The agency recently made a big announcement about a regulation that could eliminate 41,700 products from the market. We need to keep up the pressure to protect access. Action Alert!<\/a><\/strong><\/p>\n THE TOPLINE<\/strong><\/p>\n A few weeks ago, we reported<\/strong><\/a> that 2024 could be the year the FDA finally publishes the final version of its natural product-destroying \u201cnew dietary ingredient\u201d (NDI) guidance that it has been working on since 2011. It appears that we might have been right. On January 17, the FDA published a notice<\/strong><\/a> in the Federal Register explaining that it intends to break this up into several guidance documents while also naming the issues it intends to prioritize. It is a tactic we\u2019ve seen the agency deploy in its war against compounded medicine: rather than issue a policy outright and risk the backlash, the FDA takes a piecemeal approach to diffuse the negative reactions to what it is doing. Even more concerning, it shows the level of focus the FDA is committing to the various issues contained in the guidance. We need to keep hammering away at our elected representatives to take notice of what the FDA is doing.<\/p>\n The Federal Register notice states that the issues FDA is prioritizing are administrative procedures, identity, safety, and master files. The FDA\u2019s webpage<\/strong><\/a> describing the guidance documents it plans to issue over the next year has been updated accordingly, with a \u201cprocedures and timeframes guidance\u201d listed before a master files guidance.<\/p>\n Master files are one of the changes that came about in 2016 when the 2011 guidance was revised<\/strong><\/a>. Master files contain specifications and other information needed to completely describe generic ingredients. If a company wants to make several products with the same ingredient but at different dosages or concentrations, this could save a lot of time. These master files can also be shared with other companies to avoid excessive duplication.<\/p>\n But master files could also block innovation. Let\u2019s consider the example of curcumin or curcuminoids derived from turmeric root and rhizome, popular multi-system support ingredients used especially to help reduce inflammation in the body. A master file on curcumin would contain reams of information on \u201crun-of-the-mill\u201d curcumin: its chemical identity, its safety, potential risks, etc.<\/p>\n But innovative companies are trying to find ways to make curcumin or broader spectrum curcuminoids more effective and more bioavailable, for example by using different extraction methods and by creating liposomal delivery systems. Because liposomal curcumin extracts would likely not be part of the master file, that innovative company would need to start from scratch in terms of gathering all the information necessary for a new dietary ingredient notification\u2014a massive undertaking. This creates a barrier such that innovation won\u2019t even happen, or it will be an option only for the largest companies which, as we\u2019ve seen<\/strong><\/a>, are often owned by Big Pharma or Big Food. This is about insidious regulation via guidelines that bypasses the formal regulatory and democratic law-making process. It\u2019s also creating a form of pre-market approval and building obstacle courses so challenging in terms of data provision that only a few\u2014and the largest\u2014corporations can negotiate it. Oh, and let\u2019s not rule out this possibility: it provides a potential mechanism to raise money for the FDA via filing fees, the very thing that\u2019s part and parcel of the cozy relationship developed with Big Pharma.<\/p>\n That the safety issue is a priority is concerning but not surprising. As we\u2019ve argued previously<\/strong><\/a>, the FDA is turning what is meant to be a notification system into a de facto <\/em>pre-approval system requiring studies to prove safety\u2014a drug standard.<\/p>\n \u201cIdentity\u201d is another issue the FDA wants to focus on\u2014that is, the information the FDA requires in an NDI submission on a supplement that characterizes the chemical and molecular identity<\/a><\/strong> of all the ingredients, a detailed description of every step of the production process, and specific requirements for each dietary ingredient whether it is a botanical, vitamin, salt, etc. This may sound reasonable, but these are the kinds of requirements demanded of drugs. It can sometimes be very difficult<\/strong><\/a> to provide this level of detail on natural molecules, especially when they occur as mixtures of compounds, which might vary batch to batch, just as the chemical composition of the broccoli on your dinner plate varies according to how and where it was grown, what environmental conditions were during its cultivation, what the post-harvest treatment was, how long it was in your refrigerator, how you cooked or prepared it, and so on. The same tools that are used to identify synthetically-produced drug molecules simply don\u2019t work for natural compounds and mixtures.<\/p>\n The very fact that the FDA is breaking up the NDI guidance into several pieces is also a concern because, if history is any instructor, this will be an incredibly drawn-out process, possibly taking years. It\u2019s akin to boiling the frog slowly. Yet, as we\u2019ve highlighted with the cases of NMN<\/strong><\/a>, NAD+<\/strong><\/a>, CBD<\/strong><\/a>, and others, the fact that there is uncertainty in the supplement industry about how to comply with NDI procedures makes it more likely that Big Pharma can come in and create monopoly drugs from natural compounds.<\/p>\n As we\u2019ve discussed previously<\/strong><\/a>,\u00a0if a given supplement is considered \u201cnew\u201d (it came to the market after 1994) then the company selling it must submit a NDI notification to the FDA. But if a drug company files an investigational new drug application (IND) and studies that ingredient before the FDA receives a \u201cnew\u201d supplement notification on it, it can no longer be sold as a supplement. If there\u2019s confusion about which supplements require NDIs and which don\u2019t, or about how to properly submit an NDI, etc., then the chances that Big Pharma can use the FDA back-channel to turn supplements into drugs only increases.<\/p>\n There are even more problems with the guidance that interested readers can reference in our\u00a0previous coverage\u00a0<\/strong><\/a>of this topic. Our other recent piece<\/strong><\/a> also highlighted the fact that yes, we want safe supplements, but the data clearly show that supplements are already overwhelmingly safe, in fact safer than foods<\/a><\/strong>. The only reason to impose more stringent standards is to deprive Americans of healthy products so they turn to drugs instead.<\/p>\n The overarching mission, as we argued<\/strong><\/a> with mandatory product listing, seems to be to create a global, harmonized market for supplements. The European Union has already done much of the work in creating a restrictive model that, for example, controls which vitamin and mineral ingredients can and can\u2019t be used, is set to limit high-dose supplements, drastically restricts what claims can be made for foods and supplements, and is in the process of instigating very onerous data requirements for novel and innovative products, especially if they contain ingredients in the nanoscale (1 \u2013 100 nm in at least one dimension), which is the case for most if not all natural molecules.<\/p>\n Why would the FDA create its own, bespoke regulatory framework for supplements when a restrictive template has already been developed by EU institutions, a template that is closely intertwined with the global food standardization framework created through the UN\u2019s Codex Alimentarius? The big players, like the pharmaceutical giants and the supplement companies they own, want global harmonization because it makes it easier to do global business. The EU template includes pre-market notification of supplements and massive data requirements, especially for food or supplement ingredients deemed novel<\/a><\/strong> (i.e. those not used to a significant degree within the EU prior to May 1997). That\u2019s not all: then there\u2019s compliance with the EU\u2019s guidance<\/strong><\/a> on the risk assessment of nanomaterials in food and supplements\u2014an issue that we will be keeping a close eye on as the FDA goes through its process.<\/p>\n The FDA\u2019s development of new NDI guidance is one of the most blatant attempts to eliminate Americans\u2019 ability to stay healthy, naturally with dietary supplements. We must vehemently push back against this potentially disastrous guidance\u2014and demand changes where it knee-caps public access to safe, affordable supplements and health foods.<\/p>\n Action Alert!<\/strong>\u00a0Write to Congress and the FDA to urge drastic changes to the NDI guidance to protect supplement access.\u00a0Please send your message immediately.<\/strong><\/p>\n
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\nMaster files vs innovation<\/h3>\n
Boiling the frog \u2013 slowly<\/h3>\n
A final note<\/h3>\n
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