The FDA has presented a troubling issue regarding nutritional supplements. A GUIDANCE issued by the FDA calls for such incredible constraint on the supplement industry that, if enacted, could truly have a profound effect on the availability of a vast array of products. Since virtually all of us, including myself, use dietary supplements, I urge you to take immediate action by sending the attached letters to your representatives. A text version is also at the end of this email – you may cut and paste it into an email to your elected representatives in Washington, but you will need to fill out a brief contact form first. I believe faxing is the best way to be heard. Feel free to change the letters and personalize them.
Follow this link for Website address for government contact information including mailing addresses and fax numbers for your Senators and Representatives. www.usa.gov/Contact/Elected.shtml
DEADLINE IS DECEMBER 2, 2011 FOR COMMENTS – The FDA is proposing certain regulations to impede, restrict, and ban dietary supplements. This has happened in Europe and other countries. Please help to stop it from happening in America!
The following are a few highlights of the Guidance document:
The FDA’s draft Guidance requires companies to possess exorbitant amounts of information concerning their existing dietary supplements to prove that New Dietary Ingredient (NDI) notifications are not required for the products they are currently marketing. In many cases, it will be impossible to gather such information, thereby threatening the future availability of numerous dietary supplement products on the market today.
In order to market a product that contains a new dietary ingredient, manufacturers will be required to submit a tremendous amount of information concerning historical use of the ingredient or conduct a multitude of animal and human studies which are overly burdensome and costly. Establishing such excessive requirements is both contrary to Congressional intent and unnecessary given the safety record of dietary supplements over the past few decades.
Any change in the manufacturing process of a dietary ingredient that results in chemical alteration of such ingredient or a change in specifications of the ingredient,regardless of how insignificant the alteration or change is, will require the submission of a NDI notification. This will discourage manufacturers from using the most advanced and efficient manufacturing technologies and pursuing methods that can improve the safety and effectiveness of dietary supplement products.
Any increase of the amount of a dietary ingredient in a dietary supplement or any change in formula of a dietary supplement, regardless of how minute or insignificant, will require the submission of a NDI notification. This will discourage the innovation of new products.
……………………………………………………… SAMPLE LETTER BELOW
November , 2011
To My Elected Representative:
My name is , and I am a constituent in your District. I am deeply concerned about the Food and Drug Administration’s (FDA) recently issued Draft Guidance document entitled New Dietary Ingredient Notifications and Related Issues.
Dietary supplements are an important part of my and my family’s health-maintenance routine. We consider access to affordable supplements to be a crucial part of our healthy lifestyle to mitigate the need for expensive medical procedures and promote good health to improve and extend our lives.
The FDA’s issuance of its draft Guidance is very troubling because it signals a dramatic shift in its policy towards dietary supplements, and I believe the FDA is attempting to establish a system of pre-market approval for these products. It has been nearly two decades since enactment of the Dietary Supplement Health and Education Act of 1994 (DSHEA). Back then the industry was in a fight for its life because of the FDA’s insistence on using the vague standards in the food additive provisions as a means of removing from the marketplace ingredients it disapproved of even for reasons unrelated to safety. The FDA abused its authority, and through a lot of hard work, we won the battle.
Now we find ourselves having to defend the very existence of this industry once again. While DSHEA purposely had drafted in it, a sensible and reasonable system by which the agency must be notified of the marketing of a new dietary ingredient and the basis for which the manufacturer believes that a dietary supplement containing such dietary ingredient will reasonably be expected to be safe, the FDA has taken positions in its draft Guidance that indicate that it intends to treat dietary ingredients as food additives once again. Even more disturbing, is FDA’s insistence that any change in the formula of a dietary supplement that contains a new dietary ingredient will require the submission of a NDI notification. The agency has announced its intention that all dietary supplements containing new dietary ingredients be pre-cleared by the FDA. This is contrary to Congressional intent in passing DSHEA. If the FDA deems it necessary to make such drastic changes in the way dietary supplements are regulated, I think it should have to go through Congress. This is a bureaucracy that is out-of-control. It would needlessly restrict access to safe dietary supplement products, and is a job killer for the dietary supplement industry.
As a concerned constituent in your District, I am requesting that you do everything in your power to stop the FDA from enforcing DSHEA in a manner that is contrary to Congressional intent and in a manner that has the potential to destroy an industry that has brought so much good to so many people.
If you would like to send a letter to your representative to help stop this from going into affect, you can download the customized letter, here. Please help to keep our rights when it comes to nutritional supplements. I truly believe in the benefit of nutritional supplements and don't know where I would be without them, I hope I never have to find out.
If you would like to read more about this issue, click here.
Pura Vida!
Alica Ryan, NTP
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