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The long-awaited revision of FDA guidance rules for new supplements is finally here. It is very bad news. Highest-level Action Alert!
We normally publish our newsletter on Tuesday, but are sending out this issue today because of its urgency.
What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements. The FDA, working as usual on behalf of the drug industry, says no. We need your help to stop this right now. It will take a huge effort on all of our parts and we need to start immediately.
Over the last few years, one of the biggest issues facing the supplement industry has been the confusion over how to comply with the new dietary ingredient (NDI) provisions contained in the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA), the main law governing supplements. For the layman, “new dietary ingredient” is usually just government jargon for “new supplement.”
Under DSHEA, any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product.
In 2011, the FDA released a draft guidance setting forth the agency’s thinking on how companies should comply with DSHEA’s NDI requirements: how and when a NDI notification should be submitted, what information should be included, what is or is not considered an NDI, etc.
The 2011 draft guidance was a massive broadside aimed at crippling—if not eliminating—the supplement industry. An economic analysis at the time by an Emory University professor estimated that the FDA’s outrageous interpretation of the DSHEA-mandated NDI notification language would have meant:
ANH-USA and others submitted detailed comments to the FDA concerning its deeply flawed guidance document, and ANH-USA members flooded the agency with comments. After a major backlash of 146,000 pages of comments, Congressman Peter Roskam (R-IL) stepped in and said the FDA had reversed the intent of DSHEA, which was meant to expand, not restrict, consumer access to supplements.
ANH-USA and our partners were then able to persuade Congress to add language to an appropriations bill urging the FDA to go back to the drawing board, and the agency eventually agreed. We have been waiting for the agency’s updated draft ever since.
We need to keep in mind some history about this and in particular why DSHEA was passed in the first place. In 1992, the FDA published its Task Force Report on Dietary Supplements. It included the statement that dietary supplements represented a “disincentive for patented drug research.”
This report, plus the news that the clinic of Dr. Jonathan Wright had been raided at gunpoint (later referred to as “The Great B Vitamin Bust”), sent shockwaves through every integrative doctor’s office and every health food store in America.
News of this raid turned out to be the shot heard ’round the world for health freedom. Everybody got organized and started to fight back.
By 1994, over two million letters went to Congress, which led to the passage of DSHEA. Congress for the first time began to have an inkling that diet mattered greatly for health and that dietary supplements could make a great deal of difference in our diet. When President Bill Clinton signed the bill into law, he stated that it represented “common sense.”
The draft of regulations governing new dietary supplements under DSHEA, arriving twenty-two years after the passage of the legislation, and further delayed after the disastrous first draft in 2011, was finally published last Friday. 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 thought it openly defies the intent of Congress in passing DSHEA, which was meant to expand consumer access to dietary supplements.
Over the coming weeks we will continue to dissect the guidance and strategize about the best way to overturn this guidance in order to protect consumer access to dietary supplements. But right now, we need to send messages to the FDA but especially to Congress. We need to immediately register our opposition and dismay at what the FDA is, once again, trying to do in its relentless war against dietary supplements.
By now, it should be clear that the FDA cannot provide credible oversight of the supplement industry. Another regulator is needed.
Action Alert! Write to Congress and the FDA and to protest this revised guidance that threatens our access to supplements. Please send your message immediately.
from The Alliance for Natural Health http://ift.tt/2bvHmyb via Aloe for Health
The long-awaited revision of FDA guidance rules for new supplements is finally here. It is very bad news. Highest-level Action Alert!
We normally publish our newsletter on Tuesday, but are sending out this issue today because of its urgency.
What we are dealing with here is whether the supplement industry is allowed to innovate and create new supplements. The FDA, working as usual on behalf of the drug industry, says no. We need your help to stop this right now. It will take a huge effort on all of our parts and we need to start immediately.
Over the last few years, one of the biggest issues facing the supplement industry has been the confusion over how to comply with the new dietary ingredient (NDI) provisions contained in the landmark Dietary Supplement Health and Education Act of 1994 (DSHEA), the main law governing supplements. For the layman, “new dietary ingredient” is usually just government jargon for “new supplement.”
Under DSHEA, any dietary supplement introduced to the market in the US after 1994 is considered “new” (an NDI) and the manufacturer must notify the FDA at least seventy-five days in advance of marketing the product.
In 2011, the FDA released a draft guidance setting forth the agency’s thinking on how companies should comply with DSHEA’s NDI requirements: how and when a NDI notification should be submitted, what information should be included, what is or is not considered an NDI, etc.
The 2011 draft guidance was a massive broadside aimed at crippling—if not eliminating—the supplement industry. An economic analysis at the time by an Emory University professor estimated that the FDA’s outrageous interpretation of the DSHEA-mandated NDI notification language would have meant:
ANH-USA and others submitted detailed comments to the FDA concerning its deeply flawed guidance document, and ANH-USA members flooded the agency with comments. After a major backlash of 146,000 pages of comments, Congressman Peter Roskam (R-IL) stepped in and said the FDA had reversed the intent of DSHEA, which was meant to expand, not restrict, consumer access to supplements.
ANH-USA and our partners were then able to persuade Congress to add language to an appropriations bill urging the FDA to go back to the drawing board, and the agency eventually agreed. We have been waiting for the agency’s updated draft ever since.
We need to keep in mind some history about this and in particular why DSHEA was passed in the first place. In 1992, the FDA published its Task Force Report on Dietary Supplements. It included the statement that dietary supplements represented a “disincentive for patented drug research.”
This report, plus the news that the clinic of Dr. Jonathan Wright had been raided at gunpoint (later referred to as “The Great B Vitamin Bust”), sent shockwaves through every integrative doctor’s office and every health food store in America.
News of this raid turned out to be the shot heard ’round the world for health freedom. Everybody got organized and started to fight back.
By 1994, over two million letters went to Congress, which led to the passage of DSHEA. Congress for the first time began to have an inkling that diet mattered greatly for health and that dietary supplements could make a great deal of difference in our diet. When President Bill Clinton signed the bill into law, he stated that it represented “common sense.”
The draft of regulations governing new dietary supplements under DSHEA, arriving twenty-two years after the passage of the legislation, and further delayed after the disastrous first draft in 2011, was finally published last Friday. 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 thought it openly defies the intent of Congress in passing DSHEA, which was meant to expand consumer access to dietary supplements.
Over the coming weeks we will continue to dissect the guidance and strategize about the best way to overturn this guidance in order to protect consumer access to dietary supplements. But right now, we need to send messages to the FDA but especially to Congress. We need to immediately register our opposition and dismay at what the FDA is, once again, trying to do in its relentless war against dietary supplements.
By now, it should be clear that the FDA cannot provide credible oversight of the supplement industry. Another regulator is needed.
Action Alert! Write to Congress and the FDA and to protest this revised guidance that threatens our access to supplements. Please send your message immediately.
Related article: FDA: Massive Attack on Supplements
Trouble Taking Action? Click here.
Related article: FDA: Massive Attack on Supplements
Trouble Taking Action? Click here.
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The world is focused on glyphosate, but another commonly used farm herbicide could be just as poisonous. Action Alert!
The Environmental Protection Agency (EPA) is required to review pesticides and herbicides approved for use in the US every fifteen years. The agency just completed its updated environmental impact assessment of atrazine, the second most widely used herbicide.
Atrazine is a chlorine-based chemical just like DDT—the once-popular insecticide—and PCBs (polychlorinated biphenyl). It can persist in soil for twenty-two years. Lots of evidence shows the extent to which atrazine is contaminating our food supply, which is little surprise given that as much as 70 million pounds of the stuff is used by farmers each year, mostly on corn.
In its 500-page draft report, the EPA found that atrazine, which is produced by biotech giant Syngenta, can be dangerous to animals and fish—and leaves behind a troubling amount of residue. According to the report, atrazine exceeds the agency’s “levels of concern” for chronic risks to animals and fish by 198 times and 62 times, respectively. Despite the length of the report, the EPA found it convenient to omit all discussion of atrazine’s risk to humans, promising to return to that subject in the future.
What the EPA did report, however, vindicates the research of Tyrone Hayes, PhD, who found that atrazine exposure was chemically castrating male frogs. At the time, he was working for Novartis, which is now owned by Syngenta—which of course refused to publish his research. Hayes quit, obtained independent funding, and published the research, but was then the victim of what seemed clearly to be a smear campaign by Syngenta.
Atrazine does not typically kill animals outright, but has been shown to adversely affect their developmental, hormonal, and reproductive systems. In its draft report, the EPA also acknowledges that adverse effects on animals can occur at exposure levels much lower than previously thought.
Heavy atrazine use can cause dire consequences for plant life. The EPA found that atrazine runoff and spray drift reduces land-based plant biodiversity, among other problems.
The EPA is expected to release its assessment of atrazine’s impact on human health later this year. But the risk to farm children is already known to be particularly severe. One analysis of towns in the “corn belt” found that tap water in some communities contained fourteen times the legally allowed amount of atrazine. In some towns, infants reached their maximum lifetime safe dosage of atrazine in less than four months. This analysis was done in the late 1990s—and levels are almost certainly worse, since more and more of the stuff is being dumped on crops each year.
Beyond farm families, there is already plenty of evidence of the dangers of atrazine:
We shouldn’t wait for the EPA to produce another weighty and hard-to-understand report on whether atrazine poses human health problems. It clearly does, and decisive steps need to be taken to remove this product from the market.
Action Alert! Write to the EPA and tell the agency to revoke its approval of atrazine. Please send your message immediately.
Other articles in this week’s Pulse of Natural Health:
US Department of Monsanto (a.k.a. USDA)
MRIs: What Your Doctor May Not Warn You About
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This particular crony alliance isn’t even secretive about it. Action Alert!
We think of Monsanto and other companies as developers and promoters of GMOs. But thanks to passage of the Federal Technology Transfer Act of 1986, as well as President Reagan’s Executive Order #12591—“Facilitating Access to Science and Technology”—the USDA is also directly in the business of developing, patenting, and promoting biotechnology inventions. The difference is that the USDA slips the patents, developed from government research and paid for by US taxpayers, into the hands of private companies such as Monsanto and Syngenta.
You read that right. According to the USDA’s own Agricultural Research Service (ARS), about sixty new patents are issued for USDA inventions each year. These patents are then transferred through licenses to the private sector—mostly to biotech companies. ARS has released more than 400 new crop germplasm lines since 2000, and the USDA spends about $220 million taxpayer dollars on biotechnology research each year.
A cursory search through the recent inventions of the USDA reveals nearly two dozen inventions in the “plant genes” and “crop protection” categories. These patents range from the use of RNA interference to control gypsy moth populations, to genetically altered citrus plants that protect the plant from citrus greening and citrus canker. The USDA’s research into plant genes includes isolating genes in peach, plum, almond, and apricot trees that can be manipulated to affect tree shape with “desired branch angles.” Another patent uses double-stranded RNA constructs to inhibit the expression of certain proteins and kill aphids. There are many more such examples.
The biotech industry is a young industry. The potential for destroying the ecosystem of the planet is ever-present—not to mention the potential for genetically altering the human species. That the USDA, in concert with Monsanto and others, is rushing into inventing and marketing genetically altered organisms, and bragging about this collaborative effort, tells us all we need to know about this crony alliance.
Nineteen members of the EU have already rejected GMO crops in their countries. The Center for Food Safety, a Washington-based nonprofit environmental advocacy group, reports that the overwhelming majority of Americans in all demographics support GMO labeling on all food products. Yet in response, Congress just handed us a fake labeling law that would actually protect Big Food from having to label GMOs at all.
The USDA’s involvement in genetic engineering goes beyond developing technologies and licensing them to the biotech industry. In delineating its role in agricultural biotechnology, the agency actually admits that its primary function is to “provide regulatory oversight of organisms derived through genetic engineering.” However, the agency seems to have “reinterpreted” this job out of existence. Once again, as with vaccines, we see a government agency promoting and making money from what it is supposed to regulate.
By its own admission, the USDA’s Economic Research Service (ERS) “conducts research on the economic aspects of the use of genetically engineered organisms, including the rate of and reasons for adoption of biotechnology by farmers. ERS also addresses economic issues related to the marketing, labeling, and trading of biotechnology-derived products.” Translated, this means the intended regulator is also the cheerleader and promoter.
None of this is surprising when we consider the revolving door between biotech giants like Monsanto and the federal government. For instance, a few years ago, the Obama administration appointed Roger Beachy, director of the Monsanto-owned Danforth Plant Science Center, to head the National Institute of Food and Agriculture, which has the power to grant or reject agricultural research grants. And a Monsanto lobbyist was appointed to be the agriculture trade representative. This revolving door between the private and the public sector is facilitated by what are called cooperative research and development agreements.
This degree of cronyism between the biotech industry and the USDA is truly an insult to the American public. It is time for the American public to speak up, because nobody else will.
Action Alert! Write to your senators and representative in Congress—and send a copy of your message to the USDA—and tell them to protect consumers, not the profits of the biotech industry! Please send your message immediately.
Other articles in this week’s Pulse of Natural Health:
MRIs: What Your Doctor May Not Warn You About
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