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Senator Durbin & the FDA Viciously Attack Dietary Supplements
July 23, 2011
Under the cover of the July 4th holiday, Senator Richard Durbin (D-Illinois) and the FDA launched an unprecedented and coordinated assault on the dietary supplement industry – in essence a direct attack on consumers who rely on dietary supplements to support their health.
Without a massive consumer protest of this abhorrent abuse of regulatory power, consumers will be denied access to many dietary supplements they currently take. Furthermore, the cost of dietary supplements will skyrocket due to the unnecessary regulatory burden imposed upon supplement companies, ongoing legal wars, and reduced competition in the industry.
While there are many political forces in play, it is clear that one of the main goals of this attack is to allow the pharmaceutical companies to take over the dietary supplement industry.
It is very difficult for the typical consumer of dietary supplements to understand why extreme harassment of the dietary supplement industry is taking place. Such attacks are typically launched under the false cover of “consumer safety,” a pretense that plays well for sound bites and is without merit. Thus, it is of great importance to explain this current attack in the historical and political context in which it is occurring.
It is of even greater importance that every consumer of dietary supplements takes immediate action to preserve their access to quality, cost effective dietary supplements. At the end of this article is a Take Action Now section that explains the steps you should take today.
The dietary supplement industry has no traditional political party as an ally. Dietary supplements empower people to be in charge of their own health, to improve their mental and physical health, and to be more self-determined in their decision making. This flies in the face of what the globalist, ruling-class elite of both political parties desire.
The elimination of health options is required for the control of a population, while the preservation of health freedom is a leading indicator of the overall freedom within a society. The ruling class knows that the control of health options is as important as the control of food and money. If you can keep a population living in fear of their health problems, worried about their financial future, and concerned about rising food prices/shortages, then you can easily control that population. Understand that much of the chaos now going on in the world is intentional and provoked by the global ruling elite.
Big Pharma and its legendary lobby buy whatever political influence they need to force healthy Americans to pay for the drugs of others, drugs which seldom fix health problems. We recently saw Big Pharma purchase the Obama administration and lock in drug sales at taxpayer expense for years to come, as President Obama needed Big Pharma backing for his health reform legislation. Unbelievably, the popular Democratic initiative of drug re-importation at lower prices, which could have easily passed both the House and Senate when they were under Democratic control, was blocked by the Obama administration as part of pandering to the interests of Big Pharma. Big Pharma influences Democrats by aligning itself with the desire to create a socialist-style health care system that includes the unchecked sales of Big Pharma drugs at taxpayer expense.
It is not an accident that 10% of the U.S. population is on zombie-producing brain medications, helping to make a more pliable herd of sheeple. It was President George W. Bush that opened the door and encouraged massive illegal and off-label marketing of brain drugs to children and the elderly. It is shocking that atypical antipsychotic medication is now the best selling drug in the U.S. by dollar value, with most uses of the drug to control behavior and not for the intended use of the drug – typically at taxpayer expense. Of course, President Bush passed Big Pharma legislation committing taxpayers to a massive unfunded liability of paying for many of the drugs seniors take – drugs that generally do not improve health or fix health problems.
Big Pharma influences Republicans by aligning itself as a corporate conglomerate that is too big to fail, one that should be free of prudent safety regulations or reduction in grotesquely inflated prices. It fights against drug safety at every turn, while at the same time lobbying to pass laws that lock in sales or eliminate its competition. The media plays along, as Big Pharma is a wonderful source of advertising dollars that are in no small part made possible by taxpayer funding of Big Pharma drug sales.
While Big Pharma sees many aspects of the dietary supplement industry as competition, it is also the case that many pharmaceutical companies are in some aspect of the dietary supplement industry, often as raw material suppliers. Big Pharma does not want to see the dietary supplement industry eliminated, it wants to see the small and medium sized independent businesses in the dietary supplement industry eliminated and it wants to own the industry.
Their key strategy to accomplish this at this time is to lobby to pass costly laws and regulations which they can comply to and which other smaller, independent companies cannot. Such a power play to take over an industry will create a pharmaceutical-based, anti free enterprise monopoly that will massively drive up prices to consumers.
Keep in mind, the U.S. problem is part of a global elitist strategy. Similar campaigns are under way in Europe and Canada – and further along. CODEX continues to be a huge threat not only to health freedom in the U.S. but to the very sovereignty of our country. It is an FDA-supported effort to make U.S. companies comply with international laws that make U.S. citizens subservient to the desires of a band of globalist companies, with Big Pharma influences sitting at the head of the table. The FDA, through the FDA Trilateral Cooperation Charter, is also trying to harmonize U.S. citizens to conform to the existing regulations of Canada and Mexico, which are draconian compared to the rights of U.S. citizens. While pretending to be interested in consumer safety, the FDA is actually a police force bully that is using regulation as a tool to help implement a global elitist agenda. In other words, the attacks are methodical, ongoing, and coming from multiple directions.
Support for dietary supplements can come from a small minority of either Republicans or Democrats, based more on the personal beliefs of those individuals and representation of their constituents, not on a broad consensus of party politics. For example, the 1994 DSHEA (Dietary Supplements Health and Education Act) legislation, which is now at the center of the current attack, was a bipartisan effort led by Tom Harkin (D-Iowa) and Orin Hatch (R-Utah).
While Harkin and Hatch have been steadfast defenders of dietary supplements, they have paid a political price. They are under constant attack for having passed DSHEA from the various forces I have explained. Thus, the rights of consumers granted by DSHEA hang by a thread of support while health freedom for all Americans teeters on a precipice. The only counter balance to the Big Pharma agenda that matters to politicians is the collective voice of individual consumers.
In 1994, it was a massive consumer uprising that enabled the passage of DSHEA. Big Pharma learned their lesson and has sought to take over control of the dietary supplement industry piece by piece, trying to avoid another massive consumer protest. They have taken over major trade groups within the dietary supplement industry, invited expensive FDA regulation of the industry, while sitting back and laughing in their board rooms. They have been able to whittle away at the industry until they got it vulnerable enough for a major attack – which is now underway.
Senator Durbin represents the global elitist faction of the far left. He is the #2 Democrat on the Senate side, and is a close advisor to President Obama, sharing many associations in the Illinois political scene as well as being the former co-chair of his presidential campaign. His leadership role in the Council on Foreign Relations and other well-publicized affiliations make him a very controversial figure. His anti-American position on numerous topics is well documented and has recently been reviewed by attorney Jonathan Emord in his article, Dick Durbin, Enemy of the Founding Fathers’ Republic.
Throughout his Senate career, Durbin has consistently attacked the dietary supplement industry and food industry, seeking to destroy health freedom, family businesses and small businesses, natural health options, and wholesome food. When questioned about his motives it is always the same old sickening answer – he pretends to be concerned about consumer safety. His actual motives are about ever-increasing regulations in the dietary supplement industry and food industry that favor large multi-national corporations and seek to wipe out their competition – as part of his overall globalist agenda.
This man does nothing to investigate the 100,000 or more Americans who are needlessly killed and the more than a million who are seriously injured by Big Pharma medications every year. Rather, he does everything he can to get more people connected to this failing system of health management. At the same time he aggressively attacks the competition to Big Pharma drugs. He is a total hypocrite. The dietary supplement industry has a sterling safety record. Current FDA regulations already allow for consumer protection – no more laws or regulations are needed.
On June 30, 2011, Durbin launched his latest attempt at a new law to damage the dietary supplement industry. It is called S.1310 “Dietary Supplement Labeling Act of 2011.” It is not often that the entire dietary supplement industry agrees on much. However, the industry as a whole is against this legislation. It is an alarming regulatory nightmare that is trying to treat vitamins as if they are drugs. Durbin and the FDA can’t stand the fact that these compounds are inherently safe and that by law the FDA must prove them unsafe. Rather, they want the supplement industry to prove safety with burdensome and costly regulations when no safety issues exist. Such regulations would run small and medium size companies out of business, reduce consumer access to safe products, drive up costs, and reduce the number of people taking supplements, all of which are Durbin goals. Such unnecessary regulatory efforts create a major opportunity for Big Pharma companies to wipe out the dietary supplement industry as we know it today.
S.1310 has now been referred to the HELP committee (Health, Education, Labor, & Pensions). Thankfully for the dietary supplement industry Tom Harkin is the chairman of the committee and we all hope that he would never let this bill out of committee. However, we can take no chances. It is possible that a last minute back room deal in the middle of the night could attach this bill as an amendment to some other legislation, as part of a tit-for-tat bargain. This means that this disastrous piece of legislation needs to be on the radar screen of every Senator, especially those on the HELP committee. Please write your Senators and tell them NO on S.1310.
The second part of the Durbin-orchestrated attack is by utilizing the FDA to concoct regulations and retroactively applying them to damage the dietary supplement industry. This diabolical stunt has been planned for some time. Durbin’s Food Safety Modernization Act, another regulatory nightmare attacking small family farms, was signed into law by President Obama on January 4th 2011, after sliding through in the dark hours of the Lame Duck session. Within that bill Durbin had inserted language requiring the FDA to issue guidance within 180 days of the passage of the Food Safety Modernization Act on a section of the 1994 DSHEA law regarding the definition of a New Dietary Ingredient or NDI. It is important to understand that this is a Durbin effort to ruin the dietary supplement industry, using both newly proposed legislation (S.1310) and retroactively redefining the DSHEA law through new FDA regulations to reflect what is being proposed in S.1310 – undermining the clear intent of the DSHEA law. The DSHEA law intended consumers to have wide access to dietary supplements. Durbin is intent upon the opposite.
The 1994 DSHEA legislation was by no means perfect. Compromises were made to satisfy the anti-vitamin, pro-pharmaceutical lobby. The language in the law regarding new dietary ingredients was such an undesirable compromise. It was able to grandfather in every dietary supplement in use as of 1994 while offering up a vague description of what a new dietary ingredient may be and requiring its approval before it enters the market. The dietary supplement industry has interpreted the law to mean that if the ingredient existed in food prior to 1994 (or in a dietary supplement), then it was grandfathered in.
The working understanding between the FDA and the dietary supplement industry was that if you were trying to bring something to market as a dietary supplement that was outside this definition then you better get approval of that ingredient as an NDI.
This understanding of NDI, along with a number of other understandings between the FDA and dietary supplement industry based on gray areas of the DSHEA language, has provided a relatively peaceful relationship between the FDA and industry. Prior to 1994 it was a decades-long war. It appears headed back in that direction.
On July 1, 2011, as part of the coordinated Durbin attack, the FDA issued proposed new regulatory guidelines to define NDI and who needed to apply for one. Shockingly, the new definitions far exceed anything written or intended by DSHEA – rather they mirror the opinions of Durbin. These regulations seek to change what was essentially a notification process into a costly approval process. This is a flagrant disregard for the intent of the DSHEA law, for which the FDA is suddenly writing regulations 18 years after the fact.
The net effect of the regulations is to reclassify many nutritional compounds currently on the market as NDI. This would force them off the market until they get NDI approval, which will take months and may never be granted. This will throw the industry into chaos, massively disrupt your access to dietary supplements, drive up your prices, and deny you access to many supplements you have counted on for your health.
The FDA is trying to say that production and extraction methods for dietary supplements could readily reclassify a formerly grandfathered nutrient as an NDI. This means that advances in production technology that have enabled better extracts of nutrients to be produced will now put that nutrient back to ground zero – potentially and likely eliminating it from the market. This is ludicrous.
Furthermore, it will not only be required for the manufacturer of the NDI to get approval, every distributor of the product that wants to use the NDI would need to file a separate NDI application. In other words, a costly approval process has to be undertaken over and over again simply to sell something that was safe in the first place. This is completely illogical, bordering on regulatory insanity.
These regulations are also obsessed with the dosing levels of the NDI, forcing any dosing above the amount in food to have drug-like safety testing. This is a key strategy in the global CODEX campaign to water down the therapeutic benefit of dietary supplements so as to reduce their effectiveness and eliminate competition to Big Pharma sales. This is psychotic paranoia on the topic of public health. The only real threat is to the ongoing sales of Big Pharma drugs that don’t fix health problems and actually injure and kill many.
This is an effort by the FDA and Durbin to force dietary supplement companies to get drug-like or food-additive-like safety approval for all their nutrients under the false premise of a need to demonstrate safety. Within the current law, it is up to the FDA to prove that any dietary supplement is not safe. The FDA has the ability and expansive regulatory powers to do this right now so as to protect the safety of the public regarding any issue involving dietary supplements.
Thus, their grand plan is to force a redefinition of what defines an NDI. Then they will retroactively apply this definition to all products currently on the market and try to force them off the market or force them off the market for an undefined period of time while the company goes through extensive and costly NDI approval. If companies don’t comply they will send armed U.S. Marshals to seize their highly effective and safe products as some sort of tainted/adulterated drug. Compliance would likely cost small companies millions of dollars that they cannot possibly afford.
This chess game is being played with a pathetic opening strategy based on imaginary safety problems. The gambit requires an ignorant public for its success. It requires naïve, spineless, and self-serving dietary supplement companies – of which there are many. And it requires dietary supplement trade groups like CRN and NPA to go along with key provisions – which is more likely to happen than you may think.
A 90-day comment period on these proposed guidelines currently exists for consumers and members of the dietary supplement industry to let the FDA know what they think about this. It expires on September 30, 2011.
It is vital that all consumers file a written protest to the FDA explaining your concerns over their rewriting of the intent of the DSHEA law based on their newly proposed regulations. You are especially concerned that products you rely on for your health could be eliminated from the market and/or will cost you significantly more money. Urge them that no matter what guidelines they eventually issue, all dietary supplement products on the market prior to the issuance of their final guidelines should be grandfather in so as not to disrupt the current market and potentially injure the health of Americans.
Members of the dietary supplement industry should also submit comments to preserve their rights to pursue future legal challenges, though such comments need to be written in legal language and will require costly legal advice (just the beginning of burdensome legal expenses for small and medium size dietary supplement companies).
Once this comment period is over, then the FDA can take as long as it wants to issue final guidelines. In fact, they don’t have to issue final guidelines if they don’t want to. They can simply begin enforcement based on their current thinking as explained in their draft guidelines and then establish court rulings to foster their position. It is more likely they will issue some type of final ruling. Large dietary supplement companies will weather the storm and bear the expenses, jockeying for their position in the New World Order of dietary supplements. Such large companies, including those aligned with Big Pharma interests and many involved with the largest dietary supplement trade groups (CRN and NPA), would actually like their competition from smaller companies to be eliminated. Yes, it is a greedy dog-eat-dog world.
Smaller companies will do what they can to get ready. It is likely that the FDA will go after 10 – 15 of them, trying to make an example for the rest of the industry. Some companies will buckle immediately; others will stand and fight the David vs. Goliath battle.
The losers are consumers. Consumers will have fewer health options in terms of nutrients that can assist their health. What is left on the market will be far higher in price. Innovation in the industry will be set back to the Dark Ages and all new ingredients will come to the market with Big Pharma dollars. We are witnessing the attempted takeover of an entire industry.
All that stands in the way of this outcome is a massive outcry from outraged consumers. The forces orchestrating this attack have no answer to the power of the consumer joined together on social media and the internet. If you rely on dietary supplements for your health it is time to spread the word.
1) Pass on this article to everyone you know who values their access to dietary supplements as a safe way to enhance their health.
2) Take action here - Write your Senators and tell them to be aware of S.1310 and to vote no on it. Write the FDA and tell them you want all nutrients currently on the market grandfathered in so that none of them need to comply retroactively to new NDI guidelines. Tell them it is vital you have access to all of the nutrients currently on the market and that their regulatory actions will drive up prices, cause nutrients to needlessly disappear from the market, and result in health harm to the American public – not improved safety.
For more information:
To read Senate bill S.1310, click here.
To see a list of Senators on the HELP committee, which you could also write about S.1310, click here.
To read the FDA draft guidance on NDI, click here.
To read legal analysis of the FDA draft guidance on new dietary ingredients, click here and here.
To better understand why the FDA is such a corrupt and morally bankrupt organization, read my 2006 book, Fight for Your Health, Exposing the FDA's Betrayal of America.
Without a massive consumer protest of this abhorrent abuse of regulatory power, consumers will be denied access to many dietary supplements they currently take. Furthermore, the cost of dietary supplements will skyrocket due to the unnecessary regulatory burden imposed upon supplement companies, ongoing legal wars, and reduced competition in the industry.
While there are many political forces in play, it is clear that one of the main goals of this attack is to allow the pharmaceutical companies to take over the dietary supplement industry.
It is very difficult for the typical consumer of dietary supplements to understand why extreme harassment of the dietary supplement industry is taking place. Such attacks are typically launched under the false cover of “consumer safety,” a pretense that plays well for sound bites and is without merit. Thus, it is of great importance to explain this current attack in the historical and political context in which it is occurring.
It is of even greater importance that every consumer of dietary supplements takes immediate action to preserve their access to quality, cost effective dietary supplements. At the end of this article is a Take Action Now section that explains the steps you should take today.
Politics, Big Pharma, Globalism & Dietary Supplements
The dietary supplement industry has no traditional political party as an ally. Dietary supplements empower people to be in charge of their own health, to improve their mental and physical health, and to be more self-determined in their decision making. This flies in the face of what the globalist, ruling-class elite of both political parties desire.
The elimination of health options is required for the control of a population, while the preservation of health freedom is a leading indicator of the overall freedom within a society. The ruling class knows that the control of health options is as important as the control of food and money. If you can keep a population living in fear of their health problems, worried about their financial future, and concerned about rising food prices/shortages, then you can easily control that population. Understand that much of the chaos now going on in the world is intentional and provoked by the global ruling elite.
Big Pharma and its legendary lobby buy whatever political influence they need to force healthy Americans to pay for the drugs of others, drugs which seldom fix health problems. We recently saw Big Pharma purchase the Obama administration and lock in drug sales at taxpayer expense for years to come, as President Obama needed Big Pharma backing for his health reform legislation. Unbelievably, the popular Democratic initiative of drug re-importation at lower prices, which could have easily passed both the House and Senate when they were under Democratic control, was blocked by the Obama administration as part of pandering to the interests of Big Pharma. Big Pharma influences Democrats by aligning itself with the desire to create a socialist-style health care system that includes the unchecked sales of Big Pharma drugs at taxpayer expense.
It is not an accident that 10% of the U.S. population is on zombie-producing brain medications, helping to make a more pliable herd of sheeple. It was President George W. Bush that opened the door and encouraged massive illegal and off-label marketing of brain drugs to children and the elderly. It is shocking that atypical antipsychotic medication is now the best selling drug in the U.S. by dollar value, with most uses of the drug to control behavior and not for the intended use of the drug – typically at taxpayer expense. Of course, President Bush passed Big Pharma legislation committing taxpayers to a massive unfunded liability of paying for many of the drugs seniors take – drugs that generally do not improve health or fix health problems.
Big Pharma influences Republicans by aligning itself as a corporate conglomerate that is too big to fail, one that should be free of prudent safety regulations or reduction in grotesquely inflated prices. It fights against drug safety at every turn, while at the same time lobbying to pass laws that lock in sales or eliminate its competition. The media plays along, as Big Pharma is a wonderful source of advertising dollars that are in no small part made possible by taxpayer funding of Big Pharma drug sales.
While Big Pharma sees many aspects of the dietary supplement industry as competition, it is also the case that many pharmaceutical companies are in some aspect of the dietary supplement industry, often as raw material suppliers. Big Pharma does not want to see the dietary supplement industry eliminated, it wants to see the small and medium sized independent businesses in the dietary supplement industry eliminated and it wants to own the industry.
Their key strategy to accomplish this at this time is to lobby to pass costly laws and regulations which they can comply to and which other smaller, independent companies cannot. Such a power play to take over an industry will create a pharmaceutical-based, anti free enterprise monopoly that will massively drive up prices to consumers.
Keep in mind, the U.S. problem is part of a global elitist strategy. Similar campaigns are under way in Europe and Canada – and further along. CODEX continues to be a huge threat not only to health freedom in the U.S. but to the very sovereignty of our country. It is an FDA-supported effort to make U.S. companies comply with international laws that make U.S. citizens subservient to the desires of a band of globalist companies, with Big Pharma influences sitting at the head of the table. The FDA, through the FDA Trilateral Cooperation Charter, is also trying to harmonize U.S. citizens to conform to the existing regulations of Canada and Mexico, which are draconian compared to the rights of U.S. citizens. While pretending to be interested in consumer safety, the FDA is actually a police force bully that is using regulation as a tool to help implement a global elitist agenda. In other words, the attacks are methodical, ongoing, and coming from multiple directions.
Support for dietary supplements can come from a small minority of either Republicans or Democrats, based more on the personal beliefs of those individuals and representation of their constituents, not on a broad consensus of party politics. For example, the 1994 DSHEA (Dietary Supplements Health and Education Act) legislation, which is now at the center of the current attack, was a bipartisan effort led by Tom Harkin (D-Iowa) and Orin Hatch (R-Utah).
While Harkin and Hatch have been steadfast defenders of dietary supplements, they have paid a political price. They are under constant attack for having passed DSHEA from the various forces I have explained. Thus, the rights of consumers granted by DSHEA hang by a thread of support while health freedom for all Americans teeters on a precipice. The only counter balance to the Big Pharma agenda that matters to politicians is the collective voice of individual consumers.
In 1994, it was a massive consumer uprising that enabled the passage of DSHEA. Big Pharma learned their lesson and has sought to take over control of the dietary supplement industry piece by piece, trying to avoid another massive consumer protest. They have taken over major trade groups within the dietary supplement industry, invited expensive FDA regulation of the industry, while sitting back and laughing in their board rooms. They have been able to whittle away at the industry until they got it vulnerable enough for a major attack – which is now underway.
The Global Elitist Senator Durbin Orchestrates Dietary Supplement Attack
Senator Durbin represents the global elitist faction of the far left. He is the #2 Democrat on the Senate side, and is a close advisor to President Obama, sharing many associations in the Illinois political scene as well as being the former co-chair of his presidential campaign. His leadership role in the Council on Foreign Relations and other well-publicized affiliations make him a very controversial figure. His anti-American position on numerous topics is well documented and has recently been reviewed by attorney Jonathan Emord in his article, Dick Durbin, Enemy of the Founding Fathers’ Republic.
Throughout his Senate career, Durbin has consistently attacked the dietary supplement industry and food industry, seeking to destroy health freedom, family businesses and small businesses, natural health options, and wholesome food. When questioned about his motives it is always the same old sickening answer – he pretends to be concerned about consumer safety. His actual motives are about ever-increasing regulations in the dietary supplement industry and food industry that favor large multi-national corporations and seek to wipe out their competition – as part of his overall globalist agenda.
This man does nothing to investigate the 100,000 or more Americans who are needlessly killed and the more than a million who are seriously injured by Big Pharma medications every year. Rather, he does everything he can to get more people connected to this failing system of health management. At the same time he aggressively attacks the competition to Big Pharma drugs. He is a total hypocrite. The dietary supplement industry has a sterling safety record. Current FDA regulations already allow for consumer protection – no more laws or regulations are needed.
On June 30, 2011, Durbin launched his latest attempt at a new law to damage the dietary supplement industry. It is called S.1310 “Dietary Supplement Labeling Act of 2011.” It is not often that the entire dietary supplement industry agrees on much. However, the industry as a whole is against this legislation. It is an alarming regulatory nightmare that is trying to treat vitamins as if they are drugs. Durbin and the FDA can’t stand the fact that these compounds are inherently safe and that by law the FDA must prove them unsafe. Rather, they want the supplement industry to prove safety with burdensome and costly regulations when no safety issues exist. Such regulations would run small and medium size companies out of business, reduce consumer access to safe products, drive up costs, and reduce the number of people taking supplements, all of which are Durbin goals. Such unnecessary regulatory efforts create a major opportunity for Big Pharma companies to wipe out the dietary supplement industry as we know it today.
S.1310 has now been referred to the HELP committee (Health, Education, Labor, & Pensions). Thankfully for the dietary supplement industry Tom Harkin is the chairman of the committee and we all hope that he would never let this bill out of committee. However, we can take no chances. It is possible that a last minute back room deal in the middle of the night could attach this bill as an amendment to some other legislation, as part of a tit-for-tat bargain. This means that this disastrous piece of legislation needs to be on the radar screen of every Senator, especially those on the HELP committee. Please write your Senators and tell them NO on S.1310.
The second part of the Durbin-orchestrated attack is by utilizing the FDA to concoct regulations and retroactively applying them to damage the dietary supplement industry. This diabolical stunt has been planned for some time. Durbin’s Food Safety Modernization Act, another regulatory nightmare attacking small family farms, was signed into law by President Obama on January 4th 2011, after sliding through in the dark hours of the Lame Duck session. Within that bill Durbin had inserted language requiring the FDA to issue guidance within 180 days of the passage of the Food Safety Modernization Act on a section of the 1994 DSHEA law regarding the definition of a New Dietary Ingredient or NDI. It is important to understand that this is a Durbin effort to ruin the dietary supplement industry, using both newly proposed legislation (S.1310) and retroactively redefining the DSHEA law through new FDA regulations to reflect what is being proposed in S.1310 – undermining the clear intent of the DSHEA law. The DSHEA law intended consumers to have wide access to dietary supplements. Durbin is intent upon the opposite.
Twisting the NDI Issue to Wreck the Dietary Supplement Industry
The 1994 DSHEA legislation was by no means perfect. Compromises were made to satisfy the anti-vitamin, pro-pharmaceutical lobby. The language in the law regarding new dietary ingredients was such an undesirable compromise. It was able to grandfather in every dietary supplement in use as of 1994 while offering up a vague description of what a new dietary ingredient may be and requiring its approval before it enters the market. The dietary supplement industry has interpreted the law to mean that if the ingredient existed in food prior to 1994 (or in a dietary supplement), then it was grandfathered in.
The working understanding between the FDA and the dietary supplement industry was that if you were trying to bring something to market as a dietary supplement that was outside this definition then you better get approval of that ingredient as an NDI.
This understanding of NDI, along with a number of other understandings between the FDA and dietary supplement industry based on gray areas of the DSHEA language, has provided a relatively peaceful relationship between the FDA and industry. Prior to 1994 it was a decades-long war. It appears headed back in that direction.
On July 1, 2011, as part of the coordinated Durbin attack, the FDA issued proposed new regulatory guidelines to define NDI and who needed to apply for one. Shockingly, the new definitions far exceed anything written or intended by DSHEA – rather they mirror the opinions of Durbin. These regulations seek to change what was essentially a notification process into a costly approval process. This is a flagrant disregard for the intent of the DSHEA law, for which the FDA is suddenly writing regulations 18 years after the fact.
The net effect of the regulations is to reclassify many nutritional compounds currently on the market as NDI. This would force them off the market until they get NDI approval, which will take months and may never be granted. This will throw the industry into chaos, massively disrupt your access to dietary supplements, drive up your prices, and deny you access to many supplements you have counted on for your health.
The FDA is trying to say that production and extraction methods for dietary supplements could readily reclassify a formerly grandfathered nutrient as an NDI. This means that advances in production technology that have enabled better extracts of nutrients to be produced will now put that nutrient back to ground zero – potentially and likely eliminating it from the market. This is ludicrous.
Furthermore, it will not only be required for the manufacturer of the NDI to get approval, every distributor of the product that wants to use the NDI would need to file a separate NDI application. In other words, a costly approval process has to be undertaken over and over again simply to sell something that was safe in the first place. This is completely illogical, bordering on regulatory insanity.
These regulations are also obsessed with the dosing levels of the NDI, forcing any dosing above the amount in food to have drug-like safety testing. This is a key strategy in the global CODEX campaign to water down the therapeutic benefit of dietary supplements so as to reduce their effectiveness and eliminate competition to Big Pharma sales. This is psychotic paranoia on the topic of public health. The only real threat is to the ongoing sales of Big Pharma drugs that don’t fix health problems and actually injure and kill many.
This is an effort by the FDA and Durbin to force dietary supplement companies to get drug-like or food-additive-like safety approval for all their nutrients under the false premise of a need to demonstrate safety. Within the current law, it is up to the FDA to prove that any dietary supplement is not safe. The FDA has the ability and expansive regulatory powers to do this right now so as to protect the safety of the public regarding any issue involving dietary supplements.
Thus, their grand plan is to force a redefinition of what defines an NDI. Then they will retroactively apply this definition to all products currently on the market and try to force them off the market or force them off the market for an undefined period of time while the company goes through extensive and costly NDI approval. If companies don’t comply they will send armed U.S. Marshals to seize their highly effective and safe products as some sort of tainted/adulterated drug. Compliance would likely cost small companies millions of dollars that they cannot possibly afford.
This chess game is being played with a pathetic opening strategy based on imaginary safety problems. The gambit requires an ignorant public for its success. It requires naïve, spineless, and self-serving dietary supplement companies – of which there are many. And it requires dietary supplement trade groups like CRN and NPA to go along with key provisions – which is more likely to happen than you may think.
A 90-day comment period on these proposed guidelines currently exists for consumers and members of the dietary supplement industry to let the FDA know what they think about this. It expires on September 30, 2011.
It is vital that all consumers file a written protest to the FDA explaining your concerns over their rewriting of the intent of the DSHEA law based on their newly proposed regulations. You are especially concerned that products you rely on for your health could be eliminated from the market and/or will cost you significantly more money. Urge them that no matter what guidelines they eventually issue, all dietary supplement products on the market prior to the issuance of their final guidelines should be grandfather in so as not to disrupt the current market and potentially injure the health of Americans.
Members of the dietary supplement industry should also submit comments to preserve their rights to pursue future legal challenges, though such comments need to be written in legal language and will require costly legal advice (just the beginning of burdensome legal expenses for small and medium size dietary supplement companies).
Once this comment period is over, then the FDA can take as long as it wants to issue final guidelines. In fact, they don’t have to issue final guidelines if they don’t want to. They can simply begin enforcement based on their current thinking as explained in their draft guidelines and then establish court rulings to foster their position. It is more likely they will issue some type of final ruling. Large dietary supplement companies will weather the storm and bear the expenses, jockeying for their position in the New World Order of dietary supplements. Such large companies, including those aligned with Big Pharma interests and many involved with the largest dietary supplement trade groups (CRN and NPA), would actually like their competition from smaller companies to be eliminated. Yes, it is a greedy dog-eat-dog world.
Smaller companies will do what they can to get ready. It is likely that the FDA will go after 10 – 15 of them, trying to make an example for the rest of the industry. Some companies will buckle immediately; others will stand and fight the David vs. Goliath battle.
The losers are consumers. Consumers will have fewer health options in terms of nutrients that can assist their health. What is left on the market will be far higher in price. Innovation in the industry will be set back to the Dark Ages and all new ingredients will come to the market with Big Pharma dollars. We are witnessing the attempted takeover of an entire industry.
All that stands in the way of this outcome is a massive outcry from outraged consumers. The forces orchestrating this attack have no answer to the power of the consumer joined together on social media and the internet. If you rely on dietary supplements for your health it is time to spread the word.
Take Action Now
1) Pass on this article to everyone you know who values their access to dietary supplements as a safe way to enhance their health.
2) Take action here - Write your Senators and tell them to be aware of S.1310 and to vote no on it. Write the FDA and tell them you want all nutrients currently on the market grandfathered in so that none of them need to comply retroactively to new NDI guidelines. Tell them it is vital you have access to all of the nutrients currently on the market and that their regulatory actions will drive up prices, cause nutrients to needlessly disappear from the market, and result in health harm to the American public – not improved safety.
For more information:
To read Senate bill S.1310, click here.
To see a list of Senators on the HELP committee, which you could also write about S.1310, click here.
To read the FDA draft guidance on NDI, click here.
To read legal analysis of the FDA draft guidance on new dietary ingredients, click here and here.
To better understand why the FDA is such a corrupt and morally bankrupt organization, read my 2006 book, Fight for Your Health, Exposing the FDA's Betrayal of America.
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