I received a letter from one of my senators, which I understood to mean that the issue was a done deal. It isn't. Comments are open till the first of Dec. PLEASE get your comments in NOW and KEEP COMMENTING until Dec. 1st. Write, fax or call or email your senators and reps on a weekly basis. Demand they leave out supplements alone. Raise holy hell or they will keep on intruding more and more into our private choices!
Love and blessings,
Jan Slama
Vibrant Energy
http://vibrantenergy.webs.com
Change your energy, change your life!
Your Source for MMS, Diatomaceous Earth and Lugol's 5% Iodine.
"For we wrestle not against flesh and blood, but against principalities, against powers, against the rulers of the darkness of this world, against spiritual wickedness in high places." Ephesians 6:12.
Not by might nor by power, but by My Spirit, Says the Lord almighty." Zach. 4:6.
Pray without ceasing, because our only hope for our nation is in God.
-----Original Message-----
From: Garret Wood [mailto:GWood@Soundpub.com]
Sent: Friday, November 04, 2011 12:32 PM
To: Jan Slama
Subject: Re: From the Office of Senator Cantwell
The guidance was published for public comment in July. The deadline for commenting was originally October. That was extended to December 1.
So the guidance is not yet finalized. We are trying to go through Congress because we think pressure from them will be more effective.
Garret
On Nov 4, 2011, at 2:37 PM, "Jan Slama" <slama.jan@comcast.net<mailto:slama.jan@comcast.net>> wrote:
Garret, but what I'm understanding from her letter is that it is a done deal! THEY Passed it in Jan. of this year and July of this year they published the guidelines. Is it a done deal and it won't do any good to write the politicians? See highlighted in red below. This was my original question.
Love and blessings,
Jan Slama
Vibrant Energy
http://vibrantenergy.webs.com<http://vibrantenergy.webs.com/>
Change your energy, change your life!
Your Source for MMS, Diatomaceous Earth and Lugol's 5% Iodine.
"For we wrestle not against flesh and blood, but against principalities, against powers, against the rulers of the darkness of this world, against spiritual wickedness in high places." Ephesians 6:12.
Not by might nor by power, but by My Spirit, Says the Lord almighty." Zach. 4:6.
Pray without ceasing, because our only hope for our nation is in God.
From: Garret Wood [mailto:GWood@Soundpub.com]
Sent: Friday, November 04, 2011 10:58 AM
To: slama.jan@comcast.net<mailto:slama.jan@comcast.net>
Subject: RE: From the Office of Senator Cantwell
Jan,
It is good of Senator Cantwell's office to send you a detailed reply. Unfortunately, the Senator is missing several key points.
It is true that the DSHEA of 1994 directed the FDA to define "New Dietary Ingredients." But the FDA did nothing for 17 years. In that time, hundreds -- maybe thousands -- of "new" ingredients have been introduced.
Now the FDA wants to ignore nearly two decades of innovation and turn back the clock. Dr. Robert Rowen made a good comparison. What if someone from the government came along and replaced your current computer with a model from 1994? Or swapped your smart phone for a clunky early model cell phone? That's what the FDA wants to do.
Also, I put "new" in quotes above because these nutrients really aren't new. They come from nature.
But under these proposed guidelines, the FDA will consider any ingredient "new" if a different extraction process is used, if a different "life stage" (like ripe instead of unripe) is used, or even if a supplement uses more of an ingredient than was used 17 years ago.
Senator Cantwell also glosses over what kind of proof the FDA will require to consider a "new" ingredient safe. Bear in mind, that people have been safely taking these ingredients for years – even decades! Yet the FDA will require companies to conduct prohibitively expensive studies on every ingredient in a product and on every product a company sells.
This is not hysteria. This is not a mis-reading of the FDA's proposed guidelines. This information comes directly from the FDA's own website.
I would urge you to continue to try to educate Senator Cantwell's office – and others on your lists and groups – about the very real threat these guidelines pose.
Everything is explained in great detail on our website:
http://www.advancedbionutritionals.com/Special-Offers/FDA-letter-1.htm
Sincerely,
Garret W. Wood
President
Advanced Bionutritionals
From: Jan Slama [mailto:slama.jan@comcast.net]
Sent: Thursday, November 03, 2011 2:23 PM
To: Anthony Chamberlain
Subject: From the Office of Senator Cantwell
Please get back to me on this. We need updated info to send to our lists and groups.
Love and blessings,
Jan Slama
Vibrant Energy
http://vibrantenergy.webs.com<http://vibrantenergy.webs.com/>
Change your energy, change your life!
Your Source for MMS, Diatomaceous Earth and Lugol's 5% Iodine.
"For we wrestle not against flesh and blood, but against principalities, against powers, against the rulers of the darkness of this world, against spiritual wickedness in high places." Ephesians 6:12.
Not by might nor by power, but by My Spirit, Says the Lord almighty." Zach. 4:6.
Pray without ceasing, because our only hope for our nation is in God.
From: Maria_Cantwell@cantwell.senate.gov<mailto:Maria_Cantwell@cantwell.senate.gov> [mailto:Maria_Cantwell@cantwell.senate.gov]
Sent: Thursday, November 03, 2011 9:11 AM
To: slama.jan@comcast.net<mailto:slama.jan@comcast.net>
Subject: From the Office of Senator Cantwell
[cid:image001.jpg@01CC9AE6.1ADFC550]<http://cantwell.senate.gov/>
Dear Mrs. Slama,
Thank you for contacting me about the Food and Drug Administration's draft guidance on new dietary ingredients. I appreciate hearing from you on this important issue.
The federal law that governs the regulation of dietary supplements in the United States is the Dietary Supplement Health and Education Act of 1994, implemented by the U.S. Food and Drug Administration (FDA). Under this law, the dietary supplement manufacturer is responsible for ensuring that a dietary supplement is safe before it is marketed to the public, and that it is labeled correctly. Manufacturers do not need to register with the FDA or gain approval before selling it to the public; the FDA's role is to take action if the supplement is found to be unsafe.
The exception to this federal law is the introduction of a dietary supplement that contains a "new dietary ingredient." In this case, a manufacturer is required to notify the FDA at least 75 days before introducing a new dietary ingredient, and must produce information supporting the safety of this ingredient. If a manufacturer fails to do so, their product may be considered adulterated under the Federal Food, Drugs and Cosmetics Act.
The FDA Food Safety Modernization Act (P.L. 111-353), which was enacted on January 4, 2011, requires the FDA to release guidance documents to help manufacturers comply with federal law regarding the introduction of new dietary ingredients. In July 2011, FDA published this guidance, which clarifies when a manufacturer must submit a new ingredient notification and what kind of information and evidence the manufacturer must produce.
Although the Dietary Supplement Health and Education Act of 1994 defines a "new dietary ingredient" as an ingredient that was not marketed in the United States before October 15, 1994, the law does not specify the type or amount of evidence that must be included in a new ingredient notification. In its new guidance the FDA recommends that a manufacturer should include information explaining the composition of the ingredient, why the ingredient is considered new, recommended usage by consumers, and why the ingredient is considered safe. This draft guidance only applies to new ingredients in dietary supplements; it does not cover ingredients in other food products governed by the Federal Food, Drugs and Cosmetics Act. Guidance documents do not establish legally enforceable responsibilities; rather, they are intended as recommendations to help industries understand FDA's position on areas of federal law.
I understand you have concerns that FDA actions could restrict consumer's access to certain supplements and thank you again for contacting me to share your thoughts on this matter. You may be interested in signing up for my periodic update for Washington State residents. If you are interested in subscribing to this update, please visit my website at http://cantwell.senate.gov. Please do not hesitate to contact me in the future if I can be of further assistance.
Sincerely,
Maria Cantwell
United States Senator
For future correspondence with my office, please visit my website at http://cantwell.senate.gov/contact/index.html
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