Congress Changing Natural Supplements to Prescription
I was deeply concerned to learn that the FDA is planning to move forward with its draft guidance for the new dietary ingredient (NDI) notification process. This guidance threatens consumer access to thousands of dietary supplements. The biggest issues in the original guidance remain in the revised version, and it is critical that the document be revised again to reflect what was intended in the Dietary Supplement Health and Education Act of 1994 (DSHEA): to expand, not restrict, consumer access to supplements, and not to turn supplements over to drug companies.
The 2011 draft guidance threatened to cripple -- if not eliminate -- the supplement industry. An economic analysis at the time from an Emory University professor estimated that the FDA's outrageous interpretation of the DSHEA-mandated NDI notification language would have meant: the elimination of tens of thousands of supplements from the market; an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA's NDI notification protocols; and the loss of between 55,270 and 104,475 jobs in the supplement industry.
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 would 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 population-specific safety studies 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.
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 that drug companies can use this confusion to claim that supplements, which have been around for decades, have been sufficiently "altered" and that they can be claimed as drugs.
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. This to me seems intentional: the FDA is trying to destroy the supplement industry by making innovation impossible.
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.
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.
Moreover, this guidance is just one more of an unending series of attacks on supplements by the FDA that are clearly intended to benefit the drug industry. By now, it should be clear that the FDA cannot provide credible oversight of the supplement industry. Another regulator is needed.
The NDI guidance needs to be amended to protect my supplement access and to reflect what Congress intended in DSHEA.
The 2011 draft guidance threatened to cripple -- if not eliminate -- the supplement industry. An economic analysis at the time from an Emory University professor estimated that the FDA's outrageous interpretation of the DSHEA-mandated NDI notification language would have meant: the elimination of tens of thousands of supplements from the market; an industry-wide cost of between $2 billion and $165 billion in animal and human product safety studies to comply with the FDA's NDI notification protocols; and the loss of between 55,270 and 104,475 jobs in the supplement industry.
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 would 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 population-specific safety studies 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.
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 that drug companies can use this confusion to claim that supplements, which have been around for decades, have been sufficiently "altered" and that they can be claimed as drugs.
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. This to me seems intentional: the FDA is trying to destroy the supplement industry by making innovation impossible.
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.
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.
Moreover, this guidance is just one more of an unending series of attacks on supplements by the FDA that are clearly intended to benefit the drug industry. By now, it should be clear that the FDA cannot provide credible oversight of the supplement industry. Another regulator is needed.
The NDI guidance needs to be amended to protect my supplement access and to reflect what Congress intended in DSHEA.
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