How The FDA Works to Suppress Knowledge about Nutritional Supplement Benefits

What follows is an actual letter sent by the FDA to owners of a health food store in upstate NY. By reading it, you can see how the FDA literally uses words to make it a crime to share actual, scientifically-verified facts about nutritional and botanical supplements. I explain more about this after the letter.

From the FDA:

This is to advise you that the Food and Drug Administration (FDA) has reviewed your website..and has determined that the products "Kyolic Original Formula 100" (200 cap), "Nature's Way Sarsaparilla Root" (100 cap), "Nutrition Now PB 8 Pro-Biotic Acidophilus" (60 cap), and "Nature's Way Alfa-Max" (100 cap) are promoted for conditions that cause the products to be drugs under section 201 (g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. § 321(g)(1)(B)]. The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease. (emphasis added) The marketing of these products with these claims violates the Act.

Examples of some of the claims observed on your website include:

Kyolic Original Formula 100 (200 cap)

• "Kyolic Formula 100 ... may be beneficial for ... blood pressure, cholesterol levels, heart disease ... arteriosclerosis, arthritis, asthma, cancer ... infections of the eyes, ears, throat, respiratory infections ... flu ... fungal infections, viral infections ...."

Nature's Way Sarsaparilla Root (100 cap)

• "Sarsaparilla [an ingredient in your product] may help in the treatment of congestive heart failure, high blood pressure impotence ... swelling and discomfort from rheumatism and arthritis ... psoriasis ... syphilis ...."

Nutrition Now PB 8 Pro-Biotic Acidophilus (60 cap)

• "Acidophilus [an ingredient in your product] ... has anti-fungal activity ... and play [sic] a role in yeast infections, urinary tract infections, cancer prevention, cholesterol levels ...."

Nature's Way Alfa-Max (100 cap)

• "Alfalfa [an ingredient in your product] ... may be used for allergies, anemia, arthritis, asthma, blood disorders ... high cholesterol and diabetes ...."

Your products are not generally recognized as safe and effective for the above referenced uses and therefore, the products are "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(P)]. New drugs may not be legally marketed in the U.S. without prior approval from FDA as described in section 505(a) of the Act [21 U.S.C. § 355(a)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective. Furthermore, because your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written so that a layman can use the products safely for their intended uses. Thus, your products "Kyolic Original Formula 100" (200 cap), "Nature's Way Sarsaparilla Root" (100 cap), "Nutrition Now PB 8 Pro-Biotic Acidophilus" (60 cap), and "Nature's Way Alfa-Max" (100 cap) are also misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)] in that the labeling for these drugs fails to bear adequate directions for use. The introduction of a misbranded drug into interstate commerce is a violation of § 301(a) of the Act, 21 U.S.C. § 331(a).

The above violations are not meant to be an all-inclusive list of deficiencies in your products and their labeling. While reviewing your website, we noticed that you were promoting other products for disease treatment and/or prevention. The unlawful disease treatment and prevention claims on your website were too numerous to list in this letter. It is your responsibility to ensure that products marketed by your firm comply with the Act and its implementing regulations. We advise you to review your website, product labels, and other labeling and promotional materials for your products to ensure that the claims you make for your products do not cause them to violate the Act.

You should take prompt action to correct the violations described above and prevent their future recurrence. Failure to do so may result in enforcement action without further notice. The Act authorizes the seizure of illegal products and injunctions against manufacturers and distributors of those products [21 U.S.C. §§ 332 and 334].

Please notify this office, in writing, within fifteen (15) working days of the receipt of this letter, as to the specific steps you have taken to correct the violations noted above and to assure that similar violations do not occur. Include any documentation necessary to show that correction has been achieved. If corrective actions cannot be completed within fifteen working days, state the reason for the delay and the time within which the corrections will be completed.


My Comments

Note this sentence from the FDA's letter: "The therapeutic claims on your website establish that the products are drugs because they are intended for use in the cure, mitigation, treatment, or prevention of disease." By claiming the definition and usage of the word "drug", the FDA makes it illegal for any nutritional supplement company to share any health benefits related to their supplements without prior permission from the FDA (permission that will not be granted).

Also note that in the majority of examples the FDA cites, the website only said "may" in terms of the potential health benefits that the products might provide. More importantly, science does support the benefits attributed to the product. Kyolic, for instance, is a garlic supplement, and garlic has been shown to be beneficial for the conditions the website cites.

But as soon as someone shares these facts in conjunction with selling supplements, the FDA accuses them of a crime because doing so, they claim, means they are marketing "drugs."

But it's perfectly OK for drug companies to hawk their drugs to anyone without such FDA interference. Despite the fact that drugs, properly prescribed and taken, kill over 100,000 Americans each and every year, hospitalize another 2 million people, and cause additional harm to 20 million more, and these are conservative estimates.

This abominable double standard is just one example of how deeply the FDA is in bed with Big Pharma.

Is the Profit Motive Harming and Killing Cancer Patients?

“It is difficult to get a man to understand something when his salary depends on his not understanding it.” – Upton Sinclair

Here is a shocking fact you most likely did not know: Unlike other kinds of doctors, cancer doctors (oncologists) are allowed to profit from the sale of chemotherapy drugs. In fact, most of the annual income oncologists earn comes from the profit that they make from selling these highly toxic drugs to their patients.

That’s not supposition on my part. That’s a fact reported by NBC Nightly News back in 2006. You can watch the report here.

As NBC reported, oncologists buy chemotherapy drugs at wholesale prices and then sell them to their patients at “marked up prices.”


This absurd practice was made legal years ago after Medicare and health insurance companies decided it would be a good idea to move cancer patients out of hospitals and into the care of private practice oncologists. Their reasoning was that this was necessary in order to save money. What happened as a result of this misguided decision was the exact opposite.

Instead of saving money, the cost of chemotherapy drugs skyrocketed to tens of thousands of dollars a year, and in some cases, tens of thousands of dollars per month.

Medical ethicists have for years questioned the wisdom of allowing oncologists to continue to earn the majority of their incomes from the sale of chemotherapy drugs, correctly pointing out that doing so creates a serious conflict of interest between patient welfare and oncologists’ desire to prescribe the drugs that they are going to make the most money from even when they are not what their patients needs. This includes over-prescribing drugs beyond the point in which they are effective.

How many cancer patients have died because their doctors succumbed to the lure of maximizing their profits and administered chemotherapy drugs inappropriately?

No one can say, but in all likelihood at least some cancer patients did die because of their doctors’ desire for profits.

This is a travesty and it needs to stop!

Correctly this great wrong won’t be easy, however, nor can oncologists as a whole be blamed.

Although I strongly disagree with the use of chemotherapy drugs the way they are administered by conventional oncologists—for the simple reason that, in the majority of cases, they do not work—at the same time I recognize that most cancer doctors and their staffs are extremely dedicated professionals who are doing all they can, based on how they have been taught (persuaded, would be the better word) to treat cancer.

In short, it’s not oncologists who are at the root of this problem; it’s the system in which they are trapped!

This fact was admitted to by Dr. Peter Eisenberg, a conventional cancer specialist who was interviewed as part of the NBC report mentioned above. In it, he said, “Patients should feel that their physician has their best interest at heart, always. And the way the system is set up, because of the incentives [for selling chemotherapy drugs to their patients], does something to destroy that.”

So, what can be done about this?

The first step appears clear-cut. The profit motive for oncologists must be eliminated in the arena of cancer care, by eliminating their ability to buy drugs at wholesale and then to sell them at often much higher prices. (Note: Usually, it is not the cancer patients who pay these exorbitant prices; it is health insurance companies and/or Medicare/Medicaid. The end result is higher health insurance premiums for all of us, and a further drain of taxpayer money from our federal government’s already overstrained resources.)

Oncologists must return to administering their drugs in the same way that all other MDs do: Instead of selling drugs directly, they must simply prescribe them, as they once used to do.

But this step alone, will not fix the problem, and here’s where things get more complicated. And more suspect.

You see, the real reason cancer drugs cost so much has very little to do with how much it costs drug companies to develop them and bring them to market. Nor does their cost have anything to do with their potential to save lives. If that were the case for chemotherapy drugs, their price would be extremely low given how abysmal a track record they have for improving cancer patients’ quality of life and extending their survival rates, let alone actually curing cancer, which they most certainly do not (at best, they only temporarily put cancer into remission).

No, the real reason cancer drugs in the United States costs so much (well over $100,000 a year for a single patient in the case of many of the new generation of cancer drugs) is very simple:

Cancer drugs—especially the new generation of drugs—cost so much because they have no competitors.

In other words, drug companies can charge whatever they want for their cancer drugs, and they do exactly that!

You might think that such price-gouging by the drug companies could easily be curtailed if health insurance companies if they simply refused to pay the prices Big Pharma demands for their cancer drugs. In theory, this is correct, but the reality of this situation paints a different story. First, refusing to pay the cost of cancer drugs would garner a lot of ill-will towards health insurance companies by the public, and these companies already have enough of that as it is.

But the bigger issue has to do with Medicare. You see, when it comes to paying for the price of drugs, both cancer drugs and otherwise, health insurance companies take their lead from Medicare. Medicare does not provide coverage for most types of drugs, but it does cover the use cancer drugs. Most health insurance companies simply follow the guidelines for drug reimbursement that are established by the government’s Centers for Medicare and Medicaid Services (CMS). And when it comes to the price of cancer drugs, as far as CMS is concerned, anything goes!

This is in stark contrast to how CMS acts with regard to all other types of drugs. Aside from cancer drugs, CMS controls medical costs by establishing the fees that are paid under Medicare/Medicaid for nearly all other medical procedures, including drug usage, by both doctors and hospitals. Once CMS establishes these fees, health insurance companies set their own rates of coverage to coincide with them.

What this means is very simple to understand: If CMS dealt with the price of cancer drugs in the same way that it does for all other medications, the price of cancer drugs would quickly plummet, largely sparing oncologists of the temptation to try and profit from their use.

When it comes to cancer drugs, CMS must change its policies!

Then there is a third, and equally important factor to consider: The Pharmaceutical Research and Manufacturers of America (PhRMA). PhRMA bills itself as the pharmaceutical industry trade group. In plain English, it means that it’s a drug lobby. And since 1992 its work has paid huge dividends for Big Pharma, from which its funding is derived. You see, PhRMA convinced the US Congress and President Bill Clinton to enact a bill known as the Prescription Drug User Fee Act (PDUFA) of 1992. Once the act was passed and signed into law, Big Pharma effectively became the fox guarding the henhouse of the Food and Drug Administration (FDA). This came about because the act means that, since its passage, Big Pharma actually helps fund the FDA’s research and approval process of the very pharmaceutical drugs the FDA is supposed to be regulating on our behalf. Not only does Big Pharma’s funding of the FDA create a direct and serious conflict of interest, it also ensures that the FDA provides a speedier approval process of pharmaceutical drugs, many of which later prove to be ineffective, life-threatening, or both!

By now, I’m sure you can understand that one of the most serious underlying problems that have kept conventional cancer treatment in the US focused almost entirely on dangerous and ineffective cancer drugs is the fact that cancer is big business. Hundreds of billions of dollars are spent each and every year on behalf of cancer patients and their loved ones who are desperate to reverse this terrible disease. And all of that money winds up in the pockets of the doctors and clinics that treating cancer with these cancer drugs, and, most especially, the pharmaceutical drug companies who manufacture them and promote their use.

Human nature being what it is, it would be foolish to expect those who profit most from the use of these cancer drugs, including oncologists, will suddenly change course and start investigating the cheaper, safer, and far more effective cancer treatments that I have spent decades of my life investigating. Not when their livelihoods depend so greatly on the status quo of cancer care today.

Therefore, it is up to each and every one of us to pressure our elected officials to clean up this sad state of affairs that we are in. To do so, we must insist on the following:

• Oncologists must be prohibited from buying and reselling cancer drugs for profit.

• The Centers for Medicare and Medicaid Services must begin to establish the fees that are paid under Medicare/Medicaid for cancer drugs and cancer treatments, just as they do for all other drugs and medical procedures.

• The influence of Big Pharma and their lobbyist group the Pharmaceutical Research and Manufacturers of America must end, both at the FDA, and within Congress (the drug lobby has more lobbyists in Congress and spends more lobbying money there than any other lobbyist group), and the Prescription Drug User Fee Act of 1992 must be rescinded.

If we as a nation can achieve these goals, then truly effective approaches for treating cancer in the United States may at last come into the full light of day.

More Proof the FDA Protects Big Pharma and Other Special Interests, Not Your Health

The Food and Drug Administration (FDA) has long been in the pockets of Big Pharma and other special interests opposed to the public’s right to access non-drug-based health care methods of their choice. Sadly, however, most people today believe that the FDA lives up to its mandate to protect them. While there are certainly many dedicated and conscientious scientists and researchers employed by the FDA who are attempting to do just that, their efforts are often thwarted at the FDA’s administration level, due to the cozy and incestuous relationship between FDA higher ups, including many of its commissioners, past and present, and the special interest groups the FDA is charged with regulating.

What follows are two recent examples of the FDA’s abuse of its power at the expense of we the people who fund its operations with our tax dollars. The first was forwarded to me by my friend Dr. Garry Gordon, who wrote: “This is sad. We find out that the Commissioner of FDA was a director of Henry Schein, a major supplier of amalgam to the dentists. She has chosen to protect her stock value and ignore the mercury health risk to children.”

FDA’s Sharfstein Covers Up Mercury-Neurological Harm Nexus (6 August 2009)

FDA Deputy Commissioner Joshua Sharfstein has given his seal of approval to major mercury exposure for millions of America’s children and unborn children – and to covering up both the neurological risks and the flawed rulemaking process.

Despite admitting that amalgam causes mercury exposure -- and despite knowing that mercury causes neurological harm to developing brains -- Sharfstein rejects putting on contraindications for amalgam, rejects putting on warnings on amalgam and even rejects a requirement that dentists tell patients that amalgam is mainly mercury.

Sharfstein even withdraws FDA’s website warning that dental mercury can cause permanent neurological harm to children and unborn children. Sharfstein’s rule actually says FDA wants to stop a decline in amalgam sales. At Joshua Sharfstein’s FDA, commerce trumps safety.

When the Republicans ran FDA, to their real credit, they put this warning on the FDA website: “Dental amalgams contain mercury, which may have neurotoxic effects on the nervous systems of developing children and fetuses.” Upon assuming power, the Democrats withdrew this warning, covering up the fact that mercury from amalgam causes permanent harm to young children and kills unborn babies. Is this the change we Americans voted for?

Washington is famous for the revolving door -- those in the party out of power takes highly paid corporate positions, then returns to government to bail out their benefactors. The new FDA Commissioner, Margaret Hamburg, worked in the Clinton Administration, then went out and became a director at the dental products colossus Henry Schein, earning a quarter million dollars a year for the handful of hours it takes to be a director. Corporations do this because they know the other party will return to power, at which time the corporations will call in their chits.

Upon becoming Commissioner, Dr. Hamburg owned between $250,000 and $500,000 of Henry Schein stock. Certainly the Harvard-educated Hamburg knew the amalgam rule had the potential to affect her stock value. She could have done the right thing -- recuse herself from the rule. Instead, she worked on the rule for a while, then recused herself gradually, first by “deciding not to participate,” then finally “recusing.” Certainly her next-in-command, Deputy Commissioner, Joshua Sharfstein got the message that there was more at stake than good government.

On what date did Hamburg sell her Schein stock? What work did Hamburg do on the rule before she recused herself? What work did she do protecting amalgam from regulators while at Schein? Through her lawyer, Hamburg refuses to answer any of these questions. Ironically, Sharfstein heads a new a FDA “transparency task force.” A perfect first project would be to expose the Hamburg-Henry Schein links.

Joshua Sharfstein had the opportunity to protect children from amalgam, to save unborn babies and nursing babies from mercury exposure, and to warn us all that amalgam exposes us to toxic mercury. He came to Washington as a child advocate, but changed his stripes once he saw the revolving door game in action. Throwing his reputation out the window, Joshua Sharfstein chose to ally with the amalgam industry and cover up the mercury, turning his back on the children of America.

Just as Margaret Hamburg has embarrassed President Obama for bringing back revolving-door government, Joshua Sharfstein has embarrassed the President for deciding not to reduce the use of mercury in oral health care. If ever a President entered office as an inalterable opponent of mercury, it is Barack Obama, who wrote a law banning mercury exports and who is working for a treaty to phase out man-made mercury by a date certain. But at FDA, his appointee Sharfstein is sabotaging the President’s policies by hiding the mercury from Americans and hence keeping amalgam sales going into the indefinite future.

FDA doesn’t even defend its rule on the science. FDA admits it does not know if mercury fillings are safe for children six and under, or for nursing mothers whose mercury goes through the breast milk, or for pregnant women whose dental mercury No, it’s not science -- it’s about commerce. FDA wants Americans to keep buying amalgam.

The children of America have lost. Another generation will be mercury toxic.

Need further evidence on who won? Just yesterday (Aug. 5), Henry Schein’s CEO Stanley Bergman offered this salute to Dr. Hamburg:

“I would like to extend on behalf of the company, our Board and our shareholders our sincere thanks to Dr. Margaret Hamburg, who has served as the Director of Henry Schein Company's Board since 2003. Dr. Hamburg left our Board following her confirmation as Commissioner of the U.S. Food and Drug Administration. We would like to thank Dr. Hamburg for the insight she shared with the Henry Schein Board throughout the years and wish her continued success.”

Hamburg claims she broke her ties with Schein three months ago. But Schein’s CEO issues his thank-you the day after the FDA rule was published in the Federal Register. Margaret Hamburg may not be in the hip pocket of Henry Schein Inc, but Schein’s CEO sure thinks she is. And he has the evidence to show it: a rule that allows Schein to sell amalgam to anyone, a rule that covers up the mercury, a rule that contains propaganda to be used by Schein to defend against the upcoming class action suits.

FDA bans mercury in all veterinary products. The new FDA, under Margaret Hamburg and her Sancho Panza, Joshua Sharfstein, have decided that children don’t merit the protection FDA gives horses and dogs.

The Washington bigshots have direct access to Joshua Sharfstein. So should you: his e-address is JMSharf1@fda.hhs.gov Why not write him yourself? Talking points follow:

Questions to consider asking Deputy Commissioner Sharfstein

(1) Dr Sharfstein, why, under your rule, are children less important than horses and dogs when it comes to mercury exposure?

(2) Why did you Democrats withdraw FDA’s website warning that dental mercury can cause neurological harm to children and unborn children, which the Republican Commissioner agreed to last year?

(3) Will your new “transparency task force” disclose the details of your boss’s ties with Henry Schein, or will she be allowed to cover it up like you cover up the risks of ental mercury?

(4) Does President Obama know that you approved a rule that will keep Americans from learning that amalgam is mainly mercury, and does the President know about Commissioner Hamburg’s conflict of interest with Henry Schein?

Charles G. Brown, National Counsel
Consumers for Dental Choice
www.toxicteeth.org

This next item was sent to me by Deborah A. Ray, MT of the American Association for Health Freedom, an organization I strongly support. (To find out more about AAHF, visit www.healthfreedom.net.)

FDA Attacks Natural Thyroid Millions Depend On

We have learned that Time-Cap Labs, producer of a generic version of the brand name drug Armour, a natural and bioidentical thyroid replacement, has been ordered by the FDA to stop production. The FDA has decided to classify the company’s product, available for over a century, as an unapproved new drug. Since the new drug approval process is prohibitively expensive for a non-patentable substance, the FDA is in effect banning the natural product. The purpose? Presumably to protect the profits of other, inferior drugs that have been FDA approved.

According to statistics by the American Association of Clinical Endocrinologists and other medical organizations, approximately twenty-seven million Americans have a thyroid disorder. Thyroid consumer advocate Mary Shomon projects that 2 million of these patients take either Armour Thyroid or a generic equivalent.

Armour and other "whole" natural thyroid preparations (including Westhroid and Nathroid as well as Time-Cap Lab’s Thyroid) are bio-identical, complete hormone preparations, containing "T4" "T3" "T2" and "T1" in the same proportions made by the human thyroid.

The FDA approved preparations Synthroid (T4), Cytomel (T3), and Levethyroxine (T4) include bio-identical molecules, but are not complete or totally bio-identical as they do not contain "T2" or "T1". It’s no wonder so many people feel much better with the balanced natural products that have been available for generations.

As famed physician Dr. Jonathan Wright observes: “Natural thyroid has never killed or severely harmed anyone since first use in the 1890s, prior to the FDA itself. It is a mainstay not only in the treatment of hypothyroidism but also in ‘healthy aging’ therapy. That the FDA should even be its thinking of requiring a new drug approval for a safe, 100 plus year old natural treatment is outrageous.”

We will report further as soon as we confirm more of the facts, and as always, we’ll let you know how you can get involved.