• Current good manufacturing practices (cGMPs) for supplements could not be more stringent. Laws to guarantee safe products are already on the books, and it is up to the FDA to enforce those laws. FDA memos, retrieved through Freedom of Information Act requests, show that the agency has, at least in the past, deliberately refused to enforce laws in the hope that something would occur which was so bad that current supplement law would be abandoned in favor of a drug-type regulation scheme. If once in a great while some bad actors fail to meet current high standards, and the FDA fails to hold them accountable, this should not reflect on the entire industry. The FDA already has the power it needs, so passing more regulations would simply be redundant.
• The testing regimens which the supplement industry are held to under cGMPs are one reason that supplements have such a proven track record of safety—more so than food, not to mention FDA-approved pharmaceuticals. One report from the Government Accountability Office found that there were an average of 1,575 adverse event reports (AERs) related to supplements per year between 2008 and 2011. When you factor in that about half of Americans (157 million people) take supplements every day, this means that only one-hundredth of one percent of all supplement users ever experience any problems at all. It is also worth noting that AERs are not concrete evidence of supplements being a factor in an adverse event, but simply a possible correlation. By contrast, in 2008, there were 526,527 AERs from pharmaceuticals—488 times more than the number of supplement AERs. Our counterparts at ANH-Europe found that UK residents were about as likely to get struck by lightning as die from taking dietary supplements.
• Because cGMPs already cover the lion’s share of what the AG’s letter is asking for, what Mr. Schneiderman and the other AGs really seem to be after—as evidenced by their use of specific language like “safety and efficacy”—is a regulatory regime that would subject supplements to the same pre-approval process that pharmaceutical drugs must go through. An economic analysis ANH-USA conducted in response to a less-stringent regulatory proposal than the one Mr. Schneiderman seems to be asking for found that between 22,240 and 41,700 dietary supplements would disappear from the market as a result. This hurts consumers far more than it helps them.

Given these considerations, one wonders what is motivating Mr. Schneiderman and his coalition of AGs in the first place. Is he trying to curry favor with the drug industry, in the hope that this will help him finance future campaigns—for governor, perhaps? There will be a huge political upside for him if Congress decides to act. It will create a media frenzy, with the NY AG’s name headlining all the stories, without his having to make a viable case for his position—something he has so far been unable or unwilling to do—or explain how any of this benefits New York’s taxpayers.
The possibility exists, of course, that he is simply misinformed. This is disturbing, since his initial tests have been completely invalidated. With no safety violation and no evidence of fraud, the NY AG’s office might have withdrawn its case and issued a mea culpa. If the entire process was predicated on faulty data, which appears to be the case, the AG needs to explain how his office could have acted so rashly and with such gross incompetence. Instead—and without a scintilla of scientific evidence or a single public health violation—he has redoubled his attack.
One thing is certain: consumers must speak out in a clear voice to tell congressional leaders not to cave in to these specious demands and to preserve consumer access to important dietary supplements.
Action Alert! Send a message to the senators who received this letter and urge them to protect our access to quality supplements! Please send your message immediately!

The post NY Attorney General—and Now Thirteen Other AGs—Take Their Assault on Supplements to Congress first appeared on Alliance for Natural Health USA - Protecting Natural Health.

• According to an important study published in the Journal of Orthomolecular Medicine, the Ebola virus seems to be selenium-dependent—that is, the virus rapidly drains its host of the mineral selenium, making the patient vulnerable to high levels of oxidative stress, which in turn contributes to hemorrhaging and a breakdown of the immune system. Patients who are already selenium deficient—as people in developing nations often are, due to food and nutrition insufficiencies—are most vulnerable to Ebola.Multiple studies have looked at selenium yeast—the organic form of selenium, which is superior in terms of bioavailability and metabolism when compared with inorganic forms of dietary selenium such as selenite—as having a profound impact on the incidence and progression of a variety of infectious and degenerative diseases. There is no question that selenium yeast is associated with increased ability to counteract oxidative stress.
• Intravenous vitamin C may be useful in hospitals and clinics, but it isn’t offered there, and many patients won’t get that far or might not even be welcome if they did. Such patients might be given high doses of vitamin C in a liposome version—it is gentler on the body, and can be gotten to patients in rural areas where medical facilities may be lacking. Glutathione—also in a liposome version, if taken orally—helps recirculate vitamin C and helps strengthen the immune system. NAC, a precursor of glutathione, might be also be helpful. Liposomal forms of oral C are not a substitute for IV C, but any form of C could help tremendously if given to bowel tolerance.
• Vitamin D is a vital necessity for our immune system to fight off viruses. Unfortunately, the darker one’s skin is—that is, the more melanin one has—the more sunlight one needs for the body to make its own vitamin D, so supplementation is critical. Megadoses would be indicated for patients who have already come in contact with the Ebola virus. Of course, at the moment, the dosages the government describes as megadoses barely get a patient into the upper range of “good” on a blood test. The current reference range in conventional medicine for adequate vitamin D in the blood is 30-100 ng/ml. Many people need 10,000 iu a day of supplemented D just to get above 60. Vitamin D in the blood is thought by many experts to be most antiviral around 70 ng/ml.
• Curcumin, the active ingredient in turmeric, can down-regulate the “cytokine storms” that are often the immediate cause of death from Ebola and other pandemic viruses. A cytokine storm is the potentially fatal immune reaction caused by a positive feedback loop between cytokines (small proteins that affect normal cell behavior) and white blood cells. The primary symptoms of a cytokine storm are high fever, swelling and redness, extreme fatigue, and nausea.In addition to curcumin, omega-3 fatty acids can also down-regulate the cytokine storm.
• Other natural antivirals being studied include zinc, vitamins A, B12 (the latter as an adjunct to other antiviral therapies), and melatonin. Some of the best integrative doctors consulted by ANH-USA recommend vitamin A at high doses (over 100,000 iu a day) for viral infections in general.

ANH-USA staff know a patient who had ultraviolet blood irradiation in conjunction with intravenous peroxide (among other things) for Lyme and viral co-infections several years ago, and it was very effective. The treatment was used in the 1940s and ’50s, though it is very difficult to find information on it as the FDA considers it illegal! Given its mechanism of action, this treatment might be effective for Ebola. Ozone taken intravenously or rectally also might work, but faces similar government hostility since it would threaten existing drug monopolies. In a related article, we discuss the use of ultraviolet therapy in a medical device to disinfect hospitals of Ebola.
Action Alert! Write to both FDA and Congress. Ask them to review natural treatments for Ebola without the lengthy drug approval process. Send your message today!
* Editor’s note:  This article was amended on October 23, 2014.

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The post Ebola: WHO Turns To Experimental Drugs, But Not Proven Natural Remedies first appeared on Alliance for Natural Health USA - Protecting Natural Health.

The agency has just issued a warning to consumers. As is so often the case, what they don’t tell you is more important than what they do tell you.

• Traumatic brain injury (TBI) and post-traumatic stress disorder (PTSD), both suffered most often by returning wounded veterans. Tragically, the Department of Defense refuses to use HBOT off-label for veterans, claiming that they don’t prescribe off-label medications and treatments for these diagnoses, and saying they can only use HBOT after it has been approved by the FDA for this use.

This isn’t even true. The DoD often uses antipsychotic drugs off-label to treat TBI and PTSD. About 20% of veterans diagnosed with PTSD—or nearly 87,000 patients—are prescribed an antipsychotic each year even though it is an off-label use.

In total, including prescriptions outside the military, nearly 280,000 individuals received antipsychotic medications in 2007. Yet over 60% of them had no record of a diagnosis for which these drugs are approved. Antipsychotic drugs were prescribed off-label for PTSD (42% of the patients), minor depression (40%), major depression (23%), and anxiety disorder (20%)—with about 20% having more than one condition.

• Autism. You may recall our story from two years ago where we told you about the successes one mother of three autistic boys had with HBOT. This treatment, like the treatment for brain injury, was pioneered by Dr. Paul G. Harch, president of the International Hyperbaric Medical Association Foundation.

• The American Cancer Society says HBOT can help when used as a mainstream treatment for the prevention and treatment of osteoradionecrosis, a term for delayed bone damage caused by radiation therapy. There is also some evidence suggesting HBOT may be helpful as an extra treatment for soft tissue injury caused by radiation.

• The Undersea and Hyperbaric Medical Society’s Committee on Hyperbaric Oxygen Therapy also recommends it for treatment of thermal (heat) burns, abscess in the brain or head, osteomyelitis (chronic bone inflammation) that does not respond to standard treatment, and blockage of the retinal artery (blood vessel in the back of the eyeball).

• Some research indications—where HBOT is performed on a more experimental basis—include acute carbon tetrachloride poisoning, cerebral palsy, cerebrovascular accident (acute-thrombotic or embolic), fracture healing and bone grafting, hydrogen sulfide poisoning, invasive aspergillosis, sickle cell anemia crises, brown recluse spider bites, and acute spinal cord injuries.

• Stroke, Lyme disease, major viral infections, multiple sclerosis, heart disease, sinusitis, head injuries, and many other problems may respond well to HBOT, but it is rarely prescribed for any of these conditions.

Oxygen is necessary for healing. HBOT saturates tissues with ten to thirteen times as much oxygen as can normally be breathed in. Hyperbaric chambers and hyperbaric oxygen therapy have been used clinically since the mid-1800s. HBOT was tested and further developed by the US military after World War I. Today, nearly every hospital owns a hyperbaric oxygen chamber. Most of these sit empty and unused.
With so many conditions that HBOT can treat effectively, why in the world should we keep people sick or in pain when we have the means to ease and even reverse their condition? And why is FDA issuing warnings to consumers to keep them from pursuing such a vital therapy?
The FDA’s consumer warning continues that HBOT is not “the kind of universal treatment it has been touted to be on some Internet sites. FDA is concerned that some claims made by treatment centers using HBOT may give consumers a wrong impression that could ultimately endanger their health.”
The warning continues, “Patients may incorrectly believe that these devices have been proven safe and effective for uses not cleared by FDA, which may cause them to delay or forgo proven medical therapies.” “Proven medical therapies” like dangerous drugs and expensive, invasive surgery, perhaps?
This is part of the problem. The FDA tends to protect therapies that are non-natural and patentable, so that drug companies can afford to spend $1 billion on average for agency approval. Bringing these drugs through the approval process pays the agency’s bills, including salaries. Indeed much of the cost of the FDA is born directly by drug companies, which creates a huge conflict of interest.
The other piece of information left out of the FDA’s warning is that patents on HBOT tanks ran out long ago, so that bringing the therapy back for additional use approvals is very difficult if not impossible. The FDA is thus telling you not to use it for unapproved uses, but failing to disclose that other uses will likely never be approved, that pleas for government funding of HBOT research will go nowhere, and that the agency itself won’t lift a finger to do something about this situation, no matter how much human suffering this policy creates.

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Nutritional deficiencies such as iodine, iron, selenium, zinc, vitamin A, riboflavin, pyridoxine, and B12, along with the use of certain medications including beta-blockers, birth control pills, estrogen, iodinated contrast agents, lithium, phenytoin, and theophylline, can inhibit the conversion of T4 into T3. Other factors that can cause this inhibition include aging, alcohol, alpha-lipoic acid, diabetes, fluoride, lead, mercury, pesticides, radiation, stress, and surgery.

Another problem is that too much T4 can convert to something called “reverse T3,” which has only 1% of the effect of T3, but also binds to the T3 receptor, thus blocking T3 from doing its job:

Factors that may lead to a preferential conversion to reverse T3 include high cortisol, glucocorticoids, stress, excess estrogen, and nutritional deficiencies such as selenium, iodine, zinc, and iron.

All of these factors are common. Some—such as aging, stress, fluoride, and pesticides—are so ubiquitous that it is easy to imagine that a large percentage of thyroid patients are inadequately converting T4 to T3, and thus need a thyroid preparation that contains some T3. There is also the possibility that T1 and T2 are performing functions in the body that we are not yet aware of, and that they need to be supplemented along with T3 and T4 (as they are with DTE).
The basic screening test for hypothyroidism is the TSH test, which is short for thyroid-stimulating hormone. TSH is secreted by the pituitary gland when it senses that thyroid levels in the blood have dropped too low, so low levels of TSH generally mean that there is plenty of thyroid hormone in circulation. But for a variety of reasons, the pituitary can sometimes fail to produce enough TSH (even though thyroid levels are low), in which case a low TSH level would give the false impression of having plenty of thyroid. And even under optimal circumstances, TSH levels can fluctuate.
In 2002, the American Association of Clinical Endocrinologists (AACE), recognizing that many patients are misdiagnosed, lowered the upper end of acceptable TSH levels from 5.0 to 3.0, doubling the number of people needing treatment for hypothyroidism. Under the old guidelines, these people had been considered totally normal, and many had been denied treatment despite predisposing family histories and symptoms such as weight gain, depression, fatigue, hair loss, constipation and high cholesterol, all of which can be caused by low thyroid.
Is it any wonder that best-selling thyroid author Mary Shomon’s motto is, “We’re patients, not lab values”?
Speaking of the acceptable TSH ranges, Shomon notes:

This narrow-minded means of diagnosis has been the “standard of care” for conventional doctors and endocrinologists for decades, based on a near-slavish reliance on the TSH test—often to the exclusion of clinical evidence, symptoms and medical observation.

On About.com, Shomon has questionnaires to assess the risk of both hypothyroidism (too little) and hyperthyroidism (too much).
Another approach followed by some integrative doctors is to use an underarm temperature test, which may be more reliable than the TSH test. One simply measures underarm temperature before getting out of bed. A temperature below 97.4 for several days running generally indicates a problem.
In 2009, thyroid patients on DTE were thrown a loop when the two major makers of DTE—Armour and Nature-throid—both experienced mysterious shortages and could not meet demand at the same moment. Many patients spent hours on the phone, calling pharmacy after pharmacy to find a source of DTE. Fortunately, compounding pharmacies were able to fill in, as they can make DTE in any dose, using the same raw materials as Armour and Nature-throid (although at a higher price).
We’ve been telling you over the past few months (here and here) about a bill moving through Congress to outlaw certain compounded medications. This bill is a blatant move by pharmaceutical companies to eliminate the competition from compounding pharmacies and force people to buy the mass-marketed version of the drugs. That would mean that in the event of future shortages of DTE, people might be forced to switch to the T4-only preparations that leave so many patients with unresolved symptoms.
If you haven’t sent an Action Alert yet on the compounding bill, it’s not too late. We’re asking the Senate to vote No on S.959, to ensure that we don’t lose access to the important therapies supplied by compounding pharmacies. Please take action today!

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The New York Times has published another shameful op-ed bashing nutritional supplements. Here’s our response.

• We do not get enough nutrients from our food. The soil in factory farms is depleted of nutrients, resulting in less nutritious vegetables. The runoff from CAFOs and their animals, together with the pesticide residue on plants, produce foodstuffs that are considerably less safe and healthful than their organic counterparts.
• Many Americans do not eat a healthy diet, and instead consume primarily processed foods—resulting in severe nutrient deficiency. A 2005 USDA report found that 93% of Americans have an inadequate intake of vitamin E, 56% have an inadequate intake of magnesium, 44% have an inadequate intake of vitamin A, 31% have an inadequate intake of vitamin C, 14% have an inadequate intake of vitamin B6, 12% have an inadequate intake of zinc, and 8% have an inadequate intake of folate.
• The notion that “nutrition experts” agree with the recommended daily allowances (RDAs) is absurd—the Academy for Nutrition and Dietetics adhere slavishly to RDAs. The vast majority of nutritionists and naturopaths provide treatment through vitamin and mineral supplementation, often recommending dosages well above the RDA.
• In fact, RDAs are not the best way to determine optimal levels of vitamin and mineral intake. RDAs are based on extraordinarily conservative recommendations from the Institute of Medicine and spring from a deeply flawed risk assessment approach. As Robert Verkerk, executive and scientific director at ANH-Int’l, notes in his critique of this approach, there is a “tendency for risk assessments to be undertaken on ‘nutrient groups,’ rather than discrete ‘nutrient forms,’ despite considerable variation in biological response between nutrients within given groups.” For example, a risk approach that analyzes one more potentially dangerous form of niacin at higher dosages (nicotinic acid) discriminates against other forms of the same nutrient (inositol hexanicotinate).
• Dr. Offit fails to distinguish between using nutritional supplements to maintain optimal health versus using supplements just to prevent disease (e.g., rickets), which is a much lower bar. He also ignores the fact that each individual has different nutritional needs and therefore different supplementation needs.

Dr. Offit cites a few studies indicating that vitamin E is linked to an increased risk of mortality, heart failure, and prostate cancer. Yet ANH-USA won a qualified health claim—in court, based on science—that vitamin E may actually reduce the risk of cancer!

The Life Extension Foundation (LEF) cites numerous studies that soundly contradict Dr. Offit’s assertions and show the protective effects of multivitamin supplementation. A large intervention trial published in the Journal of the American Medical Association in 2012 discussed a randomized, double-blind, placebo-controlled trial in which over 14 000 US physicians took either a multivitamin or placebo each day and were followed for an average of 11.2 years. The doctors who took a multivitamin had a statistically significant reduction in total cancer incidence compared to those who took a placebo pill. Then there’s the 2010 study published in the American Journal of Clinical Nutrition in which over 31, 000 women aged 49–83 revealed cardiovascular benefits of regular multivitamin use. In this study, women without a history of cardiovascular disease who took a multivitamin for more than five years had about a 40% reduced risk of heart attack.

Moreover, Dr. Offit referred to the Proxmire amendment, which prevented FDA from regulating megavitamins as drugs based solely on their potency (i.e., if they exceeded a certain potency, they would be considered a drug) as the agency’s biggest failure. We would call this a tremendous victory. The Proxmire amendment ensured that we would have access to high-dosage vitamins and minerals that could not go through the exorbitantly expensive drug approval process because, as natural substances that cannot be patented, manufacturers could never charge enough money to recoup the money spent in clinical trials.

As LEF notes, Dr. Offit ignores data that conflicts with his agenda. He only cites studies that suggest negative effects of supplementation and excludes important evidence to the contrary. This approach, LEF opines, may have been influenced by the fact that he will soon be publishing a book bashing alternative medicine. The entire piece seems to have been written to promote interest in his new book.

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One of the most prominent [supplement] testing laboratories does not appear to us to be either independent or impartial.

ConsumerLab.com says its stated mission is “To identify the best quality health and nutritional products through independent testing.” Unfortunately, their claim to independence does not appear to us to be valid.

ConsumerLab.com (CL) approaches dietary supplement makers and asks them to enroll in its “voluntary” testing program—for a fee. CL doesn’t publicly disclose its fee schedule, but we know that one company was charged over $4,000 to test a single product. Companies that pay the fee are guaranteed that if one of their products passes the testing under their Voluntary Certification Program, it gets listed on the site and may carry the CL Seal of Approval—and if it fails the testing, the product will never be identified publicly because the results are “proprietary to the manufacturer”!

However, companies that do not agree to pay for the voluntary certification program risk having their products tested anyway through the firm’s “product review program.” If they fail the test, those failures will be publicized on ConsumerLab.com’s website and in the media, with complete details for sale in CL’s Product Review Technical Reports.

This arrangement strikes us as nothing short of scandalous. It sounds like, “Pay up, and you won’t have to worry about the results. Don’t pay up, and you may be exposed to bad publicity.” What kind of game is this?

You might guess from the name “ConsumerLab” that the company was an actual testing facility. But CL actually farms out its product testing. Although the company admits it’s a “third party group” certifying the quality of dietary supplements, CL does not identify the laboratories it uses. Does the company do an annual audit of the labs it uses to make sure they are following Good Laboratory Practices and otherwise operating up to standard? We don’t know, and they’re not saying. Despite all this, CL is often quoted by mainstream media as being experts on supplement safety and testing.

 
In its latest report, CL tested forty-two of the leading multivitamin/multimineral products sold in the US and Canada (including three multis intended for pets). They “failed” sixteen products—some for the most specious of reasons.
 
For example, CL tested how long it took for a product to disintegrate in water, claiming that it is indicative of whether it can be absorbed in the body fast enough. Products taking longer than thirty minutes to dissolve received a failing grade. The stomach, of course, does not digest in water—and the process takes a lot longer than thirty minutes.
 
The FDA has established what are called Current Good Manufacturing Practices (cGMPs). The cGMPs require companies to set specifications for all aspects of its products, including disintegration. One supplement company, NOW Foods, established its own disintegration time of sixty minutes for relevant products, and this met with FDA’s approval. CL’s thirty minute disintegration time isn’t an arbitrary number, however: it’s based on a drug standard. This is absolutely not appropriate for supplements, because supplements are digested as foods.
 
CL also warned against products for exceeding the upper limits (UL) for nutrients set by the Institute of Medicine, whom we have taken to task for their disastrously low recommendation for vitamin D dosages. As Dr. Robert Verkerk, scientific and executive director for ANH-Europe, points out in the journal Toxicology, ULs are intrinsically flawed, as they focus on a single, most sensitive adverse effect on the most vulnerable sub-population. “Paradoxically,” he writes, “dosages that induce risks in sensitive populations commonly overlap with those which induce benefits in the majority.” The result is dietary supplement dosages that are so weak as to be ineffectual in the majority of the population.
 
One of the ULs that CL tests for is niacin. As Verkerk notes, “Given that ULs for niacin have been set at 10 and 35mg/d by the Scientific Committee on Food / European Food Safety Authority (EU) and the Institute of Medicine (USA), respectively, it is noteworthy that most of the benefits, such as blood lipid management, occur substantially above these dosages.” Further, he notes that different levels may be reached depending on the form of niacin.
 
CL “failed” one product for not meeting what CL claimed was the folic acid level claimed on the label, even though the product actually contained not folic acid but natural folates. The method for testing for natural folates (which is the method recommended by the Association of Analytical Communities) is very different from the folic acid test (which is the US Pharmacopeial Convention method). After contacting CL, they claimed to have tested the product using both methods. We’ll just have to take their word on that.
 
CL also singles out companies that were just within the UL for certain nutrients. If they are within range, why even mention these companies at all?
 
The simple “approve” or “fail” method for grading multivitamins can itself be misleading. Some supplements may “fail” on very debatable grounds, such as UL or some technicality, while others might have far more serious problems. Lumping them together appears to serve no purpose other than to encourage more companies to buy CL “services.”
 
As usual, CL’s report does not discuss the methodology they used—how many times they tested a product, what lab was used, etc. Laboratories can be very unreliable, and repeat testing may be necessary. How can they expect anyone to take them seriously while withholding this information?
 
On a recent TV show, Dr. Mehmet Oz discussed the report—and frankly hyped it—while at the same time giving viewers further misleading information. For example, Dr. Oz claims that FDA doesn’t monitor supplements as they do drugs. That is simply not true. Both have Adverse Event Reporting systems. Both have to follow cGMPs—whether the product is pure, lives up to the information on its label, etc.—which is what CL is essentially testing for.
 
The show implied that many supplements are contaminated with heavy metals such as lead, with serious health effects. In reality, only one product had any lead contamination at all, at levels that weren’t very high—and it should have been mentioned that it was one of the products marketed for pets.
 
Dr. Oz claimed that “many” products failed in the aforementioned disintegration test, when in fact only two of them did, and as we have pointed out above, it isn’t the right test.
 
Supplement safety is an important topic. We don’t have all the answers on this complicated subject, although there is evidence that supplements are the safest part of the food chain. One of the problems is that the highest quality supplements, with the most carefully sourced ingredients and the most checking, often cost more, and many consumers simply cannot afford the extra cost.
 
We urge consumers to educate themselves as much as possible in order to make an informed choice and we hope to provide more information for you on this important subject in the future. In the meantime, check out our guidelines for making sure your nutritional supplements are of the highest quality.

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• coconut oil to help prevent or halt the progression of Alzheimer’s;
• nattokinase and niacinamide to halt or even reverse memory loss;
• fish oil that is high in DHA together with PhosChol and Uridine-300, mixed with small amounts of selenium, B vitamins, and alpha-tocopherols; and
• vitamin D for healthy brain function.

Anyone worried about Alzheimer’s should be taking such natural preventive approaches—not taking hugely expensive, new-to-nature, and potentially toxic synthetic drugs even before they have the disease.
Action Alert! There is a sixty-day comment period on the FDA’s proposal. Write to the FDA and tell them if they’re going to allow Alzheimer’s drugs to be approved without being able to prove their effectiveness, they need to follow the same standards for food and supplements that treat Alzheimer’s. Allow natural substances to make disease claims without having to spend a billion dollars to prove their effectiveness! Please send your message today!
 

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Big Pharma seems to be the winner. But this could open the door for natural health companies to cite truthful science about supplements.

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