CRN sends letter urging ODSP to allocate proper resources to enforcing NDI master file framework


The Council for Responsible Nutrition has sent a letter to Cara Welch, PhD, director of the Office of Dietary Supplement Programs, urging the ODSP to allocate the necessary resources to effectively enforce the dietary supplement master file framework.

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The Council for Responsible Nutrition (CRN; Washington, D.C.) has sent a letter

(CRN's Letter to ODSP)

to Cara Welch, PhD, director of the Office of Dietary Supplement Programs, urging the ODSP to allocate the necessary resources to effectively enforce the dietary supplement master file framework. The letter is in response to the U.S. Food and Drug Administration’s (FDA) inclusion of “Dietary Supplement Master Files: Draft Guidance for Industry” to its list of priority guidance documents that are under development. CRN explains in its letter that issuing the guidance without corresponding enforcement will not serve the industry or consumers. If sufficient resources cannot be allocated toward enforcement, CRN urged ODSP to “reconsider issuing any guidance on the master file issue at all, and to redirect resources toward other topics that are likely to produce a positive impact for dietary supplement consumers.”

CRN is concerned ODSP will not have sufficient resources because of the proposed consolidation of the office into the “Office of Food Chemical Safety, Dietary Supplements, and Innovation,” diminishing the attention and resources for dietary supplement oversight. The letter also states that three years prior, “ODSP indicated to CRN that the agency could not commit resources to enforcement in this area.”

CRN has long advocated for a master file framework for new dietary ingredient (NDI) notifications. In May 2020, CRN, in addition to the Consumer Healthcare Products Association (CHPA; Washington, D.C.) and the United Natural Products Alliance (UNPA; Salt Lake City, UT) submitted a joint letter and proposed framework for NDI master files. In that letter, the trade association explained that a successful NDI master file system would level the playing field for companies that have invested the significant resources necessary for compiling the safety data required for NDI submission, and deter bad actors from bypassing the NDI notification requirement. However, the joint letter also emphasized the importance of enforcement.

“The utility, and ultimate success, of the NDI-master file will depend largely on FDA’s support and a strong commitment to enforcement of its proper use-establishing a master file program without the agency’s resolve and resources to enforce it, and to prosecute companies who ignore it, only perpetuates continued indifference and leaves the intellectual property of responsible and innovative companies unprotected,” the joint letter states.

CRN reiterates this notion in its current letter, stating: “Proper enforcement of a master file program is essential to protect public health as well as to provide assurances to the innovating firms that there is sufficient economic incentive to invest the funds and time necessary to properly submit the NDI notification. The assurance of protection of the ingredient innovator’s intellectual property goes hand-in-hand with consumer safety.”

Therefore, without the proper resources being allocated toward enforcing NDI master files, let alone NDI notification requirements, CRN believes FDA should rethink its priorities. In the letter, CRN states that “Other pressing dietary supplement issues are awaiting the agency’s action, including issuing other parts of the NDI guidance to address major concerns related to the agency’s revised NDI draft guidance issued in August 2016, as well as a response to industry’s citizen petition on the application of section 201(ff)(3)(B) of the federal Food, Drug, and Cosmetic Act—the drug preclusion provision. FDA’s attentions would be better spent on these endeavors.”

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