Thursday, September 27, 2018

Action Alert: Protect Access to Compounded Medicines

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Action Alert: Protect Access to Compounded Medicines



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Action Alert: Protect “Product of USA” Label

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Qualified Victory for Natural Medicine

The FDA has dialed back a restrictive policy that would severely limit access to natural medicines—but it’s not good enough. Action Alert!

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Think You’re Buying USA-Raised Meat? Think Again

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Action Alert: Protect “Product of USA” Label



from The Alliance for Natural Health https://ift.tt/2R4V0do via Aloe for Health
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Qualified Victory for Natural Medicine

The FDA has dialed back a restrictive policy that would severely limit access to natural medicines—but it’s not good enough. Action Alert!



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Think You’re Buying USA-Raised Meat? Think Again

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Thursday, September 13, 2018

Thursday, September 6, 2018

$32,500 for CBD Oil?

If we don’t change a key FDA policy, that’s how much you may be forced to pay if you want to purchase CBD oil. Action Alert!

For years, consumers have benefitted from access to cheap, safe, and effective CBD oil supplements. But now the FDA says that CBD is a drug, not a supplement—a drug which will be sold for $32,500 a year. Legally the FDA could at any time remove all CBD supplements from the market, on its own volition, or if the drug company who holds drug market exclusivity requests FDA do so. Unless we change the rules rules, we may see a government-sponsored monopoly on CBD oil, and in the near future, additional monopolies on other cheap, safe, and effective supplements.

This is happening because of a back-channel that allows natural supplements to be turned into drugs by the FDA. It works like this: if a company is investigating a substance as a drug, FDA rules give the company market exclusivity on that substance—even if it is currently being sold as a supplement. There are two exceptions: if the supplement was “marketed in or as a dietary supplement” before 1994, or if a supplement company has filed a “new supplement” notification with the FDA before the company’s investigation began. (Recall, too, that the FDA has not completed the policies for submitting a “new supplement” notification, so supplement companies don’t even know how to comply!) Pyridoxamine, an important form of vitamin B6 was removed from the market by the FDA through this exact same mechanism.

This means that, at any time, GW Pharmaceuticals, the manufacturer of the CBD drug, can ask the FDA to remove cheap CBD oil supplements from the market, and the only option consumers will have is their new drug that costs $32,500 a year. This hasn’t happened yet, but we think GW is simply waiting for the market for CBD oil to grow—which it is. When it reaches a tipping point, then GW can ask the FDA to remove all the CBD supplements, and wait for the cash to roll in from consumers who don’t have any other choice.

This threat to affordable CBD oil shows how broken this system is. An opioid epidemic is ravaging our country, with drug overdose deaths surpassing car accident fatalities. People are addicted to and dying from FDA-approved drugs, yet the agency is poised to eliminate consumer access to a non-addictive, cheap, safe, and effective alternative in CBD oil—all so one drug company can charge tens of thousands of dollars for what currently costs a few dollars.

The Senate Farm Bill took one step to protect CBD oil by legalizing the growth of hemp (though it remains to be seen if the final bill will contain this language), but that alone will not preserve consumer access to this important medicine. ANH-USA is crafting legislation that will, among other things, protect CBD oil and other natural substances from being turned into drugs by eliminating the market exclusivity that drug companies get when a new drug investigation is on a dietary ingredient currently being sold in the market in a dietary supplement. These rules should apply retroactively to protect CBD oil and other substances that have already (or are likely to be) removed before this legislation becomes law.

Until we close this loophole, we will see drug companies continue to turn our natural dietary supplements into drugs. News headlines are filled with Phase II or Phase III drug trials failing; Big Pharma is in search of a sure thing, and what could be better than supplements that have demonstrated health benefits? The FDA will not protect us—they’re in on it! More drugs mean more user fees—more money—for the agency, so don’t expect the FDA to defend your access to supplements.

Action Alert! Write to Congress and the FDA and tell them you support a legislative change that eliminates market exclusivity for INDs filed on substances that are currently sold in the market as dietary supplements. Please send your message immediately.

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Why Won’t EPA Protect the Public from This Cancer-Causing Product?

Lawsuits alleging glyphosate caused cancer are allowed to move forward. Action Alert!

A California jury recently found Monsanto liable for a groundskeeper’s cancer, ordering the company to pay out $289 million. It was the first lawsuit that went to trial alleging that Roundup and other glyphosate-based weedkillers cause cancer. Other research shows that cancer may only be the tip of the iceberg in describing the toll this chemical is taking on our health.

There have been hundreds of lawsuits filed against Monsanto alleging that glyphosate, the active ingredient in the Roundup herbicide, causes cancer, and now finally the Courts are taking the claims seriously as a federal judge recently ruled that these cases can proceed to trial.

The World Health Organization has labeled glyphosate a “probable carcinogen” and yet the US Environmental Protection Agency (EPA) says it isn’t—although we shouldn’t be surprised, given the crony ties that have been exposed between top EPA officials and the biotech industry.  The EPA can’t be counted on to protect our health.

Cancer isn’t the only danger. Recall our past coverage of the work of Dr. Stephanie Seneff, an MIT researcher who showed a remarkably consistent correlation between the use of Roundup on crops (and the creation of Roundup-ready GMO crop seeds) with rising rates of autism.

Children with autism have excessive glyphosate in their systems.  Dr. Seneff noted the ubiquity of glyphosate’s use—and that the side effects of autism closely mimic those of glyphosate toxicity.

Because it’s used on corn and soy, all soft drinks and candies sweetened with corn syrup and all chips and cereals that contain soy fillers have small amounts of glyphosate in them, as do our beef and poultry since cattle and chicken are fed GMO corn or soy. Wheat is often sprayed with Roundup just prior to being harvested, which means that all non-organic bread and wheat products would also be sources of glyphosate toxicity. The amount of glyphosate in each product may not be large, but the cumulative effect (especially with as much processed food as Americans eat) could be devastating for our country’s health. A recent study shows that pregnant women living near farms where pesticides are applied have a 60% increased risk of children having an autism spectrum disorder.

As if cancer and autism weren’t enough, here are some of the other negative health effects linked with glyphosate:

  • Glyphosate has been associated with epidemics of kidney failure killing farm workers.  We reported recently that glyphosate is likely disrupting the synthesis of proteins in our bodies, which can lead to all sorts of diseases and health problems
  • The chemical may be responsible for abnormal rates of birth defects in Hawaii, which is considered “ground zero for experimentation with GE crops.”
  • Glyphosate also inhibits numerous physiological processes (such as photosynthesis) in fruits like blueberries, grapes and apples—in other words, it can be toxic to plants in more ways than are intended for an herbicide.
  • Glyphosate is an endocrine disruptor, i.e., a chemical that can interfere with our hormone system’s proper functioning. Apart from numerous animal and in vitro studies demonstrating the endocrine disrupting effects of glyphosate, other peer-reviewed research shows that glyphosate disrupts male reproductive functions—decreasing testosterone by as much as 35%.

Let’s not forget that research has found that pesticide adjuvants can be up to 1,000 times more toxic to human cells than the active ingredient in weed-killers.

How is this chemical possibly in the market? When the EPA okayed glyphosate (again) in 1993, it relied on the same toxicity studies Monsanto originally submitted. Most of them were done in the 1970s, when the chemical was first used as an herbicide. Most, if not all of them, were done at the notorious Hazleton Laboratories (now Covance). This lab also provided the tobacco industry with studies showing that second-hand smoke isn’t harmful to human health. The list of alleged violations for this lab is long and includes adding extra animals to experimentsnot following scientific protocolsand secretly keeping extra animals off-site. These, and other violations dating back decades, cast serious doubt on the validity of the toxicity studies done on glyphosate

It seems beyond doubt that cronyism, rather than any honest evaluation of the scientific data, is keeping glyphosate on the market. It’s time for that to change.

Action Alert! Tell the EPA to ban glyphosate. Please send your message immediately.

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They’re Causing Asthma: Does the EPA Care?

Large factory farms are spewing toxic gases into the air that are causing human health problems, but the EPA refuses to act. Action Alert!

Imagine stepping onto your front porch to enjoy your morning coffee, but instead of fresh air and sunshine you’re met with an overpowering stench of the manure and filth from thousands of confined animals—a stench so strong that you’re forced inside. This is the reality for many Americans living in the vicinity of concentrated animal feeding lots (CAFOs), and new evidence is showing that the emissions from CAFOs are giving kids asthma and other health problems—but the EPA refuses to do anything about it.

Air pollution from CAFOs can cause numerous respiratory problems like asthma, and children are particularly vulnerable; a University of Iowa study found that kids who lived within a half mile of a CAFO had significantly higher rates of asthma than kids who lived further away. Some CAFOs emit dangerous gases such as methane, ammonia, and hydrogen sulfide—a particularly dangerous gas that can cause neurological problems, anger, and depression.

Are CAFOs held to federal standards for air pollution? No. Former EPA Director Scott Pruitt announced late in 2017 that the agency would not be regulating CAFOs under the Clean Air Act. Why? According to the EPA,

[The] complex nature of emission sources and emissions from this sector requires the agency to continue its comprehensive approach toward this sector by first evaluating CAFO emissions and then determining further regulatory actions to address these emissions.

Translation: the EPA cares more about protecting CAFOs from being held accountable for their pollution than looking out for Americans’ health and our environment.

Years ago, the EPA began studying emissions from CAFOs to determine if Clean Air Act rules would be applicable—a study which was funded by, you guessed it, the CAFO industry. Data collection was complete in 2010, but the EPA has been dragging its feet using all types of excuses: limitations in the data, difficulties in establishing standards that apply to all CAFOs, lack of expertise, etc. As a result, the EPA’s actions regarding air emissions from CAFOs are “on hold.”

The CAFO industry is fighting hard to make sure there is as little transparency about their practices as possible. Last year, a DC Circuit Court ordered the EPA to close a loophole allowing the emission of hazardous substances from CAFOs to go unreported. That’s right: it took a court order just to get CAFOs to tell the public what they were spewing into our air.

Through aggressive lobbying, the CAFO industry has prevented whistleblowers from exposing their cruel and unsanitary practices and avoided regulation of their air pollution. It’s time for some transparency.

Action Alert! Tell the EPA and Congress to hold CAFOs accountable for air pollution that is causing human health problems. Please send your message immediately.

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Voices of Freedom: Gretchen DuBeau, Esq.

A lifelong environmentalist and devotee to natural health and healing, Gretchen has found the perfect culmination of her interests at ANH-USA, where she works to shift the current medical paradigm to one that embraces real preventive and integrative medicine as the standard of care. More…

from The Alliance for Natural Health https://ift.tt/2oM9e5I via Aloe for Health



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$32,500 for CBD Oil?

If we don’t change a key FDA policy, that’s how much you may be forced to pay if you want to purchase CBD oil. Action Alert!

For years, consumers have benefitted from access to cheap, safe, and effective CBD oil supplements. But now the FDA says that CBD is a drug, not a supplement—a drug which will be sold for $32,500 a year. Legally the FDA could at any time remove all CBD supplements from the market, on its own volition, or if the drug company who holds drug market exclusivity requests FDA do so. Unless we change the rules rules, we may see a government-sponsored monopoly on CBD oil, and in the near future, additional monopolies on other cheap, safe, and effective supplements.

This is happening because of a back-channel that allows natural supplements to be turned into drugs by the FDA. It works like this: if a company is investigating a substance as a drug, FDA rules give the company market exclusivity on that substance—even if it is currently being sold as a supplement. There are two exceptions: if the supplement was “marketed in or as a dietary supplement” before 1994, or if a supplement company has filed a “new supplement” notification with the FDA before the company’s investigation began. (Recall, too, that the FDA has not completed the policies for submitting a “new supplement” notification, so supplement companies don’t even know how to comply!) Pyridoxamine, an important form of vitamin B6 was removed from the market by the FDA through this exact same mechanism.

This means that, at any time, GW Pharmaceuticals, the manufacturer of the CBD drug, can ask the FDA to remove cheap CBD oil supplements from the market, and the only option consumers will have is their new drug that costs $32,500 a year. This hasn’t happened yet, but we think GW is simply waiting for the market for CBD oil to grow—which it is. When it reaches a tipping point, then GW can ask the FDA to remove all the CBD supplements, and wait for the cash to roll in from consumers who don’t have any other choice.

This threat to affordable CBD oil shows how broken this system is. An opioid epidemic is ravaging our country, with drug overdose deaths surpassing car accident fatalities. People are addicted to and dying from FDA-approved drugs, yet the agency is poised to eliminate consumer access to a non-addictive, cheap, safe, and effective alternative in CBD oil—all so one drug company can charge tens of thousands of dollars for what currently costs a few dollars.

The Senate Farm Bill took one step to protect CBD oil by legalizing the growth of hemp (though it remains to be seen if the final bill will contain this language), but that alone will not preserve consumer access to this important medicine. ANH-USA is crafting legislation that will, among other things, protect CBD oil and other natural substances from being turned into drugs by eliminating the market exclusivity that drug companies get when a new drug investigation is on a dietary ingredient currently being sold in the market in a dietary supplement. These rules should apply retroactively to protect CBD oil and other substances that have already (or are likely to be) removed before this legislation becomes law.

Until we close this loophole, we will see drug companies continue to turn our natural dietary supplements into drugs. News headlines are filled with Phase II or Phase III drug trials failing; Big Pharma is in search of a sure thing, and what could be better than supplements that have demonstrated health benefits? The FDA will not protect us—they’re in on it! More drugs mean more user fees—more money—for the agency, so don’t expect the FDA to defend your access to supplements.

Action Alert! Write to Congress and the FDA and tell them you support a legislative change that eliminates market exclusivity for INDs filed on substances that are currently sold in the market as dietary supplements. Please send your message immediately.



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Why Won’t EPA Protect the Public from This Cancer-Causing Product?

Lawsuits alleging glyphosate caused cancer are allowed to move forward. Action Alert!

A California jury recently found Monsanto liable for a groundskeeper’s cancer, ordering the company to pay out $289 million. It was the first lawsuit that went to trial alleging that Roundup and other glyphosate-based weedkillers cause cancer. Other research shows that cancer may only be the tip of the iceberg in describing the toll this chemical is taking on our health.

There have been hundreds of lawsuits filed against Monsanto alleging that glyphosate, the active ingredient in the Roundup herbicide, causes cancer, and now finally the Courts are taking the claims seriously as a federal judge recently ruled that these cases can proceed to trial.

The World Health Organization has labeled glyphosate a “probable carcinogen” and yet the US Environmental Protection Agency (EPA) says it isn’t—although we shouldn’t be surprised, given the crony ties that have been exposed between top EPA officials and the biotech industry.  The EPA can’t be counted on to protect our health.

Cancer isn’t the only danger. Recall our past coverage of the work of Dr. Stephanie Seneff, an MIT researcher who showed a remarkably consistent correlation between the use of Roundup on crops (and the creation of Roundup-ready GMO crop seeds) with rising rates of autism.

Children with autism have excessive glyphosate in their systems.  Dr. Seneff noted the ubiquity of glyphosate’s use—and that the side effects of autism closely mimic those of glyphosate toxicity.

Because it’s used on corn and soy, all soft drinks and candies sweetened with corn syrup and all chips and cereals that contain soy fillers have small amounts of glyphosate in them, as do our beef and poultry since cattle and chicken are fed GMO corn or soy. Wheat is often sprayed with Roundup just prior to being harvested, which means that all non-organic bread and wheat products would also be sources of glyphosate toxicity. The amount of glyphosate in each product may not be large, but the cumulative effect (especially with as much processed food as Americans eat) could be devastating for our country’s health. A recent study shows that pregnant women living near farms where pesticides are applied have a 60% increased risk of children having an autism spectrum disorder.

As if cancer and autism weren’t enough, here are some of the other negative health effects linked with glyphosate:

  • Glyphosate has been associated with epidemics of kidney failure killing farm workers.  We reported recently that glyphosate is likely disrupting the synthesis of proteins in our bodies, which can lead to all sorts of diseases and health problems
  • The chemical may be responsible for abnormal rates of birth defects in Hawaii, which is considered “ground zero for experimentation with GE crops.”
  • Glyphosate also inhibits numerous physiological processes (such as photosynthesis) in fruits like blueberries, grapes and apples—in other words, it can be toxic to plants in more ways than are intended for an herbicide.
  • Glyphosate is an endocrine disruptor, i.e., a chemical that can interfere with our hormone system’s proper functioning. Apart from numerous animal and in vitro studies demonstrating the endocrine disrupting effects of glyphosate, other peer-reviewed research shows that glyphosate disrupts male reproductive functions—decreasing testosterone by as much as 35%.

Let’s not forget that research has found that pesticide adjuvants can be up to 1,000 times more toxic to human cells than the active ingredient in weed-killers.

How is this chemical possibly in the market? When the EPA okayed glyphosate (again) in 1993, it relied on the same toxicity studies Monsanto originally submitted. Most of them were done in the 1970s, when the chemical was first used as an herbicide. Most, if not all of them, were done at the notorious Hazleton Laboratories (now Covance). This lab also provided the tobacco industry with studies showing that second-hand smoke isn’t harmful to human health. The list of alleged violations for this lab is long and includes adding extra animals to experimentsnot following scientific protocolsand secretly keeping extra animals off-site. These, and other violations dating back decades, cast serious doubt on the validity of the toxicity studies done on glyphosate

It seems beyond doubt that cronyism, rather than any honest evaluation of the scientific data, is keeping glyphosate on the market. It’s time for that to change.

Action Alert! Tell the EPA to ban glyphosate. Please send your message immediately.



from The Alliance for Natural Health https://ift.tt/2wPA81c via Aloe for Health
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They’re Causing Asthma: Does the EPA Care?

Large factory farms are spewing toxic gases into the air that are causing human health problems, but the EPA refuses to act. Action Alert!

Imagine stepping onto your front porch to enjoy your morning coffee, but instead of fresh air and sunshine you’re met with an overpowering stench of the manure and filth from thousands of confined animals—a stench so strong that you’re forced inside. This is the reality for many Americans living in the vicinity of concentrated animal feeding lots (CAFOs), and new evidence is showing that the emissions from CAFOs are giving kids asthma and other health problems—but the EPA refuses to do anything about it.

Air pollution from CAFOs can cause numerous respiratory problems like asthma, and children are particularly vulnerable; a University of Iowa study found that kids who lived within a half mile of a CAFO had significantly higher rates of asthma than kids who lived further away. Some CAFOs emit dangerous gases such as methane, ammonia, and hydrogen sulfide—a particularly dangerous gas that can cause neurological problems, anger, and depression.

Are CAFOs held to federal standards for air pollution? No. Former EPA Director Scott Pruitt announced late in 2017 that the agency would not be regulating CAFOs under the Clean Air Act. Why? According to the EPA,

[The] complex nature of emission sources and emissions from this sector requires the agency to continue its comprehensive approach toward this sector by first evaluating CAFO emissions and then determining further regulatory actions to address these emissions.

Translation: the EPA cares more about protecting CAFOs from being held accountable for their pollution than looking out for Americans’ health and our environment.

Years ago, the EPA began studying emissions from CAFOs to determine if Clean Air Act rules would be applicable—a study which was funded by, you guessed it, the CAFO industry. Data collection was complete in 2010, but the EPA has been dragging its feet using all types of excuses: limitations in the data, difficulties in establishing standards that apply to all CAFOs, lack of expertise, etc. As a result, the EPA’s actions regarding air emissions from CAFOs are “on hold.”

The CAFO industry is fighting hard to make sure there is as little transparency about their practices as possible. Last year, a DC Circuit Court ordered the EPA to close a loophole allowing the emission of hazardous substances from CAFOs to go unreported. That’s right: it took a court order just to get CAFOs to tell the public what they were spewing into our air.

Through aggressive lobbying, the CAFO industry has prevented whistleblowers from exposing their cruel and unsanitary practices and avoided regulation of their air pollution. It’s time for some transparency.

Action Alert! Tell the EPA and Congress to hold CAFOs accountable for air pollution that is causing human health problems. Please send your message immediately.



from The Alliance for Natural Health https://ift.tt/2wLeb2p via Aloe for Health
from Tumblr https://ift.tt/2MTH2fR

Voices of Freedom: Gretchen DuBeau, Esq.

A lifelong environmentalist and devotee to natural health and healing, Gretchen has found the perfect culmination of her interests at ANH-USA, where she works to shift the current medical paradigm to one that embraces real preventive and integrative medicine as the standard of care. More…



from The Alliance for Natural Health https://ift.tt/2oM9e5I via Aloe for Health
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The Journey of Glyphosate


Take Action

Read Full Story



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The Journey of Glyphosate


Take Action

Read Full Story

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