Senate’s CBD Oil Rescue Offers Hope for Pain

The Senate’s version of the Farm Bill is a vast improvement on the House version, with provisions to protect organics and CBD. Action Alert!

The Senate recently released its version of the Farm Bill. For advocates of natural health, it represents a significant improvement over the House’s version of the legislation. It legalizes CBD oil and the growth of hemp; leaves out concerning provisions from the House Farm Bill regarding the regulation of pesticides, such as language that would have preempted local communities from banning pesticides and allowed more pesticides to be sprayed on organic crops; and the bill tries to address the influx of fake organic crops. We must tell our members of Congress to follow the Senate’s lead.

The best news in the Senate’s Farm Bill relates to CBD oil. The bill includes language that would legalize hemp as an agricultural commodity and remove it from the federal list of controlled substances. It also defines cannabinoids (CBD) with a THC concentration of less than 0.3% as hemp, thus legalizing CBD oil that meets the 0.3% threshold. This is an important step in our campaign to fight for consumer access to CBD oil, a cheap, safe, effective, and non-addictive alternative to opioids for pain.

Note, though, that this would only remove one of the two major threats to consumer access to CBD oil. Recall that a pharmaceutical company, GW Pharmaceuticals, has developed a CBD-based drug for a rare form of childhood epilepsy—which just received FDA approval. The FDA has said that CBD is not a supplement because GW filed an investigational new drug (IND) application on CBD before it was sold as a supplement—an agency position that we are fighting. Nonetheless, it’s encouraging that the government is proposing to remove one of the major hurdles to affordable CBD oil.

The Senate bill leaves out bad provisions that would have increased our exposure to pesticides. You can read more about those provisions in our previous coverage, but here are the highlights. The House bill included language that makes it easier to add pesticides to the list of substances that can be used on organic crops, allows farmers to spray pesticides into water (including drinking water sources), and preempts local communities from restricting the use of pesticides.

The Senate’s bill also includes provisions aimed at increasing oversight over the organic supply chain in an effort to curb the importation of fake organic grains that have been inundating the US market. Part of the problem seems to be that, while US companies importing organic products from overseas must verify that the product comes from a supplier with a valid USDA organic certificate, there isn’t a guarantee that the farm the product came from is running a legitimate organic operation. The language in the Farm Bill would require US firms importing organic goods to collect and maintain information on the product, rather than just the foreign supplier. It’s unclear whether this will really address the problem; as we’ve argued before, more regulations will not replace a will to enforce the law, which the USDA apparently lacks.  But, more serious oversight over the supply chain might help prevent some degree of fraud, so these measures could arguably help consumers.

Of course, the Senate bill includes billions of dollars in government handouts to support the growth of wheat, corn, soy, and other commodity crops—money that could be better spent supporting clean, healthy food. As we said in our coverage of the House Farm Bill, we don’t like the government picking winners and losers, but if subsidies are going to be handed out, it just makes sense not to give billions to support foods that make us unhealthy and sick.

We’re glad that the Senate bill would legalize CBD, leaves out provisions that would have expanded the use of toxic pesticides that were included in the House bill, and takes aim at fraudulent organic crops. Let’s work to make sure it stays that way.

Action Alert! Write to Congress and tell them that the Senate Farm Bill is a vast improvement over the House bill, and that you do not want the House’s pesticide provisions to be included in the final bill. Please send your message immediately.

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New Danger for Supplements?

A bill to increase oversight of certain opioids could create a new path for the federal government to ban supplements. Action Alert!

Lawmakers are considering dozens of bills aimed at addressing the crippling opioid crisis our nation is facing. One bill, the Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017, expands the power of the US Attorney General (AG) to add products to the list of controlled substances, opening another door for the federal government to remove consumer access to supplements.

Currently, controlled substances are divided into five categories, schedules 1, 2, 3, 4, and 5. The bill creates a sixth category, schedule A, and allows the US AG to either temporarily or permanently add substances to this new category with little oversight if two conditions are met: 1) the substance has a chemical structure that is “substantially similar” to the chemical structure of a controlled substance, and 2) the substance has a stimulant, depressant, or hallucinogenic effect that is “substantially similar to or greater than” that of a controlled substance.

Under normal circumstances, the US AG and the Justice Department must work with Department of Health and Human Services (HHS) and the Drug Enforcement Agency (DEA) to make additions to the controlled substances list. By law, the AG must ask HHS to conduct a scientific and medical evaluation and to make a recommendation concerning the substance the AG wants to add to a drug schedule. HHS’s recommendation is binding—if they decide the substance shouldn’t be scheduled, the AG cannot add it. The SITSA Act removes this step and allows the AG to proceed with scheduling without this input from HHS. The bill also increases the length of time a substance can be temporarily scheduled, from three to five years.

The main target of the bill appears to be synthetic opioid analogues: it adds twelve fentanyl analogues to schedule A. Our concern, however, is that the language in the bill is so broad that it creates a pathway to add natural substances to schedule A, with virtually no checks on the AGs power. Chamomile, for example, shares certain characteristics with benzodiazepine, a schedule IV drug in the US. Herbs and supplements used in natural medicine that exhibit neurological affects could be threatened, under the letter of this law. When it’s the federal government that gets to decide what is and isn’t “substantially similar” to a scheduled substance, the situation is ripe for abuse—and to further entrench Big Pharma’s monopoly over medicine by removing the competition. Usually, it’s the FDA or the FTC that goes to bat for the drug industry; now, the AG will be able to step in when these agencies can’t eliminate competition for pharmaceutical drugs.

If the government was serious about combatting the opioid crisis, it would be telling people about cheap, safe, and effective natural alternatives to opioids. There are natural alternatives to pain management, such as fish oil, sulfur-containing methylsulfonylmethane

(MSM), and cannabidiol (CBD) oil. Unfortunately, the government is making moves to remove these alternatives from the market. An FDA advisory committee voted to ban MSM medications from being made at compounding pharmacies, and the federal government is moving in on CBD oil—although there is a lifeline for CBD in the Senate’s Farm Bill. This is the kind of backwards thinking we can expect from a crony capitalist system that protects drug monopolies and throttles the competition.

Action Alert! Write to Congress and urge them to modify the SITSA Act to protect natural medicine by carving out an exemption for natural supplements and herbs. Please send your message immediately. 

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Is Your Sunscreen Making You Sick?

There’s a good chance that it is. Here are some tips on avoiding nasty chemicals when you’re out in the sun (hint: the FDA won’t help you!). Action Alert!

It’s summertime, and lots of us are spending time outdoors. When protecting yourself with sunscreen, though, it’s important to remember that many products on the market contain dangerous chemicals. The good news is there are natural alternatives, including supplements, that can help protect you without poisoning you.  Just don’t ask the FDA for more information about these healthier options; they have banned information about how cheap, safe, and effective natural medicines can protect you from the sun.

Research has shown that 96% of the US population has oxybenzone, an endocrine disruptor, in their bodies. This chemical disrupts sperm function in men and causes endometriosis (a disorder in which the tissue that normally lines the uterus grows outside the uterus) in women. The main source of exposure to this chemical? Sunscreen. Octinoxate, another chemical used in sunscreens, has been shown to cause reproductive, thyroid, and behavioral alterations in animal studies; homosalate, another sunscreen chemical, disrupts estrogen, androgen, and progesterone. Some sunscreens, even when properly used, apparently cause severe burning on young children. Mineral sunscreens, such as zinx oxide or titanium dioxide, offer a better safety profile than chemical-based sunscreens—and are better for the environment, too.

There are also nutrients that can help protect against sunburn and skin damage. Astaxanthin, a carotenoid that causes the reddish color in salmon, trout, lobster, and shrimp, has been shown to protect the skin from the harmful effects of UV radiation; a placebo-controlled, double-blinded, randomized clinical trial showed similar effects for the carotenoids lycopene and lutein. Carotenoids are also overwhelmingly safe.

Unfortunately, the FDA doesn’t want you to know about these natural alternatives. FDA Commissioner Scott Gottlieb recently announced that the FDA sent warning letters to four companies selling skin supplements. The agency argues that claims regarding the supplements’ ability to protect the skin from UV (ultraviolet) rays and sunburn turn the products into unapproved drugs, since only FDA-approved products can claim to offer broad-spectrum UV protection. Basically, to the FDA, sunburn is a disease that only FDA-approved products can treat.

Soon the FDA will be saying that dehydration is a “disease” that can only be treated with special water that has been approved as a drug by the FDA, while gagging any discussion about the benefits of tap water or “unapproved” bottled water. Where will it end? It seems the agency will stop at nothing to protect the drug industry.

This dynamic is all-too-familiar: cheap, safe, and effective natural medicine is stymied by the federal government in favor of FDA-approved, toxic products made by pharmaceutical companies. Why? Because the FDA works for the pharmaceutical industry, and anything competing with Big Pharma’s products is targeted by the agency. We can harness the power of nature to prevent illness, but nobody knows about it because the government prevents the free flow of information about these products. Are we surprised that we are facing an epidemic of chronic disease?

Tell the FDA that you want to know how cheap, safe, and effective natural medicines can protect you from the sun—and other ailments.

Action Alert! Write to the FDA and Congress and tell them to stop gagging free speech about skin supplements. Please send your message immediately.

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Senate’s CBD Oil Rescue Offers Hope for Pain

The Senate’s version of the Farm Bill is a vast improvement on the House version, with provisions to protect organics and CBD. Action Alert!

The Senate recently released its version of the Farm Bill. For advocates of natural health, it represents a significant improvement over the House’s version of the legislation. It legalizes CBD oil and the growth of hemp; leaves out concerning provisions from the House Farm Bill regarding the regulation of pesticides, such as language that would have preempted local communities from banning pesticides and allowed more pesticides to be sprayed on organic crops; and the bill tries to address the influx of fake organic crops. We must tell our members of Congress to follow the Senate’s lead.

The best news in the Senate’s Farm Bill relates to CBD oil. The bill includes language that would legalize hemp as an agricultural commodity and remove it from the federal list of controlled substances. It also defines cannabinoids (CBD) with a THC concentration of less than 0.3% as hemp, thus legalizing CBD oil that meets the 0.3% threshold. This is an important step in our campaign to fight for consumer access to CBD oil, a cheap, safe, effective, and non-addictive alternative to opioids for pain.

Note, though, that this would only remove one of the two major threats to consumer access to CBD oil. Recall that a pharmaceutical company, GW Pharmaceuticals, has developed a CBD-based drug for a rare form of childhood epilepsy—which just received FDA approval. The FDA has said that CBD is not a supplement because GW filed an investigational new drug (IND) application on CBD before it was sold as a supplement—an agency position that we are fighting. Nonetheless, it’s encouraging that the government is proposing to remove one of the major hurdles to affordable CBD oil.

The Senate bill leaves out bad provisions that would have increased our exposure to pesticides. You can read more about those provisions in our previous coverage, but here are the highlights. The House bill included language that makes it easier to add pesticides to the list of substances that can be used on organic crops, allows farmers to spray pesticides into water (including drinking water sources), and preempts local communities from restricting the use of pesticides.

The Senate’s bill also includes provisions aimed at increasing oversight over the organic supply chain in an effort to curb the importation of fake organic grains that have been inundating the US market. Part of the problem seems to be that, while US companies importing organic products from overseas must verify that the product comes from a supplier with a valid USDA organic certificate, there isn’t a guarantee that the farm the product came from is running a legitimate organic operation. The language in the Farm Bill would require US firms importing organic goods to collect and maintain information on the product, rather than just the foreign supplier. It’s unclear whether this will really address the problem; as we’ve argued before, more regulations will not replace a will to enforce the law, which the USDA apparently lacks.  But, more serious oversight over the supply chain might help prevent some degree of fraud, so these measures could arguably help consumers.

Of course, the Senate bill includes billions of dollars in government handouts to support the growth of wheat, corn, soy, and other commodity crops—money that could be better spent supporting clean, healthy food. As we said in our coverage of the House Farm Bill, we don’t like the government picking winners and losers, but if subsidies are going to be handed out, it just makes sense not to give billions to support foods that make us unhealthy and sick.

We’re glad that the Senate bill would legalize CBD, leaves out provisions that would have expanded the use of toxic pesticides that were included in the House bill, and takes aim at fraudulent organic crops. Let’s work to make sure it stays that way.

Action Alert! Write to Congress and tell them that the Senate Farm Bill is a vast improvement over the House bill, and that you do not want the House’s pesticide provisions to be included in the final bill. Please send your message immediately.

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New Danger for Supplements?

A bill to increase oversight of certain opioids could create a new path for the federal government to ban supplements. Action Alert!

Lawmakers are considering dozens of bills aimed at addressing the crippling opioid crisis our nation is facing. One bill, the Stop Importation and Trafficking of Synthetic Analogues (SITSA) Act of 2017, expands the power of the US Attorney General (AG) to add products to the list of controlled substances, opening another door for the federal government to remove consumer access to supplements.

Currently, controlled substances are divided into five categories, schedules 1, 2, 3, 4, and 5. The bill creates a sixth category, schedule A, and allows the US AG to either temporarily or permanently add substances to this new category with little oversight if two conditions are met: 1) the substance has a chemical structure that is “substantially similar” to the chemical structure of a controlled substance, and 2) the substance has a stimulant, depressant, or hallucinogenic effect that is “substantially similar to or greater than” that of a controlled substance.

Under normal circumstances, the US AG and the Justice Department must work with Department of Health and Human Services (HHS) and the Drug Enforcement Agency (DEA) to make additions to the controlled substances list. By law, the AG must ask HHS to conduct a scientific and medical evaluation and to make a recommendation concerning the substance the AG wants to add to a drug schedule. HHS’s recommendation is binding—if they decide the substance shouldn’t be scheduled, the AG cannot add it. The SITSA Act removes this step and allows the AG to proceed with scheduling without this input from HHS. The bill also increases the length of time a substance can be temporarily scheduled, from three to five years.

The main target of the bill appears to be synthetic opioid analogues: it adds twelve fentanyl analogues to schedule A. Our concern, however, is that the language in the bill is so broad that it creates a pathway to add natural substances to schedule A, with virtually no checks on the AGs power. Chamomile, for example, shares certain characteristics with benzodiazepine, a schedule IV drug in the US. Herbs and supplements used in natural medicine that exhibit neurological affects could be threatened, under the letter of this law. When it’s the federal government that gets to decide what is and isn’t “substantially similar” to a scheduled substance, the situation is ripe for abuse—and to further entrench Big Pharma’s monopoly over medicine by removing the competition. Usually, it’s the FDA or the FTC that goes to bat for the drug industry; now, the AG will be able to step in when these agencies can’t eliminate competition for pharmaceutical drugs.

If the government was serious about combatting the opioid crisis, it would be telling people about cheap, safe, and effective natural alternatives to opioids. There are natural alternatives to pain management, such as fish oil, sulfur-containing methylsulfonylmethane

(MSM), and cannabidiol (CBD) oil. Unfortunately, the government is making moves to remove these alternatives from the market. An FDA advisory committee voted to ban MSM medications from being made at compounding pharmacies, and the federal government is moving in on CBD oil—although there is a lifeline for CBD in the Senate’s Farm Bill. This is the kind of backwards thinking we can expect from a crony capitalist system that protects drug monopolies and throttles the competition.

Action Alert! Write to Congress and urge them to modify the SITSA Act to protect natural medicine by carving out an exemption for natural supplements and herbs. Please send your message immediately. 

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Is Your Sunscreen Making You Sick?

There’s a good chance that it is. Here are some tips on avoiding nasty chemicals when you’re out in the sun (hint: the FDA won’t help you!). Action Alert!

It’s summertime, and lots of us are spending time outdoors. When protecting yourself with sunscreen, though, it’s important to remember that many products on the market contain dangerous chemicals. The good news is there are natural alternatives, including supplements, that can help protect you without poisoning you.  Just don’t ask the FDA for more information about these healthier options; they have banned information about how cheap, safe, and effective natural medicines can protect you from the sun.

Research has shown that 96% of the US population has oxybenzone, an endocrine disruptor, in their bodies. This chemical disrupts sperm function in men and causes endometriosis (a disorder in which the tissue that normally lines the uterus grows outside the uterus) in women. The main source of exposure to this chemical? Sunscreen. Octinoxate, another chemical used in sunscreens, has been shown to cause reproductive, thyroid, and behavioral alterations in animal studies; homosalate, another sunscreen chemical, disrupts estrogen, androgen, and progesterone. Some sunscreens, even when properly used, apparently cause severe burning on young children. Mineral sunscreens, such as zinx oxide or titanium dioxide, offer a better safety profile than chemical-based sunscreens—and are better for the environment, too.

There are also nutrients that can help protect against sunburn and skin damage. Astaxanthin, a carotenoid that causes the reddish color in salmon, trout, lobster, and shrimp, has been shown to protect the skin from the harmful effects of UV radiation; a placebo-controlled, double-blinded, randomized clinical trial showed similar effects for the carotenoids lycopene and lutein. Carotenoids are also overwhelmingly safe.

Unfortunately, the FDA doesn’t want you to know about these natural alternatives. FDA Commissioner Scott Gottlieb recently announced that the FDA sent warning letters to four companies selling skin supplements. The agency argues that claims regarding the supplements’ ability to protect the skin from UV (ultraviolet) rays and sunburn turn the products into unapproved drugs, since only FDA-approved products can claim to offer broad-spectrum UV protection. Basically, to the FDA, sunburn is a disease that only FDA-approved products can treat.

Soon the FDA will be saying that dehydration is a “disease” that can only be treated with special water that has been approved as a drug by the FDA, while gagging any discussion about the benefits of tap water or “unapproved” bottled water. Where will it end? It seems the agency will stop at nothing to protect the drug industry.

This dynamic is all-too-familiar: cheap, safe, and effective natural medicine is stymied by the federal government in favor of FDA-approved, toxic products made by pharmaceutical companies. Why? Because the FDA works for the pharmaceutical industry, and anything competing with Big Pharma’s products is targeted by the agency. We can harness the power of nature to prevent illness, but nobody knows about it because the government prevents the free flow of information about these products. Are we surprised that we are facing an epidemic of chronic disease?

Tell the FDA that you want to know how cheap, safe, and effective natural medicines can protect you from the sun—and other ailments.

Action Alert! Write to the FDA and Congress and tell them to stop gagging free speech about skin supplements. Please send your message immediately.

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FDA Turns Its Back on Women with Menopause

Help us get Congress to step in and tell the agency to knock it off. Action Alert!

What if we were to tell you that there was a treatment for the effects of menopause that:

• Didn’t come with the dangers of the alternatives, such as increased risk of endometrial cancer and heart disease;
• Improves bone health;
• Helps with multiple sclerosis;
• Protects urinary health.

Sounds like a good deal, right? That treatment is estriol, one of the three main forms of estrogen produced by the body. With their safety profile and health benefits, it isn’t surprising that one third of women who use hormone therapy choose estriol and other safe, effective, and natural bioidentical hormones to manage the symptoms of menopause. Unfortunately, the FDA is poised to remove access to these hormones and to leave ailing women with no other option but more dangerous alternatives. ANH-USA is leading the charge to protect these crucial hormones, but we need your help to enlist members of Congress to get the FDA to back off.

Here’s what’s happened. In 2013 Congress passed a law to update the regulation of compounding pharmacies, which make customized medications for individual patients, including bioidentical hormones treatments. The FDA has made ample use of this opportunity to restrict or eliminate access to natural medicines, including bioidentical hormones.

The latest attack has been launched by nominating bioidentical hormones to the Difficult to Compound List. The FDA is in the process of reviewing the nominations; when finalized, items on this list cannot be compounded. In normal circumstances—and perhaps if the agency wasn’t beholden to pharmaceutical interests—mere nomination wouldn’t be such a cause for concern. But the track record thus far does not inspire optimism. In a related process where the FDA and its advisory committee are reviewing which substances can be compounded, the committee, following the FDA’s guidance, has voted to ban a number of demonstrably safe ingredients, such as curcumin, MSM (methylsulfonylmethane), boswelia, and aloe vera.

Bioidentical hormones including progesterone, progesterone with estradiol, and estriol have all been nominated to the Difficult to Compound List. Since there is no FDA-approved estriol product, placement on the Difficult to Compound List means that consumers will lose access to estriol altogether.

Given that customized, bioidentical hormones are safe, effective, and not difficult to compound, why is this happening? Unfortunately, the FDA appears to be working at the behest of drug manufacturers whose products compete with these compounded hormones.

Note that this isn’t the first time the FDA has targeted bioidentical hormones. In 2008, the FDA – likely acting upon a petition it received from Wyeth Pharmaceuticals, the manufacturer of Premarin (an estrogen drug made from pregnant horse mares’ urine) – went after bioidentical hormones, particularly estriol. Thanks to ANH members and the wider natural health community, the FDA backed off. Now, the FDA sees an opportunity to remove estriol and other hormones by other means and we must once again mobilize to stop them.

The FDA’s hostility towards bioidentical hormones is even more ridiculous when we consider that they are safer than the alternatives. A review of the literature came to the following conclusion: “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts.”

ANH-USA is working with Congressman Mark Pocan (D-WI) to circulate a sign-on letter to members of Congress, urging the FDA not to consider bioidentical hormones for the Difficult to Compound list, and ensure that the millions of women who rely on these treatments to stay healthy can continue to access them. ANH is also working to start a similar letter in the Senate. We must make this an issue that Congress cannot ignore.

Action Alert! Write to your member of Congress and urge him or her to sign on to Rep. Pocan’s letter to protect bioidentical hormones; write to your senators and urge them to circulate a similar letter in the Senate too. Please send your message immediately.

Donate! Support ANH’s educational and legal work to protect these life-saving compounded medications! Every dollar raised for this campaign will build our war chest to defend estriol and other compounded medicines from this and future threats!

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“Not Everyone Who Wants to Reproduce Will Be Able”

Common chemicals are causing sperm deformity and decreased sperm counts. Action Alert!

A new study suggests that when a mother is exposed to endocrine-disrupting chemicals during pregnancy, her son and the son’s future generations may suffer from decreased fertility. This is the latest among a mounting body of scientific evidence that links these common chemicals—found in a wide variety of products including plastics, pesticides, PVC piping, cosmetics, medical devices, and children’s toys—to the fertility crisis we are facing, and it’s time for regulators to do something about it.

We’ve reported on the fertility crisis a number of times over the years. Scientists say that approximately 90% of sperm in a typical young man are misshapen, meaning they are unable to swim correctly. Additionally, sperm counts have decreased sharply over the last seventy-five years. As one researcher bluntly stated, “Not everyone who wants to reproduce will be able to.”

There’s a great deal of evidence that points to endocrine disruptors as a major cause of this problem. Quite simply, these chemicals disrupt the proper functioning of hormones. One study found an association between higher concentrations of phthalates (a chemical used in plastics) and increased damage to sperm DNA. Another study by Canadian scientists found that adding endocrine disruptors to Lake Ontario turned male fathead minnows into intersexual fish (fish with both male and female characteristics), which are unable to reproduce. Unfortunately, these are far from the only studies positing a link between chemicals and infertility.

There’s also evidence that GMOs share some of the responsibility. A Russian study on hamsters showed that consumption of GM soybeans tended to slow their sexual maturation process and completely eliminated their ability to reproduce within just a few generations. An Austrian study uncovered similar infertility in third-generation mice that consumed GM corn.

That’s not all. Many of the herbicides and pesticides used in conventional farming are “environmental estrogens.” This means that their molecules mimic the activity of the human hormone estrogen, too much of which is not good for men or women; it also affects testosterone levels. GMO crops have exacerbated this problem. According to an animal study published in the journal Toxicology in Vitro, glyphosate (the active ingredient in Roundup, Bayer/Monsanto’s widely used pesticide) often leaves a residue on Roundup Ready crops—and this affects testosterone levels and men’s sperm counts. It is actually toxic to testicle cells, and significantly lowers testosterone synthesis. Consider, too, that recent research has found that “inert” ingredients in herbicides can be more toxic than the active ingredients: POEA (polyethoxylated tallow amine), an “inert” ingredient in Roundup, has been found to be 1,200 to 2,000 times more toxic to human cells than glyphosate.

It’s best to avoid exposure to these chemicals in the first instance, but this can be challenging given that they can be found in unexpected places, such as dental offices (there is bisphenol-A, or BPA, in dental sealants), checkout receipts that are coated with BPA, and trans fats, which have been linked with an increased risk of infertility by as much as 70%.  Thankfully there are natural ways to help improve male fertility where exposure is unavoidable.

There are a number of supplements that can be of use in restoring fertility. The Life Extension Foundation points out that L-carnitine and acetyl-L-carnitine have proven benefits on sperm quality, including sperm count and motility; zinc, vitamin C, and CoQ10 also improve sperm quality.  Natural medicine specialists can also help with more sophisticated tests as well as individualized food, supplement, and exercise protocols. For help finding an integrative practitioner, consult our “Find a Practitioner” page.

Although exposure oftentimes is inescapable, it shouldn’t be that way.  The EPA should expedite review of these chemicals and remove those that pose dangers to fertility or human health in general. Remember that, of the 85,000 chemicals currently on the market, the EPA has reviewed about 250, and banned only five chemicals (or classes of chemicals). In 2016 Congress passed legislation that updated chemical regulation in the US, which included a mandatory requirement for the EPA to evaluate existing chemicals with enforceable deadlines and to prioritize review of chemicals that pose the greatest risk. Given the evidence that endocrine disruptors are making large numbers of men infertile, the EPA should prioritize review of these chemicals and regulate them appropriately.

Action Alert! Write to Congress and the EPA, and tell them to prioritize review of endocrine disruptors, which are causing huge spikes in infertility. Please send your message immediately.

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FTC Clamps Down on Free Speech…Again

Will we let FTC bureaucrats decide what “science” is, and how it can be interpreted? Action Alert!

The legal claims that supplements can make are repeatedly attacked and restricted by federal regulators. This is a great situation if you’re a drug company selling expensive, dangerous drugs, but if you’re an individual trying to manage your health with cheap, safe, and effective natural medicines, you are being denied truthful information about the products you buy. This time, the FTC is banning truthful information about a supplement that can help with memory—even though the company, Quincy Bioscience, had a randomized controlled trial (RCT) to back up their claim.

The product in question is Prevagen, a supplement that is marketed for its ability to prevent memory problems associated with aging. The FTC and the New York Attorney General’s (NYAG) office alleged that Quincy, in making a structure/function claim related to Prevagen’s ability to help with memory problems, violated state and federal deceptive advertising laws. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans; they are not pre-approved by the FDA, but must be backed up by “competent and reliable scientific evidence.”

Notably, the FTC was claiming not that the RCT was inadequate to substantiate marketing claims, but rather the company’s analysis of the study’s findings was at fault. The RCT did not find benefits for the population as a whole, but did find statistically significant benefits for certain subgroups. The FTC claimed that such an analysis introduced an unacceptable risk of error, arguing that the subgroups might have experienced benefits by pure chance. A US District judge rejected this argument and dismissed the FTC’s case. The case is now being appealed by the FTC and the NYAG to the Second Circuit.

Note that requiring RCTs for structure/function claims is itself an overreach by the FTC, as we’ve argued before. By the FTC’s own admission, “there is no fixed formula for the number or type of studies required or for more specific parameters like sample size and study duration”—yet for supplement claims, the agency wants RCTs, and even then, the agency may find issue with the conclusions drawn from an RCT. Put simply, the FTC is trying to define what “science” is and how it should be interpreted. As we’ve noted before, we suspect the FTC is doing the FDA’s dirty work here, since food and supplement claims are under the authority of the FDA, and the FDA knows it couldn’t get away with requiring RCTs—a drug standard—for food and supplements.

This case sends a message to supplement companies: even if they do invest in expensive RCTs to validate claims relating to supplements, it still may not be enough to meet the FTC’s ridiculous standard. What company would spend millions on an RCT to make a claim, with the knowledge that if the FTC doesn’t like the conclusions of the study, the agency will still reject the claim?

Of course, this all takes place in the context of an unleveled playing field for dietary supplements. Only FDA-approved drugs can claim to treat or prevent disease. Supplements cannot afford to go through the FDA approval process, which costs billions of dollars, since they are not patentable—no one would pay to take vitamin D through the FDA approval process, because they couldn’t patent it and recoup those costs the way they could with a man-made synthetic drug.

ANH-USA submitted an amicus curiae (friend of the court) brief in support of the lower court decision that threw out the FTC’s case. Concerned consumers should also contact the agency, and tell them to stop gagging free speech about supplements and denying consumers important health information.

Action Alert! Write to the FTC and Congress and tell them to stop censoring free speech about supplements! Please send your message immediately.

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FDA Turns Its Back on Women with Menopause

Help us get Congress to step in and tell the agency to knock it off. Action Alert!

What if we were to tell you that there was a treatment for the effects of menopause that:

• Didn’t come with the dangers of the alternatives, such as increased risk of endometrial cancer and heart disease;
• Improves bone health;
• Helps with multiple sclerosis;
• Protects urinary health.

Sounds like a good deal, right? That treatment is estriol, one of the three main forms of estrogen produced by the body. With their safety profile and health benefits, it isn’t surprising that one third of women who use hormone therapy choose estriol and other safe, effective, and natural bioidentical hormones to manage the symptoms of menopause. Unfortunately, the FDA is poised to remove access to these hormones and to leave ailing women with no other option but more dangerous alternatives. ANH-USA is leading the charge to protect these crucial hormones, but we need your help to enlist members of Congress to get the FDA to back off.

Here’s what’s happened. In 2013 Congress passed a law to update the regulation of compounding pharmacies, which make customized medications for individual patients, including bioidentical hormones treatments. The FDA has made ample use of this opportunity to restrict or eliminate access to natural medicines, including bioidentical hormones.

The latest attack has been launched by nominating bioidentical hormones to the Difficult to Compound List. The FDA is in the process of reviewing the nominations; when finalized, items on this list cannot be compounded. In normal circumstances—and perhaps if the agency wasn’t beholden to pharmaceutical interests—mere nomination wouldn’t be such a cause for concern. But the track record thus far does not inspire optimism. In a related process where the FDA and its advisory committee are reviewing which substances can be compounded, the committee, following the FDA’s guidance, has voted to ban a number of demonstrably safe ingredients, such as curcumin, MSM (methylsulfonylmethane), boswelia, and aloe vera.

Bioidentical hormones including progesterone, progesterone with estradiol, and estriol have all been nominated to the Difficult to Compound List. Since there is no FDA-approved estriol product, placement on the Difficult to Compound List means that consumers will lose access to estriol altogether.

Given that customized, bioidentical hormones are safe, effective, and not difficult to compound, why is this happening? Unfortunately, the FDA appears to be working at the behest of drug manufacturers whose products compete with these compounded hormones.

Note that this isn’t the first time the FDA has targeted bioidentical hormones. In 2008, the FDA – likely acting upon a petition it received from Wyeth Pharmaceuticals, the manufacturer of Premarin (an estrogen drug made from pregnant horse mares’ urine) – went after bioidentical hormones, particularly estriol. Thanks to ANH members and the wider natural health community, the FDA backed off. Now, the FDA sees an opportunity to remove estriol and other hormones by other means and we must once again mobilize to stop them.

The FDA’s hostility towards bioidentical hormones is even more ridiculous when we consider that they are safer than the alternatives. A review of the literature came to the following conclusion: “Physiological data and clinical outcomes demonstrate that bioidentical hormones are associated with lower risks, including the risk of breast cancer and cardiovascular disease, and are more efficacious than their synthetic and animal-derived counterparts.”

ANH-USA is working with Congressman Mark Pocan (D-WI) to circulate a sign-on letter to members of Congress, urging the FDA not to consider bioidentical hormones for the Difficult to Compound list, and ensure that the millions of women who rely on these treatments to stay healthy can continue to access them. ANH is also working to start a similar letter in the Senate. We must make this an issue that Congress cannot ignore.

Action Alert! Write to your member of Congress and urge him or her to sign on to Rep. Pocan’s letter to protect bioidentical hormones; write to your senators and urge them to circulate a similar letter in the Senate too. Please send your message immediately.

Donate! Support ANH’s educational and legal work to protect these life-saving compounded medications! Every dollar raised for this campaign will build our war chest to defend estriol and other compounded medicines from this and future threats!

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“Not Everyone Who Wants to Reproduce Will Be Able”

Common chemicals are causing sperm deformity and decreased sperm counts. Action Alert!

A new study suggests that when a mother is exposed to endocrine-disrupting chemicals during pregnancy, her son and the son’s future generations may suffer from decreased fertility. This is the latest among a mounting body of scientific evidence that links these common chemicals—found in a wide variety of products including plastics, pesticides, PVC piping, cosmetics, medical devices, and children’s toys—to the fertility crisis we are facing, and it’s time for regulators to do something about it.

We’ve reported on the fertility crisis a number of times over the years. Scientists say that approximately 90% of sperm in a typical young man are misshapen, meaning they are unable to swim correctly. Additionally, sperm counts have decreased sharply over the last seventy-five years. As one researcher bluntly stated, “Not everyone who wants to reproduce will be able to.”

There’s a great deal of evidence that points to endocrine disruptors as a major cause of this problem. Quite simply, these chemicals disrupt the proper functioning of hormones. One study found an association between higher concentrations of phthalates (a chemical used in plastics) and increased damage to sperm DNA. Another study by Canadian scientists found that adding endocrine disruptors to Lake Ontario turned male fathead minnows into intersexual fish (fish with both male and female characteristics), which are unable to reproduce. Unfortunately, these are far from the only studies positing a link between chemicals and infertility.

There’s also evidence that GMOs share some of the responsibility. A Russian study on hamsters showed that consumption of GM soybeans tended to slow their sexual maturation process and completely eliminated their ability to reproduce within just a few generations. An Austrian study uncovered similar infertility in third-generation mice that consumed GM corn.

That’s not all. Many of the herbicides and pesticides used in conventional farming are “environmental estrogens.” This means that their molecules mimic the activity of the human hormone estrogen, too much of which is not good for men or women; it also affects testosterone levels. GMO crops have exacerbated this problem. According to an animal study published in the journal Toxicology in Vitro, glyphosate (the active ingredient in Roundup, Bayer/Monsanto’s widely used pesticide) often leaves a residue on Roundup Ready crops—and this affects testosterone levels and men’s sperm counts. It is actually toxic to testicle cells, and significantly lowers testosterone synthesis. Consider, too, that recent research has found that “inert” ingredients in herbicides can be more toxic than the active ingredients: POEA (polyethoxylated tallow amine), an “inert” ingredient in Roundup, has been found to be 1,200 to 2,000 times more toxic to human cells than glyphosate.

It’s best to avoid exposure to these chemicals in the first instance, but this can be challenging given that they can be found in unexpected places, such as dental offices (there is bisphenol-A, or BPA, in dental sealants), checkout receipts that are coated with BPA, and trans fats, which have been linked with an increased risk of infertility by as much as 70%.  Thankfully there are natural ways to help improve male fertility where exposure is unavoidable.

There are a number of supplements that can be of use in restoring fertility. The Life Extension Foundation points out that L-carnitine and acetyl-L-carnitine have proven benefits on sperm quality, including sperm count and motility; zinc, vitamin C, and CoQ10 also improve sperm quality.  Natural medicine specialists can also help with more sophisticated tests as well as individualized food, supplement, and exercise protocols. For help finding an integrative practitioner, consult our “Find a Practitioner” page.

Although exposure oftentimes is inescapable, it shouldn’t be that way.  The EPA should expedite review of these chemicals and remove those that pose dangers to fertility or human health in general. Remember that, of the 85,000 chemicals currently on the market, the EPA has reviewed about 250, and banned only five chemicals (or classes of chemicals). In 2016 Congress passed legislation that updated chemical regulation in the US, which included a mandatory requirement for the EPA to evaluate existing chemicals with enforceable deadlines and to prioritize review of chemicals that pose the greatest risk. Given the evidence that endocrine disruptors are making large numbers of men infertile, the EPA should prioritize review of these chemicals and regulate them appropriately.

Action Alert! Write to Congress and the EPA, and tell them to prioritize review of endocrine disruptors, which are causing huge spikes in infertility. Please send your message immediately.

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FTC Clamps Down on Free Speech…Again

Will we let FTC bureaucrats decide what “science” is, and how it can be interpreted? Action Alert!

The legal claims that supplements can make are repeatedly attacked and restricted by federal regulators. This is a great situation if you’re a drug company selling expensive, dangerous drugs, but if you’re an individual trying to manage your health with cheap, safe, and effective natural medicines, you are being denied truthful information about the products you buy. This time, the FTC is banning truthful information about a supplement that can help with memory—even though the company, Quincy Bioscience, had a randomized controlled trial (RCT) to back up their claim.

The product in question is Prevagen, a supplement that is marketed for its ability to prevent memory problems associated with aging. The FTC and the New York Attorney General’s (NYAG) office alleged that Quincy, in making a structure/function claim related to Prevagen’s ability to help with memory problems, violated state and federal deceptive advertising laws. Structure/function claims describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans; they are not pre-approved by the FDA, but must be backed up by “competent and reliable scientific evidence.”

Notably, the FTC was claiming not that the RCT was inadequate to substantiate marketing claims, but rather the company’s analysis of the study’s findings was at fault. The RCT did not find benefits for the population as a whole, but did find statistically significant benefits for certain subgroups. The FTC claimed that such an analysis introduced an unacceptable risk of error, arguing that the subgroups might have experienced benefits by pure chance. A US District judge rejected this argument and dismissed the FTC’s case. The case is now being appealed by the FTC and the NYAG to the Second Circuit.

Note that requiring RCTs for structure/function claims is itself an overreach by the FTC, as we’ve argued before. By the FTC’s own admission, “there is no fixed formula for the number or type of studies required or for more specific parameters like sample size and study duration”—yet for supplement claims, the agency wants RCTs, and even then, the agency may find issue with the conclusions drawn from an RCT. Put simply, the FTC is trying to define what “science” is and how it should be interpreted. As we’ve noted before, we suspect the FTC is doing the FDA’s dirty work here, since food and supplement claims are under the authority of the FDA, and the FDA knows it couldn’t get away with requiring RCTs—a drug standard—for food and supplements.

This case sends a message to supplement companies: even if they do invest in expensive RCTs to validate claims relating to supplements, it still may not be enough to meet the FTC’s ridiculous standard. What company would spend millions on an RCT to make a claim, with the knowledge that if the FTC doesn’t like the conclusions of the study, the agency will still reject the claim?

Of course, this all takes place in the context of an unleveled playing field for dietary supplements. Only FDA-approved drugs can claim to treat or prevent disease. Supplements cannot afford to go through the FDA approval process, which costs billions of dollars, since they are not patentable—no one would pay to take vitamin D through the FDA approval process, because they couldn’t patent it and recoup those costs the way they could with a man-made synthetic drug.

ANH-USA submitted an amicus curiae (friend of the court) brief in support of the lower court decision that threw out the FTC’s case. Concerned consumers should also contact the agency, and tell them to stop gagging free speech about supplements and denying consumers important health information.

Action Alert! Write to the FTC and Congress and tell them to stop censoring free speech about supplements! Please send your message immediately.

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School Shootings and Antidepressants

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Bayer’s Monsanto Name Game

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Action Alert: Tell FDA and Congress that Antidepressants Cause Violent Behavior

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School Shootings and Antidepressants

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Bayer’s Monsanto Name Game

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Action Alert: Tell FDA and Congress that Antidepressants Cause Violent Behavior

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