FDA Attacking Supplements to Boost Alzheimer’s Drug Sales?

The Oregon Attorney General, the FDA, and Sen. Claire McCaskill are targeting two supplements, but they don’t have their facts straight. Action Alert!

You will recall how the New York AG went after some herbs claiming they weren’t actually in the supplements sold. He got considerable egg on his face when it was shown that he had used the wrong test when assessing the supplements, and that scientists almost unanimously agreed that his conclusion were utterly incorrect.

The Oregon AG apparently learned nothing from that fiasco. According to USA Today, she has now filed a lawsuit alleging that “GNC, one of the world’s largest retailers of supposedly all-natural dietary supplements, has knowingly sold products spiked with two synthetic drugs.”

Interestingly, it appears to us that the US Food and Drug Administration (FDA) is actually the instigator of this action, even though they have all the power they need to take action against GNC themselves. So what is going on here?

There are two substances involved, BMPEA and picamilon. They are different and should not be lumped together. While BMPEA is a powerful synthetic stimulant, picamilon isn’t synthetic at all. It is a combination of GABA (a completely natural substance made from the amino acid glutamine) with niacin (vitamin B3). The combination is much more effective in crossing the blood-brain barrier than GABA alone.

GABA is produced by our own bodies and is the natural way we calm ourselves. It is by far the best remedy for anxiety, but is rarely used by conventional doctors, who generally favor toxic and usually ineffective drugs, often with tragic results.

The AG’s lawsuit follows a recent call from Sen. Claire McCaskill (D-MO) to pull both picamilon and vinpocetine (a substance useful for the brain) from store shelves pending an investigation into whether they should be sold as prescription drugs rather than as dietary supplements. The FDA may well be behind this too.

Why is picamilon being targeted right now? It has no serious side effects, so it clearly isn’t a safety issue. We do know that a potential blockbuster drug for Alzheimer’s is in phase three of FDA trials, and if the drug is successful it has been estimated to bring in $7.6 billion in sales by 2024. Perhaps the FDA is trying to remove any natural substances that help the brain before this new drug is approved? That has happened before. For example, the agency banned the natural substance tryptophan, which is needed for our bodies to make serotonin, just before approving the first synthetic serotonin re-uptake inhibitor drug (SSRI) for depression. And we believe this is just the tip of the iceberg, as you’ll read in our related story.

We know the FDA is involved in all this because it submitted an affidavit to the Oregon AG saying that picamilon is not a dietary ingredient. This is a puzzling position, given the fact that if the FDA thought there was a safety issue, or any other concern with picamilon, it could take its own action to remove it from the market. If there was an issue with the ingredient in question, why should it be removed only in Oregon and not everywhere else?

Action Alerts! Tell the FDA (and if you’re in Oregon or Missouri, tell the Oregon AG and Sen. McCaskill too) that picamilon is not a synthetic drug but a combination of natural ingredients that must continue to be freely available to consumers. Please send your message immediately.

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Is the Attack on a Key Brain Health Supplement the First Step in an Effort to Eliminate Thousands of Supplements?

The recent actions against picamilon provide plenty of reason to think so. Action Alerts!

As we revealed in our related story, the attack on picamilon (a natural and safe substance combining GABA with a B vitamin) spearheaded by the Attorney General of Oregon with the assistance of Sen. Claire McCaskill (D-MO) has likely been orchestrated by the US Food and Drug Administration. Since the FDA has full power to move against any supplement, what is going on here?

To get to the bottom of this, you have to know about the agency’s recent treatment of new dietary ingredients (NDIs) —or, in other words, new supplements. You can read our previous coverage for context, but this pertains to a section of the Dietary Supplement Health and Education Act (DSHEA) that deals with how the FDA is to treat NDIs. In DSHEA, “new” means a supplement or ingredient that appeared on the market after 1994.

A few years ago, the FDA released a very bad draft guidance that, if enacted, would have eliminated thousands of supplements from the market in the blink of an eye. Essentially, the agency wrote an extremely restrictive definition of what would be considered a “new” supplement, and created an onerous set of regulations—including something akin to a pre-approval system—for “new” supplements to be allowed.

Remember, too, that drug companies can gain market exclusivity on dietary ingredients by filing investigational new drug (IND) applications before an NDI is filed. A parallel FDA guidance will accelerate this process, making a bad situation even worse and eliminating consumer access to affordable nutrients. This has happened before, most recently in the case of the pyridoxamine form of vitamin B6.

The FDA agreed to revise this bad NDI draft guidance in 2012 after substantial pushback from ANH-USA members and others, and the agency has been working on a revised guidance ever since. This means that supplement companies are in the dark about how to comply properly with DSHEA’s NDI provision.

This is part of what makes the Oregon AG’s lawsuit so troubling—thousands of “new supplements” (that is, placed on the market after 1994) whose producers have not filed NDI notifications could potentially be considered illegal “drugs” or “unlawful dietary ingredients” despite the fact that the FDA won’t say how this can be prevented. If picamilon is declared an illegal drug and driven off the market, it could leave thousands of other products—products that consumers rely on—vulnerable to similar assaults.

Action Alerts! If you haven’t taken action already, click the button below to tell the Oregon AG, the FDA, and Sen. McCaskill that this lawsuit sets a very dangerous precedent. Please send your message immediately.

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Horrific Disease Creeping into the US

This is a kind of Halloween story, but it is a true one.

Chagas disease is the stuff of horror movies, but public health officials are doing very little to address it.

A rare and deadly tropical disease once thought to be limited to economically depressed regions of South America is now appearing in areas of the US Southeast—and the situation is worse than the government thinks. While the CDC estimates that just one in 300,000 Americans who donated blood was infected, a recent study predicted that one in 6,500 Americans who gave blood—fifty times more than the CDC’s estimate—were infected.

Chagas is the result of a parasitic infection, and how it is passed to humans will give you chills. Chagas is spread by insects known as “kissing bugs,” so named because they tend to bite near the mouth (like mosquitoes, kissing bugs drink the blood of humans and other vertebrates). After they finish feeding, the bugs sometimes defecate, leaving “parasitic-laden feces on their host’s skin.” Scratching the bitten area can create tiny tears in the skin that give the parasite entry into the body; touching the bite and then rubbing the eyes and nose can also spread the parasite.

How do these bugs get onto your lips? They crawl stealthily into the house, then hide out of sight until nightfall. Once you are in bed asleep, they leave their hiding places to crawl down walls and into beds and onto your body. They are very good at all this and rarely give themselves away.

Once the parasite is in the body, one’s experience may vary. Some people suffer flu-like symptoms for several days; others develop swelling near the eye; worse, others have no symptoms at all. Meanwhile the parasite can cause terrible damage, as it chews through cardiac muscle and, over time, causes heart failure in about one-third of victims.

One recent case of Chagas highlights how scary this disease is. A woman born in El Salvador had Chagas for decades without knowing it, until a blood donation was rejected after screening positive for the disease. She went to a Chagas specialist—which means navigating an ocean of red tape to get the proper medications, since these drugs are only available through a special CDC research protocol. But at this point it was too late: after thirty years, the drugs were ineffective against the vast number of parasites that riddled her body. The doctor could even see the holes and channels the parasites had eaten through her heart. She was told that the only remaining option available to her was to go on with the knowledge that she could suffer from a heart attack at any time.

Are there effective natural remedies for this disease? It is very likely there are, but reliable studies have not been done.

Cases of Chagas are appearing in parts of Texas and Louisiana, where the heat and humidity create ideal conditions for the kissing bugs. Poverty-stricken areas are particularly vulnerable, where stagnant water and poor ventilation provide fertile breeding grounds for the bugs.

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Action Alert: FDA Attacks Picamilon

Related article: FDA Attacking Supplements to Boost Alzheimer’s Drug Sales?

Trouble Taking Action? Click here.

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FDA Attacking Supplements to Boost Alzheimer’s Drug Sales?

The Oregon Attorney General, the FDA, and Sen. Claire McCaskill are targeting two supplements, but they don’t have their facts straight. Action Alert!

You will recall how the New York AG went after some herbs claiming they weren’t actually in the supplements sold. He got considerable egg on his face when it was shown that he had used the wrong test when assessing the supplements, and that scientists almost unanimously agreed that his conclusion were utterly incorrect.

The Oregon AG apparently learned nothing from that fiasco. According to USA Today, she has now filed a lawsuit alleging that “GNC, one of the world’s largest retailers of supposedly all-natural dietary supplements, has knowingly sold products spiked with two synthetic drugs.”

Interestingly, it appears to us that the US Food and Drug Administration (FDA) is actually the instigator of this action, even though they have all the power they need to take action against GNC themselves. So what is going on here?

There are two substances involved, BMPEA and picamilon. They are different and should not be lumped together. While BMPEA is a powerful synthetic stimulant, picamilon isn’t synthetic at all. It is a combination of GABA (a completely natural substance made from the amino acid glutamine) with niacin (vitamin B3). The combination is much more effective in crossing the blood-brain barrier than GABA alone.

GABA is produced by our own bodies and is the natural way we calm ourselves. It is by far the best remedy for anxiety, but is rarely used by conventional doctors, who generally favor toxic and usually ineffective drugs, often with tragic results.

The AG’s lawsuit follows a recent call from Sen. Claire McCaskill (D-MO) to pull both picamilon and vinpocetine (a substance useful for the brain) from store shelves pending an investigation into whether they should be sold as prescription drugs rather than as dietary supplements. The FDA may well be behind this too.

Why is picamilon being targeted right now? It has no serious side effects, so it clearly isn’t a safety issue. We do know that a potential blockbuster drug for Alzheimer’s is in phase three of FDA trials, and if the drug is successful it has been estimated to bring in $7.6 billion in sales by 2024. Perhaps the FDA is trying to remove any natural substances that help the brain before this new drug is approved? That has happened before. For example, the agency banned the natural substance tryptophan, which is needed for our bodies to make serotonin, just before approving the first synthetic serotonin re-uptake inhibitor drug (SSRI) for depression. And we believe this is just the tip of the iceberg, as you’ll read in our related story.

We know the FDA is involved in all this because it submitted an affidavit to the Oregon AG saying that picamilon is not a dietary ingredient. This is a puzzling position, given the fact that if the FDA thought there was a safety issue, or any other concern with picamilon, it could take its own action to remove it from the market. If there was an issue with the ingredient in question, why should it be removed only in Oregon and not everywhere else?

Action Alerts! Tell the FDA (and if you’re in Oregon or Missouri, tell the Oregon AG and Sen. McCaskill too) that picamilon is not a synthetic drug but a combination of natural ingredients that must continue to be freely available to consumers. Please send your message immediately.

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Is the Attack on a Key Brain Health Supplement the First Step in an Effort to Eliminate Thousands of Supplements?

The recent actions against picamilon provide plenty of reason to think so. Action Alerts!

As we revealed in our related story, the attack on picamilon (a natural and safe substance combining GABA with a B vitamin) spearheaded by the Attorney General of Oregon with the assistance of Sen. Claire McCaskill (D-MO) has likely been orchestrated by the US Food and Drug Administration. Since the FDA has full power to move against any supplement, what is going on here?

To get to the bottom of this, you have to know about the agency’s recent treatment of new dietary ingredients (NDIs) —or, in other words, new supplements. You can read our previous coverage for context, but this pertains to a section of the Dietary Supplement Health and Education Act (DSHEA) that deals with how the FDA is to treat NDIs. In DSHEA, “new” means a supplement or ingredient that appeared on the market after 1994.

A few years ago, the FDA released a very bad draft guidance that, if enacted, would have eliminated thousands of supplements from the market in the blink of an eye. Essentially, the agency wrote an extremely restrictive definition of what would be considered a “new” supplement, and created an onerous set of regulations—including something akin to a pre-approval system—for “new” supplements to be allowed.

Remember, too, that drug companies can gain market exclusivity on dietary ingredients by filing investigational new drug (IND) applications before an NDI is filed. A parallel FDA guidance will accelerate this process, making a bad situation even worse and eliminating consumer access to affordable nutrients. This has happened before, most recently in the case of the pyridoxamine form of vitamin B6.

The FDA agreed to revise this bad NDI draft guidance in 2012 after substantial pushback from ANH-USA members and others, and the agency has been working on a revised guidance ever since. This means that supplement companies are in the dark about how to comply properly with DSHEA’s NDI provision.

This is part of what makes the Oregon AG’s lawsuit so troubling—thousands of “new supplements” (that is, placed on the market after 1994) whose producers have not filed NDI notifications could potentially be considered illegal “drugs” or “unlawful dietary ingredients” despite the fact that the FDA won’t say how this can be prevented. If picamilon is declared an illegal drug and driven off the market, it could leave thousands of other products—products that consumers rely on—vulnerable to similar assaults.

Action Alerts! If you haven’t taken action already, click the button below to tell the Oregon AG, the FDA, and Sen. McCaskill that this lawsuit sets a very dangerous precedent. Please send your message immediately.

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Horrific Disease Creeping into the US

This is a kind of Halloween story, but it is a true one.

Chagas disease is the stuff of horror movies, but public health officials are doing very little to address it.

A rare and deadly tropical disease once thought to be limited to economically depressed regions of South America is now appearing in areas of the US Southeast—and the situation is worse than the government thinks. While the CDC estimates that just one in 300,000 Americans who donated blood was infected, a recent study predicted that one in 6,500 Americans who gave blood—fifty times more than the CDC’s estimate—were infected.

Chagas is the result of a parasitic infection, and how it is passed to humans will give you chills. Chagas is spread by insects known as “kissing bugs,” so named because they tend to bite near the mouth (like mosquitoes, kissing bugs drink the blood of humans and other vertebrates). After they finish feeding, the bugs sometimes defecate, leaving “parasitic-laden feces on their host’s skin.” Scratching the bitten area can create tiny tears in the skin that give the parasite entry into the body; touching the bite and then rubbing the eyes and nose can also spread the parasite.

How do these bugs get onto your lips? They crawl stealthily into the house, then hide out of sight until nightfall. Once you are in bed asleep, they leave their hiding places to crawl down walls and into beds and onto your body. They are very good at all this and rarely give themselves away.

Once the parasite is in the body, one’s experience may vary. Some people suffer flu-like symptoms for several days; others develop swelling near the eye; worse, others have no symptoms at all. Meanwhile the parasite can cause terrible damage, as it chews through cardiac muscle and, over time, causes heart failure in about one-third of victims.

One recent case of Chagas highlights how scary this disease is. A woman born in El Salvador had Chagas for decades without knowing it, until a blood donation was rejected after screening positive for the disease. She went to a Chagas specialist—which means navigating an ocean of red tape to get the proper medications, since these drugs are only available through a special CDC research protocol. But at this point it was too late: after thirty years, the drugs were ineffective against the vast number of parasites that riddled her body. The doctor could even see the holes and channels the parasites had eaten through her heart. She was told that the only remaining option available to her was to go on with the knowledge that she could suffer from a heart attack at any time.

Are there effective natural remedies for this disease? It is very likely there are, but reliable studies have not been done.

Cases of Chagas are appearing in parts of Texas and Louisiana, where the heat and humidity create ideal conditions for the kissing bugs. Poverty-stricken areas are particularly vulnerable, where stagnant water and poor ventilation provide fertile breeding grounds for the bugs.

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Action Alert: FDA Attacks Picamilon

Related article: FDA Attacking Supplements to Boost Alzheimer’s Drug Sales?

Trouble Taking Action? Click here.

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Video: The Monopoly On Your Health

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Video: The Monopoly On Your Health

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HHS Says Supplements Send 23,000 People to the Hospital ER! Each Year!

Balderdash. The agency’s own CDC data shows that supplements are overwhelmingly safe. Action Alert!

The mainstream media is using a new study funded by the US Department of Health and Human Services (HHS), released last week, to renew the false charges that supplements are unregulated, unsafe, and require more federal oversight.

Even a cursory examination of the data provided in the study, however, demonstrates once again that the alarmist headlines and the calls for tighter regulations are completely unsupported by the evidence.

First, over 20% of the cases analyzed were the result of unsupervised children swallowing pills. 40% of cases among those 65 and older were caused by choking. Many other cases were heart palpitations from ingesting too many diet pills, sexual enhancement pills, and energy drinks. Undoubtedly some percentage of these so-called dietary supplements were simply illegal substances, but we aren’t told what the percentage is.

One of HHS’s agencies, the Centers for Disease Control and Prevention (CDC), reports that there were actually only 3,249 supplement-related adverse event reports submitted, either from doctors or hospitals, to the FDA in 2012—a far cry from the 23,000 being claimed in the study.

Part of the gross discrepancy in the numbers is likely due to the fact that eye drops, ear drops, and other over-the-counter products that are not dietary supplements were apparently included by the researchers. Why they chose to do this, they will have to explain.

The study also omits important details on the adverse events counted. For instance, it does not report which products caused the adverse events. This is important because many adverse reactions could be the result of a handful of “adulterated” (illegal) products. The FDA already has the authority to remove adulterated products from the market. Supplements are further regulated by the FTC and must also follow stringent good manufacturing practices to ensure that products are safe.

In fact, the study actually demonstrates something we have been saying for a long time: supplements have an exemplary track record of safety. Considering that about half of all Americans—about 150 million people—use dietary supplements, even the inflated 23,000 number represents only about 0.015% of dietary supplement users.

Pharmaceutical drugs, on the other hand, even when properly prescribed, cause an estimated 1.9 million hospitalizations and 128,000 hospital deaths each year. Deaths outside of hospitals would add considerably to this total if recorded. If public health were truly HHS’s concern, shouldn’t they be focusing on prescription drugs?

What explains the misleading focus on supplements? Not surprisingly, some of the authors of the study are FDA officials. For years the agency has been trying to increase its authority over supplements, attempting to institute a drug-like approval system for them. Because Big Pharma pays the FDA’s bills and provides cushy post-government jobs, we suspect that a lot of this is attempting to curry favor with drug companies.

A drug approval system for supplements, remember, would lead to the destruction of the industry. Unable to pay the exorbitant cost of the FDA approval process (because they sell unpatentable natural substances and could never charge enough to recoup their investment for even one of their products, never mind their entire product line), supplement producers would have to shutter their doors, eliminating thousands of products from the market. This removes competition for Big Pharma and allows them either to monopolize the supplement market or more often try to turn supplements into hugely expensive prescription drugs.

Don’t be fooled by the headlines. The overall strategy at play here has little to do with consumer safety and much, much more to do with bolstering the bottom line of the world’s major pharmaceutical companies. For more information on supplement safety, visit our SupplementFactCheck.org.

Action Alert! Send a message to HHS, urging them to stop their smear campaign against supplements and to fairly represent the facts. Please send your message immediately.

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“Nail in the Coffin” for Calcium Supplements?

No, of course not. But it is true you shouldn’t take them alone.

A new British Medical Journal study has created more headlines in the mainstream media. One article opened with this: “A new study should put the final nail in the coffin for any lingering beliefs that calcium supplements are good for you.”

That’s odd. It was only a few years ago that the World Health Organization wanted to put calcium in everyone’s water supply. We didn’t like that proposal at all, but not because we think that calcium supplementation is a bad idea.

The actual data in the new BMJ study do not support the strange conclusions drawn by either Dr. Mark J. Bolland, the study’s author, or the media. Note this sentence from the study’s conclusion: “The 1-2% increase in [bone marrow density]observed with increased calcium intake would be predicted to produce a 5-10% reduction in risk of fracture.” This hardly suggests that calcium is worthless. Bone marrow density more usually declines with age, not increases.

This is familiar territory for Prof. Bolland, who has been staking out an anti-supplement position for some time with regard to bone health and osteoporosis. He published a paper in 2013 warning that calcium supplementation leads to calcification in the heart and arteries—a conclusion that has been disputed by other studies that did not find this risk.

More importantly, Bolland ignores a key point: to maximize bone health, it is crucial to combine calcium with vitamin K2, which helps move calcium into the proper areas in your body. Vitamin D and magnesium are also critical to getting calcium where it needs to go, and not letting it lodge in blood vessels and the heart. Not surprisingly, Bolland has even contested the usefulness of vitamin D for bone health, despite the overwhelming evidence that has convinced most of the medical establishment.

You can guess where the professor ends up. In addition to recommending against supplemental calcium, he concludes that people “should be encouraged to take agents with proven efficacy in preventing [fractures]”—that is, pharmaceutical drugs.

And what are the “agents with proven efficacy” Dr. Bolland recommends? Bisphosphonates, the largest class of osteoporosis drugs. And they carry the usual list of nasty side effects, including hives, headache, constipation, joint pain, dizziness, blood in the urine, and muscle pain. But those aren’t the main issues. An FDA review in 2012 acknowledged a much graver cause for concern. These drugs do not create new bone. They just prevent the elimination of old bone. This leads to weaker bones in some people. Oral surgeons notice that extractions from bone treated this way do not heal well—or do not heal at all. There have been cases of jawbone death, and believe us, you do not want to have your jawbone die.

There is also a link to esophageal cancer. Moreover, the FDA found little benefit from the drugs after three to five years of use. Bisphosphonates should have been removed from the market. Why weren’t they? How can Dr. Bolland still recommend them?

The only answer we can come up with is money. Big Pharma can’t make money from calcium and vitamin supplements, but it can from osteoporosis medications that patients take for years on end.

About that World Health Organization proposal to put calcium in drinking water—government and international agencies never get this kind of thing right and should just stop interfering. But what really alarmed us was the idea of doing without co-factors such as vitamins K and D. Nutrients—isolated and without vital co-factors, forced on consumers—are not the answer to bone health, nor are dangerous drugs. We build healthy bone the way we build healthy bodies: through proper diet, exercise, and appropriate supplementation.

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What Will Big Pharma Try to Sell Us Next—the Brooklyn Bridge?

The Food and Drug Administration recently approved a new class of cholesterol-lowering drugs that will cost more than $14,000 a year.

Why did a new class of super-expensive statins need to be developed? Partly because the older statins are coming off patent and cannot be sold at high prices anymore. Also because of the wide range of dangerous side effects associated with “regular” statins, of course!

Statins aren’t just incredibly dangerous—they’re ineffective. That is quite a combination! Dr. David Brownstein recently pointed out there is little evidence that statins work. They do not, in fact, reduce the incidence of mortality of strokes and heart attacks.

Why aren’t these facts better known? Part of the answer lies in the $29 billion of statin sales each year. One in four Americans over the age of 45 takes statins.

We also pointed out in our earlier coverage that cholesterol is not the problem and is in fact vital to human health. A real danger as we age is that our cholesterol levels can get too low—which is only exacerbated by taking statins!

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Both the Institute of Medicine and the American Diabetes Association Say, “Enjoy Your Fructose (Fruit Sugar)!”

Sorry, sugar is sugar, whether from fruit or not. And if the “fruit sugar” is actually high-fructose corn syrup—from GMO corn at that—and quaffed down in endless sodas, it just gets worse.

A recent meta-analysis published in the Mayo Clinic Proceedings confirms this yet again. It notes that both the Institute of Medicine and the American Diabetes Association publish guidelines that allow up to 25% of calories from added fructose. The authors note that “[the]intake of added fructose at such high levels would undoubtedly worsen rates of diabetes and its complications,” and add that “there is no need for added fructose or any added sugars in the diet.”

Even one soda a day will take its toll on your weight and your health. Research presented at an American Heart Association conference estimated that sodas and sugary drinks are responsible for 183,000 deaths worldwide each year—133,000 deaths from diabetes, 44,000 from heart disease, and 6,000 from cancer. Nor does it solve anything to switch to artificially sweetened sodas. They just introduce a different set of problems.

These are facts. And yet industry-supported studies are five times more likely to find no link between sugary drinks and weight gain. Such “junk science,” which seems to be all that the Institute of Medicine and the American Diabetes Association is willing to believe, is responsible for making countless Americans even sicker than they already are.

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CA Governor: No Experimental Drugs for Terminal Patients

California Gov. Jerry Brown recently vetoed the state’s Right to Try Act, which passed both the state assembly and the senate with bipartisan support.

In his veto message, the governor wrote, “Patients with life-threatening conditions should be able to try experimental drugs, and the U.S. Food and Drug Administration’s compassionate use program allows this to happen.”

If only this were true! Our previous coverage of this issue has shown the governor’s statement to be patently incorrect. As it stands now, the FDA throws numerous roadblocks and hurdles into the paths of terminally patients seeking access to experimental drugs through the FDA’s compassionate use program. The FDA can even revoke permission after it is granted.

This is, by definition, a life-or-death issue, and it is an outrage that state and federal bureaucrats are standing in the way of a person’s right to try to save his or her life, even with the guidance of qualified doctors.

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Action Alert: HHS Misrepresenting Supplements

Related article: HHS Says Supplements Send 23,000 People to the Hospital ER! Each Year!

Trouble Taking Action? Click here.

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Video: Are Supplements Dangerous?

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HHS Says Supplements Send 23,000 People to the Hospital ER! Each Year!

Balderdash. The agency’s own CDC data shows that supplements are overwhelmingly safe. Action Alert!

The mainstream media is using a new study funded by the US Department of Health and Human Services (HHS), released last week, to renew the false charges that supplements are unregulated, unsafe, and require more federal oversight.

Even a cursory examination of the data provided in the study, however, demonstrates once again that the alarmist headlines and the calls for tighter regulations are completely unsupported by the evidence.

First, over 20% of the cases analyzed were the result of unsupervised children swallowing pills. 40% of cases among those 65 and older were caused by choking. Many other cases were heart palpitations from ingesting too many diet pills, sexual enhancement pills, and energy drinks. Undoubtedly some percentage of these so-called dietary supplements were simply illegal substances, but we aren’t told what the percentage is.

One of HHS’s agencies, the Centers for Disease Control and Prevention (CDC), reports that there were actually only 3,249 supplement-related adverse event reports submitted, either from doctors or hospitals, to the FDA in 2012—a far cry from the 23,000 being claimed in the study.

Part of the gross discrepancy in the numbers is likely due to the fact that eye drops, ear drops, and other over-the-counter products that are not dietary supplements were apparently included by the researchers. Why they chose to do this, they will have to explain.

The study also omits important details on the adverse events counted. For instance, it does not report which products caused the adverse events. This is important because many adverse reactions could be the result of a handful of “adulterated” (illegal) products. The FDA already has the authority to remove adulterated products from the market. Supplements are further regulated by the FTC and must also follow stringent good manufacturing practices to ensure that products are safe.

In fact, the study actually demonstrates something we have been saying for a long time: supplements have an exemplary track record of safety. Considering that about half of all Americans—about 150 million people—use dietary supplements, even the inflated 23,000 number represents only about 0.015% of dietary supplement users.

Pharmaceutical drugs, on the other hand, even when properly prescribed, cause an estimated 1.9 million hospitalizations and 128,000 hospital deaths each year. Deaths outside of hospitals would add considerably to this total if recorded. If public health were truly HHS’s concern, shouldn’t they be focusing on prescription drugs?

What explains the misleading focus on supplements? Not surprisingly, some of the authors of the study are FDA officials. For years the agency has been trying to increase its authority over supplements, attempting to institute a drug-like approval system for them. Because Big Pharma pays the FDA’s bills and provides cushy post-government jobs, we suspect that a lot of this is attempting to curry favor with drug companies.

A drug approval system for supplements, remember, would lead to the destruction of the industry. Unable to pay the exorbitant cost of the FDA approval process (because they sell unpatentable natural substances and could never charge enough to recoup their investment for even one of their products, never mind their entire product line), supplement producers would have to shutter their doors, eliminating thousands of products from the market. This removes competition for Big Pharma and allows them either to monopolize the supplement market or more often try to turn supplements into hugely expensive prescription drugs.

Don’t be fooled by the headlines. The overall strategy at play here has little to do with consumer safety and much, much more to do with bolstering the bottom line of the world’s major pharmaceutical companies. For more information on supplement safety, visit our SupplementFactCheck.org.

Action Alert! Send a message to HHS, urging them to stop their smear campaign against supplements and to fairly represent the facts. Please send your message immediately.

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“Nail in the Coffin” for Calcium Supplements?

No, of course not. But it is true you shouldn’t take them alone.

A new British Medical Journal study has created more headlines in the mainstream media. One article opened with this: “A new study should put the final nail in the coffin for any lingering beliefs that calcium supplements are good for you.”

That’s odd. It was only a few years ago that the World Health Organization wanted to put calcium in everyone’s water supply. We didn’t like that proposal at all, but not because we think that calcium supplementation is a bad idea.

The actual data in the new BMJ study do not support the strange conclusions drawn by either Dr. Mark J. Bolland, the study’s author, or the media. Note this sentence from the study’s conclusion: “The 1-2% increase in [bone marrow density]observed with increased calcium intake would be predicted to produce a 5-10% reduction in risk of fracture.” This hardly suggests that calcium is worthless. Bone marrow density more usually declines with age, not increases.

This is familiar territory for Prof. Bolland, who has been staking out an anti-supplement position for some time with regard to bone health and osteoporosis. He published a paper in 2013 warning that calcium supplementation leads to calcification in the heart and arteries—a conclusion that has been disputed by other studies that did not find this risk.

More importantly, Bolland ignores a key point: to maximize bone health, it is crucial to combine calcium with vitamin K2, which helps move calcium into the proper areas in your body. Vitamin D and magnesium are also critical to getting calcium where it needs to go, and not letting it lodge in blood vessels and the heart. Not surprisingly, Bolland has even contested the usefulness of vitamin D for bone health, despite the overwhelming evidence that has convinced most of the medical establishment.

You can guess where the professor ends up. In addition to recommending against supplemental calcium, he concludes that people “should be encouraged to take agents with proven efficacy in preventing [fractures]”—that is, pharmaceutical drugs.

And what are the “agents with proven efficacy” Dr. Bolland recommends? Bisphosphonates, the largest class of osteoporosis drugs. And they carry the usual list of nasty side effects, including hives, headache, constipation, joint pain, dizziness, blood in the urine, and muscle pain. But those aren’t the main issues. An FDA review in 2012 acknowledged a much graver cause for concern. These drugs do not create new bone. They just prevent the elimination of old bone. This leads to weaker bones in some people. Oral surgeons notice that extractions from bone treated this way do not heal well—or do not heal at all. There have been cases of jawbone death, and believe us, you do not want to have your jawbone die.

There is also a link to esophageal cancer. Moreover, the FDA found little benefit from the drugs after three to five years of use. Bisphosphonates should have been removed from the market. Why weren’t they? How can Dr. Bolland still recommend them?

The only answer we can come up with is money. Big Pharma can’t make money from calcium and vitamin supplements, but it can from osteoporosis medications that patients take for years on end.

About that World Health Organization proposal to put calcium in drinking water—government and international agencies never get this kind of thing right and should just stop interfering. But what really alarmed us was the idea of doing without co-factors such as vitamins K and D. Nutrients—isolated and without vital co-factors, forced on consumers—are not the answer to bone health, nor are dangerous drugs. We build healthy bone the way we build healthy bodies: through proper diet, exercise, and appropriate supplementation.

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What Will Big Pharma Try to Sell Us Next—the Brooklyn Bridge?

The Food and Drug Administration recently approved a new class of cholesterol-lowering drugs that will cost more than $14,000 a year.

Why did a new class of super-expensive statins need to be developed? Partly because the older statins are coming off patent and cannot be sold at high prices anymore. Also because of the wide range of dangerous side effects associated with “regular” statins, of course!

Statins aren’t just incredibly dangerous—they’re ineffective. That is quite a combination! Dr. David Brownstein recently pointed out there is little evidence that statins work. They do not, in fact, reduce the incidence of mortality of strokes and heart attacks.

Why aren’t these facts better known? Part of the answer lies in the $29 billion of statin sales each year. One in four Americans over the age of 45 takes statins.

We also pointed out in our earlier coverage that cholesterol is not the problem and is in fact vital to human health. A real danger as we age is that our cholesterol levels can get too low—which is only exacerbated by taking statins!

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Both the Institute of Medicine and the American Diabetes Association Say, “Enjoy Your Fructose (Fruit Sugar)!”

Sorry, sugar is sugar, whether from fruit or not. And if the “fruit sugar” is actually high-fructose corn syrup—from GMO corn at that—and quaffed down in endless sodas, it just gets worse.

A recent meta-analysis published in the Mayo Clinic Proceedings confirms this yet again. It notes that both the Institute of Medicine and the American Diabetes Association publish guidelines that allow up to 25% of calories from added fructose. The authors note that “[the]intake of added fructose at such high levels would undoubtedly worsen rates of diabetes and its complications,” and add that “there is no need for added fructose or any added sugars in the diet.”

Even one soda a day will take its toll on your weight and your health. Research presented at an American Heart Association conference estimated that sodas and sugary drinks are responsible for 183,000 deaths worldwide each year—133,000 deaths from diabetes, 44,000 from heart disease, and 6,000 from cancer. Nor does it solve anything to switch to artificially sweetened sodas. They just introduce a different set of problems.

These are facts. And yet industry-supported studies are five times more likely to find no link between sugary drinks and weight gain. Such “junk science,” which seems to be all that the Institute of Medicine and the American Diabetes Association is willing to believe, is responsible for making countless Americans even sicker than they already are.

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Action Alert: HHS Misrepresenting Supplements

Related article: HHS Says Supplements Send 23,000 People to the Hospital ER! Each Year!

Trouble Taking Action? Click here.

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CA Governor: No Experimental Drugs for Terminal Patients

California Gov. Jerry Brown recently vetoed the state’s Right to Try Act, which passed both the state assembly and the senate with bipartisan support.

In his veto message, the governor wrote, “Patients with life-threatening conditions should be able to try experimental drugs, and the U.S. Food and Drug Administration’s compassionate use program allows this to happen.”

If only this were true! Our previous coverage of this issue has shown the governor’s statement to be patently incorrect. As it stands now, the FDA throws numerous roadblocks and hurdles into the paths of terminally patients seeking access to experimental drugs through the FDA’s compassionate use program. The FDA can even revoke permission after it is granted.

This is, by definition, a life-or-death issue, and it is an outrage that state and federal bureaucrats are standing in the way of a person’s right to try to save his or her life, even with the guidance of qualified doctors.

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Video: Are Supplements Dangerous?

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Action Alert: Stop Bad MA Supplement Bill

Trouble Taking Action? Click here.

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Action Alert: Stop Bad MA Supplement Bill

Trouble Taking Action? Click here.

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New Study Totally Misrepresents Adverse Events Related to Dietary Supplements

Media outlets indulge in scaremongering, when the actual study data presents a completely different story

October 15, 2015 — Yesterday, the New England Journal of Medicine released a statistical analysis of emergency room visits between 2004 and 2013. The study reported that just over 23,000 ER visits per year were linked to dietary supplements—prompting media outlets to run alarmist headlines about supplement safety and regulation. In point of fact, supplements have been proven time and time again to be incredibly safe, and the supplement industry is fully regulated. “The conclusions this study draws are almost laughable,” said Gretchen DuBeau, Legal and Executive Director for the Alliance for Natural Health USA. “A closer look at the data shows that these cases were not caused by unsafe products. Twenty percent of the cases analyzed were the result of unsupervised children swallowing pills, forty percent of the cases in patients 65 and over had trouble swallowing uncrushed pills, and many cases were heart palpitations from ingesting too many diet pills, sexual enhancement pills, and energy drinks.” Data from the Centers for Disease Control and Prevention show that there were actually only 3,249 adverse event reports submitted to the FDA related to supplements in 2012—a far cry from the 23,000 being claimed in the study. About 50% of Americans (150 million people) take supplements, so the ER visits represent about 0.015% of supplement users. “I don’t know how the study authors can talk about product safety given these numbers,” continued DuBeau. “This study shows that people need to act responsibly and follow directions. And even though most of these cases were examples of irresponsible behavior, a miniscule percentage of people had adverse reactions. Yet many groups have called for vitamins and health-supporting herbs to be regulated as if they were dangerous drugs, in order to protect the public from a harm that does not actually exist.” Most of the stories about supplements in the media claim that nutritional supplements are not regulated by the FDA, but this is simply untrue. The FDA is fully empowered to remove any product from the market that is unsafe, misbranded, or adulterated. Supplements must contain what is on the label or the FDA has the right and obligation to remove that product from store shelves. The agency is charged with enforcing the Dietary Supplement Health and Education Act, which holds supplement manufacturers to “good manufacturing practices” (industry standards for product quality); and it may take any necessary action based on adverse event reports. Both the FDA and the FTC also have to power to stop any fraudulent advertising. “The FDA needs to do a better job of enforcing the law and punishing those who fail to properly make, label, and distribute their products. But even with the agency’s shortfalls, supplements are far, far safer to ingest than FDA-approved drugs, and statistically even safer than food. We all want to remove bad actors from the supplement industry, but exaggerating the risk posed by these isolated cases is not the way to do so. If we simply enforce the laws already in place, this demonstrably safe industry will become even more so, and consumers will continue to have access to this vital component of a naturally healthy lifestyle,” said DuBeau.

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New Study Totally Misrepresents Adverse Events Related to Dietary Supplements

Media outlets indulge in scaremongering, when the actual study data presents a completely different story

October 15, 2015 — Yesterday, the New England Journal of Medicine released a statistical analysis of emergency room visits between 2004 and 2013. The study reported that just over 23,000 ER visits per year were linked to dietary supplements—prompting media outlets to run alarmist headlines about supplement safety and regulation. In point of fact, supplements have been proven time and time again to be incredibly safe, and the supplement industry is fully regulated. “The conclusions this study draws are almost laughable,” said Gretchen DuBeau, Legal and Executive Director for the Alliance for Natural Health USA. “A closer look at the data shows that these cases were not caused by unsafe products. Twenty percent of the cases analyzed were the result of unsupervised children swallowing pills, forty percent of the cases in patients 65 and over had trouble swallowing uncrushed pills, and many cases were heart palpitations from ingesting too many diet pills, sexual enhancement pills, and energy drinks.” Data from the Centers for Disease Control and Prevention show that there were actually only 3,249 adverse event reports submitted to the FDA related to supplements in 2012—a far cry from the 23,000 being claimed in the study. About 50% of Americans (150 million people) take supplements, so the ER visits represent about 0.015% of supplement users. “I don’t know how the study authors can talk about product safety given these numbers,” continued DuBeau. “This study shows that people need to act responsibly and follow directions. And even though most of these cases were examples of irresponsible behavior, a miniscule percentage of people had adverse reactions. Yet many groups have called for vitamins and health-supporting herbs to be regulated as if they were dangerous drugs, in order to protect the public from a harm that does not actually exist.” Most of the stories about supplements in the media claim that nutritional supplements are not regulated by the FDA, but this is simply untrue. The FDA is fully empowered to remove any product from the market that is unsafe, misbranded, or adulterated. Supplements must contain what is on the label or the FDA has the right and obligation to remove that product from store shelves. The agency is charged with enforcing the Dietary Supplement Health and Education Act, which holds supplement manufacturers to “good manufacturing practices” (industry standards for product quality); and it may take any necessary action based on adverse event reports. Both the FDA and the FTC also have to power to stop any fraudulent advertising. “The FDA needs to do a better job of enforcing the law and punishing those who fail to properly make, label, and distribute their products. But even with the agency’s shortfalls, supplements are far, far safer to ingest than FDA-approved drugs, and statistically even safer than food. We all want to remove bad actors from the supplement industry, but exaggerating the risk posed by these isolated cases is not the way to do so. If we simply enforce the laws already in place, this demonstrably safe industry will become even more so, and consumers will continue to have access to this vital component of a naturally healthy lifestyle,” said DuBeau.

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Job Posting: Legislative Director

­Overview:
The Alliance for Natural Health USA (ANH-USA)—a 501©4 political advocacy organization—is seeking a Legislative Director to guide the organization’s policy and lobbying agenda on Capitol Hill. The ideal candidate will have a passion for natural health policy and experience in government affairs and coalition building.

The Legislative Director position is a full-time, salaried, and exempt position that will require occasional travel and evening or weekend work. The Legislative Director will report to the Executive Director.

About ANH-USA:
ANH-USA works both on Capitol Hill and across the country to promote sustainable healthcare and freedom of choice in healthcare through good science and good law. We protect access to integrative medicine by lobbying Congress and state legislatures; acting as a government watchdog; filing comments on proposed Administrative rulemakings; educating the public, press, and decision makers on integrative medicine; initiating legal activities (e.g., lawsuits, amicus briefs, petitions); and joining and forming diverse, issue-based coalitions.

Location:
ANH-USA’s Atlanta, GA office.

Responsibilities:
The Legislative Director’s job duties may include—

• Identifying, tracking, and monitoring the movement of key legislation and policy proposals that may impact the natural health and health freedom communities
• Direct lobbying work in Washington, DC and at the state-level when necessary
• Building and maintaining relationships with key members of Congress and their staff
• Working with the Executive Director in the development and promulgation of a legislative agenda/strategy
• Conducting complex policy research and analysis
• Careful, action-oriented analysis of national and state-level legislation and regulations
• Assisting the Executive Director in developing research-informed positions that ANH-USA may take on policy and legislation, making specific recommendations that seek legislative and/or administrative action at state, local, and/or federal levels

• Supporting the Executive Director in the operation of a functional and productive office and work on various projects as needed
• Ad-hoc research to support the work of the Executive Director

A successful applicant should have:

• A law degree and/or legislative experience, preferably on Capitol Hill
• Adaptability to diverse policy issues as the relate to ANH-USA’s core mission
• Non-profit experience
• Ability to effectively identify and research policy issues, propose alternative courses of action, and make well-reasoned recommendations
• Excellent communication skills with an emphasis on brevity, persuasiveness, and the ability to relate to a number of politically diverse constituencies and audiences
• Passion, energy, and a personal interest in natural health is essential
• Willingness to travel by airplane for 3 to 5 days per month on average
• The ability to work independently with initiative and efficiency

To apply, please submit a brief cover letter and resume to Emily@ANH-USA.org. Be sure to include “Legislative Director” in your subject line. Cover letter must include salary requirements. Please do not call the office.

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Feds Taking Kombucha Off Shelves?

No, we’re not kidding. Help us stop this unwarranted attack. Action Alert!

The Alcohol and Tobacco Tax and Trade Bureau, a division of the US Treasury Department, recently sent letters to several producers of kombucha, warning them that since their beverages supposedly exceeded the allowable alcohol limit, they must be labeled as alcoholic beverages and be subject to alcohol regulation or face hefty fines and legal action.

Kombucha is a fermented tea drink brewed with yeast and bacteria. The drink contains trace amounts of alcohol, but it typically falls below the federal limit of 0.5% alcohol by volume.

Why is this happening? Is there a safety concern? Not in the least. On the contrary, kombucha appears to be very good for you. It seems unlikely that the government would go after kombucha without prodding from some special interest. Has the soft drink industry detected a threat from a rapidly growing market and decided to use the power of the federal government to eliminate competition? There doesn’t seem to be another explanation.

The facts of the case reveal just how outrageous this investigation is—further suggesting that crony interests may be pulling the strings. The government is using the same alcohol test for kombucha that it uses for wine, beer, and spirits. But the organic acids and natural sedimentation in kombucha can be read as ethanol, which throws off the results of the test.

Rep. Jared Polis (D-CO) sent a letter to the Alcohol and Tobacco Tax and Trade Bureau explaining that their testing methodology is flawed. Polis asked them to stop their harassment of the kombucha brewers until a unique testing method can be devised that is appropriate to the specific chemistry of the beverage.

Polis notes in his letter that the alcohol level can sometimes rise slightly above the federal limit, but only if the kombucha is incorrectly stored at warmer temperatures, which also spoils the drink. Polis wrote, “Eight spoiled kombuchas are roughly equivalent to one beer, but that doesn’t mean we should regulate it like we do alcohol—it makes absolutely no sense.”

Polis in past years also introduced a bill to allow food and supplement producers to tell their customers about good peer-reviewed, university research on the health aspects of their products. And he has supported the sale of raw milk. If only we had more members of Congress like him!

Unpasteurized kombucha contains the “good” bacteria that promote gut health and boost immunity. But if kombucha is regulated like alcohol, many supermarkets and convenience stores won’t be able to sell it, and it is unlikely that health-conscious consumers would travel to liquor stores to stock up on the drink.

Liquor is also very heavily regulated—by states as well as the federal government. Out-of-state shipping may be barred, and prices may be fixed by regulation. The probiotic benefits of kombucha would also be denied to anyone under 21. The combination of these factors would likely lead today’s producers to decide that it’s no longer profitable to make kombucha, thus restricting—possibly eliminating—consumer access to it. Or, just as likely, Big Food (especially soda) companies would simply take over the market.

Action Alert! Send a message to the Alcohol and Tobacco Tax and Trade Bureau urging them to stop this ridiculous attack on kombucha. Please send your message immediately.

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FDA Fires Its First Shot At Laboratory Developed Tests

How can a simple blood test magically become “an unapproved medical device”? Action Alert!

Last week, the FDA sent a letter to Pathway Genomics stating that the company’s non-invasive cancer screening test is a medical device being marketed without FDA approval. The FDA also contended that the “device” lacked sufficient clinical support.

The FDA claims that the cancer test meets the definition of a medical device because the company ships blood collection tubes—medical devices—for use with the test. As a medical device, the test is supposedly subject to FDA scrutiny.

Pathway Genomics responded in a statement that the test in question is a laboratory developed test, not a medical device, and therefore falls under the jurisdiction of the Centers for Medicare and Medicaid Services (CMS), not the FDA.

As we reported last year, laboratory-developed tests (LDTs) are diagnostic tests developed and performed by local labs. They are widely used—thousands of different LDTs are available—and include genetic tests, tests for rare conditions, and companion diagnostics. LDTs are vital tools for personalized medicine because labs can even create custom diagnostic tests.

The controversy started last year when the FDA released a draft guidance proposing to treat LDTs as medical devices, requiring pre-market approval in some cases. This led some members of Congress to accuse the FDA of overstepping its authority.

For example, Rep. Michael C. Burgess (R-TX), the House Energy and Commerce Health Subcommittee’s vice chair, said in a statement that the FDA’s regulation of LDTs in this guidance “is redundant, will stifle innovation, and will require additional taxpayer funding for the FDA.” In subsequent exchanges with the FDA, Rep. Burgess also pointed out that LDTs are overseen by CMS and do not require additional oversight by the FDA.

This is, unfortunately, a common FDA maneuver—issuing guidance documents to accomplish what they can’t get away with if they go through the normal rulemaking process.

This first letter to Pathway Genomics could be the FDA testing the waters, seeing how far they can get in illegally regulating LDTs.

If the FDA gets away with this, it could have huge implications for consumer access to these tests. LDTs are the future of medicine. People are already able to test for and spot cancers long before they manifest themselves using current methods. These tests are improving at a rapid rate. Testing can already help prevent diabetes, heart and blood vessel illness, prostate cancer, and other diseases.

LDTs are not only the future of general medicine—they are also the future of individualized medicine, which is an exciting and important development in its own right. Integrative doctors use these tests to gather information that aids them in identifying the root causes of their patients’ illnesses—this information could not be gathered and analyzed otherwise.

Consider also our earlier coverage of Theranos, the exciting new blood testing company. Its technology will allow you to walk into your Walgreens, with or without a prescription, and get blood test results the same day with astounding accuracy rates and at very low cost. Developments like this empower consumers to take a more active approach in monitoring their own health.

LDTs are different from other diagnostic tests in that LDTs don’t require any sort of standardized premarket controls, whereas other diagnostic tests need to demonstrate safety and effectiveness to the FDA using analytical studies; some must be taken through the full FDA approval process at astronomical expense. If the FDA succeeds in broadening its regulatory authority to include LDTs, innovation in this field is sure to be crushed, medicine will be held back, millions of Americans will die unnecessarily, and medical costs will rise.

Action Alert! Send a message to the FDA emphasizing that they lack regulatory authority to regulate LDTs. If they want to change that, they must follow a formal rulemaking procedure so the public will have a voice in the matter, instead of skirting the law by issuing a guidance. Please send your message immediately.

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Victory for Supplements—and Free Speech—in Bayer Case

A federal district court has ruled in favor of Bayer in a case where the government tried to regulate supplements as drugs. Here’s what it means for you.

Pharmaceutical giant Bayer AG has won a lawsuit brought by the FTC that accused the company of making unsubstantiated claims about a probiotic colon supplement.

The court ruled, in essence, that Bayer’s claims about its supplement were sufficiently substantiated by the hundreds of studies it supplied to back up its claims—without the double-blind randomized clinical trials (RCTs) that the FTC tried to demand.

In her decision, the judge wrote, “As two other courts have held, competent and reliable scientific evidence does not require drug-level clinical trials, and the Government cannot try to reinvent this standard.”

In our previous coverage of the Bayer case, we noted that the FTC is completely outside of its jurisdiction in trying to demand RCTs for food and supplement claims—a process that is under the authority of the FDA. The FTC was also acting illegally in attempting to change existing law without going through a formal rulemaking procedure.

This isn’t the first time the FTC has tried to do this. We’ve increasingly suspected that the FTC is working at the behest of the FDA, which knows it couldn’t get away with such a requirement and is asking the FTC to do its dirty work.

Other recent court cases have ruled against government efforts to gag free speech. A district court ruled late this summer that the FDA could not stop Amarin, an Irish pharmaceutical company, from showing doctors the medical studies supporting off-label uses of its fish-oil-derived drug. The FDA’s longstanding position has been that it is unlawful to market a drug for a purpose not approved by the agency, no matter what the science says.

Why does this matter? Consumers are looking for reliable information backed by legitimate scientific research to assist in making informed choices. Access to this information is essential to knowing which foods and food supplements really are healthy and helpful for good health. When government agencies prevent companies from making health claims backed by good science, consumers are denied crucial information.

It should also be noted that there are significant problems with demanding RCTs for food and supplements. First, RCTs are often inappropriate for studying food and nutrients. A new-to-nature drug molecule can be better isolated in its effects, although interactions with other drugs are inadequately studied. Foods and supplements often depend on co-factors. For example, supplemental calcium should not be taken without supplemental K2, D, and magnesium (especially the K2), but isolating it for an RCT would miss that.

RCTs are also incredibly expensive—on average $600 million each and often much more. Pharmaceutical companies can afford to pay this because their drugs have been patented, but this is not the case for natural supplement companies since natural molecules generally cannot be patented and their investment could never be recouped. Supplement companies would likely go out of business if RCTs were required in order to make health claims. This is part of the Catch-22 that we so often refer to.

And what are the statements that Bayer made that are so objectionable? They claimed that their probiotic supplement “helps defend against” the occasional constipation, loose bowels, and gas and bloating—structure/function claims that are protected by DSHEA (the Dietary Supplement Health and Education Act of 1994) and that should not, by law, require an RCT.

(Note: Structure/function claims are statements that describe the role of a nutrient or ingredient as it affects normal structure or function in humans—statements like “calcium builds strong bones” or “vitamin D boosts immune system function.”)

Will these decisions put a stop to further efforts to gag free speech? Probably not, but these court cases provide important precedents to defend against future attacks.

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Action Alert: Protect Kombucha!

Related article: Feds Taking Kombucha Off Shelves?

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Action Alert: Protect LDTs!

Related article: FDA Fires Its First Shot At Laboratory Developed Tests

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Job Posting: Legislative Director

­Overview:
The Alliance for Natural Health USA (ANH-USA)—a 501©4 political advocacy organization—is seeking a Legislative Director to guide the organization’s policy and lobbying agenda on Capitol Hill. The ideal candidate will have a passion for natural health policy and experience in government affairs and coalition building.

The Legislative Director position is a full-time, salaried, and exempt position that will require occasional travel and evening or weekend work. The Legislative Director will report to the Executive Director.

About ANH-USA:
ANH-USA works both on Capitol Hill and across the country to promote sustainable healthcare and freedom of choice in healthcare through good science and good law. We protect access to integrative medicine by lobbying Congress and state legislatures; acting as a government watchdog; filing comments on proposed Administrative rulemakings; educating the public, press, and decision makers on integrative medicine; initiating legal activities (e.g., lawsuits, amicus briefs, petitions); and joining and forming diverse, issue-based coalitions.

Location:
ANH-USA’s Atlanta, GA office.

Responsibilities:
The Legislative Director’s job duties may include—

• Identifying, tracking, and monitoring the movement of key legislation and policy proposals that may impact the natural health and health freedom communities
• Direct lobbying work in Washington, DC and at the state-level when necessary
• Building and maintaining relationships with key members of Congress and their staff
• Working with the Executive Director in the development and promulgation of a legislative agenda/strategy
• Conducting complex policy research and analysis
• Careful, action-oriented analysis of national and state-level legislation and regulations
• Assisting the Executive Director in developing research-informed positions that ANH-USA may take on policy and legislation, making specific recommendations that seek legislative and/or administrative action at state, local, and/or federal levels

• Supporting the Executive Director in the operation of a functional and productive office and work on various projects as needed
• Ad-hoc research to support the work of the Executive Director

A successful applicant should have:

• A law degree and/or legislative experience, preferably on Capitol Hill
• Adaptability to diverse policy issues as the relate to ANH-USA’s core mission
• Non-profit experience
• Ability to effectively identify and research policy issues, propose alternative courses of action, and make well-reasoned recommendations
• Excellent communication skills with an emphasis on brevity, persuasiveness, and the ability to relate to a number of politically diverse constituencies and audiences
• Passion, energy, and a personal interest in natural health is essential
• Willingness to travel by airplane for 3 to 5 days per month on average
• The ability to work independently with initiative and efficiency

To apply, please submit a brief cover letter and resume to Emily@ANH-USA.org. Be sure to include “Legislative Director” in your subject line. Cover letter must include salary requirements. Please do not call the office.

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Feds Taking Kombucha Off Shelves?

No, we’re not kidding. Help us stop this unwarranted attack. Action Alert!

The Alcohol and Tobacco Tax and Trade Bureau, a division of the US Treasury Department, recently sent letters to several producers of kombucha, warning them that since their beverages supposedly exceeded the allowable alcohol limit, they must be labeled as alcoholic beverages and be subject to alcohol regulation or face hefty fines and legal action.

Kombucha is a fermented tea drink brewed with yeast and bacteria. The drink contains trace amounts of alcohol, but it typically falls below the federal limit of 0.5% alcohol by volume.

Why is this happening? Is there a safety concern? Not in the least. On the contrary, kombucha appears to be very good for you. It seems unlikely that the government would go after kombucha without prodding from some special interest. Has the soft drink industry detected a threat from a rapidly growing market and decided to use the power of the federal government to eliminate competition? There doesn’t seem to be another explanation.

The facts of the case reveal just how outrageous this investigation is—further suggesting that crony interests may be pulling the strings. The government is using the same alcohol test for kombucha that it uses for wine, beer, and spirits. But the organic acids and natural sedimentation in kombucha can be read as ethanol, which throws off the results of the test.

Rep. Jared Polis (D-CO) sent a letter to the Alcohol and Tobacco Tax and Trade Bureau explaining that their testing methodology is flawed. Polis asked them to stop their harassment of the kombucha brewers until a unique testing method can be devised that is appropriate to the specific chemistry of the beverage.

Polis notes in his letter that the alcohol level can sometimes rise slightly above the federal limit, but only if the kombucha is incorrectly stored at warmer temperatures, which also spoils the drink. Polis wrote, “Eight spoiled kombuchas are roughly equivalent to one beer, but that doesn’t mean we should regulate it like we do alcohol—it makes absolutely no sense.”

Polis in past years also introduced a bill to allow food and supplement producers to tell their customers about good peer-reviewed, university research on the health aspects of their products. And he has supported the sale of raw milk. If only we had more members of Congress like him!

Unpasteurized kombucha contains the “good” bacteria that promote gut health and boost immunity. But if kombucha is regulated like alcohol, many supermarkets and convenience stores won’t be able to sell it, and it is unlikely that health-conscious consumers would travel to liquor stores to stock up on the drink.

Liquor is also very heavily regulated—by states as well as the federal government. Out-of-state shipping may be barred, and prices may be fixed by regulation. The probiotic benefits of kombucha would also be denied to anyone under 21. The combination of these factors would likely lead today’s producers to decide that it’s no longer profitable to make kombucha, thus restricting—possibly eliminating—consumer access to it. Or, just as likely, Big Food (especially soda) companies would simply take over the market.

Action Alert! Send a message to the Alcohol and Tobacco Tax and Trade Bureau urging them to stop this ridiculous attack on kombucha. Please send your message immediately.

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