The self-GRAS affirmation was not submitted with the docket paperwork per Joe Dowling in a post-stockholder meeting conversation, just the safety data. I did a little digging on a possible reason to withhold the self-GRAS affirmation. IMHO it boiled down to this - once submitted to the FDA and approved, then the application, along with all submitted documentation falls under the freedom of information act; CVSI is protecting proprietary information.
CVSI may be pursuing an NDI at this time as changes brewing in the supplement industry and protection may be offered for proprietary information, as well as a way for companies to recoup expenses - as competitors, if they want to site a specific NDI, they will need the companies permission - which may mean royalties.
My Theory - These changes may happen sooner rather than later specifically because of the CBD industry. Responsible companies will prevail, and fly by nights will be sanctioned.
On May 16, 2019, dietary supplement industry spokespersons, Food and Drug Administration (FDA) leaders, and other interested parties gathered together for a public meeting at the FDA’s Center for Food Safety and Applied Nutrition (CFSAN) College Park, MD headquarters to discuss dietary supplement innovation. The meeting—entitled Responsible Innovation in Dietary Supplements predominantly focused on FDA’s approach to New Dietary Ingredient (NDI) provisions of the Food, Drug and Cosmetic Act (FDCA), but also addressed many other areas in which participants felt that FDA was affecting innovation and impacting consumer safety. This was a well-attended event, with a full auditorium of speakers and attendees.
Who’s Who of the May 16th Meeting and Their Roles
Notable attendees included Steven Tave, Director of the FDA Office of Dietary Supplement Programs (ODSP) and Dr. Cara Welch, Special Assistant to the Deputy Commissioner of Policy, Legislation, and International Affairs at FDA. Leadership from major trade organizations representing the dietary supplement industry also attended and provided presentations during the Public Meeting, including representatives from the Council for Responsible Nutrition (CRN), Consumer Healthcare Products Association (CHPA), American Herbal Products Association (AHPA), United Natural Products Alliance (UNPA), and the Natural Products Association (NPA). Representatives from consumer protection groups, including the Center for Science in the Public Interest (CSPI) and Truth in Advertising (TINA), also attended and provided comment. Attendees were also fortunate to hear from the FDA’s Acting Commissioner, Dr. Ned Sharpless, who reiterated FDA’s commitment to modernize supplement regulations—a goal first articulated by his predecessor, Dr. Scott Gottlieb, in February 2019.
The meeting consisted of four panels, on which industry and consumer representatives were invited to speak. Participants also heard from representatives from Health Canada to help assess whether Canada’s regulation of health products could serve as a model to improve regulation in the U.S. The other panels explored (1) the scope of what ingredients are permissible under section 201(ff) of the FDCA; (2) issues related to when a company is not required to file a notice with FDA that they are using an NDI; and (3) how FDA can better enforce NDI notification requirements and incentivize companies to file these notifications. General attendees to the meeting also were given an opportunity to provide comments and questions following each panel and at an open public comment session at the end of the meeting.
Why All the Fuss About NDIs?
Under Section 413(a)(2) of the FDCA, the manufacturer or distributor of a dietary supplement must notify FDA 75 days before introducing a new product containing an NDI into interstate commerce. An NDI is an ingredient that was not marketed in the U.S. in a dietary supplement before October 15, 1994. As part of this notification process, companies must provide evidence establishing that “the dietary ingredient when used under the conditions recommended or suggested in the labeling of the dietary supplement will reasonably be expected to be safe” (emphasis added). There are exemptions to NDI notification requirements, such as whether the NDI has previously been used in the food supply, but, overall, NDI notifications are intended to be an important part of FDA’s process for ensuring the safety of dietary supplements.
Responsible industry participants and trade associations have often communicated to the FDA that there is a need for greater enforcement of NDI requirements since the NDI process is an important safety process. To this end, Steven Tave with FDA’s ODSP acknowledged that the number of NDI submissions has been far less than what the agency would expect given the number of dietary supplements in the marketplace.
Commenters provided potential reasons for the disconnect between the number of products on the market and NDI notifications filed. For example, the manner in which FDA treats NDI notification data was highlighted during the public meeting as problematic.While some information that a submitter provides to FDA in connection with an NDI notification is subject to limited protection under exemptions from disclosure provided by the Freedom of Information Act (FOIA) and other federal laws, data filed with an NDI notification will, for the most part, be made publicly available because FDA is required to make NDI notifications public.
Second, companies marketing what may be perceived as similar ingredients to those that were the subject of an earlier and successful notification often piggyback on the first company’s NDI notification, neglecting to file their own notification. Such a system, many commentators noted, disincentivizes companies to generate the necessary safety data specific to their NDI and to file NDI notifications. On one hand, the NDI notification process requires ingredient manufacturers to invest significant resources to establish the safety of new ingredients, when instead such manufacturers could more easily rely on an already successful notification on a similar ingredient. On the other hand, a competitor marketing a similar ingredient could potentially rely on the same notification for their own use, with no repercussions. Several commentators offered up for FDA’s consideration possible solutions to help protect a company’s valuable investment in NDI safety research and incentivize companies, not only to innovate, but also to comply with the NDI notification process.
Master Files Proposed as a Solution for FDA’s NDI Notification Woes
A number of participants at the meeting emphasized that FDA should work to provide intellectual property protection for safety data that an industry participant submits to the FDA in connection with an NDI notification. Commenters, including one of this article’s coauthor’s—Dr. Andrew Shao—noted that companies are disincentivized to participate in the process because other companies can rely on the safety data of the first notifier and come to the market without having to make the same safety investment or even file a notification.
Thus, many commenters, such as Dr. Jay Sirois with CHPA, supported the idea of a “Master File”—a system that would allow FDA to establish a means to collect and protect data investments made by ingredient manufactures that are specific to their products. Under this system, an ingredient manufacturer would submit proprietary data (including detailed specifications, manufacturing processes, safety studies, etc.) on its ingredient to FDA, which would create a Master File maintained by the agency. Other companies wishing to leverage this information for their own NDI notification, with the permission of the company that submitted the original NDI Master File, would be required to cite the Master File.
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FDA Should Seize on Current Strong FDA-Industry Relationship to Move Dietary Supplements into the Future
The Public Meeting showed a collaborative relationship between FDA and responsible industry. Both FDA and industry appear to be communicating more frequently and working together more collegially than has historically been the case. It is clear now more than ever, that both groups share key areas of common ground, including the desire to provide consumers with safe, well-made, properly labeled dietary supplements, along with the proper information to make informed decisions. This strong relationship and collaborative spirit presents FDA an opportunity to achieve its goals to modernize dietary supplement regulation and oversight, but FDA should be careful to continue to do so in a transparent manner that involves responsible industry.
