Tinnitus Cure Appears To Lie in the Brain

November 4th, 2014

Scientists were able to eliminate tinnitus—a persistent ringing in the ears—in rats by stimulating a nerve in the neck while playing a variety of sound tones over an extended period of time. The finding gives hope for a future tinnitus cure in humans.

Tinnitus usually comes in the form of a high-pitched tone in one or both ears, but can also sound like a clicking, roaring or whooshing sound. While tinnitus isn’t fully understood, it is known to be a sign that something is wrong in the auditory system: the ear, the auditory nerve that connects the inner ear to the brain, or the parts of the brain that process sound. Something as simple as a piece of earwax blocking the ear canal can cause tinnitus, but it can also arise from a number of health conditions. For example, when sensory cells in the inner ear are damaged from loud noise, the resulting hearing loss changes some of the signals in the brain to cause tinnitus.

There’s no known cure for tinnitus. Current treatments generally involve masking the sound or learning to ignore it. A research team led by Dr. Michael Kilgard at the University of Texas at Dallas and Dr. Navzer Engineer at MicroTransponder, Inc. set out to see if they could develop a way to reverse tinnitus by essentially resetting the brain’s auditory system. Their work was funded in part by NIH’s National Institute on Deafness and Other Communication Disorders (NIDCD).

The researchers paired electrical stimulation of the vagus nerve—a large nerve that runs from the head to the abdomen—with the playing of a tone. Vagus nerve stimulation (VNS) is known to release chemicals that encourage changes in the brain. This technique, the scientists reasoned, might induce brain cells (neurons) to tune to frequencies other than the tinnitus one. For 20 days, 300 times a day, they played a high-pitched tone to 8 rats during VNS.

In the advance online edition of Nature on January 12, 2011, the researchers reported that the number of neurons tuned to the high frequency had jumped by 79% compared to control rats. The scientist then tested 2 different tones in a second group of rats but stimulated the vagus nerve only for the higher one. The neurons tuned to the higher tone increased by 70%, while those tuned to the lower one decreased in number.

With the launching of a revolutionary new tinnitus management formula called Tinnitus Away AF®, this new tinnitus formula is the first formula ever released that utilizes this new research which finds that both the cochlea and the brain are co-responsible for the tinnitus” As tinnitus originates with some form of hearing loss, the real problem is actually rooted deep in the brain and caused, researchers believe, by a complex interplay of brain signals gone wrong. Tinnitus Away AF® is available at www.geromatrix.com

How I overcame my Tinnitus

October 30th, 2014

In 1996, while I was President of Javelin Systems Group in California, I woke up early one morning to ringing in my ears. At first, I thought it would be short lived like my earlier episodes. But this time it lasted and did not go away. When to the doctor who told me it was just some water in my ear and gave me a prescription to dry up the ear canal. After several days I still had the ringing and it was starting to bother me. Finally, I went to an ENT specialist who told me I had tinnitus. Not knowing what it was I started to do research about the problem and what other people were doing,

Then, I saw an interview with William Shatner about his tinnitus and the fact that he saw Dr. Nagler for his tinnitus. So off I went to Atlanta and met with Dr. Nagler who in turn sold me his Tinnitus Retaining Therapy (TRT) for thousands of dollars which never worked even though I used the system for 18 months. Then, I started exploring hypnosis and herbal remedies. With hypnosis and herbal remedies I finally started to experience some relief but still had the ringing.

At that time, I was already president of Geromatrix Nutraceutical Corporation, so I started to speak to our formulators about developing our own tinnitus formula so that I can a better response. This was a natural since Geromatrix made some of the most effective blood pressure and diabetes formulas in the world which were known in the medical community for it medicinal response to controlling those issues.
Over the next 7 years, there were many dead ends and failed formula combinations. At that time a doctor friend of mine exposed use to Josef Rauschecker, a professor of neuroscience at the Georgetown University Medical Center, who has been researching tinnitus for over a decade, In looking at his research finding it became clear that the problem begins with damage to tiny vibrating receptors called hair cells in the snail-shaped cochlea of the inner ear. That injury results in two things: hearing loss — gaps in certain frequency ranges of hearing — but also a remapping in the auditory cortex of the brain, where signals received from the inner ear are processed. The brain then tries to fill in the gaps, and it does so by creating phantom sounds or what we know as tinnitus. We also found that on MRI scans of tinnitus sufferers, scientists were seeing evidence of this as hyperactivity or an excess firing of neurons in the brain’s auditory cortex.

That is when my formulators started looking at CTM (Chinese Traditional Medicine) to see what herbs dealt with brain balance. We then combined those herbal to the herbals that bring blood to the ears and brain. After about the 10th combination, the company found a product that worked.

As I was the guinea pig, I started using it daily. At first the response was slow but at the 90 day time frame when cell regenerate it started to notice the difference. By the month 6, I was starting to consecutive days without the tinnitus sounds and each week I got better and better finally about a years after starting our formula I became tinnitus free. Finally, being able to once again enjoy silent. The road back was hard, long and trying but the results were well worth the effort. That formula is now our new Tinnitus Away AF® formula.

Natural Way To Promote Healthy Blood Pressure!

November 23rd, 2010

Blood Pressure-Lowering Drugs May Have Opposite Effect

 A new American Journal of Hypertension study has found that some commonly prescribed drugs used to lower blood pressure may actually have the opposite effect which explains why after using it for a time your blood pressure starts to go up and the doctors either increase your doage or add another prescription formula. 

The study involved 945 patients with high blood pressure who were enrolled in a workplace antihypertensive treatment program from 1981 to 1998. The patients were given a single antihypertensive medication as part of the study. 

Researchers say that a statistically significant percentage of participants actually had increases in their blood pressure readings, despite taking medication. They suggest that doctors could avoid this problem—and select drugs most suitable for their patients—by measuring blood levels of the enzyme renin through a blood test that is becoming more widely available.

“Our findings suggest that physicians should use renin levels to predict the most appropriate first drug for treating patients with hypertension,” said lead author Michael Alderman, M.D. “This would increase the likelihood of achieving blood pressure control and reduce the need for patients to take additional antihypertensive medications.

 According to the American Heart Association (AHA), hypertension increases the risk for heart attack, angina, stroke, kidney failure and peripheral artery disease. In addition to lifestyle changes like weight loss and exercise, supplements containing potassium, calcium, fish oil, magnesium and garlic may help prevent high blood pressure.

The Natural Way To Promote Healthy Blood Pressure!

Millions of people continue to suffer from blood pressure problems even though they exercise regularly and consume a sensible diet. Unhealthy blood pressure is a “silent killer” that can lead to serious heart and brain problems… blood sugar imbalance… out-of-control cholesterol levels… kidney problems… and other health issues. You can see why it’s so important to keep your blood pressure levels within the normal range. 

It’s also important to understand your risk of developing high blood pressure—because there are simple and effective steps you can take to bring it under control. Plus, there’s a unique three-step, doctor-approved combination of nutrients to help promote…

  •  Normal blood pressure levels
  •     Healthier, more elastic arteries
  •     Balanced cholesterol levels
  •     Stronger bones 

You’ll find that an all-natural approach to controlling your blood pressure can work quickly to help move calcium out of your arteries and into your bones… manage healthy water retention… and boost nitric oxide production to help keep your arteries soft and flexible. Do you want to protect and support your cardiovascular system every day?

Treating Hypertension ‘Naturally’ (part II)

August 17th, 2010

High blood pressure treatment isn’t limited to drugs. Lower blood pressure naturally. Natural treatments such as meditation and diet can have a significant effect.


Schneider is conducting a study on the use of TM in the prevention of high blood pressure in African Americans (a population at significant risk for high blood pressure). The study is not yet complete, but preliminary evidence indicates that TM is useful for high blood pressure treatment and prevention, too.

Learning TM is not difficult, says Schneider, but it should be learned from a qualified instructor. “You need someone there to guide you, and to give you feedback,” he says. “Otherwise, you won’t get the full effect.” To find an instructor near you, call 1-888-LEARN-TM.

TM is not the only non-drug approach to high blood pressure treatment. The role of diet comes into play, too, says Lawrence J. Appel, MD, MPH, professor of medicine, epidemiology, and international health at the Johns Hopkins Medical Institutions in Baltimore. Of these therapies, most are related to diet and include reducing your salt intake, drinking alcohol in moderation, increasing your potassium intake, and overall, eating a healthy diet that emphasizes fruits, vegetables, and low-fat dairy products.

Most evidence to date indicates that a diet high in salt can have an adverse effect on blood pressure, says Appel. Recent studies have also shown that a reduced salt diet can prevent high blood pressure in persons at risk for the condition, can help control high blood pressure in elderly persons who are on blood pressure medication, and can potentially prevent heart problems in overweight individuals.

According to Appel, salt intake should be limited to 2,400 mg per day; less sodium will reduce blood pressure even more in many people. To reduce the amount of salt you consume, the National Heart, Lung, Blood Institute suggests these tips:

  • Buy fresh, plain frozen, or canned no-salt-added vegetables.
  • Use fresh poultry, fish, and lean meat, rather than canned or processed foods.
  • Use herbs, spices, and salt-free seasonings in cooking and at the table.
  • Cook rice, pasta, and hot cereals without salt. Cut back on instant or flavored rice, pasta, and cereal mixes, which usually have added salt.
  • Choose “convenience” foods that are lower in sodium. Limit frozen dinners, pizza, packaged mixes, canned soups or broths, and salad dressings.
  • Rinse canned foods, such as tuna, to remove some of the sodium.
  • When available, buy low- or reduced-sodium, or no-salt-added versions of foods.
  • Choose ready-to-eat breakfast cereals that are lower in sodium.

The NHLBI also suggests eating at least 3,500 mg of potassium a day, from foods such as yogurt, cantaloupe, spinach, and bananas. Potassium may help rid the body of too much sodium by acting as a diuretic.

Chiropractor Peter Cox, director of the Chiropractic Care Center of Charlotte in North Carolina, suggests chiropractic therapy as another means of controlling stress, and by extension, blood pressure.

Treating Hypertension ‘Naturally’

July 31st, 2010

High blood pressure treatment isn’t limited to drugs. Lower blood pressure naturally. Natural treatments such as meditation and diet can have a significant effect.

By Carol Sorgen
WebMD Feature (Reviewed by Michael W. Smith, MD)

 ”Meditation, not medication,” is the advice Robert Schneider, MD, gives when it comes to high blood pressure treatment. It’s not his only advice, but it’s right up there at the top of his list.

Schneider, dean of the College of Maharishi Vedic Medicine at the Maharishi University of Management in Fairfield, Iowa, is also director of the university’s government-sponsored Center for Natural Medicine and Prevention, one of 16 such centers in the country. Schneider has been researching the positive effects of the ancient medical science of maharishi vedic medicine — of which transcendental meditation (TM) is key –for the past 15 years.

Citing statistics from the National Heart, Lung, and Blood Institute (NHLBI), Schneider says that about 50 million adults in the United States suffer from high blood pressure. If left untreated, high blood pressure can damage the kidneys and lead to stroke, heart attack, and heart failure. Heart disease and stroke are the first and third leading causes of death, respectively, in the U.S. (Cancer is second.)

High blood pressure (hypertension) is defined as systolic blood pressure — the top number — averaging 140 mmHg or greater, and/or diastolic blood pressure — the bottom number — averaging 90 mmHg or greater. The systolic pressure is the pressure of blood in the vessels when the heart contracts. Diastolic pressure is the pressure of the blood between heartbeats when the heart is at rest.

In the past 30 years, says Schneider, approximately 600 studies have been conducted worldwide on the effects of transcendental meditation on blood pressure. “TM is a simple mind-body technique that allows you to gain a unique state of restful awareness or alertness,” says Schneider. Studies have repeatedly shown it to be effective in easing stress, one of the major risk factors for heart disease. Though there are many kinds of meditative techniques, it is only TM, says Schneider, that has been studied and been proved to be effective in improving a range of risk factors for heart disease. Researchers believe that the deep rest achieved through TM sparks biochemical changes that help the body and mind reach a more balanced state, in turn triggering the body’s own self-repair mechanism.

TM involves the repetition of a word or phrase (known as a mantra) while seated in a comfortable position with the eyes closed. Most TM practitioners suggest it be practiced for 20 minutes a session, twice a day.

In a study led by Schneider and reported in 1995 in the journal Hypertension, TM was compared with progressive muscle relaxation as a means of controlling stress in older African Americans with high blood pressure. Of the 197 men and women (out of 213) who completed the screening, the reductions in blood pressure in the TM group were significantly greater than those in the progressive muscle relaxation group. TM reduced systolic blood pressure by more than 10 points and diastolic pressure by more than 6 points (compared with a 5 point reduction for systolic and a 3 point fall for diastolic with progressive muscle relaxation).

A Brief Compendium Of FDA Raids Against Good People & Good Products

July 29th, 2010

Lest one forget the long list of abuses, here follows a brief review of recent FDA actions and policies. Many of these cases are documented in greater detail elsewhere. [fre1] [asu] [arm]

  • Dr Burzynski of Houston, Texas, has been harassed by the FDA for over a decade because of his pioneering and controversial use of a preparation he calls “antineoplastons” in the treatment of otherwise untreatable brain tumors. [fbu1]In 1991 five experts from the National Cancer Institute visited Burzynski’s clinic, reviewed the records of seven of Burzynski’s patients with “incurable” brain tumors. In their report, they verified anti-cancer activity in all seven cases, as well as five complete remissions. In spite of the NCI’s recommendation for further study and clinical trials, harassment of Burzynski and his patients and seizure of his clinical records and files continued.”In 1983, FDA filed civil suit in federal court to stop Dr. Burzynski from manufacturing or treating patients with antineoplastons. In a motion dated May 2, 1983 and signed by Robert Spiller, the FDA’s Associate Chief Counsel for Enforcement, the FDA warned Federal Judge Gabrielle McDonald that the FDA would not take “no” for an answer.” In spite of this threat, Judge McDonald specifically declined to prevent Dr. Burzynski from treating patients in Texas, because she recognized that Burzynski’s intrastate operations were not proper areas of jurisdiction for the FDA. From the details of the FDA’s legal strategy, it is clear that the FDA had been frustrated in its attempts to prove that Burzynski engaged in unauthorized interstate shipment of his experimental medicine, as this is the only means by which it could obtain jurisdiction to prosecute him. Multiple grand jury hearings failed to yield any indictments of Burzynski.

    In an interview in January 1982, Dr. Richard J. Crout of the FDA, revealed the FDA’s motive for targetting Dr. Burzynski for destruction: “I never have and never will approve a new drug to an individual, but only to a large pharmaceutical firm with unlimited finances,” declared Dr. Crout. The next year, the FDA began its vendetta against Burzynski, an individual with limited finances. [fbu2]

  • 1950’s, Maine: Wilhelm Reich, M.D., in one of the most infamous cases of FDA thuggery, was railroaded through the courts for his unorthodox views on medicine, politics, and society in general. His books and research journals were incinerated. Dr. Reich died in prison and his coworker, Dr. Michael Silvert, committed suicide after being released from prison. The FDA harassed many associated with Reich, and carried out invasions of these individuals’ homes without warrant or court order. Such actions were typical of the raids generally conducted during the McCarthy period. [are] [fre1] Reich himself was well aware of the mechanisms behind such abuses of power, as evidenced by his book, The Mass Psychology of Fascism [rei].
  • 1950’s, U.S.: Harry Hoxsey’s herbal formulas for the treatment of cancer were targetted for obliteration by the FDA, after Hoxsey refused to sell his formula to Morris Fishbein, president of the AMA. The formulas were used in dozens of clinics across the USA during the 1950s. [aho]
  • Dr. Royal Rife’s methods for microscopically viewing viral activity within living cells may have yielded a major breakthrough in cancer treatment, yet before it could be thoroughly investigated, the AMA threatened and harassed physicians who dared explore the new methods. Some of these physicians died mysteriously. Rife died an embittered man in 1971. [ari]Since Rife’s death, many alternative health businesses have jumped on the bandwagon to promote Rife’s suppressed techniques. However, many of them may be selling bogus imitations, discrediting Rife’s work more effectively than any FDA harassment could possibly accomplish.
  • 1990: Max Gerson’s dietary treatments for degenerative diseases were criminalized by the FDA just as he was publishing scientific evidence and clinical reports on their effectiveness in boosting immune system function. [age]
  • 1987, Florida: The Life Extension Foundation was raided by armed FDA agents, who seized nutritional supplement supplies, files, and personal belongings. Lawsuits against the FDA are still pending. [ajw]
  • 1990, Oregon: FDA agents raided Highland Laboratories and removed everything except office furniture. No employees were informed of the legal grounds for the raid and were threatened with violence if any of them attempted to enter their workplace. The FDA never charged anyone with a violation, but no property has ever been returned. [ajw]
  • 1990, California: The FDA raided and ransacked the pet food store of Sissy Harrington-McGill. FDA agents stated that her pet store literature claiming that vitamins would keep pets healthy was a violation of the Health Claims Law, which was never passed by Congress. Ms. Harrongton-McGill served 114 days in prison, after being tried and convicted by a judge without a jury trial, in spite of her request for a jury trial. Lawsuits have been filed against the FDA. [ajw]
  • 1990, Nevada: The Century Clinic, which administered chelation therapy, homeopathy, and nutritional supplements, was raided twice by FDA and Postal Service inspectors. First, the premises were ransacked and almost all supplies and equipment removed. After no charges were filed against the clinic by the FDA, Century Clinic sued the FDA for return of the seized property. The FDA retaliated with a second raid more extensive than the first, extending to the private homes of the businesses owners and employees. Again, no charges were filed by the FDA. [ajw]
  • 1991, Tijuana, Mexico: Jimmy Keller, who administered natural healing methods in cases of cancer after healing himself of metastasized cancer unresponsive to conventional therapy, was kidnapped from his office in a Mexican hospital by bounty hunters employed by the U.S. Justice Department. On arrival in the U.S., he was arrested for wire fraud: making interstate telephone calls to attract people to his clinic in Mexico. He was convicted to two years in prison. [ajw]
  • 1991, California: FDA agents raided NutriCology, a nutrition supplement company operated by Stephen Levine, Ph.D., a molecular geneticist from the UC Berkeley. Levine spent $500,000 to defend against three different FDA injunctions, all of which were thrown out of court. [ajw]
  • 1992, Washington state: FDA agents raided and terrorized the medical clinic of Jonathan Wright, M.D. The FDA initiated the raid after a recent batch of contaminated B-vitamins was discovered in another state, yet Wright’s clinic had no connection to the company making the contaminated vitamins and dis not use their products. In spite of this, the FDA agents removed most of the clinic’s contents, meanwhile terrorizing patients and treating them like criminals. As of 1993, no clinic property has been returned, yet no charges against the clinic or any of its employees have been filed by the FDA. [ajw] [awr]
  • 1992, California: David Halpern, several of his family members, and the presidents of three European vitamin companies are charged with 198 counts of conspiracy and smuggling for importing banned nutritional supplements that are freely available in Britain and Germany. The indictments carry a potential prison term of 990 years. [ajw]
  • 1992, Texas: The FDA induced the Texas Department of Health and Texas Department of Food and Drug to raid over a dozen major health food stores. Over 250 products were seized from the shelves, including vitamin C, zinc, herbs, aloe vera, and flaxseed oil. Following a massive public outcry, FDA threatened health food store owners, “Don’t talk to the press, or we’ll come down on you twice as hard.”. No charges were ever filed by the FDA, and no products were ever returned. [ajw]
  • 1993, USA: Dozens of natural healing clinics, health food stores and natural product manufacturers throughout the U.S. were assaulted by combined forces from the FDA, DEA, IRS, Customs, and US Postal Service in commando-style SWAT raids. Stocks of vitamins and herbs were confiscated as well as bank accounts, automobiles, and computers. Especially of interest as a target of the raids were mailing lists of customers and clients. The Postal Service assisted in the actions by blocking all mail to some of the businesses, effectively preventing them from continuing any business and from conducting effective legal defense. [fre1]

The above list is by no means exhaustive, but is merely a sampling.

FDA Threatens to Seize All Natural Products that Dare to Mention H1N1 Swine Flu

July 28th, 2010


by Mike Adams, the Health Ranger, NaturalNews Editor

(NaturalNews) In an effort to censor any online text that might inform consumers of the ability of natural products to protect consumers from H1N1 influenza A, the FDA is now sending out a round of warning letters, threatening to “take enforcement action… such as seizure or injunction for violations of the FFDC Act without further notice.”

“Firms that fail to take correction action,” the FDA warns, “may also be referred to the FDA’s Office of Criminal Investigations for possible criminal prosecution for violations of the FFDC Act and other federal laws.”

The message is crystal clear: No product may be described as protecting against or preventing H1N1 infections unless it is approved by the FDA. And which products has the FDA approved? Tamiflu (the anti-viral drug that most people will never have access to), and soon the new H1N1 vaccine that’s being manufactured at a cost of one billion dollars (paid to Big Pharma by the taxpayers). This vaccine, of course, will be utterly useless because H1N1 will undoubtedly mutate between now and the time the vaccine is ready, rendering the vaccine useless.

In other words, according to the tyrants at the FDA, the only products that may be marketed alongside the term “H1N1″ are those products that either don’t work or aren’t available to most people. Anything that really works to prevent influenza infections — such as natural anti-virals, medicinal herbs, etc. — is banned from even mentioning H1N1 without the threat of being criminally prosecuted.

Note: I reveal the five most powerful natural anti-viral remedies in a free report you can read here: http://www.naturalnews.com/RR-FiveB…

Such are the operations of our U.S. Food and Drug Administration — a criminal organization that’s working hard to do what every criminal organization does: Eliminate the competition! As the defender of Big Pharma, the FDA is also the destroyer of knowledge that seeks to remove educational statements from the internet. Truth has nothing to do with it — it is verifiably true that anti-viral herbs, probiotics and other natural products help protect consumers from influenza — but the FDA cannot allow such statements to remain online for the simple fact that people might become informed. And that, it seems, would be a dangerous precedent.

If people were informed about the healing and protective powers of herbs, they would no longer remain enslaved by the medical establishment. Profits would be lost. Power would evaporate. This is why people can never be allowed to attain any real knowledge about herbs, superfoods or nutritional supplements. And the FDA will threaten people with imprisonment just to make sure they don’t dare publish knowledge that the FDA does not want the people to see.

Targeted by the FDA

Who is being attacked and threatened by the FDA? Lots of companies offering highly-effective natural remedies. You can see a list of some of the companies being targeted right here: http://www.accessdata.fda.gov/scrip…

Byron Richards’ company Wellness Resources, a favorite target of the FDA (no doubt because Richards wrote a book attacking the FDA), is also targeted in this censorship campaign. You can see the FDA’s ridiculous complaint against his company here: http://www.accessdata.fda.gov/scrip…

The FDA sends similar letters to other companies, invoking terrorizing language designed to scare companies into self-censorship. This is the FDA’s key strategy, and it largely works: Most companies are scared to death to take a stand against the FDA because the ones that do end up being shut down, with their owners arrested at gunpoint and thrown in prison.

This is how natural medicine advocates are treated in the United States of America, the “land of the free and the home of the brave.” (It is really the land of the enslaved and the home of the cowards who don’t even have the courage to protest in the streets anymore…)

This is how the FDA secretly intimidates the natural products industry: It sends threatening letters to anyone who dares tell the truth about a natural product they sell. While pharmaceuticals can openly and brazenly lie about their supposed benefits, natural product companies aren’t even allowed to state obvious truths about their products! (Like “Vitamin C helps prevent colds” or “Omega-3 oils improve moods.”)

Note, carefully, that the FDA openly brands the people promoting natural anti-viral products as “criminals.” The language from the FDA’s own website says it is listing “Web sites that are illegally marketing unapproved, uncleared, or unauthorized products in relation to the 2009 H1N1 Flu Virus.”

In reality, this FDA list is a really good list of highly effective natural products that can protect you from Swine Flu. Many of the companies on the list, in fact, offer products that are far more effective than any vaccine or Big Pharma anti-viral drug. And that, by the way, is precisely why the FDA must accuse these companies of being criminals: Products that effectively compete with Big Pharma’s drugs simply cannot be allowed to exist in the marketplace!

This is all about destroying the competition, limiting consumer options and censoring truthful health information on the internet.

And it’s all paid for by your tax dollars, by the way. This is a government operation taking place under the Obama Administration, which apparently continues in the Bush Administration’s footsteps when it comes to destroying the natural products industry and leaving consumers helpless in the next great pandemic.

Learn what the FDA hopes you never find out: Read my free report on the five most powerful anti-viral products for beating swine flu: http://www.naturalnews.com/RR-FiveB…

FDA Seeks to Regulate Your Pantry – Part II

July 27th, 2010


Why did the FDA create this document? There are a couple of theories. One is that the National Center for Complementary and Alternative Medicine (NCCAM) asked the FDA to “harmonize” with its way of thinking. Another is that importation of products (a major concern of the FDA) will soon be a top issue. Functional foods could also be a target (as forewarned by the FDA December meeting on functional foods – read about our response and presentation). Regardless of the why, we do know that the health freedom community was not consulted in the preparation of the document. Furthermore, the lumping together of food, products, medical devices, and therapies makes for an awkward, confusing, and unconstitutional “way of thinking” and does not represent what is best for the consumer.


The draft guidance, when finalized, will represent the agency’s current thinking on the regulation of complementary and alternative medicine products. Although it does not change the law, it does represent a potential major expansion with regard to how foods, therapies, and products could be regulated. Of further concern is that this document could be used by health freedom opponents and regulators to pressure Congress to change legislation. The language in the document is of great concern to us and we cannot allow an agency such as the FDA to finalize the document in its present form.


The comment period expires on April 30, 2007. It has been our experience that citizens’ letters to the FDA during the comment period rarely have an impact on the FDA’s decision-making process. This is important to know, since the appropriate response to this situation is not to just be busy (as in writing letters to the FDA) but to be effective. What the FDA has told us is that it wants to hear from practitioner groups and trade associations. Remember that FDA officials are not elected and that generally the wishes of the public fall on deaf ears.

The two things that are most likely to influence the FDA’s actions as they pertain to the issues outlined in this document are:

  • Members of Congress who have a variety of mechanisms for shaping the authority of the FDA.
  • State attorneys general who can threaten legal action if the agency tries to usurp the authority to regulate health care activities within their states.

In consideration of the above, we are taking these actions:

  • We are alerting our Congressional allies and asking them to take appropriate action. We will notify you when it is time to write to these elected officials and make your wishes known.
  • We have commissioned an extensive legal response to the guidance that has the kind of technical detail the FDA bureaucracy wants (or actually doesn’t want) to see as it strives to give this document the force of law.
  • We are planning to communicate with the proper officials in each state to notify them of the potential for federal interference in state regulatory activities.

If you do write the FDA, please send a copy of your concerns to your representatives in Congress. These elected officials do care about your opinion, and your voice matters.



We believe the CAM Regulation Guidance would set the tone of the FDA’s regulatory approach to functional foods, alternative medicine therapy, devices, and products, and dietary supplements, and could help set the stage for future legislation that would restrict access to all of the above. While public comments to the FDA by individuals are a course of action, we want you to be aware that fighting FDA’s “way of thinking” will require a stronger course of action and that we are prepared to follow through. We have fought the FDA before and have been successful.

There are numerous issues facing the health freedom community that need attention and where your action can make a big difference: a draft bill to restrict access to individualized/compounding medicine; the right of the practitioner to practice being threatened by individual states; and Rep. Dingell wanting to “kill” dietary supplements because they are a “snake” to be killed.

FDA Seeks to Regulate Your Pantry

July 26th, 2010

The FDA is seeking to ban the sale of natural foods if the intended use of the food is to prevent or treat a disease. Based on data that foods exert a potent effect in both the prevention and treatment of many diseases, this proposed ban would outlaw information that Americans need to determine which foods are best for them to consume based on their own medical history. What follows is a review of what the FDA proposes to do and what you can do to help stop it.

 The American Association for Health Freedom and the Health Freedom Foundation are very concerned with FDA document 2006D-0480 – Draft Guidance for Industry on Complementary and Alternative Medicine Products and Their Regulation by the Food and Drug Administration (FDA Summary). Read the full text of the CAM Guidance. (get Adobe® Reader®).

 Guidance like this is very confusing and there are legal issues that must be carefully examined and responded to in writing. Therefore, as a first step, we have officially requested that the FDA extend the deadline for comment to July 31, 2007. The time the FDA has provided for comment is simply too short for regulations this complex and important. We are requesting that Congress have the FDA extend the comment period. .


Much of the regulatory authority proposed in the document is already claimed by the FDA. For example, making health claims as they pertain to dietary supplements and foods is currently not permitted, and people who do so are vigorously pursued by both the FDA and the Federal Trade Commission. MAJOR CONCERNS

While we have several concerns with the CAM Regulation Guidance, the two biggest are broadening the definition of “health claim” and the desire to pre-empt the states in the regulation of some health care issues.For example, the document attempts to define how vegetable juice might be defined as a drug: “This means, for example, if a person decides to produce and sell raw vegetable juice for use in juice therapy to promote optimal health, that product is a food subject to the requirements for food in the Act and FDA regulations…If the juice therapy is intended for use as part of a disease treatment regimen instead of for general wellness, the vegetable juice would be subject to regulation as a drug under the Act.”

The FDA defines a drug as “…(B) articles intended for the use in the diagnosis, cure, mitigation, treatment or prevention of disease in man or other animals; and (C) articles (other than food) intended to affect the structure or any function of the body of man or other animals.”

 The FDA is stating that it believes that any person (or product) who states “drink some vegetable juice to prevent [insert disease]” is actually making a drug claim; and if vegetable juice is not recognized by the FDA as a legally available drug in the United States, the person (or manufacturer) making the claim is now subject to prosecution if they are not a medical professional licensed to practice medicine.

 Who is going to fund a $50,000 investigational new drug application to get carrot juice approved as a drug, or the follow-on millions in research dollars to conduct a study on the toxicity ($200,000) and efficacy of carrot juice ($3 million and up)? Keep in mind that this would have to be done separately for any disease process upon which carrot juice might have an impact.

Why Drugs Don’t Help Diabetes Patients’ Hearts; Part 2

April 1st, 2010

This is my continuation of Why Drugs Don’t Help Diabetes Patients Hearts.  It is an article that was published in Time magazine this year and is well worth the read.

“Now, results of the remaining two arms of the trial — one in which patients were treated with blood-pressure-lowering drugs and another in which they received statins to reduce cholesterol and fibrate medications to slice their trigylceride levels — showed the same trend, finding that aggressive drug treatment did little to reduce the volunteers’ risk of developing heart problems.

In the blood-pressure study, involving about 4,700 diabetes patients, researchers lowered the participants’ systolic blood pressure to either below 120 or 140 using a combination of drugs. But lower blood pressure did not lead to fewer heart attacks or heart-related deaths, and patients taking more drugs to keep their blood pressure under the lower target were more likely to suffer severe side effects.

In the statin and fibrate study, about 5,500 patients with diabetes and at least one other health problem were given cholesterol-lowering statins; half were also given a triglyceride-lowering fibrate. There was no difference in heart-attack and stroke rates between the groups.

The findings were published online in the New England Journal of Medicine (NEJM). The results of two other related studies were also published online: one large trial also looked at the effect of reducing blood pressure in diabetes patients; another trial, involving 9,300 patients who had high blood sugar and were at high risk of developing diabetes, measured the benefit of drugs that blunt the sharp peaks and valleys in blood glucose levels that occur after eating. Neither study showed benefits of these treatments in reducing risk of heart disease.

Although each of these studies included several thousand diabetes patients, which bolsters the reliability of their results, it doesn’t mean they are the final word on the tested treatments. In the blood-fats arm of the ACCORD study, for instance, about 40% of the volunteers had already had a previous heart event and the remainder had risk factors, other than diabetes, that put them at high risk for heart disease, notes Dr. Om Ganda, director of the lipid clinic at Joslin Diabetes Center in Boston. That means the trial was not truly a primary-prevention study designed to test whether aggressive drug treatment could prevent a first heart attack in newly diagnosed diabetes patients.

The researchers had hoped that treated patients would lower their risk of heart events because they were given both statin drugs, which curb the liver’s production of cholesterol, and a fibrate, which mops up harmful triglycerides in the blood and boosts levels of “good” cholesterol. But all of the volunteers either already suffered from heart disease, or had two or more major risk factors for heart problems — including cigarette smoking, family history and high cholesterol — in addition to diabetes. That may have pushed their diabetes too far along to allow them to see any benefit from the drugs. “This may be too late a state to expect major benefits from the medications,” says Ganda.”