CRN submits comments to FDA about its draft guidance for overdue NDI notifications

Photo © Shutterstock.com/AlexLMX

The Council for Responsible Nutrition (CRN; Washington, D.C.) has submitted comments to the U.S. Food and Drug Administration (FDA) regarding its “Policy Regarding Certain New Dietary Ingredients and Dietary Supplements Subject to the Requirement for Pre-Market Notification; Draft Guidance for Industry.” The draft guidance provides a 180 day discretion period in which late New Dietary Ingredient Notifications (NDINs) may be submitted. The intent of this guidance, says FDA, is “to encourage firms to correct past failures to submit an NDI notification.”

While CRN appreciates the intention of FDA’s draft guidance, the organization is critical of the Agency’s failure to address major concerns expressed by industry related to FDA’s revised NDI draft guidance, issued in August of 2016. According to CRN, it is the failure to appropriately address concerns about the NDI draft guidance that can attributed to the low amount of NDINs submitted by industry since its publication. A discretion period will not increase compliance with NDINs if industry is not incentivized to do so, says CRN.

Industry contends that much of the 2016 NDI draft guidance is inconsistent with the intent of DSHEA. CRN requests in its comments to FDA that parts of the NDI draft guidance must be withdrawn before they can expect industry to fully comply with submitting NDINs. For example, the revised NDI draft guidance has a very narrow interpretation of the Federal Food, Drug, and Cosmetic Act (FD&C) section 201(ff)(1), which defines dietary supplements. The narrow definition would needlessly exclude certain ingredients such synthetic copies of herbs or other botanicals unless they become lawfully marketed ingredients in the conventional food supply. CRN points out that FDA has no scientific or legal grounds for treating synthetic botanicals differently when they are chemically equivalent, just like synthetic vitamins which qualify as dietary ingredients under FD&C 201(ff)(1)(A).

There are also overly burdensome requirements set forth by the NDI draft guidance, such as changes in manufacturing of pre-DHSEA dietary ingredients requiring an NDI notification, or that a separate NDIN be made for each finished product using an NDI. For that matter, industry remains unclear about who has an obligation to submit an NDIN because FDA has yet to establish an authoritative list of pre-1994 dietary ingredients that would not be subject to NDIN requirements.

Additionally, intellectual property protection remains a major concern for industry when submitting NDINs. The NDI draft guidance states that companies can submit a confidential NDI master file that would allow manufacturers to use a NDI already subject to NDIN while protecting the intellectual property of the firm which originally submitted the notification. However, FDA has not established a system for implementing NDI master files, and has not engaged with industry suggestions that the NDI master file framework should be based on the existing Drug Master File system. As such, this avenue for protecting intellectual property and streamlining the NDIN process has seen little to no traction.

“Responsible companies in the dietary supplement industry invest in generating the necessary data to establish the safety of their ingredients. A significant concern for these ingredient manufacturers is that they must compete on an uneven playing field with companies that fail to generate and submit safety data specific to their NDIs and claim that their ingredients are identical to NDIs that other firms properly notified,” states CRN in its comments.

Should FDA decide to move forward with its enforcement discretion, CRN also recommended that FDA extend its catch-up submission period beyond 180 days and commit to responding to NDIN submitters within 90 days of receipt of NDINs. The extension, said CRN, would allow FDA and industry to reach common ground on unresolved NDI-related issues, and because the law requires FDA to make the existence of an NDIN public within 90 days of receipt, submitters should be assured they have the opportunity to respond to FDA comments prior to public display. As it stands currently, FDA’s draft guidance states that they may not be able to complete review of notifications within 75 days.

“The uncertainty of when submitters may receive a response from FDA, and whether they may be able to respond to any FDA comments about of their notification prior to public display of the notification’s existence, may discourage submitters,” states CRN in its comments.

CRN’s full letter to FDA can be viewed here.