Op-Ed: Is the New York Times Endorsing the Attorney General for Governor?

The New York Attorney General’s recent attacks on supplements have been highly publicized by the New York Times. Unfortunately, the AG used improper scientific methodology and drew inaccurate conclusions, which the AG now refuses to back up by opening the studies to peer review. Perpetuating this misinformation is a waste of taxpayer dollars and a disservice to consumers.

On February 3, New York Attorney General Eric Schneiderman announced in the New York Times that he sent cease-and-desist letters to four major retailers—GNC, Walmart, Target, and Walgreens—accusing them of mislabeling store brand herbal supplements. The AG made these accusations after analyzing herbal extracts from these stores using DNA barcoding technology and concluding that the products did not contain the substances listed on their labels.

The Times published the announcement, the cease-and-desist letters, and an editorial damning all supplement manufacturers based upon the AG’s investigation. Unfortunately, the Times failed to ask any questions whatsoever about the efficacy of the testing methodology or motivations of a state official who, at the expense of New York taxpayers, launched this investigation.

After the initial announcement, many prominent scientists went on record stating that DNA barcoding—the test used in Mr. Schneiderman’s investigation—is not a reliable means for testing the contents of herbal dietary supplements. A recent white paper released by industry experts shows that DNA barcoding is a well-established technique “for distinguishing fresh or living tissue obtained from distinct species such as cows and pigs” but is utterly inappropriate for identifying plant species, much less plant extracts in which little or no DNA is extracted. “As a result,” the paper states, “attempts to sequence and analyze [botanical extracts]typically would lead to false negative results, as suspected in the recent investigation by the NY AG.”

The AG’s office is not a scientific body and does not have the requisite expertise to undertake this type of investigation, so perhaps we should not be surprised that the AG reached scientifically insupportable conclusions. But he needn’t have worried about them at all: supplements are robustly regulated at the federal level by both the Food and Drug Administration and the Federal Trade Commission. Respectively, they have complete authority over manufacturing practices and labeling, and advertising, making the AG’s actions both unnecessary and inept.

Adding to the injustice here is that most of the news reports about this incident paint nutritional supplements in a negative light, when the vast majority of manufacturers subject their herbal products to rigorous and open scientific testing. On top of that, they are held to current Good Manufacturing Practices (cGMP) guidelines, which require regular testing using accepted and scientifically validated methodologies. In fact, such a testing regimen, already in use throughout the industry, is one reason supplements have such an exemplary track record of safety and efficacy.

Soon after the AG’s actions, GNC did independent testing of its supplements, using appropriate methods, and found that the products contained the extracts precisely as advertised on the product labels. The attorney general, meanwhile, refuses to release his office’s test results for peer review.

Given that the AG chose to launch this investigation using the New York Times as his own personal public relations vehicle and that the Times chose to assist him, without exercising proper due diligence, it would seem appropriate for Times readers to begin asking questions.

Why was DNA barcoding chosen when other far more accurate and scientifically appropriate testing methodologies are readily available? Did the AG know that this methodology virtually guaranteed that the results would be negative?

What prompted this investigation? What led the New York AG to venture into federal regulation? Is it possible that the AG has other motivations—such as an eye on the governor’s mansion?

What role did the New York Times play in all of this? Doesn’t the nation’s paper of record have a responsibility to make sure that crusading publicity-seekers have legitimate claims to make before it throws its considerable weight behind such efforts? Where are the follow-up stories? Where is the balanced critical eye? Why haven’t GNC’s test results been announced with the same fanfare that the Times chose in announcing the investigation? What happened to fairness and balance in reporting?

A careful analysis of the AG’s attack on supplements reveals either a willful misuse of power, or else gross incompetence within the attorney general’s office. There are certainly manufacturers within every industry who mislabel and fraudulently market products—but this certainly wasn’t the case here. It is incumbent upon prosecutors to get their facts straight before making public accusations of wrongdoing.

It is possible that the AG made an honest mistake due to his ignorance of the industry that he chose to investigate. It is possible that he isn’t following the example of so many previous AGs in using a highly publicized investigation as a means of bolstering his résumé and effectively launching a gubernatorial campaign. But if the New York Times chooses not to ask these basic questions, it might as well go ahead and offer its endorsement.

Gretchen DuBeau

Executive and Legal Director
Alliance for Natural Health USA

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Op-Ed: Is the New York Times Endorsing the Attorney General for Governor?

The New York Attorney General’s recent attacks on supplements have been highly publicized by the New York Times. Unfortunately, the AG used improper scientific methodology and drew inaccurate conclusions, which the AG now refuses to back up by opening the studies to peer review. Perpetuating this misinformation is a waste of taxpayer dollars and a disservice to consumers.

On February 3, New York Attorney General Eric Schneiderman announced in the New York Times that he sent cease-and-desist letters to four major retailers—GNC, Walmart, Target, and Walgreens—accusing them of mislabeling store brand herbal supplements. The AG made these accusations after analyzing herbal extracts from these stores using DNA barcoding technology and concluding that the products did not contain the substances listed on their labels.

The Times published the announcement, the cease-and-desist letters, and an editorial damning all supplement manufacturers based upon the AG’s investigation. Unfortunately, the Times failed to ask any questions whatsoever about the efficacy of the testing methodology or motivations of a state official who, at the expense of New York taxpayers, launched this investigation.

After the initial announcement, many prominent scientists went on record stating that DNA barcoding—the test used in Mr. Schneiderman’s investigation—is not a reliable means for testing the contents of herbal dietary supplements. A recent white paper released by industry experts shows that DNA barcoding is a well-established technique “for distinguishing fresh or living tissue obtained from distinct species such as cows and pigs” but is utterly inappropriate for identifying plant species, much less plant extracts in which little or no DNA is extracted. “As a result,” the paper states, “attempts to sequence and analyze [botanical extracts]typically would lead to false negative results, as suspected in the recent investigation by the NY AG.”

The AG’s office is not a scientific body and does not have the requisite expertise to undertake this type of investigation, so perhaps we should not be surprised that the AG reached scientifically insupportable conclusions. But he needn’t have worried about them at all: supplements are robustly regulated at the federal level by both the Food and Drug Administration and the Federal Trade Commission. Respectively, they have complete authority over manufacturing practices and labeling, and advertising, making the AG’s actions both unnecessary and inept.

Adding to the injustice here is that most of the news reports about this incident paint nutritional supplements in a negative light, when the vast majority of manufacturers subject their herbal products to rigorous and open scientific testing. On top of that, they are held to current Good Manufacturing Practices (cGMP) guidelines, which require regular testing using accepted and scientifically validated methodologies. In fact, such a testing regimen, already in use throughout the industry, is one reason supplements have such an exemplary track record of safety and efficacy.

Soon after the AG’s actions, GNC did independent testing of its supplements, using appropriate methods, and found that the products contained the extracts precisely as advertised on the product labels. The attorney general, meanwhile, refuses to release his office’s test results for peer review.

Given that the AG chose to launch this investigation using the New York Times as his own personal public relations vehicle and that the Times chose to assist him, without exercising proper due diligence, it would seem appropriate for Times readers to begin asking questions.

Why was DNA barcoding chosen when other far more accurate and scientifically appropriate testing methodologies are readily available? Did the AG know that this methodology virtually guaranteed that the results would be negative?

What prompted this investigation? What led the New York AG to venture into federal regulation? Is it possible that the AG has other motivations—such as an eye on the governor’s mansion?

What role did the New York Times play in all of this? Doesn’t the nation’s paper of record have a responsibility to make sure that crusading publicity-seekers have legitimate claims to make before it throws its considerable weight behind such efforts? Where are the follow-up stories? Where is the balanced critical eye? Why haven’t GNC’s test results been announced with the same fanfare that the Times chose in announcing the investigation? What happened to fairness and balance in reporting?

A careful analysis of the AG’s attack on supplements reveals either a willful misuse of power, or else gross incompetence within the attorney general’s office. There are certainly manufacturers within every industry who mislabel and fraudulently market products—but this certainly wasn’t the case here. It is incumbent upon prosecutors to get their facts straight before making public accusations of wrongdoing.

It is possible that the AG made an honest mistake due to his ignorance of the industry that he chose to investigate. It is possible that he isn’t following the example of so many previous AGs in using a highly publicized investigation as a means of bolstering his résumé and effectively launching a gubernatorial campaign. But if the New York Times chooses not to ask these basic questions, it might as well go ahead and offer its endorsement.

Gretchen DuBeau

Executive and Legal Director
Alliance for Natural Health USA

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California One Step Closer to Eliminating Vaccine Exemptions

Other states are considering similar moves. We need to act before a dangerous precedent is set for the rest of the country. Urgent, multi-state Action Alerts!

Last week, the California Education Committee voted in favor of SB 277, a bill that would eliminate all personal belief exemptions to vaccination. Under this law, the only way for a child to attend public school without being vaccinated would be through a very difficult to get medical waiver. We and others issued alerts to our California members, but the large number of messages against the bill did not turn the tide in a committee stacked with proponents.

The bill’s next stop is the Senate Judiciary Committee, where most of the members are either co-sponsors of the bill or have already voted for it. If approved in the Judiciary Committee, it would then get a Senate floor vote before moving into a General Assembly Committee, then to the General Assembly floor, and then to the governor’s desk to be signed into law.

SB 277 was first heard in the Education Committee on April 15, when over 700 protestors opposing the legislation flooded the state Capitol. During public testimony, about fifty members of the public spoke in favor of the bill for six minutes; news reports said that opponents dressed in matching red shirts testified for nearly two hours, “lining up out of the hearing room and convening in stairwells,” forcing the committee to delay a vote as they tinkered with some of the provisions.

On April 22, SB 277 was on the agenda again, but as a “vote only” item so that the public could not weigh in again. The bill passed by a vote of 7–2, clearing it for the Judiciary Committee on April 28. Two of the representatives who voted in favor, including the bill’s author, Richard Pan, take political money from Big Pharma. Two others in favor take money from health professionals, who often have financial incentives to vaccinate as many of their patients as possible.

It is imperative that we kill this as soon as possible. The more success this bill has as it winds its way through California’s legislative process, the more proponents of similar legislation in other states will be emboldened to continue their efforts to needlessly force vaccinations on our children. There are already scores of bills in states across the country to remove exemptions and mandate certain vaccines for public school attendance.

The current mania of anti-exemption bills was triggered by measles outbreaks at Disneyland—outbreaks that included vaccinated children and may in fact have been set off by vaccinated children, because the live vaccine virus can be contagious, and vaccine immunity may be weak and in any case does not last. We have already pointed out that no one has died of measles in recent times, while children have died from the vaccine. The media have done an excellent job in ratcheting up unwarranted fear. Let’s keep in mind that there have been under 200 cases of measles in a population of 320 million people.

Urgent Action Alert! California residents, write and call your representatives and tell them to vote NO on SB 277! Please send your message immediately.

Other state-based Action Alerts! Check below to see if your state is considering legislation to eliminate vaccine exemptions, and take action immediately!

Connecticut

Illinois

Maine

Minnesota

New Jersey

Pennsylvania

Rhode Island

Texas

Vermont

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Mainstream Media Predictably Ignores Problems with JAMA’s New Vaccine Study

They say this is the final nail is in the coffin of the vaccine safety debate. But whose coffin?

Last week, JAMA, the Journal of the American Medical Association, published a study claiming to have found no link between autism and the MMR vaccine (MMR stands for measles, mumps, and rubella). The mainstream press immediately fell into line and triumphantly declared the case closed.

Here are some examples of the headlines that ran: “Study Rules Out Link Between Autism and MMR Vaccine even in At-Risk Kids”; “MMR Vaccine and Autism: Yet Again, No Link Exists—Even For Children At Risk For Autism”; Measles Vaccine Still Doesn’t Cause Autism; “Another Nail in Coffin of MMR-Autism Link.”

As we’ve pointed out previously, this sort of smugness is common to the proponents of vaccines. They want to appear perfectly objective and reasonable, but they vehemently dismiss legitimate questions regarding vaccine safety.

Since a critical examination of the JAMA study would require the media to qualify their one-sided narrative, the limitations of the study have not been a significant part of the conversation. We at ANH-USA thought we would take a closer look.

First, the study was funded jointly by the National Institutes of Health and by the Department of Health and Human Services, government agencies with a well-known agenda of insisting on the safety of vaccines. This extends to winning “hearts and minds” through propaganda campaigns created to instill confidence in vaccines, as we reported last week.

Second, as the authors of the study themselves point out, there are major problems with the methodology used—problems big enough to throw the results into question. The study used a sample of about 100,000 children, comparing vaccinated kids to an unvaccinated control group. To determine which children were vaccinated and which were not, the authors looked at a health insurance claims database: if a child’s parents were billed for a vaccination, then that child of course counted as vaccinated; if the child was not billed for a vaccination, then it was assumed that child was unvaccinated. But, as the study notes, this distorts the numbers because “children in [the]study who are considered unvaccinated may have received vaccines in settings such as schools or public health clinics in which claims were not submitted”!

The authors also note that their findings “may not be as applicable to more ethnically and socioeconomically diverse populations that have less access to health care services.” This issue is covered in one sentence of the study, but is a major concern. Last year, we wrote about the CDC whistleblower, Dr. William Thompson, who broke a decade of silence over the government’s deliberate concealment of the link between the MMR vaccine and a dramatically increased risk of autism, particularly in African American boys. If the sample used by the study is not representative of the American population, especially segments who could be at higher risk for developing autism, the results are thrown into question.

Taken together, these two methodological limitations show that this study is not the last word in the debate about vaccine safety. It is absurd to argue that vaccines cannot or should not be made safer, that dangerous ingredients should not be removed, and that a one-size-fits all approach must be forced upon unwilling participants. Sensible vaccine policy should be based on legitimate science and individual choice, not government mandates and bullying.

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California One Step Closer to Eliminating Vaccine Exemptions

Other states are considering similar moves. We need to act before a dangerous precedent is set for the rest of the country. Urgent, multi-state Action Alerts!

Last week, the California Education Committee voted in favor of SB 277, a bill that would eliminate all personal belief exemptions to vaccination. Under this law, the only way for a child to attend public school without being vaccinated would be through a very difficult to get medical waiver. We and others issued alerts to our California members, but the large number of messages against the bill did not turn the tide in a committee stacked with proponents.

The bill’s next stop is the Senate Judiciary Committee, where most of the members are either co-sponsors of the bill or have already voted for it. If approved in the Judiciary Committee, it would then get a Senate floor vote before moving into a General Assembly Committee, then to the General Assembly floor, and then to the governor’s desk to be signed into law.

SB 277 was first heard in the Education Committee on April 15, when over 700 protestors opposing the legislation flooded the state Capitol. During public testimony, about fifty members of the public spoke in favor of the bill for six minutes; news reports said that opponents dressed in matching red shirts testified for nearly two hours, “lining up out of the hearing room and convening in stairwells,” forcing the committee to delay a vote as they tinkered with some of the provisions.

On April 22, SB 277 was on the agenda again, but as a “vote only” item so that the public could not weigh in again. The bill passed by a vote of 7–2, clearing it for the Judiciary Committee on April 28. Two of the representatives who voted in favor, including the bill’s author, Richard Pan, take political money from Big Pharma. Two others in favor take money from health professionals, who often have financial incentives to vaccinate as many of their patients as possible.

It is imperative that we kill this as soon as possible. The more success this bill has as it winds its way through California’s legislative process, the more proponents of similar legislation in other states will be emboldened to continue their efforts to needlessly force vaccinations on our children. There are already scores of bills in states across the country to remove exemptions and mandate certain vaccines for public school attendance.

The current mania of anti-exemption bills was triggered by measles outbreaks at Disneyland—outbreaks that included vaccinated children and may in fact have been set off by vaccinated children, because the live vaccine virus can be contagious, and vaccine immunity may be weak and in any case does not last. We have already pointed out that no one has died of measles in recent times, while children have died from the vaccine. The media have done an excellent job in ratcheting up unwarranted fear. Let’s keep in mind that there have been under 200 cases of measles in a population of 320 million people.

Urgent Action Alert! California residents, write and call your representatives and tell them to vote NO on SB 277! Please send your message immediately.

Other state-based Action Alerts! Check below to see if your state is considering legislation to eliminate vaccine exemptions, and take action immediately!

Connecticut

Illinois

Maine

Minnesota

New Jersey

Pennsylvania

Rhode Island

Texas

Vermont

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Mainstream Media Predictably Ignores Problems with JAMA’s New Vaccine Study

They say this is the final nail is in the coffin of the vaccine safety debate. But whose coffin?

Last week, JAMA, the Journal of the American Medical Association, published a study claiming to have found no link between autism and the MMR vaccine (MMR stands for measles, mumps, and rubella). The mainstream press immediately fell into line and triumphantly declared the case closed.

Here are some examples of the headlines that ran: “Study Rules Out Link Between Autism and MMR Vaccine even in At-Risk Kids”; “MMR Vaccine and Autism: Yet Again, No Link Exists—Even For Children At Risk For Autism”; Measles Vaccine Still Doesn’t Cause Autism; “Another Nail in Coffin of MMR-Autism Link.”

As we’ve pointed out previously, this sort of smugness is common to the proponents of vaccines. They want to appear perfectly objective and reasonable, but they vehemently dismiss legitimate questions regarding vaccine safety.

Since a critical examination of the JAMA study would require the media to qualify their one-sided narrative, the limitations of the study have not been a significant part of the conversation. We at ANH-USA thought we would take a closer look.

First, the study was funded jointly by the National Institutes of Health and by the Department of Health and Human Services, government agencies with a well-known agenda of insisting on the safety of vaccines. This extends to winning “hearts and minds” through propaganda campaigns created to instill confidence in vaccines, as we reported last week.

Second, as the authors of the study themselves point out, there are major problems with the methodology used—problems big enough to throw the results into question. The study used a sample of about 100,000 children, comparing vaccinated kids to an unvaccinated control group. To determine which children were vaccinated and which were not, the authors looked at a health insurance claims database: if a child’s parents were billed for a vaccination, then that child of course counted as vaccinated; if the child was not billed for a vaccination, then it was assumed that child was unvaccinated. But, as the study notes, this distorts the numbers because “children in [the]study who are considered unvaccinated may have received vaccines in settings such as schools or public health clinics in which claims were not submitted”!

The authors also note that their findings “may not be as applicable to more ethnically and socioeconomically diverse populations that have less access to health care services.” This issue is covered in one sentence of the study, but is a major concern. Last year, we wrote about the CDC whistleblower, Dr. William Thompson, who broke a decade of silence over the government’s deliberate concealment of the link between the MMR vaccine and a dramatically increased risk of autism, particularly in African American boys. If the sample used by the study is not representative of the American population, especially segments who could be at higher risk for developing autism, the results are thrown into question.

Taken together, these two methodological limitations show that this study is not the last word in the debate about vaccine safety. It is absurd to argue that vaccines cannot or should not be made safer, that dangerous ingredients should not be removed, and that a one-size-fits all approach must be forced upon unwilling participants. Sensible vaccine policy should be based on legitimate science and individual choice, not government mandates and bullying.

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Is the FDA Now Going After Arthritic Patients and Their Doctors?

Vague FDA regulations could spell the end for platelet treatments that use centrifuges, most likely to protect Big Pharma profits. Action Alert!

You may have heard of platelet-rich-plasma (PRP) injections, which are used by orthopedic doctors to treat bone and joint pain. Essentially, PRP treatment begins by drawing blood from a patient, separating platelets from other components of the blood using a centrifuge, then injecting the platelet-rich blood into arthritic joints. PRP is also used in sports medicine to treat tendon, ligament, and muscle injuries.

PRP treatment offers a number of benefits. When compared with surgery, which is often another treatment option, PRP is safer, less costly, and has a more rapid recovery time. It is also a great example of natural medicine, using the body’s own healing powers to treat injuries, as opposed to synthetic drugs or invasive surgeries. In the words of Dr. Steven Sampson, a clinical instructor at UCLA’s medical school, “What’s more natural than your own blood? All we’re doing is amplifying the body’s own healing mechanism. And we’re doing this in the most minimal way possible. There’s no adverse reaction, no immune response, because it’s your blood. Only better.”

As far as clinical evidence of PRP’s effectiveness, there are promising results. One study of patients with chronic elbow tendinitis (“tennis elbow”) found significant improvement in patients treated with PRP in comparison to a control group. Another controlled study compared patients treated with PRP versus patients treated with hyaluronic acid, a lubricant that is often used to treat joint pain; those who received PRP experienced statistically better results. Two other studies also concluded that PRP decreased pain and improved function better than placebo and hyaluronic acid.

So we have a safer, cheaper, and more natural alternative to surgery and pharmaceutical drugs for a whole spectrum of bone, muscle, tendon, and ligament injuries. The only ones who might not be pleased with this treatment are surgeons and drug manufacturers. Unfortunately, they’re the only ones the FDA seems to be listening to.

As is often the case with FDA regulations, it gets a bit complicated, but bear with us as we untangle the threads.

According to FDA rules, human cells, tissues and cellular or tissue-based products (HCT/Ps) intended for implantation, transplantation, infusion or transfer into a human recipient are regulated to “prevent the introduction, transmission, and spread of communicable diseases.”

There are, however, a number of exemptions to this rule. For instance, if you remove HCT/Ps from an individual and implant them back into the same individual during the same surgical procedure, you are exempted from the FDA’s regulations. What constitutes the “same surgical procedure”?

FDA’s view is that autologous cells or tissues that are removed from an individual and implanted into the same individual without intervening processing steps beyond rinsing, cleansing, or sizing, or certain manufacturing steps, raise no additional risks of contamination and communicable disease transmission beyond that typically associated with surgery [emphasis added].

You will note that spinning blood in a centrifuge for PRP treatment is not mentioned. It’s unclear whether this is a conscious move by the FDA to make it more difficult and costly to perform PRP treatments, or an error of omission.

If this phrasing is intentional, it would force doctors to go to approved centers for the type of cells they could far more easily extract from a patient’s blood in their own in-office centrifuges. This would almost certainly result in increased costs, fewer docs willing to go through the hassle, and worst of all, patients not being able to use their own blood and therefore incurring a much greater risk of infection. But even if the omission was unintentional, the uncertainty created by the FDA concerning PRP will likely cause many doctors not to offer the treatment to their patients to avoid having the book thrown at them.

The FDA has been bold in extending its reach over these kinds of treatments. In 2012, we reported on a court case in Colorado in which the court agreed with the FDA that stem cell treatments similar to the PRP treatment described above are now considered to be “drugs” under the FDA’s jurisdiction. In that case, the medical clinic offering the treatment argued, quite logically, that stem cell treatments using the patient’s own cells for the benefit of that same patient should be regulated at the state level as the practice of medicine.

At one point, the FDA even argued that the patient’s own feces, if used therapeutically, would become a “drug” and would therefore be subject to FDA approval, although it later backed off this ridiculous claim. It seems likely to us that these FDA power-grabs are a ploy to protect the market for FDA-approved drugs. Something similar could be at work in the case of PRP. After all, Big Pharma’s arthritis drugs bring in an annual $35 billion in profits worldwide.

Action Alert! Write to the FDA today and urge them to clearly indicate that PRP treatments using in-office centrifuges are exempt from their regulations. Please take action immediately.

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Action Alert: Tell the FDA that PRP Treatments Should Be Exempt from Regulation!

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Is the FDA Now Going After Arthritic Patients and Their Doctors?

Vague FDA regulations could spell the end for platelet treatments that use centrifuges, most likely to protect Big Pharma profits. Action Alert!

You may have heard of platelet-rich-plasma (PRP) injections, which are used by orthopedic doctors to treat bone and joint pain. Essentially, PRP treatment begins by drawing blood from a patient, separating platelets from other components of the blood using a centrifuge, then injecting the platelet-rich blood into arthritic joints. PRP is also used in sports medicine to treat tendon, ligament, and muscle injuries.

PRP treatment offers a number of benefits. When compared with surgery, which is often another treatment option, PRP is safer, less costly, and has a more rapid recovery time. It is also a great example of natural medicine, using the body’s own healing powers to treat injuries, as opposed to synthetic drugs or invasive surgeries. In the words of Dr. Steven Sampson, a clinical instructor at UCLA’s medical school, “What’s more natural than your own blood? All we’re doing is amplifying the body’s own healing mechanism. And we’re doing this in the most minimal way possible. There’s no adverse reaction, no immune response, because it’s your blood. Only better.”

As far as clinical evidence of PRP’s effectiveness, there are promising results. One study of patients with chronic elbow tendinitis (“tennis elbow”) found significant improvement in patients treated with PRP in comparison to a control group. Another controlled study compared patients treated with PRP versus patients treated with hyaluronic acid, a lubricant that is often used to treat joint pain; those who received PRP experienced statistically better results. Two other studies also concluded that PRP decreased pain and improved function better than placebo and hyaluronic acid.

So we have a safer, cheaper, and more natural alternative to surgery and pharmaceutical drugs for a whole spectrum of bone, muscle, tendon, and ligament injuries. The only ones who might not be pleased with this treatment are surgeons and drug manufacturers. Unfortunately, they’re the only ones the FDA seems to be listening to.

As is often the case with FDA regulations, it gets a bit complicated, but bear with us as we untangle the threads.

According to FDA rules, human cells, tissues and cellular or tissue-based products (HCT/Ps) intended for implantation, transplantation, infusion or transfer into a human recipient are regulated to “prevent the introduction, transmission, and spread of communicable diseases.”

There are, however, a number of exemptions to this rule. For instance, if you remove HCT/Ps from an individual and implant them back into the same individual during the same surgical procedure, you are exempted from the FDA’s regulations. What constitutes the “same surgical procedure”?

FDA’s view is that autologous cells or tissues that are removed from an individual and implanted into the same individual without intervening processing steps beyond rinsing, cleansing, or sizing, or certain manufacturing steps, raise no additional risks of contamination and communicable disease transmission beyond that typically associated with surgery [emphasis added].

You will note that spinning blood in a centrifuge for PRP treatment is not mentioned. It’s unclear whether this is a conscious move by the FDA to make it more difficult and costly to perform PRP treatments, or an error of omission.

If this phrasing is intentional, it would force doctors to go to approved centers for the type of cells they could far more easily extract from a patient’s blood in their own in-office centrifuges. This would almost certainly result in increased costs, fewer docs willing to go through the hassle, and worst of all, patients not being able to use their own blood and therefore incurring a much greater risk of infection. But even if the omission was unintentional, the uncertainty created by the FDA concerning PRP will likely cause many doctors not to offer the treatment to their patients to avoid having the book thrown at them.

The FDA has been bold in extending its reach over these kinds of treatments. In 2012, we reported on a court case in Colorado in which the court agreed with the FDA that stem cell treatments similar to the PRP treatment described above are now considered to be “drugs” under the FDA’s jurisdiction. In that case, the medical clinic offering the treatment argued, quite logically, that stem cell treatments using the patient’s own cells for the benefit of that same patient should be regulated at the state level as the practice of medicine.

At one point, the FDA even argued that the patient’s own feces, if used therapeutically, would become a “drug” and would therefore be subject to FDA approval, although it later backed off this ridiculous claim. It seems likely to us that these FDA power-grabs are a ploy to protect the market for FDA-approved drugs. Something similar could be at work in the case of PRP. After all, Big Pharma’s arthritis drugs bring in an annual $35 billion in profits worldwide.

Action Alert! Write to the FDA today and urge them to clearly indicate that PRP treatments using in-office centrifuges are exempt from their regulations. Please take action immediately.

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Action Alert: Tell the FDA that PRP Treatments Should Be Exempt from Regulation!

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Action Alert: Tell the FDA to Stop Censoring Scientific Info on Food Labels!

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Action Alert: Tell the National Vaccine Advisory Committee to Listen to Parents

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Action Alert: Urge Your Congressperson to Co-sponsor the Compassionate Freedom of Choice Act!

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Action Alert: Tell Your AG and the FTC to Investigate ConsumerLab.com!

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Action Alert: Tell the FDA that Homeopathic Products Are Safe, and Current Policies Are Working Perfectly!

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Action Alert: Protect Consumer Access to Quality Supplements!

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Action Alert: Tell Congress NOT to Co-Sponsor the Voluntary GMO Labeling Bill!

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Action Alert: Tell Your State Attorney General Not to Join the Anti-Supplement Coalition!

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Action Alert: Support Rep. Slaughter’s Preservation of Antibiotics for Medical Treatment Act!

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Action Alert: Tell Google Not to Game the System Against Natural Health!

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Action Alert: Tell the FDA to Stop Censoring Scientific Info on Food Labels!

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Action Alert: Tell the National Vaccine Advisory Committee to Listen to Parents

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Action Alert: Urge Your Congressperson to Co-sponsor the Compassionate Freedom of Choice Act!

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Action Alert: Tell Your AG and the FTC to Investigate ConsumerLab.com!

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Action Alert: Tell the FDA that Homeopathic Products Are Safe, and Current Policies Are Working Perfectly!

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Action Alert: Protect Consumer Access to Quality Supplements!

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Action Alert: Tell Congress NOT to Co-Sponsor the Voluntary GMO Labeling Bill!

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Action Alert: Tell Your State Attorney General Not to Join the Anti-Supplement Coalition!

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Action Alert: Support Rep. Slaughter’s Preservation of Antibiotics for Medical Treatment Act!

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Action Alert: Tell Google Not to Game the System Against Natural Health!

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Government Vaccine Committee Considers How to Build Vaccine Confidence

…but verifying or improving the safety of vaccines is not on the list. Action Alert!

You may remember our article on the National Vaccine Advisory Committee’s (NVAC) plan to increase adult immunizations, which could eventually lead to adult mandates. Now, NVAC’s Vaccine Confidence Working Group has released a draft report that considers “how confidence in vaccines impacts the optimal use of recommended childhood vaccines in the United States.”

It is clear from the first lines of the draft report that, from the perspective of the Working Group and NVAC, parents who disagree with the government’s recommended vaccination schedule need to be steamrolled, not reassured. The very existence of such parents amazes the authors. The draft report states, “[There are] parents whose reluctance, hesitation, concerns, or lack of confidence has caused them to question or forego recommended vaccines.” Imagine!

The report goes on to say that the ultimate goal is to “achieve acceptance of all Advisory Group on Immunization Practices (AGIP) recommended vaccinations by parents and healthcare providers.” This recommended schedule is more or less the same as the CDC’s, which include about nineteen injections in the first six months of life.

This is a crucial point. While one could read this report and naively think that there is a good faith attempt on the part of government health officials to answer real questions about vaccine safety, the real intent seems to be to find the most effective propaganda techniques to convince everyone of the virtues of the CDC’s vaccine schedule without any review or modification whatsoever. A number of the recommendations made by the Working Group to achieve these ends are particularly troubling.

One such proposal is to ramp up already existing pay-for-performance initiatives, which are financial incentives or mandates for physicians to achieve both “an immunizing standard within a practice” as well as “continued improvement in immunization coverage rates within a provider’s practice.” This recommendation would also provide billing codes for vaccine counseling, so doctors can “gauge how they are performing when taking time to explain the risks and benefits of vaccination to parents or patients.” In fact, docs can just check a box and they will receive even more money from insurance companies, just for trying to convince parents to vaccinate their kids.

In other words, doctors get more money if they hit a certain vaccination standard, with a bonus for counseling their patients to vaccinate, or they get paid nothing if they fail to hit the required number of vaccinations. They have a double incentive to urge vaccination, which is actually a disincentive for physicians to provide balanced information. The fact that this sets up a glaring conflict of interest is surely blindingly clear to the health officials responsible for this report.

These incentives or mandates would never be disclosed to the patient. It will all be done in secret.

The Working Group also recommends that states “strengthen” their policies regarding personal belief and religious exemptions to vaccination, thus ensuring that exemptions “are only available after appropriate parent education and acknowledgement of the associated risks of not vaccinating, to their child and community.”

Among the more telling recommendations made by the Working Group to achieve full confidence in vaccinations is the following:

NVAC recommends [that] healthcare providers, immunization programs, and those involved in promoting recommended vaccinations actively reinforce that vaccination according to the ACIP recommended schedule is the social norm and not the exception. Misperceptions that vaccination in line with the ACIP recommended schedule is not the norm should be appropriately addressed [emphasis added].

In other words, why use rational discussion to address a parent’s concerns when shaming and school-yard-style peer pressure will do? Will this lead to putting parents in jail, as Maryland did briefly?

There’s a certain logic to the strategy of callously dismissing reasonable concerns about vaccine safety and labeling parents concerned about their children as irrational, uneducated “nuts”: when you marginalize the opposition, nothing need be done to improve vaccine safety—a topic that very few people in government and the scientific community (and none in the vaccine industry) seem to be concerned about.

Action Alert! Submit your comment to NVAC and tell them that they need to listen to parents and be willing to make changes in vaccine ingredients and schedule. Informed consent is the basis for a sensible policy on vaccination—not bullying and public humiliation. Please send your message immediately.

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One-Third of Seniors with Dementia Are Being Given Antipsychotics

—even though such toxic drugs are not approved to treat dementia!

A report from the Government Accountability Office (GAO) found that nearly one-third of older adults with dementia who spent more than 100 days in a nursing home were given antipsychotics through Medicare’s prescription drug program in 2012. We previously reported that a similar situation exists with brain-damaged veterans—and even with infants and young children, especially those treated through Medicaid. They are all given these very toxic and inappropriate medications.

Why is this happening? Are Big Pharma profits more important than the health of our most vulnerable populations—seniors and young people?

A bipartisan pair of senators are now calling for the Department of Health and Human Services (HHS) to investigate the potential misuse and overuse of these drugs. According to the letter from Sens. Tom Carper (D-DE) and Susan Collins (R-ME), nearly 30% of seniors in nursing homes and nearly 14% living outside of nursing home care are being given antipsychotics to treat the behavioral symptoms of dementia—despite “specific warnings that they not be given to patients with dementia due to an increased risk of falls or death”!

The FDA has never approved such drugs to be used for behavioral problems from dementia, nor for use in especially vulnerable populations such as children, seniors, or brain-damaged patients. So where is the FDA here? By law, no drug can make a claim to treat disease without FDA approval for each treatment use. If you want to use a drug approved to treat heart disease on patients with diabetes, you have to seek the FDA’s approval of the drug specifically for diabetes—and pay another billion dollars for the clinical trials and drug approval process.

Antipsychotic drugs have a long list of serious side effects, including hypotension, movement disorders, and metabolic syndrome issues.

Aside from the appalling abuse and maltreatment represented by prescribing the off-label use of antipsychotic drugs to young children and now seniors, the sheer cost to the American taxpayer is staggering, according to the senators’ letter: to treat seniors with dementia with antipsychotics cost Medicare $363 million in 2012. Between 1999 and 2008, Medicaid more than doubled the amount it spent on antipsychotics—more than any other class of drugs. This is great news for the pharmaceutical companies manufacturing these drugs, but less exciting for the seniors and children to whom they are administered.

Along with calls to reduce the use of antipsychotics by 30% by 2016, the letter also calls for alternative treatments.

We’ve reported before that there has been strong evidence to show that coconut oil can prevent, and even reverse, Alzheimer’s disease and dementia. Fish oil has also been found to reduce the inflammation associated with dementia, with one study finding that the risk of all forms of dementia could be reduced by almost half with fish oil. Encouraging work has shown that B vitamins could reduce the rate of brain atrophy in patient with mild cognitive impairment—50% of which go on to develop Alzheimer’s. HBOT (hyperbaric oxygen therapy) is one of the best treatments for brain damage. Most hospitals have the HBOT tanks. But because they are not FDA-approved for this use, they sit empty most of the time.

HHS should promote these alternative, natural, and safer approaches to treating these diseases. But it won’t, because in our opinion it is a prime example of a government agency captured by special interests—one no longer principally concerned with working for the welfare of the public.

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Government Vaccine Committee Considers How to Build Vaccine Confidence

…but verifying or improving the safety of vaccines is not on the list. Action Alert! You may remember our article on the National Vaccine Advisory Committee’s (NVAC) plan to increase adult immunizations, which could eventually lead to adult mandates. Now, NVAC’s Vaccine Confidence Working Group has released a draft report that considers “how confidence in vaccines impacts the optimal use of recommended childhood vaccines in the United States.” It is clear from the first lines of the draft report that, from the perspective of the Working Group and NVAC, parents who disagree with the government’s recommended vaccination schedule need to be steamrolled, not reassured. The very existence of such parents amazes the authors. The draft report states, “[There are] parents whose reluctance, hesitation, concerns, or lack of confidence has caused them to question or forego recommended vaccines.” Imagine! The report goes on to say that the ultimate goal is to “achieve acceptance of all Advisory Group on Immunization Practices (AGIP) recommended vaccinations by parents and healthcare providers.” This recommended schedule is more or less the same as the CDC’s, which include about nineteen injections in the first six months of life. This is a crucial point. While one could read this report and naively think that there is a good faith attempt on the part of government health officials to answer real questions about vaccine safety, the real intent seems to be to find the most effective propaganda techniques to convince everyone of the virtues of the CDC’s vaccine schedule without any review or modification whatsoever. A number of the recommendations made by the Working Group to achieve these ends are particularly troubling. One such proposal is to ramp up already existing pay-for-performance initiatives, which are financial incentives or mandates for physicians to achieve both “an immunizing standard within a practice” as well as “continued improvement in immunization coverage rates within a provider’s practice.” This recommendation would also provide billing codes for vaccine counseling, so doctors can “gauge how they are performing when taking time to explain the risks and benefits of vaccination to parents or patients.” In fact, docs can just check a box and they will receive even more money from insurance companies, just for trying to convince parents to vaccinate their kids. In other words, doctors get more money if they hit a certain vaccination standard, with a bonus for counseling their patients to vaccinate, or they get paid nothing if they fail to hit the required number of vaccinations. They have a double incentive to urge vaccination, which is actually a disincentive for physicians to provide balanced information. The fact that this sets up a glaring conflict of interest is surely blindingly clear to the health officials responsible for this report. These incentives or mandates would never be disclosed to the patient. It will all be done in secret. The Working Group also recommends that states “strengthen” their policies regarding personal belief and religious exemptions to vaccination, thus ensuring that exemptions “are only available after appropriate parent education and acknowledgement of the associated risks of not vaccinating, to their child and community.” Among the more telling recommendations made by the Working Group to achieve full confidence in vaccinations is the following: NVAC recommends [that] healthcare providers, immunization programs, and those involved in promoting recommended vaccinations actively reinforce that vaccination according to the ACIP recommended schedule is the social norm and not the exception. Misperceptions that vaccination in line with the ACIP recommended schedule is not the norm should be appropriately addressed [emphasis added]. In other words, why use rational discussion to address a parent’s concerns when shaming and school-yard-style peer pressure will do? Will this lead to putting parents in jail, as Maryland did briefly? There’s a certain logic to the strategy of callously dismissing reasonable concerns about vaccine safety and labeling parents concerned about their children as irrational, uneducated “nuts”: when you marginalize the opposition, nothing need be done to improve vaccine safety—a topic that very few people in government and the scientific community (and none in the vaccine industry) seem to be concerned about. Action Alert! Submit your comment to NVAC and tell them that they need to listen to parents and be willing to make changes in vaccine ingredients and schedule. Informed consent is the basis for a sensible policy on vaccination—not bullying and public humiliation. Please send your message immediately.

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One-Third of Seniors with Dementia Are Being Given Antipsychotics

—even though such toxic drugs are not approved to treat dementia! A report from the Government Accountability Office (GAO) found that nearly one-third of older adults with dementia who spent more than 100 days in a nursing home were given antipsychotics through Medicare’s prescription drug program in 2012. We previously reported that a similar situation exists with brain-damaged veterans—and even with infants and young children, especially those treated through Medicaid. They are all given these very toxic and inappropriate medications. Why is this happening? Are Big Pharma profits more important than the health of our most vulnerable populations—seniors and young people? A bipartisan pair of senators are now calling for the Department of Health and Human Services (HHS) to investigate the potential misuse and overuse of these drugs. According to the letter from Sens. Tom Carper (D-DE) and Susan Collins (R-ME), nearly 30% of seniors in nursing homes and nearly 14% living outside of nursing home care are being given antipsychotics to treat the behavioral symptoms of dementia—despite “specific warnings that they not be given to patients with dementia due to an increased risk of falls or death”! The FDA has never approved such drugs to be used for behavioral problems from dementia, nor for use in especially vulnerable populations such as children, seniors, or brain-damaged patients. So where is the FDA here? By law, no drug can make a claim to treat disease without FDA approval for each treatment use. If you want to use a drug approved to treat heart disease on patients with diabetes, you have to seek the FDA’s approval of the drug specifically for diabetes—and pay another billion dollars for the clinical trials and drug approval process. Antipsychotic drugs have a long list of serious side effects, including hypotension, movement disorders, and metabolic syndrome issues. Aside from the appalling abuse and maltreatment represented by prescribing the off-label use of antipsychotic drugs to young children and now seniors, the sheer cost to the American taxpayer is staggering, according to the senators’ letter: to treat seniors with dementia with antipsychotics cost Medicare $363 million in 2012. Between 1999 and 2008, Medicaid more than doubled the amount it spent on antipsychotics—more than any other class of drugs. This is great news for the pharmaceutical companies manufacturing these drugs, but less exciting for the seniors and children to whom they are administered. Along with calls to reduce the use of antipsychotics by 30% by 2016, the letter also calls for alternative treatments. We’ve reported before that there has been strong evidence to show that coconut oil can prevent, and even reverse, Alzheimer’s disease and dementia. Fish oil has also been found to reduce the inflammation associated with dementia, with one study finding that the risk of all forms of dementia could be reduced by almost half with fish oil. Encouraging work has shown that B vitamins could reduce the rate of brain atrophy in patient with mild cognitive impairment—50% of which go on to develop Alzheimer’s. HBOT (hyperbaric oxygen therapy) is one of the best treatments for brain damage. Most hospitals have the HBOT tanks. But because they are not FDA-approved for this use, they sit empty most of the time. HHS should promote these alternative, natural, and safer approaches to treating these diseases. But it won’t, because in our opinion it is a prime example of a government agency captured by special interests—one no longer principally concerned with working for the welfare of the public.

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FDA Doubles Down on Censoring Food Labels

As usual, it gets the science wrong, and we think we detect a hidden, commercial motive as well. Action Alert!

The FDA recently sent a warning letter to KIND, the company known for making several varieties of fruit-and-nut bars. The letter contends that four of KIND’s products bear the claim on their labels that they are “healthy and tasty, convenient and wholesome” without meeting the federal definition of “healthy.”

As part of this definition, a food cannot exceed one gram of saturated fat per “reference amount customarily consumed”—basically, one gram of saturated fat per serving. According to KIND’s website, the four bars mentioned by the FDA contain anywhere between one and five grams of saturated fat. Even if saturated fat were actually bad for your heart, which scientists have now refuted, this wouldn’t exactly be an artery-clogging amount.

Other absurdities abound. The FDA’s letter was also thorny about KIND’s use of the words “plus,” “antioxidant-rich,” and “good source of fiber” on their labels.

But let’s focus on saturated fat for the present. As we’ve said, the idea that we should avoid fat is just a myth with no current scientific support. There is a great deal of evidence now suggesting that saturated fat—in particular, saturated fat from the right sources—is not the main culprit in heart disease or obesity, misinformation from the American Heart Association notwithstanding! In fact, saturated fat from foods like butter from grass-fed cows, avocados, coconut oil, and eggs has numerous health benefits.

The real source of obesity and related ills such as diabetes and heart disease is sugar, and the starchy foods that break down into sugars in the body, plus of course a lack of exercise. We’ve covered the negative health effects of different types of sugar and sweeteners elsewhere. Dr. Joseph Mercola has also been a staunch critic of sweet drinks—whether sweetened by sugar, high-fructose corn syrup, or artificial sweeteners—because of the link to obesity and other diseases.

The sweetener used in KIND’s bars is usually honey. We don’t eat much of it ourselves, because it is a form of sugar, but it is at least a more natural form, assuming the honey in question is raw and organic. And, from what we can tell, most of the saturated fat in the bars comes from nuts like almonds, cashews, and peanuts. Basically, apart from the sugar content, the bars seem mostly healthy!

The main takeaway is that the FDA is using pathetically outdated science in its action against KIND and its overall determination of what is “healthy”—not unlike the Dietary Guidelines Advisory Committee’s recommendations about reducing red meat in our diet, which totally ignored the vast nutritional differences between grain-fed, hormone- and antibiotic-infused beef and grass-fed organic beef.

Unfortunately, we don’t think this is just a case of the FDA simply being woefully ignorant of the latest science. There may be another, perhaps even more insidious, game being played. If the FDA is going to start hitting companies for inappropriately claiming their products are “healthy” on the labels, this could be just the opening salvo in a renewed attack on food and supplement producers claiming any health benefits from their products, no matter how much supporting science there is.

Bear with us for a moment as we sort through some FDA law:

• At present, the law does not allow the seller of a food or supplement to say that the product will help prevent or treat a health condition or disease. Only a drug company selling an FDA-approved drug may make such a claim.
• Any violation of this rule can result in massive fines and a long jail sentence. For example, the producer of a vitamin D supplement cannot legally cite the science showing that vitamin D prevents and treats the flu. Influenza is a disease, so this is forbidden, no matter what the science says.
• The supplement producer can, however, make a legal structure/function claim—for example, by saying that vitamin D “supports immune system function.”
• Alternatively, the vitamin D producer might ask the FDA for permission to make a qualified health claim, saying that vitamin D may prevent or treat the flu (note the qualifying term “may”). But the FDA never agrees to allow this unless the agency is dragged into court at vast expense. An FDA employee once told a lawyer involved in this kind of litigation that he would have to keep suing and suing, because the agency had unlimited legal funds and he didn’t.

As we’ve seen before, this wouldn’t be the first time the FDA has tried to attack structure/function claims or qualified health claims. The agency has been trying for years to lump food, supplements, and drugs all into one category, to be subjected to the same regulations. The problem, of course, is what we call the “Catch-22” of drug economics: it costs billions of dollars to go through the FDA’s drug approval process, which is an entirely prohibitive cost to natural supplement and food companies because they cannot patent protect their products, whereas Big Pharma companies are able to patent their new-to-nature molecules—and charge exorbitant sums to consumers.

FDA success in this regard would be a great boon for the pharmaceutical industry, because competition would be eliminated. This, in turn, is good for the FDA, because Big Pharma pays the agency’s bills, in addition to offering lucrative employment for those who leave government.

For consumers who want information so they can make informed choices about food, however, it would be a devastating loss. Consumers are already willfully kept in the dark about the value of nutritional superfoods such as walnuts and cherries. If there were no structure/function claims, the supplement industry would be crippled.

Action Alert! Write to the FDA and tell them to stop censoring truthful scientific information on food labels, and especially stop the kind of censorship based on junk science. Please send your message immediately.

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

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FDA Doubles Down on Censoring Food Labels

As usual, it gets the science wrong, and we think we detect a hidden, commercial motive as well. Action Alert! The FDA recently sent a warning letter to KIND, the company known for making several varieties of fruit-and-nut bars. The letter contends that four of KIND’s products bear the claim on their labels that they are “healthy and tasty, convenient and wholesome” without meeting the federal definition of “healthy.” As part of this definition, a food cannot exceed one gram of saturated fat per “reference amount customarily consumed”—basically, one gram of saturated fat per serving. According to KIND’s website, the four bars mentioned by the FDA contain anywhere between one and five grams of saturated fat. Even if saturated fat were actually bad for your heart, which scientists have now refuted, this wouldn’t exactly be an artery-clogging amount. Other absurdities abound. The FDA’s letter was also thorny about KIND’s use of the words “plus,” “antioxidant-rich,” and “good source of fiber” on their labels. But let’s focus on saturated fat for the present. As we’ve said, the idea that we should avoid fat is just a myth with no current scientific support. There is a great deal of evidence now suggesting that saturated fat—in particular, saturated fat from the right sources—is not the main culprit in heart disease or obesity, misinformation from the American Heart Association notwithstanding! In fact, saturated fat from foods like butter from grass-fed cows, avocados, coconut oil, and eggs has numerous health benefits. The real source of obesity and related ills such as diabetes and heart disease is sugar, and the starchy foods that break down into sugars in the body, plus of course a lack of exercise. We’ve covered the negative health effects of different types of sugar and sweeteners elsewhere. Dr. Joseph Mercola has also been a staunch critic of sweet drinks—whether sweetened by sugar, high-fructose corn syrup, or artificial sweeteners—because of the link to obesity and other diseases. The sweetener used in KIND’s bars is usually honey. We don’t eat much of it ourselves, because it is a form of sugar, but it is at least a more natural form, assuming the honey in question is raw and organic. And, from what we can tell, most of the saturated fat in the bars comes from nuts like almonds, cashews, and peanuts. Basically, apart from the sugar content, the bars seem mostly healthy! The main takeaway is that the FDA is using pathetically outdated science in its action against KIND and its overall determination of what is “healthy”—not unlike the Dietary Guidelines Advisory Committee’s recommendations about reducing red meat in our diet, which totally ignored the vast nutritional differences between grain-fed, hormone- and antibiotic-infused beef and grass-fed organic beef. Unfortunately, we don’t think this is just a case of the FDA simply being woefully ignorant of the latest science. There may be another, perhaps even more insidious, game being played. If the FDA is going to start hitting companies for inappropriately claiming their products are “healthy” on the labels, this could be just the opening salvo in a renewed attack on food and supplement producers claiming any health benefits from their products, no matter how much supporting science there is. Bear with us for a moment as we sort through some FDA law:

• At present, the law does not allow the seller of a food or supplement to say that the product will help prevent or treat a health condition or disease. Only a drug company selling an FDA-approved drug may make such a claim.
• Any violation of this rule can result in massive fines and a long jail sentence. For example, the producer of a vitamin D supplement cannot legally cite the science showing that vitamin D prevents and treats the flu. Influenza is a disease, so this is forbidden, no matter what the science says.
• The supplement producer can, however, make a legal structure/function claim—for example, by saying that vitamin D “supports immune system function.”
• Alternatively, the vitamin D producer might ask the FDA for permission to make a qualified health claim, saying that vitamin D may prevent or treat the flu (note the qualifying term “may”). But the FDA never agrees to allow this unless the agency is dragged into court at vast expense. An FDA employee once told a lawyer involved in this kind of litigation that he would have to keep suing and suing, because the agency had unlimited legal funds and he didn’t.

As we’ve seen before, this wouldn’t be the first time the FDA has tried to attack structure/function claims or qualified health claims. The agency has been trying for years to lump food, supplements, and drugs all into one category, to be subjected to the same regulations. The problem, of course, is what we call the “Catch-22” of drug economics: it costs billions of dollars to go through the FDA’s drug approval process, which is an entirely prohibitive cost to natural supplement and food companies because they cannot patent protect their products, whereas Big Pharma companies are able to patent their new-to-nature molecules—and charge exorbitant sums to consumers. FDA success in this regard would be a great boon for the pharmaceutical industry, because competition would be eliminated. This, in turn, is good for the FDA, because Big Pharma pays the agency’s bills, in addition to offering lucrative employment for those who leave government. For consumers who want information so they can make informed choices about food, however, it would be a devastating loss. Consumers are already willfully kept in the dark about the value of nutritional superfoods such as walnuts and cherries. If there were no structure/function claims, the supplement industry would be crippled. Action Alert! Write to the FDA and tell them to stop censoring truthful scientific information on food labels, and especially stop the kind of censorship based on junk science. Please send your message immediately.

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