Compounded Meds Will Cost You More (or Disappear Altogether!) Because of FDA’s Attack on “Office Use”

Once again the rogue agency is thumbing its nose at members of Congress. Action Alert!

Last week we told you about the new threat to compounded drugs from the US Pharmacopeial Convention (USP) and asked you to send a protest message to USP. Our thanks to the many thousands of you who responded. Now the US Food and Drug Administration is dramatically increasing the cost of compounded drugs and is once again interfering with the practice of medicine. At issue is what is called “office use.”

As we explained in 2012, “office use” is when a physician, in his or her office or other treatment area, administers a compounded medicinal preparation directly to a patient for the immediate treatment of a problem. In these instances a doctor would need to have a reserve supply of compounded drugs on hand without a prescription. Pharmacies might be called upon to repackage manufactured drugs to produce various compounded formulations in advance of a prescription—especially if they know they have a standing order on certain formulations.

Now the FDA, purportedly based on underlying congressional action, appears to be trying to kill office use and pharmacy repackaging. In a response to a letter from concerned members of Congress, the FDA stated, “A compounding pharmacist may not dispense compounded medications for office use, but rather, must obtain a prescription for an individually identified patient.” The agency has also sent a warning letter to a pharmacy regarding its alleged office use “violation.”

As a result, there has been tremendous confusion in the medical community and among state pharmacy boards. Fearing retaliation from the FDA, pharmacists are now reluctant to supply doctors with compounded drugs for office use. This means the FDA is actively interfering with the practice of medicine.

Doctors will now have to go through bureaucratic rigmarole and delay for each drug and each patient, which makes access to compounded drugs very difficult for patients and increases the cost of the medicine significantly. ANH-USA heard from one doctor, who described his real-world experience with office-use compounding:

I have occasion to see people with degenerative joint disease. One of the best treatments to inexpensively help the body regenerate cartilage and stop joint pain is to inject glucosamine, MSM, and methyl-B12 or hydroxy-B12 into the joint. This works so much better than injecting cortisone, and is not destructive to the cartilage as is cortisone.

Just last year I could keep bottles of these ingredients and use them in patients as needed throughout the day.

Now, I need to prescribe the glucosamine, MSM, and B12 for each individual patient, the compounding pharmacy will send the ingredients to the patient and charge for the prescription, the patient will bring the bottled ingredients to my office at their next appointment, and then I can do the injection into the joint. This delays needed treatment, and makes it unduly expensive.

I have occasion to see patients who have fibromyalgia and chronic fatigue syndrome. One of the most important treatments involves the injection of intravenous nutrients. It used to be possible to stock bottles of the several nutrients listed below and put the needed dose into an IV bottle and administer the IV solution.

Now, I need to prescribe the exact dose of each nutrient, each bottle gets charged and sent to the patient in the mail, the patient needs to bring it all to the medical center, my staff needs to put each nutrient into the IV bottle, and then the patient can receive the IV solution.

The cost has dramatically increased. We used to be able to charge about $150 for the solution; it will now cost about $400 under the new rules.

We have been providing safe and quality individualized care for many years with the help of the compounding pharmacists with whom we have relationship. Now we are severely hampered by unneeded regulation.

Several members of Congress have said that when the final version of the compounding legislation was passed, Congress did not intend to place limitations on office use. Historically, office use is addressed in state legislation and has been the purview of the state pharmacy boards.

In fact, several Congress members stated for the Congressional Record that they completely disagree with the FDA’s position on office use:

• Sen. Johnny Isakson (R-GA): “The intent of this legislation is to maintain current law with respect to patients’ and physicians’ access to drugs compounded for office use.”


• Sen. Lamar Alexander (R-TN): “The legislation does not change current law on office use compounding or repackaging.”


• Rep. Morgan Griffith (R-VA): “I know there’s a lot of concern out there by some in the medical community, particularly the doctors and some others, but this does not change the existing law on office use, and it does not change the existing law on repackaging.”

ANH-USA is part of a coalition that is tackling this issue. The coalition, which includes doctors and pharmacists (we are the only organization representing consumer interests), sent a letter to both the Senate Health, Education, Labor, and Pensions Committee and the Energy and Commerce Committee to alert them to the issue. We told them that access to many drugs for office use is being stopped, including:

• Antibiotics for urgent and emergent use in treating ophthalmology patients;


• Buffered lidocaine for use in dermatology procedures;


• Vascular endothelial growth factor inhibitors for use in treating age-related macular degeneration by ophthalmologists;


• Injection therapies for treating erectile dysfunction in urology patients (test injections are commonly administered in the doctor’s office to determine the correct dosage);


• Cantharidin for treating viral skin conditions in office by dermatologists and pediatricians; and


• Injectable methylcobalamin for the treatment of pernicious anemia and other vitamin B-12 deficiencies.

And that’s just the tip of the iceberg when it comes to the medications affected. Of course, these office use restrictions have nothing to do with the New England Compounding Center tragedy that spurred the whole legislation in the first place. Make no mistake: the FDA’s actions only make sense as a way to protect the pharmaceutical industry’s monopoly on drugs. The FDA depends on Pharma, not compounders, to pay its bills and also provide jobs following government service, which is known as the revolving door.

Action Alert! ANH-USA is launching a new microsite that explains and addresses the many serious problems physicians, pharmacists, and patients have with the FDA’s implementation of the compounding law. We will be pursuing legislative fixes, but it all starts with our petition to the FDA. Please go to http://ift.tt/1JZwdf0, learn what’s at stake, and send your messages to Congress and the FDA. Please take action immediately!

Also, if you didn’t do so last week, please send a message to the US Pharmacopeial Convention (USP) and tell them to revise their “hazardous drugs” rule!

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

from http://ift.tt/1DeIWrY

Is Your Sunscreen Making You Infertile?

A new law may help promote safer sunscreen ingredients. Action Alert!

A new study by the National Institutes of Health found that sunscreen chemicals that filter out ultraviolet rays may impair male fertility. There are twenty-nine “benzophenone-type UV filtering chemicals” in personal care products that protect skin and hair from sun damage. Researchers found that men with high exposure to two chemicals in particular had a 30% reduction in their ability to reproduce. Earlier research findings linked reduced fertility to high concentrations of phthalates and Bisphenol A (BPA) in men, chemicals that we also pick up from sources such as can linings, dental treatments, and cash register receipts.

The skin is the body’s largest organ, and how we care for our skin is extremely important. Unfortunately, the FDA’s procedure for reviewing sunscreen ingredients is incredibly sloppy—and way too slow.

The FDA classifies sunscreen as drugs, and all sunscreen products technically require preapproval before being allowed on the market. However, to avoid the lengthy and expensive new drug approval process, sunscreen ingredients are governed by monograph (a written standard for active ingredients). If a monograph has been issued for a product, all a company has to do is show that it has met the standards of that monograph to be allowed on the market. It took thirty years for the FDA to approve several final monographs for sunscreen ingredients, but they finally did so in 1999.

Even then they did a bad job. Among the list of approved monographs is one for oxybenzone, which breaks down to 4-OH-BP, one of the two chemicals that cause infertility.

If there is a new and potentially safer sunscreen ingredient, a manufacturer’s viable alternative is the Time and Extent Application. TEAs are meant to allow companies to bring technically new ingredients to the US consumer market, based on their use in other countries. The FDA then is supposed to review the ingredient to see whether it can be Generally Regarded as Safe and Effective (GRASE) for use in sunscreen.

The FDA stated that they would “strive to complete TEA evaluations in 90-180 days”—yet the agency has not approved a TEA for any sunscreen active ingredient since 2002. Only recently did FDA issue a first determination that GRASE status would not be established for two ingredients.

To address this huge delay in sunscreen ingredient review, Congress recently passed the Sunscreen Innovation Act. It will set timelines for FDA review of sunscreen ingredients and, we hope, will give a big boost to innovation and safety. As the Environmental Working Group (EWG) notes:

Companies that make sunscreens in the United States currently have limited options for formulating their products, and most of them provide inadequate protection from UVA rays. [The FDA] has failed to review and approve promising sunscreen ingredients that have been sold for years in Europe, Australia and other countries.

EWG has a guide to the best sunscreens currently available. Dr. Mercola recommends choosing a sunscreen that contains zinc or titanium materials, and has recommendations for other skin-nourishing, safe sunscreens.

Let’s also keep in mind that the human body needs sunlight. Too little sun, whether from being indoors or from using sunscreen or from living in a northern latitude, especially in the winter, is associated with more cancer, not less—especially the deadly cancers, both on the skin and elsewhere. This is probably because it leads to inadequate vitamin D, but there may be many other factors involved that we don’t yet understand. Once you’ve gotten your daily dose of vitamin D from the sun, during times when the sun is powerful enough to make D, especially from 10 a.m. to 2 p.m. in summer, it may be best to avoid sunscreens altogether and wear long sleeves and a hat!

Action Alert! Tell the FDA to remove the monograph for oxybenzone. It’s a dangerous chemical and should immediately be banned from sunscreens. They should also speed up their review of proposed new ingredients. All the delay makes consumers less safe, not more. Send your message today!

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

from http://ift.tt/1DeIWbu

Compounded Meds Will Cost You More (or Disappear Altogether!) Because of FDA’s Attack on “Office Use”

Once again the rogue agency is thumbing its nose at members of Congress. Action Alert! Last week we told you about the new threat to compounded drugs from the US Pharmacopeial Convention (USP) and asked you to send a protest message to USP. Our thanks to the many thousands of you who responded. Now the US Food and Drug Administration is dramatically increasing the cost of compounded drugs and is once again interfering with the practice of medicine. At issue is what is called “office use.” As we explained in 2012, “office use” is when a physician, in his or her office or other treatment area, administers a compounded medicinal preparation directly to a patient for the immediate treatment of a problem. In these instances a doctor would need to have a reserve supply of compounded drugs on hand without a prescription. Pharmacies might be called upon to repackage manufactured drugs to produce various compounded formulations in advance of a prescription—especially if they know they have a standing order on certain formulations. Now the FDA, purportedly based on underlying congressional action, appears to be trying to kill office use and pharmacy repackaging. In a response to a letter from concerned members of Congress, the FDA stated, “A compounding pharmacist may not dispense compounded medications for office use, but rather, must obtain a prescription for an individually identified patient.” The agency has also sent a warning letter to a pharmacy regarding its alleged office use “violation.” As a result, there has been tremendous confusion in the medical community and among state pharmacy boards. Fearing retaliation from the FDA, pharmacists are now reluctant to supply doctors with compounded drugs for office use. This means the FDA is actively interfering with the practice of medicine. Doctors will now have to go through bureaucratic rigmarole and delay for each drug and each patient, which makes access to compounded drugs very difficult for patients and increases the cost of the medicine significantly. ANH-USA heard from one doctor, who described his real-world experience with office-use compounding:

I have occasion to see people with degenerative joint disease. One of the best treatments to inexpensively help the body regenerate cartilage and stop joint pain is to inject glucosamine, MSM, and methyl-B12 or hydroxy-B12 into the joint. This works so much better than injecting cortisone, and is not destructive to the cartilage as is cortisone. Just last year I could keep bottles of these ingredients and use them in patients as needed throughout the day. Now, I need to prescribe the glucosamine, MSM, and B12 for each individual patient, the compounding pharmacy will send the ingredients to the patient and charge for the prescription, the patient will bring the bottled ingredients to my office at their next appointment, and then I can do the injection into the joint. This delays needed treatment, and makes it unduly expensive. I have occasion to see patients who have fibromyalgia and chronic fatigue syndrome. One of the most important treatments involves the injection of intravenous nutrients. It used to be possible to stock bottles of the several nutrients listed below and put the needed dose into an IV bottle and administer the IV solution. Now, I need to prescribe the exact dose of each nutrient, each bottle gets charged and sent to the patient in the mail, the patient needs to bring it all to the medical center, my staff needs to put each nutrient into the IV bottle, and then the patient can receive the IV solution. The cost has dramatically increased. We used to be able to charge about $150 for the solution; it will now cost about $400 under the new rules. We have been providing safe and quality individualized care for many years with the help of the compounding pharmacists with whom we have relationship. Now we are severely hampered by unneeded regulation.

Several members of Congress have said that when the final version of the compounding legislation was passed, Congress did not intend to place limitations on office use. Historically, office use is addressed in state legislation and has been the purview of the state pharmacy boards. In fact, several Congress members stated for the Congressional Record that they completely disagree with the FDA’s position on office use:

• Sen. Johnny Isakson (R-GA): “The intent of this legislation is to maintain current law with respect to patients’ and physicians’ access to drugs compounded for office use.”


• Sen. Lamar Alexander (R-TN): “The legislation does not change current law on office use compounding or repackaging.”


• Rep. Morgan Griffith (R-VA): “I know there’s a lot of concern out there by some in the medical community, particularly the doctors and some others, but this does not change the existing law on office use, and it does not change the existing law on repackaging.”

ANH-USA is part of a coalition that is tackling this issue. The coalition, which includes doctors and pharmacists (we are the only organization representing consumer interests), sent a letter to both the Senate Health, Education, Labor, and Pensions Committee and the Energy and Commerce Committee to alert them to the issue. We told them that access to many drugs for office use is being stopped, including:

• Antibiotics for urgent and emergent use in treating ophthalmology patients;


• Buffered lidocaine for use in dermatology procedures;


• Vascular endothelial growth factor inhibitors for use in treating age-related macular degeneration by ophthalmologists;


• Injection therapies for treating erectile dysfunction in urology patients (test injections are commonly administered in the doctor’s office to determine the correct dosage);


• Cantharidin for treating viral skin conditions in office by dermatologists and pediatricians; and


• Injectable methylcobalamin for the treatment of pernicious anemia and other vitamin B-12 deficiencies.

And that’s just the tip of the iceberg when it comes to the medications affected. Of course, these office use restrictions have nothing to do with the New England Compounding Center tragedy that spurred the whole legislation in the first place. Make no mistake: the FDA’s actions only make sense as a way to protect the pharmaceutical industry’s monopoly on drugs. The FDA depends on Pharma, not compounders, to pay its bills and also provide jobs following government service, which is known as the revolving door. Action Alert! ANH-USA is launching a new microsite that explains and addresses the many serious problems physicians, pharmacists, and patients have with the FDA’s implementation of the compounding law. We will be pursuing legislative fixes, but it all starts with our petition to the FDA. Please go to http://ift.tt/1JZwdf0, learn what’s at stake, and send your messages to Congress and the FDA. Please take action immediately!

Also, if you didn’t do so last week, please send a message to the US Pharmacopeial Convention (USP) and tell them to revise their “hazardous drugs” rule!

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

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

Is Your Sunscreen Making You Infertile?

A new law may help promote safer sunscreen ingredients. Action Alert! A new study by the National Institutes of Health found that sunscreen chemicals that filter out ultraviolet rays may impair male fertility. There are twenty-nine “benzophenone-type UV filtering chemicals” in personal care products that protect skin and hair from sun damage. Researchers found that men with high exposure to two chemicals in particular had a 30% reduction in their ability to reproduce. Earlier research findings linked reduced fertility to high concentrations of phthalates and Bisphenol A (BPA) in men, chemicals that we also pick up from sources such as can linings, dental treatments, and cash register receipts. The skin is the body’s largest organ, and how we care for our skin is extremely important. Unfortunately, the FDA’s procedure for reviewing sunscreen ingredients is incredibly sloppy—and way too slow. The FDA classifies sunscreen as drugs, and all sunscreen products technically require preapproval before being allowed on the market. However, to avoid the lengthy and expensive new drug approval process, sunscreen ingredients are governed by monograph (a written standard for active ingredients). If a monograph has been issued for a product, all a company has to do is show that it has met the standards of that monograph to be allowed on the market. It took thirty years for the FDA to approve several final monographs for sunscreen ingredients, but they finally did so in 1999. Even then they did a bad job. Among the list of approved monographs is one for oxybenzone, which breaks down to 4-OH-BP, one of the two chemicals that cause infertility. If there is a new and potentially safer sunscreen ingredient, a manufacturer’s viable alternative is the Time and Extent Application. TEAs are meant to allow companies to bring technically new ingredients to the US consumer market, based on their use in other countries. The FDA then is supposed to review the ingredient to see whether it can be Generally Regarded as Safe and Effective (GRASE) for use in sunscreen. The FDA stated that they would “strive to complete TEA evaluations in 90-180 days”—yet the agency has not approved a TEA for any sunscreen active ingredient since 2002. Only recently did FDA issue a first determination that GRASE status would not be established for two ingredients. To address this huge delay in sunscreen ingredient review, Congress recently passed the Sunscreen Innovation Act. It will set timelines for FDA review of sunscreen ingredients and, we hope, will give a big boost to innovation and safety. As the Environmental Working Group (EWG) notes:

Companies that make sunscreens in the United States currently have limited options for formulating their products, and most of them provide inadequate protection from UVA rays. [The FDA] has failed to review and approve promising sunscreen ingredients that have been sold for years in Europe, Australia and other countries.

EWG has a guide to the best sunscreens currently available. Dr. Mercola recommends choosing a sunscreen that contains zinc or titanium materials, and has recommendations for other skin-nourishing, safe sunscreens. Let’s also keep in mind that the human body needs sunlight. Too little sun, whether from being indoors or from using sunscreen or from living in a northern latitude, especially in the winter, is associated with more cancer, not less—especially the deadly cancers, both on the skin and elsewhere. This is probably because it leads to inadequate vitamin D, but there may be many other factors involved that we don’t yet understand. Once you’ve gotten your daily dose of vitamin D from the sun, during times when the sun is powerful enough to make D, especially from 10 a.m. to 2 p.m. in summer, it may be best to avoid sunscreens altogether and wear long sleeves and a hat! Action Alert! Tell the FDA to remove the monograph for oxybenzone. It’s a dangerous chemical and should immediately be banned from sunscreens. They should also speed up their review of proposed new ingredients. All the delay makes consumers less safe, not more. Send your message today!

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

from Tumblr http://ift.tt/1z0ajGY

Wi-Fi Especially Dangerous for Young Children—Cell Phones Too

Kids exposed to EMF radiation may develop cancer later in life, and the risk is much greater than previously thought.

Should we really be all that concerned about radiation from our cell phones (which we carry with us everywhere) and our Wi-Fi (which is nearly ubiquitous these days)?

The UN’s International Agency for Research on Cancer calls microwave radiation (MWR) a class 2B carcinogen, which means it possibly causes cancer in humans—it’s in the same category as lead, chloroform, gasoline fumes, and the pesticide DDT. Most of the research concerns a specific type of MWR: the radiofrequency electromagnetic fields (RF/EMF) given off by radios, televisions, microwave ovens, cell phones and Wi-Fi, and the smart meters installed in your home by the utility company.

A new study published in the Journal of Microscopy and Ultrastructure says we are right to be concerned. Children are at dramatically greater risk from RF/EMF than adults because their brain tissues are more absorbent, their skulls are thinner, and their relative size is smaller.

In general, the younger the child, the higher the risk, according to the study; fetuses are particularly vulnerable to MWR, which means pregnant women should take great care indeed.

The study also found that adults are at a lower, but still significant, risk, echoing the findings of a 2013 case study from a team of breast cancer surgeons and pathologists who raised the possibility that nonionizing radiation from cell phone EMF exposures caused multifocal invasive breast cancer in four young women. These women, all between the ages of 21 and 39, regularly carried their smartphones directly against their breasts in their bras for up to ten hours a day, for several years. All four developed tumors in areas of their breasts immediately underlying the phones. All four had no family history of breast cancer, tested negative for BRCA1 and BRCA2, and had no other known breast cancer risks. The pathology of all four cases shows striking similarities in the tumor composition.

The youngest of the group started carrying her cell phone in her bra at age 15. The Microscopy and Ultrastructure study made a particular recommendation that adolescent girls and women should never place cell phones in their bras or in hijabs (headscarves).

The study noted that exposure limits in the US are inadequate. Exposure limits were set in the 1990s, before the plethora of scientific studies showing cancer risks at levels well below the current legal exposure limit. All of those studies are based entirely on short-term exposures, with no consideration at that time of long-term exposures. We now have an abundance of data showing just how dangerous EMF may be.

Government warnings have been issued, but according to Forbes , most of the public is unaware of such warnings. Cell phone manual warnings make clear that an overexposure problem exists—but that is to limit legal liability, and besides, who reads cell phone manuals? Furthermore, FCC regulations state that devices should be tested under normal operating conditions—yet many RF/EMF products, including cell phones and laptops, usually measure exposure when the device is held 20 centimeters (a little less than 8 inches) from the body. People place laptops on their laps and keep cell phones in receiving mode (rather than the presumably safe airplane mode) in their pockets and bras all the time. Most people hold their cell phones to their heads to talk, rather than using speakerphone or a headset.

As we noted in 2011, there have been multiple reports, mostly out of Europe’s premier research institutions, of cell phone use being linked to brain damage, early-onset Alzheimer’s, senility, DNA damage, and even sperm die-offs. But after this new study on the RF/EMF dangers to young children, concern is mounting about the growing number of children’s toys that use Wi-Fi technology—and that’s not counting the number of kids who play with tablets or carry cell phones these days.

Proximity to the Wi-Fi device seems to be the most important factor. Under international guidelines, the rate that energy is absorbed into the body from Wi-Fi radio waves—the Specific Absorption Rate (SAR)—cannot exceed two watts per kilogram when averaged over any ten grams of tissue. According to Apple, during testing, iPhone radios are set to their highest transmission levels and placed in positions that simulate use against the head, with no separation, and near the body, with 5 millimeter separation; iPads are placed in positions that simulate everyday use. Apple’s devices average 0.99 watts per kilogram. The SAR of other manufacturers’ devices vary, but are all below international guidelines; according to the Federal Communications Commission, all wireless devices sold in the US go through a formal FCC approval process to ensure that they do not exceed the maximum allowable SAR level when operating at the device’s highest possible power level.

The World Health Organization (WHO), which has established an International Electromagnetic Fields Project (IEFP) to provide information on health risks, establish research needs and support efforts to harmonize RF exposure standards, provides additional information on RF exposure and mobile phone use. WHO notes the problem of determining long-term risks:

Epidemiological research examining potential long-term risks from radiofrequency exposure has mostly looked for an association between brain tumors and mobile phone use. However, because many cancers are not detectable until many years after the interactions that led to the tumor, and since mobile phones were not widely used until the early 1990s, epidemiological studies at present can only assess those cancers that become evident within shorter time periods.

WHO notes that the largest retrospective case-control study to date on adults was called Interphone, coordinated by the International Agency for Research on Cancer (IARC). It gathered data from thirteen participating countries, and was designed to determine whether there are links between use of mobile phones and head and neck cancers in adults. The study found some indications of an increased risk of gliomas for those who reported the highest 10% of cumulative hours of cell phone use, although there was no consistent trend of increasing risk with greater duration of use. While the researchers concluded that biases and errors limit the strength of these conclusions and prevent a causal interpretation, based largely on these data, IARC has classified radiofrequency electromagnetic fields as possibly carcinogenic to humans (Group 2B), a category used when a causal association is considered credible, but when chance, bias or confounding cannot be ruled out with reasonable confidence.

As for the Wi-Fi in routers and laptops, the maximum signal strength next to a router or computer transmitter is 0.1 watts, and the power level falls off very rapidly beyond a few centimeter from the transmission points. However, the more individual transmitters (the more laptops or tablets in a room), the greater the danger. It is believed that a classroom containing twenty laptops and two routers could combine and be equivalent to the emission from a mobile phone.

Unfortunately, rather than erring on the side of caution or taking precautionary steps, the US seems to be moving in the opposite direction. The FCC has noted that equipping schools with Wi-Fi is a national priority; the agency plans to invest an additional $2 billion in broadband service for schools and libraries by the end of the year.

In our increasingly tech-intensive world, we need to do a better job of evaluating the risks of moving further and further away from nature. If you are concerned about RF/EMF exposure, consider some simple changes:

• Limit your cell phone usage. Carry it away from your body, in a purse or messenger bag, or at least carry it in airplane (non-receiving) mode, and use the speakerphone function or a wired headset for conversations. Use land lines where possible.


• Consider hardwiring your computers to the modem via Ethernet instead of using Wi-Fi (that’s what we do at the ANH-USA offices).


• Reduce your children’s access to cell phones, and limit time on tablets and other devices that have Wi-Fi.


• Opt-out of installing smart meters in your home (though this may be difficult in some states).

In response to public and governmental concern, WHO has established the International Electromagnetic Fields Project to assess the scientific evidence of possible adverse health effects from electromagnetic fields. WHO will conduct a formal risk assessment of all studied health outcomes from RF fields exposure by 2016.

Dr. Mercola, in a powerful article on RF/EMF dangers, reported an interesting suggestion from a panel of experts: EMF-free zones where children, pregnant women (or those hoping to conceive), and others sensitive to EMFs, can be protected. It’s an excellent first step for protecting the most vulnerable members of our society.

from The Alliance for Natural Health USA http://ift.tt/1JCF0oW via Aloe for Health

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Wi-Fi Especially Dangerous for Young Children—Cell Phones Too

Kids exposed to EMF radiation may develop cancer later in life, and the risk is much greater than previously thought. Should we really be all that concerned about radiation from our cell phones (which we carry with us everywhere) and our Wi-Fi (which is nearly ubiquitous these days)? The UN’s International Agency for Research on Cancer calls microwave radiation (MWR) a class 2B carcinogen, which means it possibly causes cancer in humans—it’s in the same category as lead, chloroform, gasoline fumes, and the pesticide DDT. Most of the research concerns a specific type of MWR: the radiofrequency electromagnetic fields (RF/EMF) given off by radios, televisions, microwave ovens, cell phones and Wi-Fi, and the smart meters installed in your home by the utility company. A new study published in the Journal of Microscopy and Ultrastructure says we are right to be concerned. Children are at dramatically greater risk from RF/EMF than adults because their brain tissues are more absorbent, their skulls are thinner, and their relative size is smaller. In general, the younger the child, the higher the risk, according to the study; fetuses are particularly vulnerable to MWR, which means pregnant women should take great care indeed. The study also found that adults are at a lower, but still significant, risk, echoing the findings of a 2013 case study from a team of breast cancer surgeons and pathologists who raised the possibility that nonionizing radiation from cell phone EMF exposures caused multifocal invasive breast cancer in four young women. These women, all between the ages of 21 and 39, regularly carried their smartphones directly against their breasts in their bras for up to ten hours a day, for several years. All four developed tumors in areas of their breasts immediately underlying the phones. All four had no family history of breast cancer, tested negative for BRCA1 and BRCA2, and had no other known breast cancer risks. The pathology of all four cases shows striking similarities in the tumor composition. The youngest of the group started carrying her cell phone in her bra at age 15. The Microscopy and Ultrastructure study made a particular recommendation that adolescent girls and women should never place cell phones in their bras or in hijabs (headscarves). The study noted that exposure limits in the US are inadequate. Exposure limits were set in the 1990s, before the plethora of scientific studies showing cancer risks at levels well below the current legal exposure limit. All of those studies are based entirely on short-term exposures, with no consideration at that time of long-term exposures. We now have an abundance of data showing just how dangerous EMF may be. Government warnings have been issued, but according to Forbes , most of the public is unaware of such warnings. Cell phone manual warnings make clear that an overexposure problem exists—but that is to limit legal liability, and besides, who reads cell phone manuals? Furthermore, FCC regulations state that devices should be tested under normal operating conditions—yet many RF/EMF products, including cell phones and laptops, usually measure exposure when the device is held 20 centimeters (a little less than 8 inches) from the body. People place laptops on their laps and keep cell phones in receiving mode (rather than the presumably safe airplane mode) in their pockets and bras all the time. Most people hold their cell phones to their heads to talk, rather than using speakerphone or a headset. As we noted in 2011, there have been multiple reports, mostly out of Europe’s premier research institutions, of cell phone use being linked to brain damage, early-onset Alzheimer’s, senility, DNA damage, and even sperm die-offs. But after this new study on the RF/EMF dangers to young children, concern is mounting about the growing number of children’s toys that use Wi-Fi technology—and that’s not counting the number of kids who play with tablets or carry cell phones these days. Proximity to the Wi-Fi device seems to be the most important factor. Under international guidelines, the rate that energy is absorbed into the body from Wi-Fi radio waves—the Specific Absorption Rate (SAR)—cannot exceed two watts per kilogram when averaged over any ten grams of tissue. According to Apple, during testing, iPhone radios are set to their highest transmission levels and placed in positions that simulate use against the head, with no separation, and near the body, with 5 millimeter separation; iPads are placed in positions that simulate everyday use. Apple’s devices average 0.99 watts per kilogram. The SAR of other manufacturers’ devices vary, but are all below international guidelines; according to the Federal Communications Commission, all wireless devices sold in the US go through a formal FCC approval process to ensure that they do not exceed the maximum allowable SAR level when operating at the device’s highest possible power level. The World Health Organization (WHO), which has established an International Electromagnetic Fields Project (IEFP) to provide information on health risks, establish research needs and support efforts to harmonize RF exposure standards, provides additional information on RF exposure and mobile phone use. WHO notes the problem of determining long-term risks:

Epidemiological research examining potential long-term risks from radiofrequency exposure has mostly looked for an association between brain tumors and mobile phone use. However, because many cancers are not detectable until many years after the interactions that led to the tumor, and since mobile phones were not widely used until the early 1990s, epidemiological studies at present can only assess those cancers that become evident within shorter time periods.

WHO notes that the largest retrospective case-control study to date on adults was called Interphone, coordinated by the International Agency for Research on Cancer (IARC). It gathered data from thirteen participating countries, and was designed to determine whether there are links between use of mobile phones and head and neck cancers in adults. The study found some indications of an increased risk of gliomas for those who reported the highest 10% of cumulative hours of cell phone use, although there was no consistent trend of increasing risk with greater duration of use. While the researchers concluded that biases and errors limit the strength of these conclusions and prevent a causal interpretation, based largely on these data, IARC has classified radiofrequency electromagnetic fields as possibly carcinogenic to humans (Group 2B), a category used when a causal association is considered credible, but when chance, bias or confounding cannot be ruled out with reasonable confidence. As for the Wi-Fi in routers and laptops, the maximum signal strength next to a router or computer transmitter is 0.1 watts, and the power level falls off very rapidly beyond a few centimeter from the transmission points. However, the more individual transmitters (the more laptops or tablets in a room), the greater the danger. It is believed that a classroom containing twenty laptops and two routers could combine and be equivalent to the emission from a mobile phone. Unfortunately, rather than erring on the side of caution or taking precautionary steps, the US seems to be moving in the opposite direction. The FCC has noted that equipping schools with Wi-Fi is a national priority; the agency plans to invest an additional $2 billion in broadband service for schools and libraries by the end of the year. In our increasingly tech-intensive world, we need to do a better job of evaluating the risks of moving further and further away from nature. If you are concerned about RF/EMF exposure, consider some simple changes:

• Limit your cell phone usage. Carry it away from your body, in a purse or messenger bag, or at least carry it in airplane (non-receiving) mode, and use the speakerphone function or a wired headset for conversations. Use land lines where possible.


• Consider hardwiring your computers to the modem via Ethernet instead of using Wi-Fi (that’s what we do at the ANH-USA offices).


• Reduce your children’s access to cell phones, and limit time on tablets and other devices that have Wi-Fi.


• Opt-out of installing smart meters in your home (though this may be difficult in some states).

In response to public and governmental concern, WHO has established the International Electromagnetic Fields Project to assess the scientific evidence of possible adverse health effects from electromagnetic fields. WHO will conduct a formal risk assessment of all studied health outcomes from RF fields exposure by 2016. Dr. Mercola, in a powerful article on RF/EMF dangers, reported an interesting suggestion from a panel of experts: EMF-free zones where children, pregnant women (or those hoping to conceive), and others sensitive to EMFs, can be protected. It’s an excellent first step for protecting the most vulnerable members of our society.



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Compounded Medications Even More At Risk

A new threat to compounded drugs (including bioidentical estriol for women and compounded time-release thyroid) has emerged. Action Alert!

The US Pharmacopeial Convention (USP) has released an overreaching draft proposal that may inadvertently crush many small compounding pharmacies—unless we take action. USP is a nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines (including compounded drugs), food ingredients, and dietary supplements. Since USP is considered an authoritative standard-setting body, it is very likely that these USP standards, like earlier ones, will be adopted into law.

The USP is creating new standards with “General Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings .” Its stated intention is to protect healthcare workers from exposure to hazardous drugs (HDs). But many of the drugs in question are not hazardous at all. In addition, many compounding pharmacies—especially small traditional pharmacies—will be unable to implement the new standards and as a result could be forced out of business.

Here are just some of the problems with the new USP standards:

• They are not within the USP’s purview or expertise. The USP is supposed to set standards to maintain the quality of drugs and drug components. Protecting compounding and environmental workers from hazardous exposures, while an important goal, is already covered elsewhere under current law. On the federal level there are EPA and OSHA laws that ensure worker safety, and there are state laws as well. There is simply no need for these additional standards—they will lead only to duplication, confusion, and overregulation.


• There has been no assessment by the USP on the extent to which the proposed standards would jeopardize patient access to compounded medicines.


• The USP’s list of drugs considered “hazardous” is overly broad. It includes many commonly used medications such as azathioprine, carbamazepine, and clonazepam, not to mention all contraceptives and hormone replacement therapies that contain estrogen—which means bioidentical estriol is also on the list! These drugs are dispensed by pharmacists, administered by nurses or medication aides, or are self-administered by patients every day.


• The USP is relying on the National Institute for Occupational Safety and Health’s (NIOSH) list of antineoplastic and other hazardous drugs (HDs) used in healthcare settings. However, NIOSH’s own list states in multiple place that there is uncertainty about the contents of their list. They even state that “no attempt has been made to perform drug risk assessments or propose exposure limits.” NIOSH acknowledges that there is little evidence that some of these drugs are hazardous to healthcare personnel, and explains that the organization was enlisted to provide guidance to healthcare facilities, not to provide a mandate—yet the USP is using that same list in its entirety without proper review.


• Many small pharmacies and healthcare facilities will be unable to comply with the requirements.The new standards require that HDs be unpacked from their shipping container and stored in negative-pressure rooms. These have to be entirely separate from so-called non-hazardous drugs. This would require many different physical spaces, which means new construction in most cases. Most small compounding pharmacies simply cannot afford to build entirely separate rooms—in fact, a compounding pharmacy told us that the cost to build new rooms and buy the negative-pressure equipment could cost several hundred thousand dollars. Some hospitals may have more money, but they and physicians’ offices may also lack the physical space for negative-pressure areas. Furthermore, the new standards do not discuss how to handle a combination of so-called hazardous and non-hazardous drugs—which many compounders mix on a daily basis. The requirement for separate rooms should be balanced with the level of risk compounders actually face, not to mention the economic burden being placed on them.


• The impact will be far-reaching.While these standards will have the greatest impact on compounding pharmacies—small traditional compounding pharmacies in particular—they will also affect the day-to-day practices of every healthcare facility that receives, stores, compounds, and administers HDs: regular pharmacies, wholesalers, distributers, hospitals, clinics, and all long-term care and assisted facilities. In the most likely scenario, compounding pharmacies will simply stop making vital drugs that millions of Americans depend upon, while other healthcare facilities will pass the new costs on to the consumer. Once again, regulators are not showing any common sense.

The USP predates the Food Drug and Cosmetic Act (FD&C) and has influenced the development of all drug, compounding, and supplement standards in the US. However, there is a great deal of crossover between the USP and the FDA. For example, FDA staff acts as liaisons to various USP standards committees, and they can ask USP to develop or modify standards. Moreover, FDA can comment on proposed USP standards. In return, USP staff have participated in FDA advisory committees.

That’s why we feel the timing of this revision is suspicious. It comes on the heels of the FDA’s draconian implementation of the new compounding law, which also threatens to force compounders out of business, leaving drugs only available from large pharmaceutical companies producing their one-size-fits-all (and often flawed) products. There has been no inciting incident, no official call to address HDs, as a letter to USP from the International Academy of Compounding Pharmacists makes clear—in short, there is simply no logical reason why USP should suddenly want to create these new standards.

Already some insurance companies are no longer covering certain compounded medications, restricting your access to them. If the USP formally adopts this draft proposal, it will likely only be a matter of time before these new standards are incorporated into federal or state law, just as previous USP standards have been—and that may mean the end of most important compounded drugs altogether.

These new USP standards could easily be the final nail in the coffin for small, traditional compounding pharmacies:

• As we’ve reported in earlier articles, the new compounding law allows traditional compounding pharmacies to ship no more than 5% of their products out of state, while the newly created category of compounder, massive “outsourcing facilities” (which are likely owned by Big Pharma) do not have the 5% restriction. Small pharmacies are crippled right from the start. Note also how nonsensical a small percentage limitation like this is. How can pharmacies know how much 5% really is until the end of the year? By then they have violated the rule!


• These massive outsourcing facilities may have the financial resources to build the new negative-pressure rooms required by the new USP standards—something that could further impoverish small, traditional pharmacies.


• If the traditional compounding pharmacies are forced to shut down, important medications like bioidentical estriol and time-released thyroid will almost certainly disappear with them: big outsourcing facilities are allowed to compound only those medications that appear on the FDA’s yet-to-be-released “allowed” list. As regular Pulse readers will know, the FDA has attempted repeatedly to eliminate estriol, so it’s extremely likely it won’t be on the list.

We can’t stress strongly enough the importance of the small, traditional compounding pharmacies. Without them, natural health advocates will simply lose all access to some of the most important medications they rely upon.

Action Alert! The USP is accepting public comments until May 31, 2015. Tell the USP that General Chapter <800> should not be considered a mandate for healthcare facilities and compounding pharmacies, but instead should be listed in the “recommendations” section of the USP standards. Even more importantly, ask the USP to revise their standards to account for the concerns we raised above. Please send your message to USP today!

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Supplements Are Not Food Additives

Federal law makes it very clear that food additives and supplements are not to be treated the same way. But once again the FDA doesn’t seem to care about the law. Action Alert!

Last month the FDA held an open meeting to receive input from the public on updating “Redbook.” That’s the agency’s informal term for its guidance called “Toxicological Principles for the Safety Assessment of Food Ingredients .” The FDA is considering significantly expanding the scope of the guidance to include nutritional supplements and supplement ingredients.

Redbook 2000, the current version, details what the FDA would expect to see from manufacturers who are seeking approval of a new food or color additive in terms of animal toxicological studies.

Unfortunately, the FDA has not been very open at this stage about how exactly they plan to include dietary supplements in Redbook. But we are very concerned by this development for a number of reasons:

Redbook was designed as a how-to guide to prove that food and color additives are safe for pre-approval. This is a troubling paradigm to impose on dietary supplements which, by law, are specifically not subject to FDA approval. Furthermore, the evidentiary standard for dietary ingredients (which includes supplements) is very different from the standard for food additives: dietary ingredients need to have a “reasonable expectation” of safety, whereas food additives must have a “reasonable certainty” of safety .

The law says that supplements on the market before 1994 are “grandfathered” into the system—that is, they are considered safe by their history of long use by the public, and do not require FDA review. If supplements get subsumed into Redbook, would it mean grandfathered ingredients would have to prove their toxicological safety? This could endanger thousands of supplements because of what we call the “Catch-22” of drug economics. Drug companies can pay the huge sums for toxicological studies because they are working with non-natural, new-to-nature (and new-to-the-human-body) substances that can be patented and turned into huge money-makers. But who would spend that money on toxicological studies for natural supplements, knowing that anyone could produce and sell it with out a patent? The answer is obvious: no one. So the real FDA intent is simply to eliminate any competition for patented drugs, since these drugs pay the agency’s bills. Besides, supplements were grandfathered initially because, according to Congress, they had such a long history of safety—so toxicology studies are, by definition, unnecessary.

Including supplements in Redbook blurs the line between food additives and dietary ingredients—something Sens. Orrin Hatch (R-UT) and Tom Harkin (D-IA) explicitly stopped Rep. Henry Waxman (D-CA) from doing legislatively when DSHEA was being crafted twenty years ago. As Sen. Hatch said when that landmark legislation was introduced, “For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors….[DSHEA] makes clear that dietary supplements are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a product is unsafe.”

The last time FDA attempted to overtly apply food additive standards to dietary supplements, the agency’s efforts were soundly rejected —dare we say ridiculed—by not one but two US circuit courts of appeals:

In US v. Traco Labs , the Seventh Circuit stated that “the only justification for this Alice-in-Wonderland approach is to allow the FDA to make an end-run around the statutory scheme and shift to the processors the burden of proving the safety of a substance in all circumstances.”

In US v. Oakmont Investment Co. , the First Circuit wrote, “The proposition that placing a single-ingredient food product into an inert capsule as a convenient method of ingestion converts that food into a food additive perverts the statutory text, undermines legislative intent, and defenestrates common sense. We cannot accept such anfractuous reasoning.”

In 2011, we wrote that FDA seemed to be determined to try the same tactics the agency used in 1994 when it tried to derail DSHEA—and here we go again. David Kessler, then FDA commissioner, ordered FDA not to enforce DSHEA because he was convinced that the worst elements of the dietary supplement industry would then come to the fore, causing Congress to repeal the law. This of course did not happen.

Expanding Redbook to include nutritional supplements is, at any rate, premature, given that the next version of the NDI (new supplement) guidance has not yet been released. Any required toxicological and safety studies for NDI notification should be addressed after that release.

In addition, if both the NDI guidance and Redbook end up addressing safety data for dietary supplements, it will lead to massive industry confusion, which will ultimately choke innovation, raise costs, and limit access to supplements. This may be exactly what the FDA wants in order to shield drugs from competition.

Not surprisingly, Sens. Hatch and Harkin sent the FDA a letter expressing their concern about Redbook , noting that “DSHEA contained an essential exclusion of dietary ingredients from the statutory definition of food additives,” and that the NDI guidance for dietary ingredients should be handled quite separately from Redbook: “The statutory clarity between dietary ingredients and food additives necessitates that guidance documents be separately released for these two different types of ingredients.” They also note that if FDA moves forward in including dietary ingredients in food additive paradigm, it would require rulemaking.

ANH-USA is preparing formal comments and will submit them shortly. Action Alert! Tell the FDA that Redbook should not be expanded to include dietary ingredients, and that any safety assessments for dietary ingredients should be addressed strictly in the context of the NDI guidance. Send your message today!

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Compounded Medications Even More At Risk

A new threat to compounded drugs (including bioidentical estriol for women and compounded time-release thyroid) has emerged. Action Alert! The US Pharmacopeial Convention (USP) has released an overreaching draft proposal that may inadvertently crush many small compounding pharmacies—unless we take action. USP is a nonprofit organization that sets standards for the identity, strength, quality, and purity of medicines (including compounded drugs), food ingredients, and dietary supplements. Since USP is considered an authoritative standard-setting body, it is very likely that these USP standards, like earlier ones, will be adopted into law. The USP is creating new standards with “General Chapter <800>: Hazardous Drugs—Handling in Healthcare Settings .” Its stated intention is to protect healthcare workers from exposure to hazardous drugs (HDs). But many of the drugs in question are not hazardous at all. In addition, many compounding pharmacies—especially small traditional pharmacies—will be unable to implement the new standards and as a result could be forced out of business. Here are just some of the problems with the new USP standards:

• They are not within the USP’s purview or expertise. The USP is supposed to set standards to maintain the quality of drugs and drug components. Protecting compounding and environmental workers from hazardous exposures, while an important goal, is already covered elsewhere under current law. On the federal level there are EPA and OSHA laws that ensure worker safety, and there are state laws as well. There is simply no need for these additional standards—they will lead only to duplication, confusion, and overregulation.


• There has been no assessment by the USP on the extent to which the proposed standards would jeopardize patient access to compounded medicines.


• The USP’s list of drugs considered “hazardous” is overly broad. It includes many commonly used medications such as azathioprine, carbamazepine, and clonazepam, not to mention all contraceptives and hormone replacement therapies that contain estrogen—which means bioidentical estriol is also on the list! These drugs are dispensed by pharmacists, administered by nurses or medication aides, or are self-administered by patients every day.


• The USP is relying on the National Institute for Occupational Safety and Health’s (NIOSH) list of antineoplastic and other hazardous drugs (HDs) used in healthcare settings. However, NIOSH’s own list states in multiple place that there is uncertainty about the contents of their list. They even state that “no attempt has been made to perform drug risk assessments or propose exposure limits.” NIOSH acknowledges that there is little evidence that some of these drugs are hazardous to healthcare personnel, and explains that the organization was enlisted to provide guidance to healthcare facilities, not to provide a mandate—yet the USP is using that same list in its entirety without proper review.


• Many small pharmacies and healthcare facilities will be unable to comply with the requirements.The new standards require that HDs be unpacked from their shipping container and stored in negative-pressure rooms. These have to be entirely separate from so-called non-hazardous drugs. This would require many different physical spaces, which means new construction in most cases. Most small compounding pharmacies simply cannot afford to build entirely separate rooms—in fact, a compounding pharmacy told us that the cost to build new rooms and buy the negative-pressure equipment could cost several hundred thousand dollars. Some hospitals may have more money, but they and physicians’ offices may also lack the physical space for negative-pressure areas. Furthermore, the new standards do not discuss how to handle a combination of so-called hazardous and non-hazardous drugs—which many compounders mix on a daily basis. The requirement for separate rooms should be balanced with the level of risk compounders actually face, not to mention the economic burden being placed on them.


• The impact will be far-reaching.While these standards will have the greatest impact on compounding pharmacies—small traditional compounding pharmacies in particular—they will also affect the day-to-day practices of every healthcare facility that receives, stores, compounds, and administers HDs: regular pharmacies, wholesalers, distributers, hospitals, clinics, and all long-term care and assisted facilities. In the most likely scenario, compounding pharmacies will simply stop making vital drugs that millions of Americans depend upon, while other healthcare facilities will pass the new costs on to the consumer. Once again, regulators are not showing any common sense.

The USP predates the Food Drug and Cosmetic Act (FD&C) and has influenced the development of all drug, compounding, and supplement standards in the US. However, there is a great deal of crossover between the USP and the FDA. For example, FDA staff acts as liaisons to various USP standards committees, and they can ask USP to develop or modify standards. Moreover, FDA can comment on proposed USP standards. In return, USP staff have participated in FDA advisory committees. That’s why we feel the timing of this revision is suspicious. It comes on the heels of the FDA’s draconian implementation of the new compounding law, which also threatens to force compounders out of business, leaving drugs only available from large pharmaceutical companies producing their one-size-fits-all (and often flawed) products. There has been no inciting incident, no official call to address HDs, as a letter to USP from the International Academy of Compounding Pharmacists makes clear—in short, there is simply no logical reason why USP should suddenly want to create these new standards. Already some insurance companies are no longer covering certain compounded medications, restricting your access to them. If the USP formally adopts this draft proposal, it will likely only be a matter of time before these new standards are incorporated into federal or state law, just as previous USP standards have been—and that may mean the end of most important compounded drugs altogether. These new USP standards could easily be the final nail in the coffin for small, traditional compounding pharmacies:

• As we’ve reported in earlier articles, the new compounding law allows traditional compounding pharmacies to ship no more than 5% of their products out of state, while the newly created category of compounder, massive “outsourcing facilities” (which are likely owned by Big Pharma) do not have the 5% restriction. Small pharmacies are crippled right from the start. Note also how nonsensical a small percentage limitation like this is. How can pharmacies know how much 5% really is until the end of the year? By then they have violated the rule!


• These massive outsourcing facilities may have the financial resources to build the new negative-pressure rooms required by the new USP standards—something that could further impoverish small, traditional pharmacies.


• If the traditional compounding pharmacies are forced to shut down, important medications like bioidentical estriol and time-released thyroid will almost certainly disappear with them: big outsourcing facilities are allowed to compound only those medications that appear on the FDA’s yet-to-be-released “allowed” list. As regular Pulse readers will know, the FDA has attempted repeatedly to eliminate estriol, so it’s extremely likely it won’t be on the list.

We can’t stress strongly enough the importance of the small, traditional compounding pharmacies. Without them, natural health advocates will simply lose all access to some of the most important medications they rely upon. Action Alert! The USP is accepting public comments until May 31, 2015. Tell the USP that General Chapter <800> should not be considered a mandate for healthcare facilities and compounding pharmacies, but instead should be listed in the “recommendations” section of the USP standards. Even more importantly, ask the USP to revise their standards to account for the concerns we raised above. Please send your message to USP today!

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Supplements Are Not Food Additives

Federal law makes it very clear that food additives and supplements are not to be treated the same way. But once again the FDA doesn’t seem to care about the law. Action Alert! Last month the FDA held an open meeting to receive input from the public on updating “Redbook.” That’s the agency’s informal term for its guidance called “Toxicological Principles for the Safety Assessment of Food Ingredients .” The FDA is considering significantly expanding the scope of the guidance to include nutritional supplements and supplement ingredients. Redbook 2000, the current version, details what the FDA would expect to see from manufacturers who are seeking approval of a new food or color additive in terms of animal toxicological studies. Unfortunately, the FDA has not been very open at this stage about how exactly they plan to include dietary supplements in Redbook. But we are very concerned by this development for a number of reasons: Redbook was designed as a how-to guide to prove that food and color additives are safe for pre-approval. This is a troubling paradigm to impose on dietary supplements which, by law, are specifically not subject to FDA approval. Furthermore, the evidentiary standard for dietary ingredients (which includes supplements) is very different from the standard for food additives: dietary ingredients need to have a “reasonable expectation” of safety, whereas food additives must have a “reasonable certainty” of safety . The law says that supplements on the market before 1994 are “grandfathered” into the system—that is, they are considered safe by their history of long use by the public, and do not require FDA review. If supplements get subsumed into Redbook, would it mean grandfathered ingredients would have to prove their toxicological safety? This could endanger thousands of supplements because of what we call the “Catch-22” of drug economics. Drug companies can pay the huge sums for toxicological studies because they are working with non-natural, new-to-nature (and new-to-the-human-body) substances that can be patented and turned into huge money-makers. But who would spend that money on toxicological studies for natural supplements, knowing that anyone could produce and sell it with out a patent? The answer is obvious: no one. So the real FDA intent is simply to eliminate any competition for patented drugs, since these drugs pay the agency’s bills. Besides, supplements were grandfathered initially because, according to Congress, they had such a long history of safety—so toxicology studies are, by definition, unnecessary. Including supplements in Redbook blurs the line between food additives and dietary ingredients—something Sens. Orrin Hatch (R-UT) and Tom Harkin (D-IA) explicitly stopped Rep. Henry Waxman (D-CA) from doing legislatively when DSHEA was being crafted twenty years ago. As Sen. Hatch said when that landmark legislation was introduced, “For more than three decades, FDA has tried to restrict severely the ability of the dietary supplement industry to sell and market its products and, consequently, the ability of consumers to buy them. The agency has repeatedly attempted to impose unnecessarily stringent standards that would leave many if not most supplement companies with no practical choice but to close their doors….[DSHEA] makes clear that dietary supplements are not food additives or drugs, and that the burden of proof shall be on the FDA to prove that a product is unsafe.” The last time FDA attempted to overtly apply food additive standards to dietary supplements, the agency’s efforts were soundly rejected —dare we say ridiculed—by not one but two US circuit courts of appeals: In US v. Traco Labs , the Seventh Circuit stated that “the only justification for this Alice-in-Wonderland approach is to allow the FDA to make an end-run around the statutory scheme and shift to the processors the burden of proving the safety of a substance in all circumstances.” In US v. Oakmont Investment Co. , the First Circuit wrote, “The proposition that placing a single-ingredient food product into an inert capsule as a convenient method of ingestion converts that food into a food additive perverts the statutory text, undermines legislative intent, and defenestrates common sense. We cannot accept such anfractuous reasoning.” In 2011, we wrote that FDA seemed to be determined to try the same tactics the agency used in 1994 when it tried to derail DSHEA—and here we go again. David Kessler, then FDA commissioner, ordered FDA not to enforce DSHEA because he was convinced that the worst elements of the dietary supplement industry would then come to the fore, causing Congress to repeal the law. This of course did not happen. Expanding Redbook to include nutritional supplements is, at any rate, premature, given that the next version of the NDI (new supplement) guidance has not yet been released. Any required toxicological and safety studies for NDI notification should be addressed after that release. In addition, if both the NDI guidance and Redbook end up addressing safety data for dietary supplements, it will lead to massive industry confusion, which will ultimately choke innovation, raise costs, and limit access to supplements. This may be exactly what the FDA wants in order to shield drugs from competition. Not surprisingly, Sens. Hatch and Harkin sent the FDA a letter expressing their concern about Redbook , noting that “DSHEA contained an essential exclusion of dietary ingredients from the statutory definition of food additives,” and that the NDI guidance for dietary ingredients should be handled quite separately from Redbook: “The statutory clarity between dietary ingredients and food additives necessitates that guidance documents be separately released for these two different types of ingredients.” They also note that if FDA moves forward in including dietary ingredients in food additive paradigm, it would require rulemaking. ANH-USA is preparing formal comments and will submit them shortly. Action Alert! Tell the FDA that Redbook should not be expanded to include dietary ingredients, and that any safety assessments for dietary ingredients should be addressed strictly in the context of the NDI guidance. Send your message today!

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You Could Be Quarantined and Forced to Take Toxic Drugs

A new federal executive order expands the list of illnesses for which you could be detained, isolated, and treated against your will if you are entering the US or traveling between states—even if you are completely healthy. Some states have similar or worse laws that would even allow entry into your home.

President Obama has signed an executive order expanding the list of illnesses that could result in forced detention, isolation, and quarantine for anyone exposed, even if they are not sick. It updates a Bush-era executive order, adding “severe acute respiratory syndromes” except for influenza to the list of detainable communicable diseases.

The Public Health Service Act allows the government to apprehend and detain individuals based on communicable diseases named in the Act, or named by presidential executive orders. Executive orders do not have to get congressional approval.

Not only can people with the disease be forcibly isolated, but the CDC also has the power to quarantine anyone who may have been exposed. The new executive order allows detentions for “diseases that are associated with fever and signs and symptoms of pneumonia or other respiratory illness…capable of being transmitted from person to person, and that either are causing, or have the potential to cause, a pandemic, or, upon infection, are highly likely to cause mortality or serious morbidity if not properly controlled” [italics ours]. In other words, if you have been exposed to one of the listed communicable diseases—even if you do not show symptoms—you may be forcibly detained and quarantined.

This is broad authority, as the CDC notes: “In addition to serving as medical functions, isolation and quarantine also are ‘police power’ functions, derived from the right of the state to take action affecting individuals for the benefit of society.” And since this is federal law, it covers people entering into the United States and people traveling between states as well.

Even worse, because of various draconian state laws, individuals can also be detained against their will within their state—which includes being forced from their home. Once in quarantine, a potentially toxic drug regimen is generally enforced. While detention authority and scope differs from state to state, some have excessively broad powers. For example

• In Alabama, the governor or state board of health may proclaim a quarantine whenever it is deemed necessary. The board of health has full powers of enforcement, and may formulate any rules it believes necessary.


• In Idaho, the state reserves the right to enter an individual’s home by force if an occupant may have been exposed.


• Maine reserves the right to impose emergency regulations at the mere threat of an outbreak.


• New York can also detain patients in a locked ward at Bellevue hospital.


• In 2009 the Massachusetts Senate considered a bill allowing the police, during a declared public health emergency, to arrest people without a warrant if they have “probable cause” to think they’re not complying with orders (including verbal orders from the public health commissioner or local public health authority). Under this bill, citizens could have been detained for as long as necessary for the public authorities to “convey information to you regarding the disease.” Happily, because of grassroots activists like you and opposition from the Massachusetts House, the bill did not pass and was never reintroduced.

Of deep concern is that, in most instances, natural treatments will be denied in favor of state-mandated treatments. In New York, for example, a patient with tuberculosis was placed in mandatory isolation for two weeks—and now, even after being released from isolation, he still must take three powerful antibiotics every day and is monitored by health officials via smartphone from his home. In Arkansas, for those under mandated treatment for tuberculosis, “disorderly conduct” can be punished with confinement of up to six months. Does disorderly conduct include not accepting the state-mandated treatment? We don’t know for certain, but it seems likely.

Keep yourself healthy! Vitamin D is an excellent preventive treatment for influenza and other viral diseases, and is being studied as a powerful tool to treat and prevent tuberculosis and other communicable diseases and potential pandemics. For other viral treatments, see our recent article on the Ebola virus.

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An Update on Our Recommended Supplement Companies

In September we offered a list of supplement companies recommended by the experts. Our readers responded with their suggestions, and after further research we have expanded our list. If readers have further thoughts and suggestions, please continue sending them in!

All companies listed are high quality supplement producers and known for their manufacturing standards, testing, and nutrient potency. Their products are often, although not always, derived from whole foods (such as taking vitamin C from acerola). In our listing, we also note whether the supplement company’s products are certified organic or in a few cases contain mostly complete vitamins. These terms are defined as follows:

Certified Organic supplements are those that use USDA Certified Organic source ingredients. The USDA’s organic certification is the only official set of criteria for organic products. To be labeled organic, 95% of the supplement must meet the following standards:

• All produce grown in soil free of synthetic pesticide and fertilizer


• No synthetics at all, unless on a USDA-certified list


• No GMOs


• No antibiotics or growth hormones

To be fully organic, a food or supplement must say both “USDA Certified” and “100% Organic.”

Organic ingredients are particularly important for some whole food-based nutrients to avoid too many harmful chemicals. Supplements using green tea, for instance, may contain residues from pesticides unless the tea has been Certified Organic. Some mainstream, non-organic tea companies were independently tested and found to have harmful pesticide chemicals in nearly 100% of their products.

Mostly complete vitamin companies offer exclusively or almost exclusively whole foods vitamins that are made from whole food sources and don’t contain fractionated or isolated nutrients. For instance, a product listing vitamin C on its ingredients label would offer a whole foods source ingredient like papaya. A fractionated vitamin C would be listed as “ascorbic acid,” since the nutrient is synthetic, isolated, or both. A complete vitamin is not necessarily superior or inferior to a fractionated vitamin. It depends on which supplements and how they are being used. For example, mostly complete vitamins are rarely high potency.

Here, then, is our updated list of supplement makers recommended by leading integrative doctors with whom we have consulted:

Advanced Bionutritionals (Drs. Nan Fuchs, Robert Rowen, and Frank Shallenberger)

Allergy Research Group

Ayush Herbs

Beehive Botanicals

Bio-Alternatives

Bio Innovations

Bio-Tech Pharmacal

Biotics Research

Bronson Laboratories

Carlson Laboratories

CHI Health Products

Country Life

Craig Nutraceuticals

Designs for Health

Douglas Laboratories

Eclectic Institute

Ecological Formulas

EcoNugenics

Enzymatic Therapy

Essential Formulas

• Chia Omega Formulas


• Dr. Ohhira’s Probiotics

Fungi Perfecti: Certified Organic

Gaia Herbs: Certified Organic

Garden of Life: Certified Organic, mostly complete vitamin company

Green Medicine (Dr. Jonathan V. Wright)

Herb Pharm

Invision International Health Solutions

Jarrow Formulas

Klaire

Life Extension

LivOn Labs

Living Fuel

MegaFood: Certified organic, mostly complete vitamin company

Dr. Mercola Premium Supplements (Dr. Joseph A. Mercola)

Metagenics

Moss Nutrition

Natural Immunogenics

Nordic Naturals

NOW Foods

Nutraceutical Corporation

• allOne


• AllVia


• bioAllers


• Emerita


• Health from the Sun


• Herbs for Kids


• Kal


• Life-flo


• LifeTIME


• Montana Big Sky


• NatraBio


• Natural Sport


• Nature’s Life


• Nutra BioGenesis


• Oakmont Labs


• Organix South


• Pioneer


• Premier One


• Solaray


• Sunny Green


• Thompson


• Vaxa


• VegLife


• VitaLogic


• Zand

Nutramedix

Nutricology

Olympian Labs

Optimox

Optimum Health International

Ortho Molecular Products

Perricone MD Nutraceuticals (Dr. Nick Perricone)

Primal Force (Dr. Al Sears)

Pro-Caps

Pure Encapsulations

Pure Synergy: Certified Organic, mostly complete vitamin company

Purest Colloids

Ronald Hoffman, MD, CNS (Dr. Ronald Hoffman)

Dr. Sinatra (Dr. Steven Sinatra)

Source Naturals

Standard Process: Certified Organic

Thorne

Touchstone Essentials

Tropical Traditions: Certified Organic

Dr. Whitaker (Dr. Julian Whitaker)

Dr. David Williams (Dr. David Williams)

Wakunaga of America

Xymogen

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