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Why the Cost of Supplements Is Likely to Soar (Within the Next 12 Months)

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Posted By Dr. Mercola | September 14 2011

Story at-a-glance
  • The "Dietary Supplement Labeling Act of 2011" treats vitamins and other supplements as if they are drugs, and imposes regulations that could cause your favorite supplements to be taken off the market
  • The cost of your dietary supplements is also likely to greatly increase
  • The open comment period on the FDA's proposed guidelines expires on September 30, 2011; act now to help protect your health freedom

By Dr. Mercola

S.1310: Dietary Supplement Labeling Act of 2011, introduced at the end of June by U.S. Senator Richard Durbin (D-Illinois) is, using Byron J. Richards' words, "an alarming regulatory nightmare that is trying to treat vitamins as if they are drugs."

Its stated purpose is to:

"… improve the safety of dietary supplements by amending the Federal Food, Drug, and Cosmetic Act to require manufacturers of dietary supplements to register dietary supplement products with the Food and Drug Administration and to amend labeling requirements with respect to dietary supplements."

As is typical of most diabolical laws, it initially sounds harmless enough. But there's more. 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.

We've seen proposed legislation that sorely threatens your health and well-being before, but this time they're really trying to hit the alternative health field, and your right to take control of your own life, hard.

It's Not about Safety, It's about Profits

Whose profit, you might ask?

Why, the pharmaceutical industry, of course. Vitamins, minerals and herbal supplements have a tremendously safe track record. Drugs are known to cause well over 100,000 deaths per year whentaken as prescribed.

For comparison, look at the latest statistics available from the U.S. National Poison Data System, which covers acute poisonings. In 2007, 1,597 people reportedly died from drugs. Meanwhile there was not one single fatality caused by a vitamin or dietary mineral supplement that year. Yet, Durbin and the FDA want you to think that they're just acting in your best interest. Nothing could be further from the truth!

Up to this point, the FDA has had to prove a supplement unsafe in order to take action against it, but now they want the supplement industry to prove the safety of what in many cases amount to food, before they can reach the market.

Why add an extremely costly testing and approval process for compounds that are inherently safe? Well, an obvious side effect of these proposed regulations will be the elimination of small and medium sized companies, which in turn will drive up costs while at the same time reduce your access to historically safe nutritional products. The end result is that fewer people will use supplements to improve their health; driving them back into the extremely profitable fold of conventional medicine and drugs.

Byron J. Richards writes:

"The elimination of health options is required for the control of a population, while the preservation of health freedom is a leading indicator of the overall freedom within a society… [T]he control of health options is as important as the control of food and money.

… Big Pharma influences Republicans by aligning itself as a corporate conglomerate that is too big to fail, one that should be free of prudent safety regulations or reduction in grotesquely inflated prices. It fights against drug safety at every turn, while at the same time lobbying to pass laws that lock in sales or eliminate its competition.

The media plays along, as Big Pharma is a wonderful source of advertising dollars that are in no small part made possible by taxpayer funding of Big Pharma drug sales. While Big Pharma sees many aspects of the dietary supplement industry as competition, it is also the case that many pharmaceutical companies are in some aspect of the dietary supplement industry, often as raw material suppliers.

Big Pharma does not want to see the dietary supplement industry eliminated, it wants to see the small and medium sized independent businesses in the dietary supplement industry eliminated and it wants to own the industry. Their key strategy to accomplish this at this time is to lobby to pass costly laws and regulations which they can comply to and which other smaller, independent companies cannot. "

The Second Part of an Orchestrated Attack

Back in the early 1990s, the FDA threatened the availability of dietary supplements to the point that consumers staged a massive revolt, which resulted in the Dietary Supplement Health and Education Act of 1994 (DSHEA). The law specifically protects your access to dietary supplements by classifying them as foods, not food additives or drugs, and it grand-fathered in dietary supplements that were already in use as of 1994. Only novel ingredients introduced after October 15, 1994 are required to seek FDA approval.

Now, along with Durbin's bill, the FDA has concocted new proposed mandates regarding the definition of a New Dietary Ingredient , known as NDI, that can be retroactively applied to products already on the market.

You can read the FDA Draft Guidance on New Dietary Ingredients (NDI's) hereA detailed analysis of the FDA Draft Guidance is also available.

According to Richards:

"It is important to understand that this is a Durbin effort to ruin the dietary supplement industry, using both newly proposed legislation (S.1310) and retroactively redefining the DSHEA law through new FDA regulations to reflect what is being proposed in S.1310 – undermining the clear intent of the DSHEA law.

The DSHEA law intended consumers to have wide access to dietary supplements. Durbin is intent upon the opposite." These regulations seek to change what was essentially a notification process into a costly approval process. The net effect of the regulations is to reclassify many nutritional compounds currently on the market as NDI."

The DSHEA legislation 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;
  • dietary supplements are safe within a broad range of intake, and safety problems with the supplements are relatively rare;
  • and legislative action that protects the right of access of consumers to safe dietary supplements is necessary in order to promote wellness

The proposed mandates directly contradict what DSHEA sought to prevent, and the FDA is using its authority in direct violation of Congressional intent. As explained in an article by Alliance for Health, the proposed regulations turn what was clearly supposed to be a pre-market notification system into a pre-approval system, just like that of drugs. As a result, dietary supplements that have been freely available for nearly two decades can be forced off the market until they receive NDI approval. And the NDI approval process is a lengthy affair that may take months or years to complete, and cost a small fortune.

What might make an "old" ingredient "new," under the new regulation?

The methods of production and extraction, for example… As bizarre as that sounds, the mere fact that a product is being extracted or produced by improved means compared to methods used in the past, could reclassify any grandfathered nutrient as an NDI that would now have to undergo the same type of safety testing and approval process as a drug.

Ridiculously Excessive Safety Testing Would be Required Under New Rules

If the FDA and Durbin get their way, once a supplement is taken off the market pending approval as an NDI, the manufacturer would have to conduct outrageously expensive studies using abnormally high doses—in some situations multiplied by a "safety factor" up to 2,000-times the recommended dosage on a per product basis. In fact, some of the safety thresholds are in excess of those required by pharmaceutical drugs despite studies showing supplements are FAR safer than drugs!

An estimated 106,000 hospitalized patients die each year from drugs that, by medical standards, are properly prescribed and administered, and 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 morethan 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 (one of which was reportedly due to Ephedra; the herbal supplement banned the year before for being too dangerous. In 2005, low-dose Ephedra was also subsequently banned).

Now, since dietary supplements are not patented drugs with outrageous profit margins, very few supplement makers will be able to afford the required safety studies, which could run in the millions of dollars per ingredient! Furthermore, the manufacturer is not the only one that would have to seek approval—every distributor that wants to use the NDI would have to file a separate NDI application.

Get Involved NOW!

Folks, this is not the time to doze off on the sidelines. Durbin's bill and the FDA proposed mandates for NDI's are a poorly veiled attempt to usurp your rights and health freedom. As Richards writes:

"This chess game is being played with a pathetic opening strategy based on imaginary safety problems. The gambit requires an ignorant public for its success."

It's time to prove them wrong yet again, just like we did back in 1994. 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. Durbin's bill and the FDA proposal pose 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 by following the steps outlined below:

  1. Write to your State Senators and tell them to beware of S.1310 and to vote NO on it. 

  2. 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
  3. Call FDA at 1-888-723-3366 and read this petition to personnel at the Office of Nutrition, Labeling and Dietary Supplements
  4. 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.)
  5. 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:

  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 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:

  1. 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 a profoundly adverse impact on this nation's health.

All of these proposals results 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:

  1. 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.
  2. 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.
  3. 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.
  4. 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.
  5. 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.
  6. 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.
  7. 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.
  8. 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.
  9. 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.
  10. 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.
  11. 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.
  12. 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.
  13. 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.
  14. 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.
  15. 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.
  16. 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.
  17. 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.
  18. 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.
  19. 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,

 

 

(Send your news to foodconsumer.org@gmail.com, Foodconsumer.org is part of the Infoplus.com ™ news and information network)

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