One reason that industry regulation gets a bad rap, no doubt, is that so much bad regulation seems to get passed.
It seems like for every sensible rule that gets proposed – for instance, the one that would require amalgam separators in all dental offices – we get another 9 like the one that’s working its way through the FDA right now: their long overdue revision to guidelines for new supplements.
Unfortunately, as written, the guidelines could deal a major blow to the supplement industry – and, thus, your ability to get products you want and need on your journey to optimal health. It would be yet another blow against health freedom.
The proposed guidelines – “Dietary Supplements: New Dietary Ingredient Notifications and Related Issues” – remain open to public comment until October 11. We strongly encourage you to submit your comments to the FDA here.
This excerpt from the Alliance for Natural Health’s Action Alert below outlines the major problems with the new guidelines.
The draft of regulations governing new dietary supplements…was finally published…. It is a little better in some respects, but the biggest problems remain. It represents a dire threat to the supplement industry and, by extension, consumer access to supplements.
First, the improvements. In the original guidance, the FDA had said that all dietary ingredients contained in supplements sold before 1994, but not marketed as a standalone dietary supplement, required a NDI notification. So if a green tea supplement marketed before 1994 also contained other natural dietary ingredients, the green tea would be grandfathered and not require a NDI, but the other ingredients would—an absurd stance that has been corrected in the new guidance. Now, dietary ingredients that were marketed as or were contained in dietary supplements before 1994 are grandfathered.
The FDA’s new guidance also allows the submission of “NDI master files,” which contain specifications and other information needed to completely describe an ingredient. 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.
There is still no authoritative list of “grandfathered” ingredients that do not need to submit NDIs, but FDA has said in the new guidance that it is willing to develop such a list based on independent and verifiable data. This appears to be just another stalling tactic after twenty-two years of stalling. We can be sure that the agency will keep the list as short as possible.
Unfortunately, that is the extent of the improvements in the new guidance versus the first draft. Most of the other problems that were in the original guidance remain in the updated draft.
The guidance imposes safety requirements on new supplements that are not even expected of drugs! The FDA describes how to determine what kind of safety studies to submit with an NDI notification. Note that safety studies in the past have been required of drugs, not of supplements. In addition the agency states that additional safety studies may be needed if the target population changes. For example, if a history of safe use has been established with adults, but a substance will be used in a dietary supplement marketed for young children, the FDA would require another NDI notification.
Are other drugs—even dangerous antipsychotics, antidepressants, and stimulants—subject to similar requirements when they are used on children? The answer is a resounding No. In the FDA’s own words, “Most drugs prescribed for children have not been tested in children.” The same is true for use with elderly people. The drugs have almost never been tested on elderly people. This makes the FDA’s new position on supplements especially hypocritical.
The section on investigational new drugs (INDs) also remains. These provisions could destroy the future availability of many supplements. The jargon used here in the guidance is confusing, probably intentionally so, but bear with us.
Remember that an IND refers to a new drug, while an NDI refers to a new supplement. Under current law, if an IND application is filed for an ingredient—that is, an ingredient is being studied for use as part of a new drug—that ingredient can no longer be produced or included in a supplement if a NDI has not previously been accepted. This has already happened to pyridoxamine, a form of vitamin B6, even though in the end it resulted in this valuable form of natural B6 being no longer available either as supplement or drug.
Apparently the FDA couldn’t care less that this form of natural B6 is no longer available in any form. Indeed it has been considering a petition to ban the only remaining natural form of B6, the most important form of all, because all B6, synthetic or natural, must be converted to it in order for our bodies to use it.
In this guidance, the FDA explicitly states that even when an IND is rescinded or does not lead to a new drug, the supplement form is still banned. Well, at least they admit what they are doing!
But just imagine the mischief this could cause when some enterprising drug company decides to corner the market on a whole list of ingredients to keep them out of the hands of supplement formulators forever more. This could very easily be done under this guidance. Remember that it is not always clear what counts as a NDI or what has been grandfathered, so drug companies can use this confusion to claim that supplements which have been around for decades have been sufficiently “altered” that they can be claimed as drugs.
The agency has also kept intact its ridiculous position that synthetic botanical ingredients are, for the most part, not dietary ingredients. This would likely remove many products from store shelves, such as vinpocetine, which is needed to keep our brains healthy. There is an exception for synthetic botanicals that are lawfully used as an ingredient in the conventional food supply, such as vanillin. What makes this even more confusing is that the FDA has already accepted NDI notifications for vinpocetine from a number of supplement producers. Note that in most cases, the FDA does not ever have to resolve the status of NDI notifications.
The FDA is also broadening the group of substances that must submit NDIs by adopting a loose definition of what it means for a supplement to be “chemically altered.” If a post-DSHEA ingredient has been present in the food supply and has not been chemically altered, it is exempted from submitting a NDI notification. The problem is that the FDA’s definition of “chemically altered” is so broad that only the most basic manufacturing methods would not “chemically alter” an ingredient. This language will stifle innovations in manufacturing and ignores the fact that new and more effective ways of producing supplements have arisen in the last twenty-two years since DSHEA passed. It appears that this is quite intentional. The aim is to destroy supplement innovation in the hope that this will eventually destroy the supplement industry.
It’s the same old story. The agency, under the guise of protecting us, is really just protecting its funder, the drug industry, and is throttling any chance of innovation and improvement in supplements. This is so corrupt that it is hard to understand how Congress can continue to turn a blind eye to it, but of course Big Pharma funds political campaigns as well.
Probiotics—the “good” bacteria which our bodies, and in particular, our immune systems, absolutely depend on—could also be on the chopping block. The agency cites risks for these supplements which are purely theoretical and have never posed a problem. Is it a coincidence that Big Pharma is now very interested in producing its own versions of this product? Having probiotics subject to prescription—or costing $100 a bottle—will be a disaster for the health of Americans.
This is pure nonsense. Why would the FDA do this? Clearly these are the actions of an agency looking to restrict the supplement market and remove as many products as possible in as many ways as possible—even though it openly defies the intent of Congress in passing DSHEA, which was meant to expand consumer access to dietary supplements.
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By now, it should be clear that the FDA cannot provide credible oversight of the supplement industry. Another regulator is needed.
TAKE ACTION NOW!
- Leave a public comment for the FDA.
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Image by Health Gauge, via Flickr