Monsanto’s Spy Software to Control the Entire Agriculture Market

We must stop this attempt to create a new and potentially even bigger monopoly. Action Alert!

Monsanto recently reached a deal with Deere & Co. that could dramatically alter the US agricultural market, and not for the better.

John Deere, the world’s largest producer of agricultural machinery, agreed to purchase Monsanto’s Precision Planting LLC equipment unit. As part of the deal, information on crops contained in Monsanto’s FieldView software app, used with the equipment, will send continuous information back to Monsanto. Monsanto will know which farmers have planted which crops, and where.

Importantly, Monsanto has similar deals with two other top producers of similar agricultural machinery, CNH Industrial NV and Agco Corporation.

As Dr. Mercola brought to our attention and astutely points out, access to this information imbedded in farming equipment across the country will give the company “unprecedented insight into market yields of any harvest before anyone else, and this information could allow [Monsanto] to manipulate and reign supreme over the commodities market.”

This is an outrage. The government has done everything in its power to grant Monsanto a monopoly over the seed industry. Now, these technology deals could give Monsanto another monopoly—this time over agricultural information and, through that, the commodities market.

Action Alert! Write to the Federal Trade Commission, the Department of Justice, and the Commodities Trading Futures Commission, and tell them they must act to stop this outrageous expansion of Monsanto’s monopoly power. Please send your message immediately.

Other articles in this week’s Pulse of Natural Health:

Plan for an End Run around GMO Labeling

Big Pharma Connections? No Problem, Says Nominee for FDA Chief

Feds Crack Down on Criminal Supplement Dealer

from The Alliance for Natural Health http://ift.tt/1P6Q0k8 via Aloe for Health

from http://ift.tt/1OeVU1b

Plan for an End Run around GMO Labeling

This would be a behind-the-scenes move by Sen. Stabenow. We also discuss bias in the media, “Frankenfish” approval, and EPA corruption. Action Alerts!

Rider Will Thwart State GMO Laws

The House of Representatives has approved the so-called “Safe and Accurate Food Labeling Act of 2015,” otherwise known as the “Deny Americans the Right to Know (DARK) Act,” introduced by Rep. Mike Pompeo (R-KS). Now, in the Senate, Sen. Debbie Stabenow (D-MI) is working to attach DARK Act-like provisions to the end-of-the-year budget bill. In exchange, companies would develop an alternative, completely voluntary disclosure system, such as scannable codes on food packaging that would tell consumers whether or not the product contains GMOs. This would eliminate state-mandated GMO labeling without even voting on the DARK Act proposal.

If you want to know which foods contain genetically modified organisms, all you need do is bring your own scanner to the store with you! That is, if producers choose to put GMO info into their barcodes on a voluntary basis, which isn’t very likely.

The cynical rationale for this sneaky maneuver is all too apparent. Because the industry is having trouble gaining the political support it needs to pass legislation like the DARK Act, the biotech and Big Food lobbies are urging senators to resort to the familiar tactic of attaching riders (completely unrelated legislation) to must-pass omnibus bills in the hope that the measure will slip by without notice. We saw a similar strategy at work earlier this year when Sen. Dick Durbin (D-IL) attached anti-supplement amendments to a must-pass national defense bill. It is an especially useful tactic when members of Congress would like to avoid high-profile votes on controversial issues that would upset their constituents.

There’s another reason why industry cannot wait for Congress to approve the DARK Act or similar legislation. Vermont’s landmark GMO labeling legislation takes effect in July 2016. This maneuver is industry’s last hope to kill Vermont’s law before it goes into effect.

Media Bias

We recently reported that the biotech industry was buying off scientists and mom-bloggers. Unsurprisingly, it appears as if freelance journalists and other mainstream media outlets are also on biotech and “Big Farma’s” payroll.

A recent story probed the question of whether it is ethical for journalists covering GMO issues to accept travel and speaking expenses, as well as other gifts, from the biotech industry. Outlets like the Washington Post, Science, and Nature, the article notes, have recently come under fire for failing to disclose that reporters had some of their expenses paid by industry—charges the media outlets largely dismiss. With times getting increasingly tough for the print media, it’s not hard to imagine editors blurring the ethical lines to save the outlet some money. The problem can be even more pronounced with freelancers who are not beholden to an outlet’s ethical guidelines, however loosely they may be defined.

The story is a good reminder that the ideal—an objective press that informs the public and speaks truth to power—is very, very far from the crony reality.

GMO “Frankenfish” Heading to Market

Last week the FDA approved a genetically engineered salmon, making it the first GE animal to be approved for human consumption.

The salmon, which we’ve been warning the public about since 2010, is genetically altered so that it grows to market size twice as fast as natural salmon. They start with an Atlantic salmon and implant the Chinook salmon growth hormone gene, plus an antifreeze protein gene from the ocean pout—an eel-like creature from a different family of marine organisms. As with other GMO foods, there is no requirement (nor any likelihood!) that the fish will be labeled as genetically altered.

AquAdvantage, the producer of the GE salmon, first approached the FDA for approval in the 1990s. The FDA has said that the approval process took so long because it was the first approval of its kind.

The approval of the GE salmon will likely lead to the development of more GE animals. The New York Times reports that “there has been a surge in interest in developing new genetically engineered animals and pets because new techniques…allow scientists to edit animal genomes rather than add genes from other species.” Scientists in China, for instance, have created goats with more muscle and longer hair. We can only imagine the variety of GMO animal products that will be hitting stores in the near future.

The salmon is expected to enter the market in about two years, but some major retailers have already pledged not to carry it, including Safeway, Target, Whole Foods, and Trader Joe’s. A complete list of the stores that signed the pledge can be found here.

EPA in the Pocket of Monsanto?

Finally, a recent report revealed that the Environmental Protection Agency’s determination that glyphosate is not an endocrine disruptor—a finding that flies in the face of a decade of scientific studies which demonstrate the herbicide’s toxicity to mammals—was based almost entirely on industry-backed studies.

The EPA’s review relied on thirty-two studies, twenty-seven of which were either conducted or funded by the biotech industry. Now that the EPA has made its determination, no further safety tests of glyphosate’s effect on the endocrine system will be required.

Of the five that were independently funded, three found evidence that glyphosate, marketed worldwide by Monsanto as Roundup, could indeed harm the endocrine system!

Even more troubling is the fact that endocrine disruption is far from the only hazard that glyphosate poses to human health. Stephanie Seneff, PhD, noted a few years ago that the side effects of autism closely mimic those of glyphosate toxicity—and the skyrocketing rates of autism are also remarkably consistent with the increasing use of Roundup on US crops. And perhaps most importantly, the World Health Organization concluded that glyphosate was a “probable carcinogen” earlier this year. So why in the world is the EPA doing the bidding of Monsanto and the biotech industry?

There is also evidence that glyphosate severely impairs mitochondrial function. For more on that, watch our new video, GMOs Are 125 Times More Deadly Than Thought.

TWO Action Alerts!

1. Write to your senators and urge them to oppose Sen. Stabenow’s dangerous rider if it comes up in the omnibus budget bill.

2. Send a message to urge major supermarket chains that haven’t signed the “No Frankenfish Pledge”–chains like Walmart and Public–to do so immediately.

Other articles in this week’s Pulse of Natural Health:

Monsanto’s Spy Software to Control the Entire Agriculture Market

Big Pharma Connections? No Problem, Says Nominee for FDA Chief

Feds Crack Down on Criminal Supplement Dealer

from The Alliance for Natural Health http://ift.tt/1YstW5e via Aloe for Health

from http://ift.tt/1T1guBx

Monsanto’s Spy Software to Control the Entire Agriculture Market

We must stop this attempt to create a new and potentially even bigger monopoly. Action Alert!

Monsanto recently reached a deal with Deere & Co. that could dramatically alter the US agricultural market, and not for the better.

John Deere, the world’s largest producer of agricultural machinery, agreed to purchase Monsanto’s Precision Planting LLC equipment unit. As part of the deal, information on crops contained in Monsanto’s FieldView software app, used with the equipment, will send continuous information back to Monsanto. Monsanto will know which farmers have planted which crops, and where.

Importantly, Monsanto has similar deals with two other top producers of similar agricultural machinery, CNH Industrial NV and Agco Corporation.

As Dr. Mercola brought to our attention and astutely points out, access to this information imbedded in farming equipment across the country will give the company “unprecedented insight into market yields of any harvest before anyone else, and this information could allow [Monsanto] to manipulate and reign supreme over the commodities market.”

This is an outrage. The government has done everything in its power to grant Monsanto a monopoly over the seed industry. Now, these technology deals could give Monsanto another monopoly—this time over agricultural information and, through that, the commodities market.

Action Alert! Write to the Federal Trade Commission, the Department of Justice, and the Commodities Trading Futures Commission, and tell them they must act to stop this outrageous expansion of Monsanto’s monopoly power. Please send your message immediately.

Other articles in this week’s Pulse of Natural Health:

Plan for an End Run around GMO Labeling

Big Pharma Connections? No Problem, Says Nominee for FDA Chief

Feds Crack Down on Criminal Supplement Dealer

from The Alliance for Natural Health http://ift.tt/1P6Q0k8 via Aloe for Health
from Tumblr http://ift.tt/1NbLRt6

Plan for an End Run around GMO Labeling

This would be a behind-the-scenes move by Sen. Stabenow. We also discuss bias in the media, “Frankenfish” approval, and EPA corruption. Action Alerts!

Rider Will Thwart State GMO Laws

The House of Representatives has approved the so-called “Safe and Accurate Food Labeling Act of 2015,” otherwise known as the “Deny Americans the Right to Know (DARK) Act,” introduced by Rep. Mike Pompeo (R-KS). Now, in the Senate, Sen. Debbie Stabenow (D-MI) is working to attach DARK Act-like provisions to the end-of-the-year budget bill. In exchange, companies would develop an alternative, completely voluntary disclosure system, such as scannable codes on food packaging that would tell consumers whether or not the product contains GMOs. This would eliminate state-mandated GMO labeling without even voting on the DARK Act proposal.

If you want to know which foods contain genetically modified organisms, all you need do is bring your own scanner to the store with you! That is, if producers choose to put GMO info into their barcodes on a voluntary basis, which isn’t very likely.

The cynical rationale for this sneaky maneuver is all too apparent. Because the industry is having trouble gaining the political support it needs to pass legislation like the DARK Act, the biotech and Big Food lobbies are urging senators to resort to the familiar tactic of attaching riders (completely unrelated legislation) to must-pass omnibus bills in the hope that the measure will slip by without notice. We saw a similar strategy at work earlier this year when Sen. Dick Durbin (D-IL) attached anti-supplement amendments to a must-pass national defense bill. It is an especially useful tactic when members of Congress would like to avoid high-profile votes on controversial issues that would upset their constituents.

There’s another reason why industry cannot wait for Congress to approve the DARK Act or similar legislation. Vermont’s landmark GMO labeling legislation takes effect in July 2016. This maneuver is industry’s last hope to kill Vermont’s law before it goes into effect.

Media Bias

We recently reported that the biotech industry was buying off scientists and mom-bloggers. Unsurprisingly, it appears as if freelance journalists and other mainstream media outlets are also on biotech and “Big Farma’s” payroll.

A recent story probed the question of whether it is ethical for journalists covering GMO issues to accept travel and speaking expenses, as well as other gifts, from the biotech industry. Outlets like the Washington Post, Science, and Nature, the article notes, have recently come under fire for failing to disclose that reporters had some of their expenses paid by industry—charges the media outlets largely dismiss. With times getting increasingly tough for the print media, it’s not hard to imagine editors blurring the ethical lines to save the outlet some money. The problem can be even more pronounced with freelancers who are not beholden to an outlet’s ethical guidelines, however loosely they may be defined.

The story is a good reminder that the ideal—an objective press that informs the public and speaks truth to power—is very, very far from the crony reality.

GMO “Frankenfish” Heading to Market

Last week the FDA approved a genetically engineered salmon, making it the first GE animal to be approved for human consumption.

The salmon, which we’ve been warning the public about since 2010, is genetically altered so that it grows to market size twice as fast as natural salmon. They start with an Atlantic salmon and implant the Chinook salmon growth hormone gene, plus an antifreeze protein gene from the ocean pout—an eel-like creature from a different family of marine organisms. As with other GMO foods, there is no requirement (nor any likelihood!) that the fish will be labeled as genetically altered.

AquAdvantage, the producer of the GE salmon, first approached the FDA for approval in the 1990s. The FDA has said that the approval process took so long because it was the first approval of its kind.

The approval of the GE salmon will likely lead to the development of more GE animals. The New York Times reports that “there has been a surge in interest in developing new genetically engineered animals and pets because new techniques…allow scientists to edit animal genomes rather than add genes from other species.” Scientists in China, for instance, have created goats with more muscle and longer hair. We can only imagine the variety of GMO animal products that will be hitting stores in the near future.

The salmon is expected to enter the market in about two years, but some major retailers have already pledged not to carry it, including Safeway, Target, Whole Foods, and Trader Joe’s. A complete list of the stores that signed the pledge can be found here.

EPA in the Pocket of Monsanto?

Finally, a recent report revealed that the Environmental Protection Agency’s determination that glyphosate is not an endocrine disruptor—a finding that flies in the face of a decade of scientific studies which demonstrate the herbicide’s toxicity to mammals—was based almost entirely on industry-backed studies.

The EPA’s review relied on thirty-two studies, twenty-seven of which were either conducted or funded by the biotech industry. Now that the EPA has made its determination, no further safety tests of glyphosate’s effect on the endocrine system will be required.

Of the five that were independently funded, three found evidence that glyphosate, marketed worldwide by Monsanto as Roundup, could indeed harm the endocrine system!

Even more troubling is the fact that endocrine disruption is far from the only hazard that glyphosate poses to human health. Stephanie Seneff, PhD, noted a few years ago that the side effects of autism closely mimic those of glyphosate toxicity—and the skyrocketing rates of autism are also remarkably consistent with the increasing use of Roundup on US crops. And perhaps most importantly, the World Health Organization concluded that glyphosate was a “probable carcinogen” earlier this year. So why in the world is the EPA doing the bidding of Monsanto and the biotech industry?

There is also evidence that glyphosate severely impairs mitochondrial function. For more on that, watch our new video, GMOs Are 125 Times More Deadly Than Thought.

TWO Action Alerts!

1. Write to your senators and urge them to oppose Sen. Stabenow’s dangerous rider if it comes up in the omnibus budget bill.

2. Send a message to urge major supermarket chains that haven’t signed the “No Frankenfish Pledge”–chains like Walmart and Public–to do so immediately.

Other articles in this week’s Pulse of Natural Health:

Monsanto’s Spy Software to Control the Entire Agriculture Market

Big Pharma Connections? No Problem, Says Nominee for FDA Chief

Feds Crack Down on Criminal Supplement Dealer

from The Alliance for Natural Health http://ift.tt/1YstW5e via Aloe for Health
from Tumblr http://ift.tt/1YswDDF

Big Pharma Connections? No Problem, Says Nominee for FDA Chief

Robert Califf doesn’t think his many ties to pharmaceutical companies will affect his objectivity in regulating the industry. Congress seems to agree, but we don’t. Action Alert!

Last Tuesday, President Obama’s nominee to take charge of the federal Food and Drug Administration, Dr. Robert Califf, defended his longstanding ties to Big Pharma in a Senate confirmation hearing in which few lawmakers seemed to oppose his candidacy.

By now, Dr. Califf’s lucrative dealings with the drug industry are well known. He ran a clinical research center at Duke University that received the majority of its multi-million dollar budget from Pharma. According to financial disclosures from last year, Dr. Califf received money for consulting with at least seven drug and medical device companies, and six other companies supported his university salary including Merck, Novartis, and Eli Lilly. The conflict of interest section of a paper he wrote for the European Heart Journal last year lists financial support from more than twenty companies.

All of this has led Daniel Carpenter, a Harvard political science professor and an expert on the FDA, to call Califf the “ultimate industry insider.” Indeed, the New York Times notes that “he has deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory.”

The FDA has increasingly been doing the bidding of Big Pharma, since the drug companies pay the agency’s bills and provide lucrative post-government employment opportunities. Califf’s nomination shows that federal officials are dropping all pretenses of picking someone who would actually protect public health or stand up to industry, and instead are baldly installing a fox to guard the henhouse.

Action Alert! Tell Congress to oppose the nomination of Dr. Califf to FDA Commissioner. Please send your message immediately.

Other articles in this week’s Pulse of Natural Health:

Monsanto’s Spy Software to Control the Entire Agriculture Market

Plan for an End Run around GMO Labeling

Feds Crack Down on Criminal Supplement Dealer

from The Alliance for Natural Health http://ift.tt/1lges5I via Aloe for Health

from http://ift.tt/21eCCON

Action Alert: Oppose Monsanto Monopoly

Related article: Monsanto’s Spy Software to Control the Entire Agriculture Market

Trouble Taking Action? Click here.

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Feds Crack Down on Criminal Supplement Dealer

In contrast to other recent actions against supplement companies, this time it appears justified.

Last week, the US Department of Justice, in conjunction with the Federal Trade Commission and the FDA, announced criminal indictments against a sports supplement manufacturer, USPLabs, as part of a nationwide sweep that included more than 100 supplement makers.

The USPLabs criminal charges alleged that the company falsified documents to cover up the sale of products containing illegal and unsafe ingredients. According to the DOJ’s press release, the company imported ingredients from China using “false certificates of analysis and false labeling and then lied about the source and nature of those ingredients.”

In one instance, USPLabs allegedly made a product it knew could cause liver damage and sold it anyway for its weight loss potential.

For decades the government—the FDA in particular—has seemingly pursued a strategy of deliberately not moving against firms breaking the law in the apparent hope that a scandal would follow leading to more restrictions on supplements, which would in turn reduce competition for drugs. At one point, a Freedom of Information Act request revealed the then-head of the FDA laying out this very strategy in an internal memo.

ANH-USA, along with other supporters of natural health, support federal regulators in their long-delayed efforts to root out criminal behavior in the supplement industry. It is unfortunately true, as it is in most industries, that a few bad actors can put millions of consumers and the entire supplement industry at risk by breaking the laws and regulations that govern that industry. Wrongdoers should be held accountable for genuine crimes—like this one.

We also hope that these actions do not embolden lawmakers like Sen. Durbin to press forward with their crusade to eliminate supplements from the market altogether. In the past these efforts have required little prompting, so we’ll be on the lookout for more threats.

Other articles in this week’s Pulse of Natural Health:

Monsanto’s Spy Software to Control the Entire Agriculture Market

Plan for an End Run around GMO Labeling

Big Pharma Connections? No Problem, Says Nominee for FDA Chief

from The Alliance for Natural Health http://ift.tt/1P6MTc3 via Aloe for Health

from http://ift.tt/21eCCyr

Action Alert: Oppose GMO Budget Rider

Related article: Plan for an End Run around GMO Labeling

Trouble Taking Action? Click here.

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Action Alert: Oppose Dr. Califf as FDA Commissioner

Related article: Big Pharma Connections? No Problem, Says Nominee for FDA Chief

Trouble Taking Action? Click here.

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Action Alert: Tell Retailers to Reject GMO Salmon

Related article: Plan for an End Run around GMO Labeling

Trouble Taking Action? Click here.

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Big Pharma Connections? No Problem, Says Nominee for FDA Chief

Robert Califf doesn’t think his many ties to pharmaceutical companies will affect his objectivity in regulating the industry. Congress seems to agree, but we don’t. Action Alert!

Last Tuesday, President Obama’s nominee to take charge of the federal Food and Drug Administration, Dr. Robert Califf, defended his longstanding ties to Big Pharma in a Senate confirmation hearing in which few lawmakers seemed to oppose his candidacy.

By now, Dr. Califf’s lucrative dealings with the drug industry are well known. He ran a clinical research center at Duke University that received the majority of its multi-million dollar budget from Pharma. According to financial disclosures from last year, Dr. Califf received money for consulting with at least seven drug and medical device companies, and six other companies supported his university salary including Merck, Novartis, and Eli Lilly. The conflict of interest section of a paper he wrote for the European Heart Journal last year lists financial support from more than twenty companies.

All of this has led Daniel Carpenter, a Harvard political science professor and an expert on the FDA, to call Califf the “ultimate industry insider.” Indeed, the New York Times notes that “he has deeper ties to the pharmaceutical industry than any FDA commissioner in recent memory.”

The FDA has increasingly been doing the bidding of Big Pharma, since the drug companies pay the agency’s bills and provide lucrative post-government employment opportunities. Califf’s nomination shows that federal officials are dropping all pretenses of picking someone who would actually protect public health or stand up to industry, and instead are baldly installing a fox to guard the henhouse.

Action Alert! Tell Congress to oppose the nomination of Dr. Califf to FDA Commissioner. Please send your message immediately.

Other articles in this week’s Pulse of Natural Health:

Monsanto’s Spy Software to Control the Entire Agriculture Market

Plan for an End Run around GMO Labeling

Feds Crack Down on Criminal Supplement Dealer

from The Alliance for Natural Health http://ift.tt/1lges5I via Aloe for Health
from Tumblr http://ift.tt/1YstWSJ

Action Alert: Oppose Monsanto Monopoly

Related article: Monsanto’s Spy Software to Control the Entire Agriculture Market

Trouble Taking Action? Click here.

from The Alliance for Natural Health http://ift.tt/1lgeqKW via Aloe for Health
from Tumblr http://ift.tt/1NNKQnk

Feds Crack Down on Criminal Supplement Dealer

In contrast to other recent actions against supplement companies, this time it appears justified.

Last week, the US Department of Justice, in conjunction with the Federal Trade Commission and the FDA, announced criminal indictments against a sports supplement manufacturer, USPLabs, as part of a nationwide sweep that included more than 100 supplement makers.

The USPLabs criminal charges alleged that the company falsified documents to cover up the sale of products containing illegal and unsafe ingredients. According to the DOJ’s press release, the company imported ingredients from China using “false certificates of analysis and false labeling and then lied about the source and nature of those ingredients.”

In one instance, USPLabs allegedly made a product it knew could cause liver damage and sold it anyway for its weight loss potential.

For decades the government—the FDA in particular—has seemingly pursued a strategy of deliberately not moving against firms breaking the law in the apparent hope that a scandal would follow leading to more restrictions on supplements, which would in turn reduce competition for drugs. At one point, a Freedom of Information Act request revealed the then-head of the FDA laying out this very strategy in an internal memo.

ANH-USA, along with other supporters of natural health, support federal regulators in their long-delayed efforts to root out criminal behavior in the supplement industry. It is unfortunately true, as it is in most industries, that a few bad actors can put millions of consumers and the entire supplement industry at risk by breaking the laws and regulations that govern that industry. Wrongdoers should be held accountable for genuine crimes—like this one.

We also hope that these actions do not embolden lawmakers like Sen. Durbin to press forward with their crusade to eliminate supplements from the market altogether. In the past these efforts have required little prompting, so we’ll be on the lookout for more threats.

Other articles in this week’s Pulse of Natural Health:

Monsanto’s Spy Software to Control the Entire Agriculture Market

Plan for an End Run around GMO Labeling

Big Pharma Connections? No Problem, Says Nominee for FDA Chief

from The Alliance for Natural Health http://ift.tt/1P6MTc3 via Aloe for Health
from Tumblr http://ift.tt/1NNKRrp

Action Alert: Oppose GMO Budget Rider

Related article: Plan for an End Run around GMO Labeling

Trouble Taking Action? Click here.

from The Alliance for Natural Health http://ift.tt/1P6MTbV via Aloe for Health
from Tumblr http://ift.tt/1NNKQ6M

Action Alert: Oppose Dr. Califf as FDA Commissioner

Related article: Big Pharma Connections? No Problem, Says Nominee for FDA Chief

Trouble Taking Action? Click here.

from The Alliance for Natural Health http://ift.tt/1P6MUg1 via Aloe for Health
from Tumblr http://ift.tt/1NNKRaU

Action Alert: Tell Retailers to Reject GMO Salmon

Related article: Plan for an End Run around GMO Labeling

Trouble Taking Action? Click here.

from The Alliance for Natural Health http://ift.tt/1lgequE via Aloe for Health
from Tumblr http://ift.tt/1NNKRaG

OPED— Questions of GMO Safety Miss the Larger Point

Proponents of genetically engineered (GE) crops maintain the dogmatic stance on two issues: that genetically modified organisms (GMOs) are safe, and that the science is “settled.” Actual scientific research, however, tells a vastly different story.

The use of GE crops has led to a drastic increase in the use of glyphosate and other pesticides. On the three biggest GE crops, glyphosate use increased from 15 million pounds in 1996 to 159 million pounds in 2012—a whopping 960% increase in just a decade and a half.

The most prevalent GE crops were developed for one reason—to withstand the application of pesticides and herbicides. These crops can be found in upwards of 80% of the products in our grocery aisles. It is therefore impossible to analyze the safety of GMO technology without discussing the safety of the agricultural poisons that are the backbone of this technology—in particular, the herbicide glyphosate, a substance that has been linked to numerous negative health effects.

The World Health Organization, for instance, recently designated glyphosate as a likely carcinogen. Numerous studies establish links between this toxin and mitochondrial dysfunction in humans. Mitochondria are the parts of our cells responsible for converting glucose into energy, and are involved in a range of other processes, such as cell signaling, cellular differentiation, and control of the cell division cycle and cell growth. That’s why glyphosate is associated with increased rates of cancer, Parkinson’s, Alzheimer’s, autism, and a host of other conditions.

Glyphosate is typically applied with other chemical additives, or adjuvants, which increase absorption and potency. The world’s most used herbicide, Roundup®, combines glyphosate with a host of chemical adjuvants and a number of recent studies have clearly demonstrated that this combination is up to 125 times more damaging to human mitochondria than glyphosate alone.

Another serious concern with glyphosate exposure is that it impairs the body’s natural ability to remove toxins. Recent research has found that glyphosate inhibits the CYP450 enzyme, which is responsible for detoxifying foreign chemical compounds found in the body. Put another way, glyphosate actually enhances the damaging effects of other food-borne chemical residues and environmental toxins, according to one recent study, creating such conditions as gastrointestinal disorders, obesity, diabetes, heart disease, depression, autism, infertility, cancer, and Alzheimer’s disease.

The risks are even greater for those born with genetic polymorphisms (natural variations in a gene, DNA sequence, or chromosome) that already prevent the body properly detoxifying. It is no wonder that tests of human blood, urine, and breast milk repeatedly show dangerous levels of glyphosate present.

If we are serious about honestly assessing the safety of GMOs and the biotech industry, we must broaden the discussion to include the toxic substances that are used on them.

Gretchen DuBeau
Executive and Legal Director
Alliance for Natural Health USA

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GMOs Are 125 Times More Deadly Than Thought

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OPED— Questions of GMO Safety Miss the Larger Point

Proponents of genetically engineered (GE) crops maintain the dogmatic stance on two issues: that genetically modified organisms (GMOs) are safe, and that the science is “settled.” Actual scientific research, however, tells a vastly different story.

The use of GE crops has led to a drastic increase in the use of glyphosate and other pesticides. On the three biggest GE crops, glyphosate use increased from 15 million pounds in 1996 to 159 million pounds in 2012—a whopping 960% increase in just a decade and a half.

The most prevalent GE crops were developed for one reason—to withstand the application of pesticides and herbicides. These crops can be found in upwards of 80% of the products in our grocery aisles. It is therefore impossible to analyze the safety of GMO technology without discussing the safety of the agricultural poisons that are the backbone of this technology—in particular, the herbicide glyphosate, a substance that has been linked to numerous negative health effects.

The World Health Organization, for instance, recently designated glyphosate as a likely carcinogen. Numerous studies establish links between this toxin and mitochondrial dysfunction in humans. Mitochondria are the parts of our cells responsible for converting glucose into energy, and are involved in a range of other processes, such as cell signaling, cellular differentiation, and control of the cell division cycle and cell growth. That’s why glyphosate is associated with increased rates of cancer, Parkinson’s, Alzheimer’s, autism, and a host of other conditions.

Glyphosate is typically applied with other chemical additives, or adjuvants, which increase absorption and potency. The world’s most used herbicide, Roundup®, combines glyphosate with a host of chemical adjuvants and a number of recent studies have clearly demonstrated that this combination is up to 125 times more damaging to human mitochondria than glyphosate alone.

Another serious concern with glyphosate exposure is that it impairs the body’s natural ability to remove toxins. Recent research has found that glyphosate inhibits the CYP450 enzyme, which is responsible for detoxifying foreign chemical compounds found in the body. Put another way, glyphosate actually enhances the damaging effects of other food-borne chemical residues and environmental toxins, according to one recent study, creating such conditions as gastrointestinal disorders, obesity, diabetes, heart disease, depression, autism, infertility, cancer, and Alzheimer’s disease.

The risks are even greater for those born with genetic polymorphisms (natural variations in a gene, DNA sequence, or chromosome) that already prevent the body properly detoxifying. It is no wonder that tests of human blood, urine, and breast milk repeatedly show dangerous levels of glyphosate present.

If we are serious about honestly assessing the safety of GMOs and the biotech industry, we must broaden the discussion to include the toxic substances that are used on them.

Gretchen DuBeau
Executive and Legal Director
Alliance for Natural Health USA

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GMOs Are 125 Times More Deadly Than Thought

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Natural GMOs???

The FDA is currently taking comments on rules related to use of the word “natural” on food labels. One issue they are considering is whether to label GMOs as natural. Huh?

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Natural GMOs???

The FDA is currently taking comments on rules related to use of the word “natural” on food labels. One issue they are considering is whether to label GMOs as natural. Huh?

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New “Green Product” Claims—Outlawed?

That is exactly what an out-of-control Federal Trade Commission is doing. In the process it is rejecting science and making new rules illegally. Action Alert!

A recent FTC ruling on biodegradable plastics could put a chill on any environmentally friendly new product. ECM Biofilms, a company that produces additives for plastic products, was recently the target of an FTC suit for false advertising. ECM had developed an additive that, when incorporated into plastic, renders the plastic biodegradable, but the FTC claimed in its suit that ECM hadn’t proved its biodegradability.

What followed was a trial-type hearing, after which the FTC administrative law judge (ALJ) ruled that the additive worked. He credited over twenty state-of-the-art gas evolution tests which showed that the ECM additive, when heat-melded into conventional plastics, did indeed cause plastics to become intrinsically biodegradable and accelerated the biodegradation of those plastics. He found that the scant contrary evidence offered by the FTC staff was not credible.

Unfortunately, the FTC (that is, the full Commission) rejected both the ALJ’s decision and the generally accepted science. Instead, the Commission came up with an arbitrary rule that nothing could be said to be “biodegradable” unless it completely broke down into elements in nature within five years after customary disposal in a landfill. Why five years? According to the FTC, that is what “a minority” (11 to 20%) of consumers expect when they see the word “biodegradable” on a product’s label.

In oral arguments, the FTC prosecutor went so far as to say, “We certainly don’t hold consumers to a scientific definition. What makes a claim reasonable is whether a significant minority of consumers collectively hold a belief about a particular term.” Translation: in determining if a label is misleading, scientific fact is less important than what a small group of consumers happen to believe—or what the agency says they believe.

And voilà, out of thin air, we have a new standard created completely outside of congressional authority or a formal rulemaking process, based on what the agency claims a small subset of misguided consumers think “biodegradable” means!

Here’s the catch: according to the scientists (including the government’s own experts), no product reliably breaks down in nature in five years, not even intrinsically biodegradable substances like bananas, pieces of wood, apple cores, or paper. The rate of biodegradation depends on environmental variables that cannot be predicted in advance of disposal (temperature, moisture content, presence of biodegrading bacteria, etc.). In other words, the FTC has adopted a standard that no one can meet, which means it adopted a standard that censors use of the term “biodegradable” even on intrinsically biodegradable substances!

This decision has obvious ramifications for the plastics industry (and for agriculture in particular, which needs but won’t have ready access to biodegradable plastics), but it could also dangerously expand FTC authority in other areas, including dietary supplements. If the FTC holds companies responsible for what a minority of consumers are said to believe about a given claim on a label, no matter how erroneous that belief is, just imagine how that will affect your herbs and amino acids and other supplements!

As Emord & Associates argue, what if the FTC decided that a minority of consumers think the phrase “a good source of vitamin C” was an implied cancer claim? Would those supplement companies be guilty of false advertising? The logic of the FTC’s decision is a patently absurd view that, if widely applied, will scare companies into removing truthful scientific information from their product labels—information that helps consumers make informed choices.

The FTC has a history of setting arbitrary standards and rejecting sound science. You may recall the POM Wonderful FTC case in which the FTC attempted to bar the fruit juice company from advertising any so-called “implied disease claims” without two random-controlled trials (RCTs)—an FDA labeling standard for prescription drugs. Although POM had spent an eye-popping $35 million on peer-reviewed scientific research to support the advertising claims it was making, the FTC brushed this aside because the studies were not RCTs. The FTC unnecessarily, arbitrarily, and illegally decided to use an FDA drug standard for disease claims in advertising—actions well beyond its simple mandate to ensure that advertisements are not deceptive or misleading. We believe they were put up to doing this by the FDA, because the FDA knew it could not get away with doing the same.

The two-RCT standard was subsequently struck down as unconstitutional by a DC appeals court—with the caveat that a one-RCT standard could be needed.

The biodegradable plastics case is yet another example of the FTC rejecting science, adopting instead a completely arbitrary standard, and creating law without congressional approval and without going through any formal rulemaking process.

Those interested in learning more and supporting the important work being done by Emord & Associates can do so here.

Action Alert! Write to the FTC and tell them that their recent ruling on biodegradable plastics sets a very dangerous (and absurd) precedent, and ask them to reverse their ruling. Please send your message immediately.

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Are GMOs a “Natural” Food?

The FDA may think so. Action Alert!

Last week, the FDA announced that it would be accepting public input on how—or whether—to define the term “natural” on food labels. This action came about as a result of a number of petitions filed by the Grocery Manufacturer’s Association (GMA) and Consumers Union.

The GMA asked the FDA to redefine “natural” so that foods derived from biotechnology (read: GMO foods) could use the label, while Consumers Union separately filed a petition asking the FDA to prohibit the use of “natural” on food labels altogether since the term is vague and misleading to consumers.

The Consumers Union petition to the FDA is based on data from a Consumer Reports National Research Center survey. According to the survey, nearly 90% of consumers expect “natural” on a food label to mean much more than it does. About two-thirds of consumers thought that “natural” meant that no pesticides, GMOs, or chemicals were used in food carrying the label. Currently, however, the FDA’s policy is that it won’t object to a product sporting the word “natural” so long as it doesn’t contain added color, artificial flavors, or synthetic substances.

The FDA is asking for public input on a variety of questions revolving around which foods should be allowed to bear the term “natural” and what kinds of things—such as processing and different manufacturing methods—should bar a food from being called “natural.”

ANH-USA has staunchly defended the right of consumers to have access to information regarding food and supplements, and has vehemently opposed efforts by federal agencies to gag free speech about the benefits of natural products (see, for example, the next article in this week’s Pulse). The problem with the current “natural” label, however, is that it is so loosely defined that it confers little to no actual meaning, while the presence of the label dupes consumers into buying food they believe is healthy and truly natural but contains all sorts of non-natural ingredients and processing.

It might be worth trying to rework a definition of “natural” that is rigorous and provides useful information to consumers, but unfortunately this seems like a lost cause. The “organic” label is much more constraining than the “natural” label, and we’ve seen how even that definition is constantly threatened by Big Food. There’s no reason to think the case would be different with the much looser “natural” label. The GMA petition is a case in point—what meaning does the label have if genetically manipulated foods doused with herbicide can be called “natural”?

The FDA and other federal agencies are too open to crony influence from industry to be trusted to create a definition of “natural” that has public health—rather than industry profits—as its motivating force. We can imagine the flood of comments from Big Food companies looking for exemptions for their products. Therefore, we agree with Consumers Union that the “natural” label should be banned outright.

This may all be theatrics anyway—a ploy by the FDA to make it look like it is doing something substantive when it actually plans to punt on this issue yet again. When the FDA first considered defining “natural” in 1991, the agency similarly asked for public input to help them reach a definition of the term. After reviewing the submissions, the agency said “none of the comments provided FDA with a specific direction to follow for developing a definition regarding use of the term ‘natural.’”

Action Alert! Write to the FDA and tell them that the “natural” label is confusing to consumers and should be abandoned. Please send your message immediately.

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Are Cardiologists Dangerous?

Here is another reason to be wary.

A friend of one of our staff members went for a physical. The doctor found a “heart flutter,” a mild form of arrhythmia or irregularity of the heartbeat.

He was referred to a cardiologist who immediately scheduled him for a catheterization procedure. This means an operation in which a tube is inserted into the body to reset the heart rhythm. Sound scary? It can be a very dangerous procedure, although this version was supposed to be less risky than others.

The cardiologist warned that the catheterization needed to be done without delay! And would be followed by blood thinners and other toxic drugs.

Did the cardiologist check the patient’s minerals? No, even though it is widely understood that too little magnesium, potassium, or iron can cause this very problem. By some estimates, 80% of Americans are believed to be deficient in magnesium.

What about drug use? The patient had recently starting taking a statin (cholesterol lowering) drug. Statins deplete the body’s CoQ10, which is essential for heart function. Merck, the first drug company to introduce a statin, obviously knew this because they patented their product, Lipitor, with and without added CoQ10, but for some reason decided not to offer the version with added CoQ10. Perhaps they didn’t want to highlight the issue.

In this patient’s case, you would think that the first thing the cardiologist would do would be to stop the statin. But this seems almost never to happen. Statin use has become what appears to us to be a kind of religion, an unchallengeable article of faith among some doctors.

Another friend of a staff member reported to her doctor that she could not sleep at night because of excruciating muscle pains. She was becoming more and more haggard and unable to function. Her doctor responded by ordering an MRI and another dozen tests. When these showed nothing, she acknowledged she didn’t know what to do for the patient.

What was completely overlooked was that the doctor has just put the patient on a statin drug! And as soon as the patient stopped the statin, the pain stopped and she could sleep again. Was it really so hard for the doctor to figure out? Muscle pain is right at the top of statin side effects. And don’t forget that the heart is a muscle.

Heart attacks are falling in the US, but congestive heart failure is rising. Could this be because of statin use?
It is widely thought that the US has the best surgery in the world. Apart from the problem of virus-and-bacteria-ridden hospitals, this seems to be true. If so, it may be because there is no federal Surgery Administration to accompany the federal Food and Drug Administration. Surgery is run by doctors, not by the federal government.

At the same time, heart operations are big business. They produce about $100 billion in revenue per year. Hospitals and doctors depend on this revenue. It may be clouding their judgment. Why catheterize a patient who may just need a bit more magnesium or is taking the wrong drug?

This illustrates how basic and how important it is to be sure your magnesium, potassium, and other mineral levels are what they should be by testing and by getting advice from a qualified and willing health professional.

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Action Alert: Will FDA Define “Natural”?

Related article: Are GMOs a “Natural” Food?

Trouble Taking Action? Click here.

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Action Alert: FTC Outlaws Green Product

Related article: New “Green Product” Claims—Outlawed?

Trouble Taking Action? Click here.

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New “Green Product” Claims—Outlawed?

That is exactly what an out-of-control Federal Trade Commission is doing. In the process it is rejecting science and making new rules illegally. Action Alert!

A recent FTC ruling on biodegradable plastics could put a chill on any environmentally friendly new product. ECM Biofilms, a company that produces additives for plastic products, was recently the target of an FTC suit for false advertising. ECM had developed an additive that, when incorporated into plastic, renders the plastic biodegradable, but the FTC claimed in its suit that ECM hadn’t proved its biodegradability.

What followed was a trial-type hearing, after which the FTC administrative law judge (ALJ) ruled that the additive worked. He credited over twenty state-of-the-art gas evolution tests which showed that the ECM additive, when heat-melded into conventional plastics, did indeed cause plastics to become intrinsically biodegradable and accelerated the biodegradation of those plastics. He found that the scant contrary evidence offered by the FTC staff was not credible.

Unfortunately, the FTC (that is, the full Commission) rejected both the ALJ’s decision and the generally accepted science. Instead, the Commission came up with an arbitrary rule that nothing could be said to be “biodegradable” unless it completely broke down into elements in nature within five years after customary disposal in a landfill. Why five years? According to the FTC, that is what “a minority” (11 to 20%) of consumers expect when they see the word “biodegradable” on a product’s label.

In oral arguments, the FTC prosecutor went so far as to say, “We certainly don’t hold consumers to a scientific definition. What makes a claim reasonable is whether a significant minority of consumers collectively hold a belief about a particular term.” Translation: in determining if a label is misleading, scientific fact is less important than what a small group of consumers happen to believe—or what the agency says they believe.

And voilà, out of thin air, we have a new standard created completely outside of congressional authority or a formal rulemaking process, based on what the agency claims a small subset of misguided consumers think “biodegradable” means!

Here’s the catch: according to the scientists (including the government’s own experts), no product reliably breaks down in nature in five years, not even intrinsically biodegradable substances like bananas, pieces of wood, apple cores, or paper. The rate of biodegradation depends on environmental variables that cannot be predicted in advance of disposal (temperature, moisture content, presence of biodegrading bacteria, etc.). In other words, the FTC has adopted a standard that no one can meet, which means it adopted a standard that censors use of the term “biodegradable” even on intrinsically biodegradable substances!

This decision has obvious ramifications for the plastics industry (and for agriculture in particular, which needs but won’t have ready access to biodegradable plastics), but it could also dangerously expand FTC authority in other areas, including dietary supplements. If the FTC holds companies responsible for what a minority of consumers are said to believe about a given claim on a label, no matter how erroneous that belief is, just imagine how that will affect your herbs and amino acids and other supplements!

As Emord & Associates argue, what if the FTC decided that a minority of consumers think the phrase “a good source of vitamin C” was an implied cancer claim? Would those supplement companies be guilty of false advertising? The logic of the FTC’s decision is a patently absurd view that, if widely applied, will scare companies into removing truthful scientific information from their product labels—information that helps consumers make informed choices.

The FTC has a history of setting arbitrary standards and rejecting sound science. You may recall the POM Wonderful FTC case in which the FTC attempted to bar the fruit juice company from advertising any so-called “implied disease claims” without two random-controlled trials (RCTs)—an FDA labeling standard for prescription drugs. Although POM had spent an eye-popping $35 million on peer-reviewed scientific research to support the advertising claims it was making, the FTC brushed this aside because the studies were not RCTs. The FTC unnecessarily, arbitrarily, and illegally decided to use an FDA drug standard for disease claims in advertising—actions well beyond its simple mandate to ensure that advertisements are not deceptive or misleading. We believe they were put up to doing this by the FDA, because the FDA knew it could not get away with doing the same.

The two-RCT standard was subsequently struck down as unconstitutional by a DC appeals court—with the caveat that a one-RCT standard could be needed.

The biodegradable plastics case is yet another example of the FTC rejecting science, adopting instead a completely arbitrary standard, and creating law without congressional approval and without going through any formal rulemaking process.

Those interested in learning more and supporting the important work being done by Emord & Associates can do so here.

Action Alert! Write to the FTC and tell them that their recent ruling on biodegradable plastics sets a very dangerous (and absurd) precedent, and ask them to reverse their ruling. Please send your message immediately.

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Are GMOs a “Natural” Food?

The FDA may think so. Action Alert!

Last week, the FDA announced that it would be accepting public input on how—or whether—to define the term “natural” on food labels. This action came about as a result of a number of petitions filed by the Grocery Manufacturer’s Association (GMA) and Consumers Union.

The GMA asked the FDA to redefine “natural” so that foods derived from biotechnology (read: GMO foods) could use the label, while Consumers Union separately filed a petition asking the FDA to prohibit the use of “natural” on food labels altogether since the term is vague and misleading to consumers.

The Consumers Union petition to the FDA is based on data from a Consumer Reports National Research Center survey. According to the survey, nearly 90% of consumers expect “natural” on a food label to mean much more than it does. About two-thirds of consumers thought that “natural” meant that no pesticides, GMOs, or chemicals were used in food carrying the label. Currently, however, the FDA’s policy is that it won’t object to a product sporting the word “natural” so long as it doesn’t contain added color, artificial flavors, or synthetic substances.

The FDA is asking for public input on a variety of questions revolving around which foods should be allowed to bear the term “natural” and what kinds of things—such as processing and different manufacturing methods—should bar a food from being called “natural.”

ANH-USA has staunchly defended the right of consumers to have access to information regarding food and supplements, and has vehemently opposed efforts by federal agencies to gag free speech about the benefits of natural products (see, for example, the next article in this week’s Pulse). The problem with the current “natural” label, however, is that it is so loosely defined that it confers little to no actual meaning, while the presence of the label dupes consumers into buying food they believe is healthy and truly natural but contains all sorts of non-natural ingredients and processing.

It might be worth trying to rework a definition of “natural” that is rigorous and provides useful information to consumers, but unfortunately this seems like a lost cause. The “organic” label is much more constraining than the “natural” label, and we’ve seen how even that definition is constantly threatened by Big Food. There’s no reason to think the case would be different with the much looser “natural” label. The GMA petition is a case in point—what meaning does the label have if genetically manipulated foods doused with herbicide can be called “natural”?

The FDA and other federal agencies are too open to crony influence from industry to be trusted to create a definition of “natural” that has public health—rather than industry profits—as its motivating force. We can imagine the flood of comments from Big Food companies looking for exemptions for their products. Therefore, we agree with Consumers Union that the “natural” label should be banned outright.

This may all be theatrics anyway—a ploy by the FDA to make it look like it is doing something substantive when it actually plans to punt on this issue yet again. When the FDA first considered defining “natural” in 1991, the agency similarly asked for public input to help them reach a definition of the term. After reviewing the submissions, the agency said “none of the comments provided FDA with a specific direction to follow for developing a definition regarding use of the term ‘natural.’”

Action Alert! Write to the FDA and tell them that the “natural” label is confusing to consumers and should be abandoned. Please send your message immediately.

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Are Cardiologists Dangerous?

Here is another reason to be wary.

A friend of one of our staff members went for a physical. The doctor found a “heart flutter,” a mild form of arrhythmia or irregularity of the heartbeat.

He was referred to a cardiologist who immediately scheduled him for a catheterization procedure. This means an operation in which a tube is inserted into the body to reset the heart rhythm. Sound scary? It can be a very dangerous procedure, although this version was supposed to be less risky than others.

The cardiologist warned that the catheterization needed to be done without delay! And would be followed by blood thinners and other toxic drugs.

Did the cardiologist check the patient’s minerals? No, even though it is widely understood that too little magnesium, potassium, or iron can cause this very problem. By some estimates, 80% of Americans are believed to be deficient in magnesium.

What about drug use? The patient had recently starting taking a statin (cholesterol lowering) drug. Statins deplete the body’s CoQ10, which is essential for heart function. Merck, the first drug company to introduce a statin, obviously knew this because they patented their product, Lipitor, with and without added CoQ10, but for some reason decided not to offer the version with added CoQ10. Perhaps they didn’t want to highlight the issue.

In this patient’s case, you would think that the first thing the cardiologist would do would be to stop the statin. But this seems almost never to happen. Statin use has become what appears to us to be a kind of religion, an unchallengeable article of faith among some doctors.

Another friend of a staff member reported to her doctor that she could not sleep at night because of excruciating muscle pains. She was becoming more and more haggard and unable to function. Her doctor responded by ordering an MRI and another dozen tests. When these showed nothing, she acknowledged she didn’t know what to do for the patient.

What was completely overlooked was that the doctor has just put the patient on a statin drug! And as soon as the patient stopped the statin, the pain stopped and she could sleep again. Was it really so hard for the doctor to figure out? Muscle pain is right at the top of statin side effects. And don’t forget that the heart is a muscle.

Heart attacks are falling in the US, but congestive heart failure is rising. Could this be because of statin use?
It is widely thought that the US has the best surgery in the world. Apart from the problem of virus-and-bacteria-ridden hospitals, this seems to be true. If so, it may be because there is no federal Surgery Administration to accompany the federal Food and Drug Administration. Surgery is run by doctors, not by the federal government.

At the same time, heart operations are big business. They produce about $100 billion in revenue per year. Hospitals and doctors depend on this revenue. It may be clouding their judgment. Why catheterize a patient who may just need a bit more magnesium or is taking the wrong drug?

This illustrates how basic and how important it is to be sure your magnesium, potassium, and other mineral levels are what they should be by testing and by getting advice from a qualified and willing health professional.

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from Tumblr http://ift.tt/1WXwzi2

Action Alert: Will FDA Define “Natural”?

Related article: Are GMOs a “Natural” Food?

Trouble Taking Action? Click here.

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Action Alert: FTC Outlaws Green Product

Related article: New “Green Product” Claims—Outlawed?

Trouble Taking Action? Click here.

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New Research BANNED on Medical Food and Supplements?

The Food and Drug Administration was barreling ahead on this—and breaking the law by doing so. Now they say they’ll think about it.

A year ago we reported on a new FDA sneak attack on medical food and supplements. The idea was simple: just issue a ruling that even studying a medical food or supplement would turn it into a drug.

Perfect! That would be sure to put a stop to competition from medical food and supplements for the drug industry. At the very least, it would stop the development of any new medical food or supplement or new uses for either. Yes, it would also harm the health of Americans. But the health of Americans does not pay the FDA’s bills. The drug companies do.

We swung into action, and with your help and the help of our allies, last year fired warning shots across the FDA’s bow. Now the agency has responded: they will take some time and think about the issue. They aren’t saying they will change their proposed rule, nor are they saying they won’t.

This is standard FDA tactics. If something generates political heat, they back off a bit and wait. If the heat dies down, they move ahead. If it does not, the delay can stretch on for years.

Meanwhile, no one can make any plans. University researchers who might have studied foods and supplements will be afraid to do so—they might be breaking the law by failing to file a new drug application. Everyone, with the sole exception of the big drug companies—will be the losers.

In our prior article about this, we also noted that the FDA was trying to do all this in a way that broke the law. They were trying to do it through a so-called “guidance” document that would actually evade the need to go through the proper administrative procedures to change a rule governing food and supplement research.

At this point, we can take some pride in having slowed down the train. We have made the FDA say it will at least reconsider. But we absolutely must keep the heat on. So please help by sending a message to the FDA and Congress now. If you sent one a year ago, please send another! Please act now.

Meanwhile, here is the article we wrote last year (November 10, 2014) so you will have the full background:

Latest FDA Moves Could Stop Further Research on Supplements

…and turn supplements into drugs. What is this agency thinking? Action Alert!

What the FDA does about supplements is usually complicated—we think intentionally so, in order to confuse Congress and critics. Bear with us as we try to disentangle the threads.

We need to get this story out now because the FDA has just opened a public comment period. It is vital to flood the agency and especially Congress with messages.

The FDA has a history of preventing scientific information about food and supplements from being disseminated. Now, if the agency gets its way, the FDA will be able to keep scientific research from being performed in the first place. In fact, our confidential sources tell us that studies on nutrients and dietary supplements are already coming to an abrupt halt. And it’s all because of the FDA’s guidance on INDs, or Investigational New Drug applications.

By law, if any nutrient studies actually do get published, the FDA in most instances won’t allow the nutrient in question to be purchased in supplement form. Even more shockingly, if a drug company wants to turn the supplement into a drug, they will have market exclusivity because the supplement forms would be banned. That’s right: the public will no longer be able to obtain the nutrients and supplements that were studied, because the FDA says they may become drugs. The FDA is essentially making sure their drugs have no competition from supplements.

The FDA’s guidance requires companies to start a burdensome and expensive drug approval process if a nutrient is to be studied for its potential disease prevention or treatment—even if the supplement won’t make any related health claims or be marketed as a drug.

Companies are required to submit an Investigational New Drug (IND) application if their research could support new health claims or the expansion of existing health claims. Historically, INDs haven’t been required for nutrients or food products simply because research does not speak to the intended use of the food product.

More to the point, nutrient studies are important because they include adverse event reporting (and so can help assess safety), and they give us better understanding about the effects of the nutrient on the body, as well as any potential uses for the nutrient in the future. The public relies on such research (increasingly available on the Internet) to make informed health decisions.

There is absolutely no reason for this guidance to include food and nutrients since they are already regulated. DSHEA (the Dietary Supplement Health and Education Act) and the Orphan Drug Act already establish that dietary supplements and medical foods are not considered drugs. Having to submit new drug applications makes the companies publicly claim they’re marketing drugs—even if they’re not.

Even worse, medical foods have always been able to make disease claims—that’s their sole reason for being, after all—but this guidance means that all medical foods would now require an IND—even if a New Dietary Ingredient (new supplement) notification has already been filed. (Medical foods can still stay on the market after the research is published if they had filed an NDI, but they still have to apply for an IND and pay the $2.3 million.)

There is so little research done on nutrients because of the Catch-22 of drug economics, but now with this new rule, there will be even less incentive for research. There is an exception to a supplement being classified as a drug once study data is published: if a New Dietary Ingredient (new supplement) notification has previously been sent to the FDA. But because the FDA is twenty years behind schedule on the NDI guidance, very few notifications have been filed, making this exception a very rare one.

There is also an exception if the supplement was sold before 1994. But there is no agreed upon list of these, and in the past the FDA has interpreted this provision of the law as narrowly as possible. It is not at all clear which supplements will eventually be found to qualify, and this might take years of litigation.

Here’s the final kicker: this guidance is changing the industry even though the FDA hasn’t taken it through the Administrative Procedure Act’s formal rulemaking process. The nutrient industry has no choice but to act as if this guidance is binding law—it is especially difficult to challenge, since it is not actually law:

• According to our sources, institutional review boards (IRBs) are currently rejecting clinical studies about supplements, mainly because the boards aren’t clear about the FDA’s authority or the ramifications of this guidance.
• Insiders also tell us that industry giants like Nestlé, PepsiCo, and Danone/Dannon are taking their research money overseas to avoid the extra cost and time t get the required IND—it takes years!—avoiding the process altogether.

Connie M. Weaver, PhD, is distinguished professor and department head for the nutrition science program at Purdue University. In an interview with ANH-USA, Dr. Weaver told us that many are worried that the effects of this guidance “would decrease the competitive edge of US research.”

Joshua Miller, PhD, professor of Nutritional Sciences at Rutgers University, told us, “As an academic department chair, I would be hesitant to advise junior faculty to take up precious time applying and waiting for IND approval [for a nutrient study]as they work toward tenure. For academic research, it’s a major burden. This [guidance]may shut down new research on dietary supplements in academia. It also reduces US jobs—industry will take the research overseas where they won’t need an IND.”

The cost of an IND application is currently $2.3 million. Supplement and medical foods companies can’t usually file for an IND without Big Pharma money—and a way to recoup their investment on a nutrient, which is not usually patentable.

Research proposals are dropped because the whole process becomes “too daunting,” which in turn limits innovation. A large pharmaceutical company told us that a proposed study to investigate a popular medical food for secondary uses was rejected by an IRB for not having an IND. Another source told us that their grant was approved by the IRB, but they were told that the proposal needed to be cleared with the FDA regarding the IND requirement.

And all of this is by design: it is the FDA making the rules, and the FDA ultimately benefiting: they get $2.3 million and full regulatory authority over the product being researched, which is now classified as a drug.

Let us say that again: as soon as the research is conducted and published, these nutrients and supplements would essentially become classified as drugs. This alone will stop most research dead in its tracks, and any research that does occur is likely to eliminate access to the very nutrient being studied. Filing the IND application sets up a process that virtually guarantees that any nutrients that are studied become drugs and can no longer be marketed as supplements once that research is published.

This is nothing more than an administrative power grab. With this guidance, the FDA is vying for more administrative control over medical foods, dietary supplements, and conventional foods—even those whose manufacturers don’t intend to market for their ability to treat diseases. US food science research is suppressed once again.

Action Alert! The FDA has opened a request for comments regarding the burden of filing an IND, the first step toward drug approval. Tell them that food nutrition research has no part in the drug approval regime. And tell them to make clear through their website or letters to IRBs that the guidance has not been finalized and therefore legally cannot be enforced, to help the boards know they are acting according to current regulations. Send your message today!

Other articles in this week’s Pulse of Natural Health:

Say Goodbye to Medical Curcumin!

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