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Sunday, September 18, 2011

If You Want to Keep Your Supplements Get Involved NOW!

If You Want to Keep Your Supplements Get Involved NOW!    The following article from Dr. Mercola's site contains two letter forms for your use.  
This is such a incredibly important issue, I hope you will participate in saving your supplements and your health.  


"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
  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 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:
  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, "  http://articles.mercola.com/sites/articles/archive/2011/09/15/how-government-keeps-you-sick.aspx?e_cid=20110915_DNL_art_3
If You Want to Keep Your Supplements Get Involved NOW!  Here is the vehicle to do so. 

 

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