretion because of general consensus that they were on the market at the that and that raise no safety issues
  • Ingredients for which documentation of market presence can be uncovered.

The comments also reject the draft guidance’s potentially far-ranging application of the concept of chemical alternation when determining whether an ODI has been transformed into a NDI.

“The statute distinguishes between a “new dietary ingredient” and a grandfathered ingredient only on grounds of whether a dietary ingredient was marketed or not. Section 413(d). Moreover, there is no indication in the statute or the legislative history that Congress considered manufacturing specifications in identifying grandfathered ingredients or maintaining grandfathered status,” ​the comments read.

The comment period for the updated draft guidance will close on Dec. 12, 2016.  NutraIngredients-USA plans wrap-up coverage of the main points covered by the comments.

Related news

Show more

1 comment

GRAS with letter of No Objection from FDA

Posted by ExcelVite team,

We support the opinion that ingredients that are self-affirmed GRAS – specifically GRAS with letter of no objection from FDA should be exempt from the need to submit an NDI notification.

Report abuse

Follow us


View more