The myth of the “Unregulated Dietary Supplement Industry” began with the passage of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Of course, the irony is that the passage of DSHEA offered greater regulation of the Dietary Supplement Industry than existed before. The truth is that the Dietary Supplement Industry is regulated.
Further, the Industry knows it is regulated, the Food and Drug Administration knows the Industry is regulated yet the continued public perception remains otherwise. A corollary to this myth is that the matter of operating in the regulated environment requires cooperation. This is only partially-correct. The reality is that the most successful relationships between industries and the regulatory agencies charged with their oversight are relationships that are based on the parties being “respectful adversaries”. Each of these words is equally important for you to memorize. The parties involved must be respectful of one another while never losing sight of the fact that they are indeed adversaries.
The publication of the latest Draft Guidance on New Dietary Ingredient Notifications is another opportunity for the industry as a whole to exercise its ability to re-assert itself in this form of relationship. There is no requirement for, and thankfully so, being disrespectful toward the efforts of the FDA to describe its “current thinking” on the matter, regardless of how wrongheaded or unfounded it is.
The issuance of the August, 2016 Draft Guidance, replacing the July, 2011 Draft Guidance, however, demonstrates a good bit of disrespect toward the industry by the FDA. Perhaps they are simply anticipating that cooperation often publicized by some prominent members of the industry or the more vocal trade associations. “Just cooperate and everything will be just fine,” seems to be the collective message. Baloney. W
hen the 2011 Draft Guidance issued, more than one prominent representative of the industry commented that the whole thing should be withdrawn and FDA should start over again. For the record, I concurred. Instead, five years on, FDA has doubled down on the previous presentation. That is what cooperation will get you – additional restrictions that completely ignore the input of the respectful adversary on the other side of the CFRs – and yes – that means you.
The stance of the industry should be a reiteration of the previous input (respectfully submitted) that alerts FDA that the most appropriate action they can take and should take is to withdraw this latest attempt, sit down and listen and work with the industry to try to get things right. We are willing to engage aggressively and responsibly to ensure prompt and adequate guidance is implemented. This requires that solutions exist, presented by the industry and therein lies the shortfall of the collective efforts thus far based on our research of the recent and public commentary on the subject from various trade associations.
Putting forward a shallow critique of the hardships and speculative financial costs and impacts should not be the general position of the industry. Instead of repeatedly presenting interpretations and understandings of FDA’s “current thinking” there needs to be an active presentation of solutions. First, however there must be the identification of the fundamental challenges contained within the latest Draft Guidance.
The challenges fall into two general, and large, buckets. First is the little matter of the Law: The Federal Food, Drug and Cosmetic Act as amended to date. The most specific amendment, which remains in place, is the Dietary Supplement Health and Education Act (DSHEA). However, there is another, earlier amendment that requires reference as well. In 1976 the Rogers-Proxmire amendment to the Law was passed. The intent of that amendment was to prevent FDA from placing undue restrictions on the products that could be called (as they are today) Dietary Supplements. History tends to repeat itself however and as time passed, FDA came back with proposed regulation and even legislation that would again all but wipe out the industry. The response then was DSHEA in 1994. History returns once more with a vengeance.
This new Draft Guidance is, in many ways, legislative action without the pesky requirement to have legislators involved. It blazes new territory in terms of the intent of DSHEA, interprets the Law incorrectly and then simply continues in the same effort that was thwarted in 1976 and 1994.
Those of us who were present for both these events understand the cyclic nature of this and have clear recognition of the intent of the latest Draft Guidance. This document, issued “for comment purposes only” deserves comment with certainty. This comment should be a repeat of the commentary offered in 2011 – that the Draft Guidance be withdrawn owing to its abrogation of the Law both in spirit and in letter. This does not mean that an open dialog on the topic cannot ensue, rather it should. Let’s discuss together in an effort to present a much clearer starting point than was done in 2011. Again, the matter must be addressed as an issue between respectful adversaries and, more importantly, at least begin to offer solutions.
The second challenge contained in the Draft Guidance is the misuse, misapplication and misunderstanding of Science as a whole. Science comprises many things, but it should never be used to foster political or regulatory agendas through debasement. [Please see the debates on Climate Change and the use of bioengineering of foods as prime examples]. The Draft Guidance leans on Science for a fair amount of the justification for the detail offered in what FDA considers the requirements of notification but we are faced daily with the application of Science but the lack of common definition out of Science or definition at all (e.g. Scientifically Valid) leaves too much open. Simply stating something does not render it Scientific Fact. The same holds true for Definitions of other terms. The combination of occasional application of Scientific foundation while setting aside other aspects of Science as it suits them in the Draft Guidance are clear and noteworthy while re-creating important Definitions is fully inappropriate. Simply stating something is fact does not render it so. The challenges regarding the discussion of the scientific foundation for FDA’s Draft Guidance and the setting aside of the same science as it suits them in the Draft Guidance are clear and noteworthy. This approach totally undermines the credibility of the presentation and reveals it only as a vehicle designed to reshape Definitions and even Science itself to enforce the will of the regulatory agency. The regulations and guidance concerning NDI’s should be clearer, period. So, let’s propose exactly that! Science should serve as a foundation of the Solution, supported by a collective set of Definitions that underpin the solution. Do you agree?
The Solution requires common definitions of such things as “constituent” and “chemically altered” with those definitions coming from a science-based, scientifically-backed and documented perspective, so let’s define them rather than leave them ambiguous inclusive of other critical words such as “notify” and “basis” that result in so much legal and regulatory chaos on a daily basis. The also includes leveraging other similar, FDA accepted practices in regulated arenas under its control and to label the products accordingly. This affords companies and the consumer alike the opportunity to make informed choices and leverage the regulations while affirming the protection of the consumer. Curious to know more?
In the end, the Solution will not please everyone in the industry nor will it likely please FDA wholly, but I guarantee a much more practical and business-friendly starting point without jeopardizing the safety of the consumer. The Solution must include the agreed to Definitions and incorporate Science along with the Law as written. The current misunderstandings of the 2016 Draft Guidance by industry come as much from the incredulity expressed at how FDA largely ignored the input and comment offered against the Draft Guidance of 2011 as anything else. Educating the industry as to what the latest Draft Guidance means is a fruitful exercise provided the industry intends to go down the path of blind cooperation. Time is better spent working toward providing well-defined, scientifically based Solutions. These Solutions exist and they can be found, in part, in existing regulatory examples, but they must first be allowed the benefit of being heard and that can only occur with withdrawal of this latest rendition and a respectful approach from both sides. Let’s simply start with coming to common Definitions. I’m happy to offer some. Then follow that up with clarity from those who were there and bore witness to the efforts of the past and discussion of the matters of Law and then shape the best scientific approach, and I mean real Science.
The solution then will involve a proper application of Science, common Definitions and labeling options to form a collective Solution that results from the discussion among the respectful adversaries and leverages existing regulatory models.