By Dr. Mercola
While Americans were busy making 4th of July plans, the U.S. Food and Drug Administration released two new guidance policies on over-the-counter (OTC) products it regulates. One, a final rule on how sunscreens will be marketed in the U.S. beginning next summer, came out with a media blitz that attracted nearly every news outlet in the country.
But the other, a proposed draft policy on dietary supplements, sneaked onto the scene so silently it barely made a blip on the media radar. This was snuck in because it could effectively kill your rights to purchase natural vitamins and supplements over-the-counter or, at the very least, make them so expensive you won't be able to afford them. Both policies are perfect examples of how government keeps you sick.
The open comment period on the FDA's proposed guidelines expires on September 30, 2011. You will find details on how you can get involved at the end of this article, and I urge you to stand up and let your voice be heard on this very important issue.
The FDA's Deadly Bureaucracy of Regulating Health and Safety
Developed nations have become literal "nanny states" in the way they regulate, mandate, and deliver health care, with the U.S. leading the way. In the U.S. or any other developed country, there's no shortage of rules and regulations on health care products and procedures. Yet, it appears from the two charts below; the first one on health care expenditures and the second one on life expectancy that the more a country spends on health care, the less healthy it tends to be.
As you can see, the U.S. outspends every other industrialized nation on its health care, yet it is dead last in life expectancy compared to its peers. It's also the most vaccinated country in the world. Yet a ground-breaking study recently revealed that countries that give the most vaccines have the worst infant death rates, again, with the U.S. leading the pack. Sadly, these trends aren't limited to the U.S. – the truth is too many people in industrialized nations are sick – and getting sicker.
In her book, Death by Modern Medicine, Dr. Carolyn Dean talks about how government bureaucracy and conflicts of interest with the drug industry contribute to this. The FDA, especially, has a history of making questionable decisions possibly influenced by pharma, such as the Vioxx scandal, where 10 of 32 advisers who voted to approve Vioxx had financial ties to the drug industry.
But other drugs have gotten similar free passes, so many in fact, that last year Dr. Marcia Angell, former editor-in-chief of the New England Journal of Medicine, accused the FDA of being "a servant of the industry it regulates." Industry influence, she said, has gotten so bad that FDA employees "are inhibited from acting against drug company interests." Unfortunately, the FDA has a record of making questionable bureaucratic decisions even when there isn't an obvious conflict of interest.
Death by Failure to Act
The FDA's been working on sunscreen regulations since 1978. They published draft rules in 1999, but delayed the final ones until now. In the interim, you've been slathering on sunscreens with ascending degrees of SPFs, thinking they're protecting you from cancer because the FDA said they do. But instead of going down, rates for melanoma – the most serious type of skin cancer – have gone UP by four percent per year since 1973.
CDC scientists blame more exposure to the sun for this. But it turns out that some sunscreens may be contributing to the rise in cancer! As revealed by the Environmental Working Group (EWG), the FDA was aware of this for 10 years, but did nothing about it. They denied it, but according to the Huffington Post, documents show that the agency itself not only had done the research, but posted it on its website. You can only wonder how many people died from sunscreen-caused melanoma while the FDA failed to act on this.
Another thing that neither the FDA, nor the CDC, nor the Institute of Medicine's Food and Nutrition Board (FNB) are admitting is that their recommendations to stay out of the sun, or keep most of your body covered while you're in it, aren't in your best interest either. Australians found out the hard way that their aggressive anti-sun campaign ended up with 35 to 70 percent of the population being severely deficient in vitamin D. As a result they've seen a massive increase in osteoporosis-related broken bones, which costs their healthcare system $1.9 billion a year to treat!
We know that most Americans are deficient in vitamin D,. There's also plenty of evidence that vitamin D plays a part in cancer prevention, heart disease, and diabetes. Since even WebMD promotes safe sun exposure – sans sunscreen – for maintaining healthy levels of vitamin D, the only question left to ask is: why is the FDA bombarding the media with warnings to stay out of the sun (a natural source of vitamin D) and why would the FNB recommend such low levels of it that it literally could keep you sick?
A possible answer could be that, as Daniel Haley, a former FDA official-turned-whistleblower said, the FDA considers the drug industry their client. That's right; they're not working for you, the consumer. They work for the drug industry. And as Haley pointed out, the FDA has a history of making decisions that look out for their client. Seeing that the industry is now doing hundreds of clinical studies on synthetic versions of all kinds of natural products – something that is patentable – it's logical that the FDA may just be stalling long enough for these products to come to market.
Crazy Laws + Cookbook Medicine = A Recipe for Making and Keeping You Sick
The gold standard for insurance coverage and payments is set by the government through Medicare. It's a legislated cookbook of diseases with a pre-chosen recipe for treating and paying for them – and the guidelines and compensation don't include complementary or alternative medicine. This is especially poignant right now, as the new "affordable" health care law transitions into effect in the U.S.
Although this study was done 15 years ago at George Washington University it does explain how the Medicare paradigm became what we know as "health care" in the U.S. today. The "cookbook" part of it comes from the diagnosis-related groups known as DRGs. If there isn't a DRG for your ailment, then Medicare – and thus, private insurance – won't pay.
Most health problems are now treated with drugs instead of other forms of therapy, and the price of those drugs go far beyond the initial price tag. Not only do they not perform as well as you might want them to, but they have plenty of adverse side effects, including death. In other words, indirectly, by the way Medicare controls insurance payments, it's just another way government keeps you sick.
Supplements Don't Kill – but Drugs Do
S.1310: Dietary Supplement Labeling Act of 2011, introduced at the end of June by U.S. Senator Richard Durbin (D-Illinois) is trying to treat vitamins as if they are drugs, allegedly to "improve the safety of dietary supplements," which implies that supplements must be a major safety hazard to begin with. Durbin's bill goes hand-in-hand with new FDA regulations that amend the definitions for new dietary ingredients (NDI's), and together, they can threaten your health and freedom of choice, and further serve to strengthen the fatally flawed paradigm of health and medicine.
An estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and administered, and an estimated two million more suffer serious side effects.
How does the safety of supplements compare?
- In 2001, 84.6 percent of all substances implicated in fatal poisonings were pharmaceutical drugs, according to that year's American Association of Poison Control Centers (AAPCC) report. This compares with 0.8 percent for all dietary supplements combined, even including substances such as dinitrophenol, a dangerous (and illegal) substance banned in 1938, as well as the central nervous system stimulant Ma Huang (Ephedra). ONE drug alone, the anti-asthma drug theophylline, which was responsible for 15 deaths that year, amounted to 66 percent more than all the available dietary supplements combined.
- According to CDC mortality data for 2005, prescription drugs killed more than 33,500 people that year, second only to car accidents. That same year, the American Association of Poison Control Centers reported 27 deaths that were associated with dietary supplements
Legal DRUGS are killing massive numbers of people, not vitamins and supplements. Unfortunately, one reason for all these drug deaths could be the lax way the FDA "regulates" the drug industry by not requiring that all serious events in a trial be made public:
"When a clinical trial that is undertaken by drug companies shows that a drug has serious side effects, there is no law that says that study has to be published or made public in any way," Dr. Dean says in her book.
Vioxx is a perfect example of a product that was approved without having published all the clinical studies where serious events that resulted in the deaths of over 60,000 people were discovered.
What's obvious is that the number of people taking supplements and vitamins is continuously growing. It's a $60-billion-a-year industry, and the drug industry wants a piece of that pie, as evidenced by drug giant Pfizer, which recently announced that it's going into the supplement business to counter some of the losses from its blockbusters that are soon going off-patent. The FDA is apparently on-track to protect its client's vitamin and supplement interests by proposing the new policy it slipped in just before July 4.
Death by Denial is Government's Most Egregious Sin
This story is one with many chapters. From misleading statements about the safety of vaccines to deliberate denial of the benefit of certain herbs, vitamins and supplements, I think you can see how the government keeps you sick by denying the benefits of complementary and alternative strategies and treatments while telling you to just shut up and take your medicine – without acknowledging that most prescription medicines don't work on most people who take them.
That comment, by the way, is straight from the horse's mouth – in 2003 a senior executive at GlaxoSmithKline, Allen Roses, said:
"The vast majority of drugs – more than 90 percent – only work in 30 or 50 percent of the people. I wouldn't say that most drugs don't work. I would say that most drugs work in 30 to 50 percent of people. Drugs out there on the market work, but they don't work in everybody."
Roses gave examples too: drugs for Alzheimer's disease work for less than one in three patients; for less than a fourth of cancer patients; and for only about half of patients with arthritis, migraines, and osteoporosis. But what does work is cleverly clouded by government agencies that manipulate numbers and clinical findings to justify their mandates and regulations. I could give no better example than Great Britain, which just a few weeks ago declared that they were scrapping the pneumonia vaccine because "it didn't work" in senior citizens.
But what happened?
Very quickly, UK officials back-peddled, announcing they were going back to recommending the vaccine after all because "new trials" indicated efficacy they weren't aware of. I'd be OK with this, but as Marcia Angell has pointed out several times in her criticism of industry today, since drug officials have been known to manipulate trials to say whatever they want them to say, it makes me wonder what really happened here. After reading the transcript of the meeting where they changed their minds, I believe the decision has more to do with making sure there's a market for the pneumococcal vaccine than it does with vaccine efficacy.
The bottom line is that, unlike people in the European Union, which just passed major, oppressive regulations on vitamins and supplements, you still have a chance to voice your opinion on the FDA's proposed vitamin and supplement policy. You still have time to do study this yourself, and to form your own opinion on this proposed rule, perhaps by starting here or here and reading the government's own research on natural vitamins and supplements.
Why You are at Risk of Losing MOST of Your Supplements!
If this rule becomes permanent, vitamin and supplement companies will not be able to afford the FDA drug trial process. It costs an average of $359 million, and takes 10 years for a new drug to come to market under FDA drug trial rules. If vitamins and supplements are treated as drugs under the new proposed rules, the most likely outcome will be that most supplement companies will go out of business. And drug companies like Pfizer will pick up where they leave off.
Since the prescription drug user fees are major funding sources for the FDA, and since the FDA always wants more money, it's easy to see why the FDA wants this to happen. But don't just take my word for it. Instead, I invite you to follow all the links I've provided here and study them.
If You Want to Keep Your Supplements Get Involved NOW!
The open comment period on the FDA's proposed guidelines expires on September 30, 2011. It's vitally important for everyone to file a written protest and not allow them to rewrite the intent of the DSHEA law. The FDA proposal poses a direct threat to your health and longevity, so please, step up and defend your right to continue using supplements and to gain access to new natural ingredients with demonstrated efficacy.
Additionally, S.1310: Dietary Supplement Labeling Act of 2011, introduced at the end of June by U.S. Senator Richard Durbin (D-Illinois) is part and parcel of this current attack on your health freedom. For more information on this bill, and how it fits hand in glove with the FDA's proposed mandates, please review this recent article.
Please Take Action Today
- Write to your State Senators and tell them to beware of S.1310 and to vote NO on it.
- Log on to www.lef.org/lac to send a written petition to the FDA, or use the sample letter provided below. Print out this petition and add any words you choose and fax this to the FDA at the following number: (301) 443-9767
- Call FDA at 1-888-723-3366 and read this petition to personnel at the Office of Nutrition, Labeling and Dietary Supplements
- Send a Freedom of Information Act (FOIA) request by logging in to lef.org/FOIA to find out what pharmaceutical interests are behind these absurd proposals that will cause the cost of what supplements remain on the free market to skyrocket in price. (Sample letter is also provided below.)
- Send a letter to your Representative and two Senators demanding the FDA immediately withdraw their oppressive proposed guidelines pending rationale discussions with those who depend on dietary supplements to protect their health and livelihood. You can do this easily by logging into www.lef.org/lac, or use the sample letter below.
Empower yourself today. Recall how Consumers revolted back in 1994 and the result was a glorious victory over FDA tyranny!
Let your voice be heard by logging on to www.lef.org/lac today and exercising your right to petition the government against these serious violations of the law and scientific principle.
SAMPLE FDA PETITION:
PLEASE NOTE, it is best if you customize or change the letter below to state your specific concerns and beliefs as it will be better. If you are unable to then you can send the one below but it will work MUCH better if you can customize it.
TO: Center for Food Safety and Applied Nutrition
Office of Nutrition, Labeling and Dietary Supplements
Food and Drug Administration
5100 Paint Branch Pkwy.HFS-009
College Park, MD 20740-3835
Telephone:1-888-723-3366
Fax: (301) 443-9767
On July 11, 2011, President Obama issued an Executive Order that requires the FDA to:
- Make regulatory decisions only after consideration of their costs and benefits (both quantitative and qualitative).
- Review significant regulations to make sure they are not excessively burdensome.
- Develop and release to the public a plan within 120 days under which the FDA will periodically review its existing significant regulations to determine whether any such regulations should be modified, streamlined, expanded, or repealed so as to make the agency's regulatory program more effective or less burdensome in achieving the regulatory objectives.
I am petitioning the FDA regarding your draft guidance on New Dietary Ingredient notifications for dietary supplements (known as Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues).
I demand that you immediately disregard all the proposals you outlined and instead consider a rationale and scientific approach to regulating new dietary ingredients that will be submitted to you by the Alliance for Natural Health within the next 180 days.
Your proposed guidelines on New Dietary Ingredients will cause the price of my supplements to skyrocket and some of these life-sustaining supplements are likely to disappear altogether.
This is not acceptable, especially when there are no significant reports of adverse reactions to the supplements you plan to ban.
In as much as your threat to ban my access to new dietary ingredients is causing me great anxiety which is injurious to my health, I insist that you immediately put your proposed new rules on hold for a 180 day period so that the Alliance for Natural Health can draft guidelines that will protect me against unsafe ingredients without destroying my access to low cost effective nutrients.
Sincerely,
Name___________________Address___________________City__________________ST____ Zip_________
SAMPLE LETTER TO CONGRESS:
The Honorable _________________________Washington, DC
In direct violation of the law, the FDA is threatening to ban my access to new dietary supplements.
The FDA defines dietary supplements as being "new" if they were introduced after October 15, 1994. That means that nutrients that I have been safely using over the course of three decades will be subject to FDA's oppressive policies that mandate costly animal testing, which translates into forced withdrawal from the market, and higher prices for me if the supplement is ever allowed to be sold again.
The Dietary Supplement Health and Education Act of 1994 states that:
"The Federal Government should not take any actions to impose unreasonable regulatory barriers limiting or slowing the flow of safe products and accurate information to consumers."
It says that Congress finds that:
"dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare."
And it says that:
"legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness."
This draft guidance does the exact opposite of what Congress intended. It imposes unreasonable barriers that limit and slow the flow of safe products and accurate information to consumers. I call upon Congress to:
- Uphold the landmark legislation it passed seventeen years ago, and to direct the FDA to revise its New Dietary Ingredient draft guidelines to reflect DSHEA's (and Congress's) stated values and goals.
- Vote against the newly introduced Dietary Supplement Labeling Act as this would give the FDA even greater arbitrary powers to remove safe dietary supplements from the market, which will profoundly impact this nations' health in a negative way.
All of these proposals result in wasteful federal spending, while imposing a massive new "regulatory tax" on consumers and the vitamin industry.
Kindly let me know what actions you are taking in response to the urgent issues raised in this letter.
Sincerely,
Name___________Address____________City___________ST____ Zip___
SAMPLE FOIA REQUEST:
Below is a sample letter that you can use to select one or more of the 19 listed requests for records, or create your own individual request. You can then copy, edit, print, and send this to the FDA at the address on the letter. Please note that you are committing to paying a $25.00 charge if FDA agrees to respond to your request. The more records you request, the greater the FDA fees are likely to be. If you choose to file a Freedom of Information Act request, please read this letter carefully.
Date: _____________
Food and Drug Administration
Division of Freedom of Information
Office of Shared Services
Office of Public Information and Library Services
12420 Parklawn Drive
ELEM-1029
Rockville, MD 20857
Re: Freedom of Information Act Request
Dear FOIA staff:
Pursuant to the Freedom of Information Act, 5 U.S.C. §552, we wish to have copies at the earliest possible time, of any and all public records in the custody of the Food and Drug Administration that relate to the "Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues" released in July 2011.
I specifically request:
- All records relating to the expenditure of time and money by FDA personnel (and outside consultants) in researching, drafting and promulgating the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to communication of FDA personnel with pharmaceutical company representatives (including lobbyists) that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to communication of FDA personnel with any member of Congress or Congress as a whole that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to communication of FDA personnel with any member of private industry that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to communication of FDA personnel with any scientific advisory committee, scientific advisory board, or individual scientist that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to communication of FDA personnel with FDA' General Counsel's office, or outside legal counsel that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to FDA's evaluation of safety issues relating to new dietary ingredients that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to FDA's decision to impose barriers that limit the ability of consumers to access new dietary ingredients that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to communication of FDA personnel with other FDA personal that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to communication of FDA personnel with personal from the Department of Health and Human Services that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to communication of FDA personnel with personal from the U.S. Treasury Department that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to the cost benefit analysis performed by FDA or outside consultants that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to financial estimates made by FDA personnel or outside consultants relating to the cost to the FDA of administering the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to financial estimates made by FDA personnel or outside consultants relating to the cost burden of the dietary supplement industry in complying with the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to what human and other resources within the FDA would be utilized to oversee and administer the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to what human and other resources within the FDA would be moved or transferred from other positions within the FDA in order to oversee and administer the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to communication of FDA personnel with the Department of Justice that in any way relate to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to the steps taken by the FDA to ensure the Administrative Procedures Act was fully complied with as it relates to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
- All records relating to the steps taken by the FDA to ensure that provisions in the Dietary Supplement Health and Education Act of 1994 was fully adhered to as it relates to the Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.
I agree to pay any and all expenses up to $25.00 related to this request. If you anticipate that the nature or volume of the records requested is such as to require extensive use of information technology, resources, or extensive clerical or supervisory assistance by personnel of the Food and Drug Administration, and such expenses would exceed $25.00, I would appreciate being advised thereof in advance of the assembly of those records and the estimated charge in excess of $25.00, if any, for doing so.
If the FDA asserts an exemption from Public Records Act disclosure of any records falling within the scope of the above request, we request that it include in the records inspected, or otherwise make available to us as soon as possible and in no event no later than the date of the initial production of the records, a reasonable description of the nature of the records for which an exemption or exemptions are claimed and the statutory or other legal bases under any such exemption is claimed.
I would appreciate your contacting me, at ___________ at the earliest possible time to advise us of when the FDA will make the requested copies available.
Please call if you have any questions regarding this request.
Sincerely,