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Posts Tagged ‘FDA’

Citizens for Health Alert – 10 Days Left To Say “NO” To NDI Guidance

November 22nd, 2011 No comments

November 22, 2011

Dear Citizen for Health,

By now you are familiar with our campaign opposing the FDA’s “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”. We believe this document reflects the FDA’s intention to willfully and grossly misinterpret the law, especially the Dietary Supplement Health and Education Act of 1994 (DSHEA), regarding New Dietary Ingredients (NDIs) and filing submissions for them.

Thousands of you have demonstrated your commitment to health freedom with messages to your elected representatives and comments to the FDA, and we at CFH have submitted ours as well. You can read those comments here.

The deadline for comments is December 2. With only ten days left, we’ve created a petition to be delivered to Congress and the Presdient calling on them follow up with the FDA once the comment period closes as a final push to get this dangerous Guidance withdrawn. The targets here are different, so if you have already sent comments to the FDA, augment your voice by signing the petition too!

Sign the petition now!

As we’ve already made clear, if this guidance moves forward to govern future FDA policy it will strike at the very root of our health freedoms, and supplements and other products generally recognized as safe for nearly two decades will be re-assessed as if they contained new ingredients. This would cause major disruption in the dietary supplement market; force a significant number of products off the shelves; and result in revenue losses of over a billion dollars and the unemployment of over 100,000 Americans.

That’s why we need your help now, more than ever, to have the kind of impact that will make the FDA withdraw the guidance.

We want to amss at least 10,000 signatures in the next ten days so act quickly, and be sure to keep an eye out for further developments in this critical campaign.

As always, thanks for your participation,

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Categories: Be Socially Responsible Tags: ,

Protect Your Supplements from the FDA – File a Comment

November 21st, 2011 No comments


Besides emailing your senators and congressperson as explained in this post, it’s important to file your comments with the FDA itself, which will appear in the Federal Register and hopefully add to the voices of others and help save our supplements; otherwise, the FDA will claim that no one objected.

The link below will take you to where you can Submit a Comment. In one of the mandatory fields, it asks you the name of your organization: you can enter Citizens for Health in this (they’re one of the organizations leading our fight to save our supplements).

Feel free to customize your message and tell the FDA why access to supplements is important to you. The Comment form only allows a few words, so you might want to just put a short summary in it and save a more detailed message in a text (.txt) file, which it allows you to attach.

You can copy the text found here (sample letter) or modify the letter to congresspersons found here , and paste it into Microsoft word, word pad or notepad then save it as a .txt file.
Please note that, due to many requests from people who would be harmed by their loss of supplements, the FDA has granted an extension for us to file our comments — but we must submit them quickly, as they will not consider any submitted after December 2,  2011.

Link to where you can Submit Your Comments:
http://www.regulations.gov/#!documentDetail;D=FDA-2011-D-0376-0079

Organization:
Citizens for Health

Notice by the FDA of Comment period extension until December 2,  2011:

[Federal Register Volume 76, Number 175 (Friday, September 9, 2011)]
[Notices]
[Page 55927]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-23098]
——————————

—————————————–

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. FDA-2011-D-0376]
Draft Guidance for Industry; Dietary Supplements: New Dietary  Ingredient Notifications and Related Issues; Availability; Extension of  Comment Period

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Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues

November 21st, 2011 No comments

Re: Docket No. FDA-2011-D-0376-0079, “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues”

This guidance, if enacted, would put in place a series of onerous regulations for the supplement industry that will make it extremely expensive and difficult for the nutritional industry to keep manufacturing supplements — so expensive and difficult, in fact, that it will put most legitimate manufacturers out of business and potentially eliminate most supplements from the marketplace.

The rules as proposed seem innocent enough, requiring a stringent approval process for all supplements on the marketplace since 1994, when Congress passed the Dietary Supplement Health and Information Act (DHSEA). DHSEA was actually intended to protect nutritional and herbal manufacturers from unwarranted FDA harassment, and allow Americans access to legitimate supplements.

The sponsors of DHSEA intended that the law would reduce the regulatory burden on supplement manufacturers, and provide a streamlined process of bringing new products to market. Instead of honoring the purpose of DHSEA, the FDA in its newly proposed regulations seems determined to institute a complicated, burdensome, and financially prohibitive approval process for each and every new supplement on the market since 1994, akin to the drug approval process. No supplement company has the resources to finance such a procedure, which can run into the tens of millions of dollars for every new product. Experts who have reviewed the proposed regulations claim that the FDA could insist that even previously available supplements would also be subjected to such requirements and be classified as “synthetic food additives” – and their manufacturers frankly would have to close down.

The FDA already has the power and authority to prohibit sale of mislabeled, harmful, or dangerous supplements. Through its Good Manufacturing Practices regulations already in place, supplement manufacturers must meet stringent requirements for safety and potency. The FDA also has the authority to punish manufacturers who make inappropriate unsubstantiated claims. In effect, the FDA already has all the power it needs to regulate effectively nutritional supplements.

A colleague said, “In all the years I have been fighting for freedom of choice in health care, the currently proposed regulations are the most troubling, most far-reaching, and with potentially the most catastrophic effects, not only for my own health, family and friends, but for those tens of millions of Americans who rightfully and intelligently use nutritional products for their health-supporting benefits. In other words, this bill creates extraneous red tape, paperwork, and burdensome labeling requirements when everything the bill mandates is already being accomplished under current law!”

During this time, supplements have enjoyed an unrivaled safety record. Statistics show they’re safer than prescription drugs, cosmetics, medical devices, and even safer than food!

According to the Poison Control Centers, there were no deaths due to supplements in 2008. In 2009, there was one.

When the Dietary Health Supplement Education Act was passed, Congress intended a simple notification process for new dietary ingredients. This guidance would turn this into a pre-approval scheme, which goes against the intent of the law. The FDA already has ample regulatory authority to take action against a product if it’s unsafe. They don’t need to have this pre-approval power, too.

This could be disastrous to public health. At a time when preventative measures are even more important to health care costs, the FDA is limiting access to preventative health care.

The guidance creates unnecessary regulations that limit my access to the dietary supplements I rely on. The expensive and burdensome process will force between 20,000 and 42,000 dietary supplements to be removed from the market and will increase the cost of those supplements that remain.

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Health Risks Of Herbal Dietary Supplements

November 21st, 2011 No comments

Health Risks Of Herbal Dietary Supplements
by Dr. James A. Duke

The front page of the health section of the March 19th, 2000 Washington Post, read: “Mounting evidence suggests that increasing numbers of Americans are falling seriously ill or even dying after taking dietary supplements [...] The victims include men and women of all ages as well as children whose parents are feeding them snacks, drinks and nostrums made with herbal supplements that are neither regulated by the federal government nor tested for their effects on the young.”

With such ominous articles appearing now regularly in the media, and with more and more people taking herbs, it makes sense to ask, “How does the harm done by herbs compare with harm done by other things?” Last year, several people called to ask me what I thought about another article in the Washington Post, “Health Concerns Grow Over Herbal Aids.”

My immediate reaction: mostly nonsense and some truth. The nonsense is fertilizing fears among the lay public and driving them back into the waiting arms of the greedy “pharmaceuticalists.” Two of my good friends were so alarmed by the negative press on herbs that they stopped herbs completely.

The growing health concerns from mass-media articles are being fertilized by trigger-happy journalists, pharmaceutical manufacturers and promoters, and physicians who know so little about herbs, many of them unfamiliar with the statistic from the Journal of the American Medical Association (JAMA) that prescription drugs are killing 140,000 Americans a year. Herbs (usually through abuse or exceeding recommended dosage) are killing fewer than 100.

WHERE’S THE TRUTH

The elements of truth the Post article adduced apply mostly not to herbs, but synthetic supplements that never saw an herb. The Post article mentions ephedra, a Chinese herb, which can be used wisely and properly (in fact, various species have been used medicinally for thousands of years).

Reminding the readers that automobiles, which killed 41,826 people nationally in 1998, or diseases such as kidney disease, which killed 26,295, kill more people than herbs, the author of the Post article, in all fairness, should have included the other figures, the 40,000-100,000 killed by medical mistakes, the 98,000-140,000 a year killed by prescription drugs in American hospitals and the 77,000-88,000 killed by hospital-caused nosocomial infections. Surely he was aware of these figures. If not, he should not have condemned the more salubrious herbal statistics without comparing the pharmaceutical death rate.

I’ll do that for him today — honestly, not sensationally. Summary: regulated pharmaceuticals kill many more Americans than herbal medicine, a thousand fold more.

Then Guggliotta attempts to nail some of my herbal alternatives. St. John’s wort is fast becoming a Prozac “competitor.” Actually, St. John’s wort is fast becoming a Zoloft competitor, and is being studied as such at Duke University. I predict that St. John’s wort will prove to have fewer side effects than Zoloft. Kava is a more logical alternative to Prozac, less addictive and probably much safer.

Melatonin is a good remedy for jet lag with in my own experience. A supplement it is. An herb it ain’t. Ginkgo biloba allegedly slows dementia. Conversely, Tacrine (Cognex), the first FDA-approved drug for Alzheimer’s, helps about 25 percent of the patients for no more than two years, allegedly upsetting the livers of 25 percent of those patients.

Matter of fact, as Guggliotta says, senna, a natural purgative, was added to Ex-Lax last year to replace a a side-effect-associated synthetic chemical. I suppose Guggliotta’s comments might have herbal people, frightened by his comments, abandoning the ephedra and rushing out to get Ex-Lax for weight-loss and exercise regimes. Most of the alternative practitioners discourage the use of any laxative, natural or synthetic, for protracted periods. Instead, we urge exercise and diet (at least five fruits and five vegetables).

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Protect Your Supplements from the FDA – An Easy Method to Contact Your Senators and Congressperson

November 21st, 2011 No comments

Please contact your congressperson ASAP.

This website will automatically look up your senators and congressperson and email them: http://salsa.democracyinaction.org/o/750/p/dia/action/public/?action_KEY=8252 – This website has an already-written letter. Please copy the letter below and paste it the message box to replace the letter that is automatically shown.  The letter below is longer but it addresses the issue with more detail.  Read it as well to get educated on the issue.  The Senators seem to not know how wide of an impact this FDA regulation will be.

Detailed letter:

Subject: FDA Supplement Guidance Will Result In The Loss Of Tens Of Thousands Of Jobs and Cost the Economy $21.2 Billion To $39.8 Billion Annually.

What the FDA is telling Congress is misleading. In recent weeks, the FDA has launched an aggressive new campaign to put in place a series of onerous regulations for the supplement industry that in effect would drive most legitimate manufacturers out of business and potentially eliminate most supplements from the marketplace and increase the cost of others by many folds.

Unfortunately, there was a dangerous loophole in the 1994 DSHEA law: while supplements that existed at the time were protected by law, the FDA was given the authority to regulate any new ingredients introduced after Oct. 15, 1994.

What the FDA is telling Congress is misleading: that it has “released draft guidelines intended to assist the dietary supplement industry in deciding when a premarket safety notification for a dietary supplement containing a new dietary ingredient (NDI) is necessary, and in preparing premarket safety notifications. This guidance, when finalized, does not create new regulations or law”, but the problem is that the FDA is trying to turn the clock back with the laws it already has. Our elected officials clearly don’t understand the problem yet. The FDA is trying to turn the clock back with the laws it already has. The guidance document makes it clear that the FDA is willfully and grossly misinterpreting the law, especially the Dietary Supplement Health and Education Act of 1994 (DSHEA), with regard to re-defining NDIs and filing submissions for them. The agency’s attempt to create new regulatory requirements using a guidance document is also in violation of the Administrative Procedure Act (APA), and therefore the agency is in violation of the law.

Those of us who researched this issue need Congress’s help because it has the power to rein in the FDA and have done so in the past when many voters complained that their health would suffer if their supplements were taken away.

This is a blatant abuse of power. What the FDA is doing here is performing an end-run around the existing law. According to the law, the FDA has to prove a dietary supplement is unsafe for it to be taken off the market. These new guidelines turn that on its head. They are clearly not what Congress intended.

The FDA rules as proposed seem innocent enough, requiring a stringent approval process for all supplements on the marketplace since 1994, when Congress passed the Dietary Supplement Health and Information Act (DHSEA). DHSEA was actually intended to protect nutritional and herbal manufacturers from unwarranted FDA harassment, and allow Americans access to legitimate supplements.

The cost of complying with these guidelines would be astronomical. Experts estimate that the studies required would cost between $100,000 and $200,000 per ingredient notification. That adds up to millions of dollars per supplement company. Smaller companies would not be able to afford this and would go out of business.

The economy is already hurting and we have high unemployment. If enacted as currently proposed, this guidance will have a massive impact to the dietary supplement industry and further hurts our economy. Expert analyses show that this guidance will cost the economy $21.2 billion to $39.8 billion annually and result in the loss of tens of thousands of jobs.

Numerous attorneys have pointed out that the FDA’s attempt to create new regulatory requirements using a guidance document is in violation of the Administrative Procedure Act (APA), and that this amounts to illegal sleight-of-hand, using a guidance as a side-door effort to avoid the public meetings that would promote a more formal debate. Some have stated:

“The Draft Guidance on NDIs is contemptuous of the intent of Congress when it passed DSHEA, because instead of ensuring access to a full range of products, it obstructs their path to the marketplace. The guidance document makes it clear that the FDA is willfully and grossly misinterpreting the law, especially the Dietary Supplement Health and Education Act of 1994 (DSHEA), with regard to re-defining NDIs and filing submissions for them. The agency’s attempt to create new regulatory requirements using a guidance document is also in violation of the Administrative Procedure Act (APA), and therefore the agency is in violation of the law.

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Natural & Herbal Medicines & the FDA – Bollinger and Farley

November 12th, 2011 1 comment

The below is text from the CoastZone newsletter from http://www.coasttocoastam.com. In it is a mention of Ty Bollinger and Michael Farley.

Ty Bollinger’s book “Cancer — Step Outside the Box” is worth getting, you can visit his website at http://www.cancertruth.net

Quote:

On Tuesday’s show, author and health freedom advocate, Ty Bollinger, and naturopathic doctor, Michael Farley, discussed the uses of herbal and natural medicines and addressed why harmless herbal products may be taken off the market while deadly drugs are still legal, and how the FDA is attacking herbs and vitamins. Recent articles declaring the inefficacy of dietary/herbal supplements are backed by Big Pharma, said Bollinger. But when it comes to products that have no medicinal value, he continued, statin drugs have been shown by pharmaceutical companies’ own research to not extend lifespans, and antidepressants actually double your risk of relapsing into depression.

The FDA is looking to change earlier legislation about dietary supplements, and gain further control over them, like the UN’s Codex Alimentarius is doing, Bollinger cautioned. Their restrictive plan would have supplement makers remove their products for 75 days, and fill out an approval application for each new ingredient combination since 1994, he detailed. Dr. Farley (joining the program in the third hour) cited the difference between allopathic medicine, which treats symptoms, and the naturopathic approach which treats the whole person. “Dr. Farley has developed numerous herbal remedies for cancer that are amazingly effective,” Bollinger said.

Among the natural compounds Farley cited were: Chrysin, a flavonoid from the Passion Flower, that works with hormone levels to prevent the invasion of cancer cells; Coriolus Versicolor, a Chinese mushroom which increases the cytotoxity of natural killer cells; Diindolymethane, a phytochemical from cruciferous vegetables that inhibits cancer cells; as well as turmeric, resveratrol, and green tea extract.

He also mentioned a quick, natural cure for food poisoning such as from E.coli or Listeria: a cup of raw honey mixed with a couple tablespoons of ginger.

The FDA – Anti You, Pro Who?

November 10th, 2011 1 comment

This article is special. I have collected and I am pasting here a series of emails from different sources, and a couple articles on the current debacle and the threat to your choice of natural and other nutritional supplements curtsy to the FDA and their fear mongering and abuse of government powers.

Allopathic medicine is pathetic, their drugs kill people,  and now they are trying to make supplements sound like a dangerous drug.

At least 100,000 people die from pharmaceutical drugs each year.. almost none dies from supplements.  Not to mention that pharmaceuticals are unnatural, often have side effects and are pulled out of the market after too many injuries or deaths. One also must remember that most pharmaceuticals cover the symptoms rather than help the body reach a balanced healthy state.  Read this article “death by medicine” http://www.seekingwholeness.com/crazy-world/death-by-medicine

Gold-Dollar-Sign

President Barack Obama has appointed two experts, one in food the other in drugs, to head up the soon to be reorganized Food & Drug Administration in preparation for an agency split that would separate the FDA into two — one agency to oversee foods and the other to regulate drugs. But just exactly where does that leave dietary supplements?

The Dietary Supplement Health & Education Act of 1994 (DSHEA) declares dietary supplements to be products intended to supplement the diet. But the FDA contends DSHEA severely limits the FDA in regulating a growing industry. A recently issued report from the General Accounting Office claims the FDA does not have the resources to adequately regulate dietary supplements. The GAO report appears to be part of an orchestrated effort to soften the public up for a major change in the classification and regulation of dietary supplements.

Supplements, vitamins, minerals, probiotics, herbs, etc are safer than pharmaceuticals. In fact, surveys conducted by poison control centers show dietary supplements to be the safest products of all.

Recently, the FDA classified a form of vitamin B6 (pyridoxine) as a new drug (Pyridorin, Biostratum) … Imagine having to need a prescription from a physician just to take vitamin B!

Now let’s see what these doctors have to say,

Please find below a special message from Advanced Bionutritionals. They have some very important information to share with you about the latest attempt by the FDA to ban supplements.

Read the shocking news below.

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