The one force that government agencies may listen to is Congress. This link will allow you to look up your elected Senators and Representatives, based only on your zip code.
This is a rough draft of a proposed letter. PLEASE put it in your own words. If you are members of any professional groups that ever use essential oils - natural products associations, soap or toiletries makers, natural health organizations, please discuss both the earlier blog article about the seizing and this letter with them. One or two letters can be dismissed. If we can bombard them, perhaps they will respond.
TO:
congressman so and so or
Senator……….
I am writing you today to request your help and intercession with the Food and Drug Administration pertaining to unwarranted seizure of Pelargonium graveolens essential oil (Rose Geranium) and the reclassification of this oil as a new drug. (see Notice of FDA action/ Entry number 399-0344329-7 attached)
Pelargonium graveolens is on the GRAS list (generally regarded as safe) and has been safely used for decades.
The FDA has seized a shipment of this essential oil and charged unsupported health claims have been made. This is not true. The importer, Duerst Lahti Global, LLC, never has made any health claim. When asked to produce any evidence of the allegations, the FDA’s Compliance Officer, Sherea Dillon, ignored the request and refused to identify the source of the claim.
The FDA has further overreached their authority by ordering the manufacturer to return the shipment from whence it came or destroy it. This is outrageous and uncalled for. The manufacturer cannot be held responsible for something someone, somewhere said about a natural product. The FDA has failed to show just cause or any evidence supporting these ridiculous allegations. The actions of the FDA appear to be capricious at best and in obvious violation of DSHEA 1994, and
a complete misinterpretation of FDA/FTC regulations.
I respectfully request you use your influence to call a halt to this blatant misuse of the FDA’s authority. I look forward to your response.
* This just an example of the type of letter that can be used to contact everyone's Congressman or Senator.
*A copy of the FDA notice and Lahti’s response must be attached when sending letter or email. (See earlier blog article, http://naturesgiftaromatherapy.blogspot.com/2013/09/rose-geranium-new-drug.html)
The main point should be made that the product is safe, approved and no claims have been made by the responsible parties. To further try to comply with FDA requests ignores the fact they have not shown any evidence of wrongdoing, and in this case, being guilty until proven innocent.
Letters and emails should be sent and phone calls made from any person who uses, makes or even LIKES essential oils and other natural products.
This advice comes from a friend who has had years of experience dealing with government regulation of natural products.
Thank you for your attention to this matter. Together we can make a difference.
1 comment:
Thank you for this effort. In addition I believe reporting the companies making these false claims is also important - to demonstrate that the industry at large is operating according to the law - and it is those companies that they should focus on, not the companies that obey the law!
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