The NDI draft guidance states that companies can submit a confidential NDI master file that would allow manufacturers to use a NDI already subject to NDIN while protecting the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. 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.Īdditionally, intellectual property protection remains a major concern for industry when submitting NDINs. There are also overly burdensome requirements set forth by the NDI draft guidance, such as changes in manufacturing of pre-DHSEA dietary ingredients requiring an NDI notification, or that a separate NDIN be made for each finished product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. 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). 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. For example, the revised NDI draft guidance has a very narrow interpretation of the Federal Food, Drug, and Cosmetic Act (FD&C) section 201(ff)(1), which defines dietary supplements. CRN requests in its comments to FDA that parts of the NDI draft guidance must be withdrawn before they can expect industry to fully comply with submitting NDINs. Industry contends that much of the 2016 NDI draft guidance is inconsistent with the intent of DSHEA. A discretion period will not increase compliance with NDINs if industry is not incentivized to do so, says CRN.
According to CRN, it is the failure to appropriately address concerns about the NDI draft guidance that can attributed to the low amount of NDINs submitted by industry since its publication.
While CRN appreciates the intention of FDA’s draft guidance, the organization is critical of the Agency’s failure to address major concerns expressed by industry related to FDA’s revised NDI draft guidance, issued in August of 2016. The intent of this guidance, says FDA, is “to encourage firms to correct past failures to submit an NDI notification.” 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 Council for Responsible Nutrition (CRN Washington, D.C.) has submitted comments to the U.S.
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