I Take Vitamins
Please Contact Government Officials In Opposition To The Fda's Plans (in Service Of The Drug Industry) To Make Fewer Dietary Supplements Available And Greatly Drive Up The Prices Of The Ones Allowed... This is an evil plan. It would damage the health of me and millions of other Americans by making fewer dietary supplements available and making the ones available into expensive drugs sold by the pharmaceutical industry. Please contact people in the government September 8 or later if you read this story later.
http://www.lef.org/featured-articles/0719_FDA-views-supplements-as-synthetic-food-preservatives.htm
On September 8th tell your Representative and Senators the FDA should not view your supplements the same way they view synthetic food preservatives!
Listen to William Faloon discuss the FDA's Latest Attempt to Ban your Dietary Supplements as recorded during the recent Life Extension Scientific Advisory Board meeting [at http://www.youtube.com/watch?v=1cEaR9aypOg&feature=pla<x>yer_em<x>bedded#!]
According to the FDA's New Dietary Ingredient guidelines issued on July 1, 2011, the FDA believes that “new dietary supplements” must be regulated similarly to synthetic food preservatives. The FDA guidelines have modeled the outrageous safety thresholds after those in place for food additives. This appears to be in direct violation of DSHEA, the law enacted in 1994 to protect consumer access to dietary supplements, which classifies dietary supplements as foods, not food additives.
The FDA proposes that new dietary supplement ingredients should adhere to aggressive safety margins, which are typically reserved for chemical compounds known to be dangerous in all but the most miniscule concentrations.
Since food additives or preservatives such as aspartame, monosodium glutamate, and sodium nitrate are known to cause cancer or other severe health problems, the FDA has implemented safety guidelines which limit allowable concentrations of these food additives to levels that are supposed to be physiologically inert.
The fact that the FDA is trying to impose the same limits upon dietary supplements seems to be arbitrary and completely unfounded. In fact, when someone takes a dietary supplement, their intent is to positively affect the structure or function of their bodies in some way — limiting dosages of dietary supplements to physiologically inert levels defeats the entire purpose of supplementation with health-sustaining nutrients.
The FDA’s new guidelines are so flawed that even nutrients shown to be completely safe in hundreds of human clinical studies would fail to accommodate the unreasonable safety margins.
To give you an example, each manufacturer of certain fish oils would have to conduct a one year study where animals would have to consume the human equivalent of 240,000 milligrams each day of fish oil. Note the typical dose of EPA/DHA people take each day is around 2,400 mg — 100 times less than what the FDA proposes must be tested.
Another option under the FDA’s proposed mandates is to conduct a 90-day, 1,000-fold safety margin study in which two species of animals — one being non-rodent, likely young beagle dogs — will theoretically consume the equivalent of 2.4 million milligrams of fish oil daily. We know of virtually no species that can tolerate this high dose, so by default, FDA guidelines will make it impossible for certain omega-3 supplements to be sold.
Since these are not patented drugs, no supplement maker will be able to afford these “safety” studies, which means that many of the nutrients you now purchase at low prices will convert into high-priced drugs.
Pharmaceutical industry profit threatened by low cost supplements
It appears that the FDA is claiming that dietary supplements are unsafe, and in order to “protect consumers” the agency must place a stranglehold on the dietary supplement industry by requesting exorbitant safety testing. These ludicrous safety thresholds are in excess of those required by pharmaceutical drugs despite studies showing supplements are far safer than drugs.
According to the 2001 report of the American Association of Poison Control Centers (AAPCC), of the substances implicated in fatal poisonings in 2001, 84.6% were pharmaceutical drugs, with analgesics being implicated as the primary cause of death in 32% of fatalities or 341 deaths. This compares with 0.8% 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). Interestingly,the anti-asthma drug theophylline alone was responsible for 15 deaths, 66% more than all the available dietary supplements combined. {Reference: 2001 Annual Report of the American Association of Poison control Centers Toxic Exposure Surveillance System, Amer. J Emerg Med, 20, 391, 2002.}
A review of 2009 information for adverse events reported to the national control center’s data system shows that:
No major adverse events or deaths were reported for botanical supplements like St. John’s wort, ginseng, and Echinacea;
No major adverse events or deaths were reported for hormone supplements like DHEA, melatonin, and pregnenolone;
No major adverse events or deaths were reported for phytoestrogen supplements;
No major adverse events or deaths were reported for the joint- and cartilage-support supplements glucosamine and chondroitin;
No major adverse events were reported for vitamins A and E, and only one adverse event each was reported for vitamin B6 and C.
In total, 41 major adverse events were reported for the entire spectrum of supplements including botanicals, amino acids, and vitamins, and one death.
In contrast, more than 7,000 major adverse events were reported for pharmaceutical drugs, including a total of 496 deaths. And ba<x>sed on previous studies, we know the overall death rate for physician prescribed drugs to be far higher.
So there is no rational basis for the FDA to insist that dietary supplements that have been safely used in large populations as early as 1994 should be removed from the market and forced to undergo costly animal testing at absurdly high doses before they can be sold again.
There is, however, a huge economic benefit for the pharmaceutical industry if the proposed guidelines are enforced by the FDA. Health-conscious Americans who properly supplement slash their risk of degenerative disease. The FDA’s new rules, if enacted, will force the price of many supplements to surge upwards, while outlawing many effective ones altogether. That means that more aging people will have to rely on side effect-laden presc<x>ription drugs to treat the degenerative diseases they will contract because they will be denied access to health-promoting nutrients.
Participate in a groundswell to stop this impending carnage. Call your Representative and your two Senators on September 8th.
As a citizen, you have the constitutional right to petition the government to redress your grievances. In this case, FDA proposals pose a direct threat to your health and longevity.
It's time to take extraordinary measures to defend your right to continue using supplements your very life depends on … and to gain access to new natural ingredients that demonstrate efficacy in scientific studies.
Be heard on September 8th! Click here to find the phone numbers you need and the talking points you need to communicate.
Phone Numbers to Call [You will find this link when visiting the URL at the outset of the story.]
Talking Points to Use [See below *]
In addition, you can opt to follow all six steps below to reinforce your message.
Click here to get a sample petition letter you can send to the FDA Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements [See below **]
Print out this petition and add any words you choose and fax this to the FDA at the following number: (301) 436-2639.
Call the FDA at 1-888-723-3366 and read this petition to personnel at the Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements.
Send a Freedom of Information Act (FOIA) request to find out which pharmaceutical interests are behind these absurd proposals that will cause the cost of the supplements that remain on the free market to skyrocket in price. [See the link on the page of the URL at outset of this story]
Send a letter to your Representative and two Senators demanding the FDA immediately withdraw their oppressive proposed guidelines pending rational discussions with those who depend on dietary supplements to protect their health and livelihood. [See below ***]
Send a letter to the President’s Office of Management and Budget [See below ****] as the FDA’s proposed guidelines on new dietary ingredients directly conflict with an Executive Order issued July 11, 2011 that orders the FDA to streamline and repeal burdensome regulations that interfere with job creation, economic growth, and innovation. [Read the Executive Order at http://www.lef.org/featured-articles/0719_Executive-Order-Letter.htm]
Empower yourself today. Recall how consumers revolted back in 1994 and the result was a glorious victory over FDA tyranny!
Follow the six easy steps outlined above by logging on to a website that lets you easily contact your members of Congress and the appropriate officials within the FDA. Let your voice be heard by taking action today and exercising your right to petition the government against these serious violations of the law and scientific principle.
* http://www.lef.org/featured-articles/0719_Talking-Points.htm?source=INFEML_Bill_0408&key=logo&sourcecode=ING100E
What you can say to your Representative & Senators on September 8th
Refer to this helpful guide when calling Members of Congress on September 8, 2011, to express opposition to the FDA's Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredients Notification and Related Issues.
Talking Points/sc<x>ript:
My name is [Name] and I am a constituent of [Representative's name].
I am very concerned about the new FDA draft guidance on dietary supplements and new dietary ingredients.
I request that Congress direct the FDA to carefully review their draft guidance, and unless they amend the guidance to reflect my concerns, to call hearings at the end of the review process.
When the Dietary Supplement Health and Education Act was passed, Congress intended there be a simple notification system for new supplements. But now the FDA is turning it into a pre-approval scheme—one that Congress never intended. This will reduce the number of supplements sold and increase the cost of those that remain.
I am simply asking that the FDA honor Congressional intent and protect my access to the supplements I depend on to stay healthy.
Mention at least one of the following points on your call:
Congress recognized that dietary supplements are natural ingredients and therefore inherently safer than drugs and chemical food additives. It did not intend that the FDA would have the power to approve or reject dietary supplements.
The FDA's draft 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.
The draft guidance hurts our economy. Expert analyses show that this guidance will cause a total economic loss of $21.2 billion to $39.8 billion annually.
Closing:
Please keep close watch of the FDA to stop them from defying Congressional intent with their new draft guidance.
Thank you for your time.
Tips:
Be courteous and respectful.
Keep your comments brief and focused on the facts.
Always thank the staff member for their time taking your call.
** http://www.lef.org/featured-articles/0719_Petition-Letter-to-the-FDA.htm
Petition Letter to the FDA
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
Dear Staff:
On July 11, 2011, President Obama issued an Executive Order that requires the FDA to:
1) Make regulatory decisions only after consideration of their costs and benefits (both quantitative and qualitative).
2) Review significant regulations to make sure they are not excessively burdensome.
3) 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 ob<x>jectives.
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 rational and scientific approach to regulating new dietary ingredients that will be submitted to you by the Alliance for Natural Health within the next 90 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 90-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___
*** http://www.capwiz.com/lef/issues/alert/?alertid=51641606&type=CO [You can e-mail your three congressmen from this URL.]
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 the 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 proposed by the FDA 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:
1) Force the FDA 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.
2) 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 have a profoundly adverse impact on this nation's health.
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.
**** http://www.lef.org/featured-articles/0719_Letter-to-the-White-House.htm
Letter to the White House
Office of Management and Budget
The White House
Washington, DC
Dear Staff:
On July 11, 2011, your office issued an Executive Order directing the FDA (and other agencies) 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 ob<x>jectives.
Contradicting this Executive Order are draft guidelines issued by the FDA that affect every dietary supplement introduced after October 15, 1994. These new regulations will require extremely costly animal testing on each product the FDA asserts is a “new dietary ingredient,” even if consumers have safely been using it for decades.
If this proposed regulation is implemented, some of the most effective nutrients Americans use will be removed from the market. This includes many fish oil formulas and natural plant extracts.
These burdensome regulations are exactly what a law passed in 1994 (Dietary Supplement Health and Education Act) sought to prevent. The FDA is using its regulatory authority in direct violation of congressional intent.
In order for dietary supplements to return to the market, the FDA will require manufacturers to conduct outrageously expensive studies using absurdly high doses, in some situations multiplied by a “safety factor” up to 2,000-times the recommended dosage on a per product basis.
And remember, the FDA is defining a dietary supplement as being “new” if it was introduced after October 15, 1994. That means that nutrients that have been safely used for many years will be subject to the FDA’s oppressive policies that mandate costly animal testing.
The name of this draft guidance regarding so-called new dietary ingredients is the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”
I ask that your office contact the FDA and order them to immediately disregard their proposed guidelines regarding new dietary ingredients as they directly contradict the Executive Order of July 11, 2011, provisions stating that regulations should be streamlined or repealed so as to make the agency's regulatory program more effective or less burdensome in achieving the regulatory ob<x>jectives.
If FDA new guidelines on New Dietary Ingredients are not repealed, they will cause the price of my supplements to skyrocket, while causing some of these life-sustaining supplements to disappear altogether.
This is not acceptable, especially when there are no significant reports of adverse reactions to the supplements the FDA bureaucratically declares as “new.”
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 ask that you to immediately contact the FDA Office below and insist the FDA complies with your Executive Order and repeal these proposed guidelines as they will interfere with innovation, job creation and economic growth:
Corey Hilmas
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
Kindly let me know the outcome of your inquiry to the FDA.
Sincerely,
Name___________
Address____________
City___________ST____ Zip___
Conceptualclarity : I urge you also to contact the President himself. The page to use is http://www.whitehouse.gov/contact/
http://www.lef.org/featured-articles/0719_FDA-views-supplements-as-synthetic-food-preservatives.htm
On September 8th tell your Representative and Senators the FDA should not view your supplements the same way they view synthetic food preservatives!
Listen to William Faloon discuss the FDA's Latest Attempt to Ban your Dietary Supplements as recorded during the recent Life Extension Scientific Advisory Board meeting [at http://www.youtube.com/watch?v=1cEaR9aypOg&feature=pla<x>yer_em<x>bedded#!]
According to the FDA's New Dietary Ingredient guidelines issued on July 1, 2011, the FDA believes that “new dietary supplements” must be regulated similarly to synthetic food preservatives. The FDA guidelines have modeled the outrageous safety thresholds after those in place for food additives. This appears to be in direct violation of DSHEA, the law enacted in 1994 to protect consumer access to dietary supplements, which classifies dietary supplements as foods, not food additives.
The FDA proposes that new dietary supplement ingredients should adhere to aggressive safety margins, which are typically reserved for chemical compounds known to be dangerous in all but the most miniscule concentrations.
Since food additives or preservatives such as aspartame, monosodium glutamate, and sodium nitrate are known to cause cancer or other severe health problems, the FDA has implemented safety guidelines which limit allowable concentrations of these food additives to levels that are supposed to be physiologically inert.
The fact that the FDA is trying to impose the same limits upon dietary supplements seems to be arbitrary and completely unfounded. In fact, when someone takes a dietary supplement, their intent is to positively affect the structure or function of their bodies in some way — limiting dosages of dietary supplements to physiologically inert levels defeats the entire purpose of supplementation with health-sustaining nutrients.
The FDA’s new guidelines are so flawed that even nutrients shown to be completely safe in hundreds of human clinical studies would fail to accommodate the unreasonable safety margins.
To give you an example, each manufacturer of certain fish oils would have to conduct a one year study where animals would have to consume the human equivalent of 240,000 milligrams each day of fish oil. Note the typical dose of EPA/DHA people take each day is around 2,400 mg — 100 times less than what the FDA proposes must be tested.
Another option under the FDA’s proposed mandates is to conduct a 90-day, 1,000-fold safety margin study in which two species of animals — one being non-rodent, likely young beagle dogs — will theoretically consume the equivalent of 2.4 million milligrams of fish oil daily. We know of virtually no species that can tolerate this high dose, so by default, FDA guidelines will make it impossible for certain omega-3 supplements to be sold.
Since these are not patented drugs, no supplement maker will be able to afford these “safety” studies, which means that many of the nutrients you now purchase at low prices will convert into high-priced drugs.
Pharmaceutical industry profit threatened by low cost supplements
It appears that the FDA is claiming that dietary supplements are unsafe, and in order to “protect consumers” the agency must place a stranglehold on the dietary supplement industry by requesting exorbitant safety testing. These ludicrous safety thresholds are in excess of those required by pharmaceutical drugs despite studies showing supplements are far safer than drugs.
According to the 2001 report of the American Association of Poison Control Centers (AAPCC), of the substances implicated in fatal poisonings in 2001, 84.6% were pharmaceutical drugs, with analgesics being implicated as the primary cause of death in 32% of fatalities or 341 deaths. This compares with 0.8% 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). Interestingly,the anti-asthma drug theophylline alone was responsible for 15 deaths, 66% more than all the available dietary supplements combined. {Reference: 2001 Annual Report of the American Association of Poison control Centers Toxic Exposure Surveillance System, Amer. J Emerg Med, 20, 391, 2002.}
A review of 2009 information for adverse events reported to the national control center’s data system shows that:
No major adverse events or deaths were reported for botanical supplements like St. John’s wort, ginseng, and Echinacea;
No major adverse events or deaths were reported for hormone supplements like DHEA, melatonin, and pregnenolone;
No major adverse events or deaths were reported for phytoestrogen supplements;
No major adverse events or deaths were reported for the joint- and cartilage-support supplements glucosamine and chondroitin;
No major adverse events were reported for vitamins A and E, and only one adverse event each was reported for vitamin B6 and C.
In total, 41 major adverse events were reported for the entire spectrum of supplements including botanicals, amino acids, and vitamins, and one death.
In contrast, more than 7,000 major adverse events were reported for pharmaceutical drugs, including a total of 496 deaths. And ba<x>sed on previous studies, we know the overall death rate for physician prescribed drugs to be far higher.
So there is no rational basis for the FDA to insist that dietary supplements that have been safely used in large populations as early as 1994 should be removed from the market and forced to undergo costly animal testing at absurdly high doses before they can be sold again.
There is, however, a huge economic benefit for the pharmaceutical industry if the proposed guidelines are enforced by the FDA. Health-conscious Americans who properly supplement slash their risk of degenerative disease. The FDA’s new rules, if enacted, will force the price of many supplements to surge upwards, while outlawing many effective ones altogether. That means that more aging people will have to rely on side effect-laden presc<x>ription drugs to treat the degenerative diseases they will contract because they will be denied access to health-promoting nutrients.
Participate in a groundswell to stop this impending carnage. Call your Representative and your two Senators on September 8th.
As a citizen, you have the constitutional right to petition the government to redress your grievances. In this case, FDA proposals pose a direct threat to your health and longevity.
It's time to take extraordinary measures to defend your right to continue using supplements your very life depends on … and to gain access to new natural ingredients that demonstrate efficacy in scientific studies.
Be heard on September 8th! Click here to find the phone numbers you need and the talking points you need to communicate.
Phone Numbers to Call [You will find this link when visiting the URL at the outset of the story.]
Talking Points to Use [See below *]
In addition, you can opt to follow all six steps below to reinforce your message.
Click here to get a sample petition letter you can send to the FDA Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements [See below **]
Print out this petition and add any words you choose and fax this to the FDA at the following number: (301) 436-2639.
Call the FDA at 1-888-723-3366 and read this petition to personnel at the Center for Food Safety and Applied Nutrition, Office of Nutrition, Labeling and Dietary Supplements.
Send a Freedom of Information Act (FOIA) request to find out which pharmaceutical interests are behind these absurd proposals that will cause the cost of the supplements that remain on the free market to skyrocket in price. [See the link on the page of the URL at outset of this story]
Send a letter to your Representative and two Senators demanding the FDA immediately withdraw their oppressive proposed guidelines pending rational discussions with those who depend on dietary supplements to protect their health and livelihood. [See below ***]
Send a letter to the President’s Office of Management and Budget [See below ****] as the FDA’s proposed guidelines on new dietary ingredients directly conflict with an Executive Order issued July 11, 2011 that orders the FDA to streamline and repeal burdensome regulations that interfere with job creation, economic growth, and innovation. [Read the Executive Order at http://www.lef.org/featured-articles/0719_Executive-Order-Letter.htm]
Empower yourself today. Recall how consumers revolted back in 1994 and the result was a glorious victory over FDA tyranny!
Follow the six easy steps outlined above by logging on to a website that lets you easily contact your members of Congress and the appropriate officials within the FDA. Let your voice be heard by taking action today and exercising your right to petition the government against these serious violations of the law and scientific principle.
* http://www.lef.org/featured-articles/0719_Talking-Points.htm?source=INFEML_Bill_0408&key=logo&sourcecode=ING100E
What you can say to your Representative & Senators on September 8th
Refer to this helpful guide when calling Members of Congress on September 8, 2011, to express opposition to the FDA's Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredients Notification and Related Issues.
Talking Points/sc<x>ript:
My name is [Name] and I am a constituent of [Representative's name].
I am very concerned about the new FDA draft guidance on dietary supplements and new dietary ingredients.
I request that Congress direct the FDA to carefully review their draft guidance, and unless they amend the guidance to reflect my concerns, to call hearings at the end of the review process.
When the Dietary Supplement Health and Education Act was passed, Congress intended there be a simple notification system for new supplements. But now the FDA is turning it into a pre-approval scheme—one that Congress never intended. This will reduce the number of supplements sold and increase the cost of those that remain.
I am simply asking that the FDA honor Congressional intent and protect my access to the supplements I depend on to stay healthy.
Mention at least one of the following points on your call:
Congress recognized that dietary supplements are natural ingredients and therefore inherently safer than drugs and chemical food additives. It did not intend that the FDA would have the power to approve or reject dietary supplements.
The FDA's draft 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.
The draft guidance hurts our economy. Expert analyses show that this guidance will cause a total economic loss of $21.2 billion to $39.8 billion annually.
Closing:
Please keep close watch of the FDA to stop them from defying Congressional intent with their new draft guidance.
Thank you for your time.
Tips:
Be courteous and respectful.
Keep your comments brief and focused on the facts.
Always thank the staff member for their time taking your call.
** http://www.lef.org/featured-articles/0719_Petition-Letter-to-the-FDA.htm
Petition Letter to the FDA
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
Dear Staff:
On July 11, 2011, President Obama issued an Executive Order that requires the FDA to:
1) Make regulatory decisions only after consideration of their costs and benefits (both quantitative and qualitative).
2) Review significant regulations to make sure they are not excessively burdensome.
3) 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 ob<x>jectives.
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 rational and scientific approach to regulating new dietary ingredients that will be submitted to you by the Alliance for Natural Health within the next 90 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 90-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___
*** http://www.capwiz.com/lef/issues/alert/?alertid=51641606&type=CO [You can e-mail your three congressmen from this URL.]
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 the 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 proposed by the FDA 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:
1) Force the FDA 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.
2) 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 have a profoundly adverse impact on this nation's health.
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.
**** http://www.lef.org/featured-articles/0719_Letter-to-the-White-House.htm
Letter to the White House
Office of Management and Budget
The White House
Washington, DC
Dear Staff:
On July 11, 2011, your office issued an Executive Order directing the FDA (and other agencies) 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 ob<x>jectives.
Contradicting this Executive Order are draft guidelines issued by the FDA that affect every dietary supplement introduced after October 15, 1994. These new regulations will require extremely costly animal testing on each product the FDA asserts is a “new dietary ingredient,” even if consumers have safely been using it for decades.
If this proposed regulation is implemented, some of the most effective nutrients Americans use will be removed from the market. This includes many fish oil formulas and natural plant extracts.
These burdensome regulations are exactly what a law passed in 1994 (Dietary Supplement Health and Education Act) sought to prevent. The FDA is using its regulatory authority in direct violation of congressional intent.
In order for dietary supplements to return to the market, the FDA will require manufacturers to conduct outrageously expensive studies using absurdly high doses, in some situations multiplied by a “safety factor” up to 2,000-times the recommended dosage on a per product basis.
And remember, the FDA is defining a dietary supplement as being “new” if it was introduced after October 15, 1994. That means that nutrients that have been safely used for many years will be subject to the FDA’s oppressive policies that mandate costly animal testing.
The name of this draft guidance regarding so-called new dietary ingredients is the “Draft Guidance for Industry: Dietary Supplements: New Dietary Ingredient Notifications and Related Issues.”
I ask that your office contact the FDA and order them to immediately disregard their proposed guidelines regarding new dietary ingredients as they directly contradict the Executive Order of July 11, 2011, provisions stating that regulations should be streamlined or repealed so as to make the agency's regulatory program more effective or less burdensome in achieving the regulatory ob<x>jectives.
If FDA new guidelines on New Dietary Ingredients are not repealed, they will cause the price of my supplements to skyrocket, while causing some of these life-sustaining supplements to disappear altogether.
This is not acceptable, especially when there are no significant reports of adverse reactions to the supplements the FDA bureaucratically declares as “new.”
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 ask that you to immediately contact the FDA Office below and insist the FDA complies with your Executive Order and repeal these proposed guidelines as they will interfere with innovation, job creation and economic growth:
Corey Hilmas
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
Kindly let me know the outcome of your inquiry to the FDA.
Sincerely,
Name___________
Address____________
City___________ST____ Zip___
Conceptualclarity : I urge you also to contact the President himself. The page to use is http://www.whitehouse.gov/contact/
