The above titled blog post has been deleted because an individual has chosen to use it to further her own political agenda, without asking my permission or agreement.
The situation that she sees as a reason to make what we do even more difficult was resolved.
She did NOT have my permission to use this as the basis for her campaign.
Sorry folks, it's a non-issue and ancient history.
Thursday, September 12, 2013
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19 comments:
A real concern!!!
This is just horrifying and points again to the irresponsible claims and uses made by some companies in the USA. What can we do? Letter writing? Scientific studies? Reports? Give me a task, and let me help!
Liana in San Diego
Rose Geranium is on the FDA GRAS list.
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr=582.20
Robert, I know it's on the GRAS list. none the less, they blocked it as a "new drug" because of what someone else's website says. they could care LESS about GRAS.
It's an extremely odd story, though the fundamental point - medicinal claims for unlicensed medicines - should be of concern. The suggestion to the FDA that they seize all rose geranium oil suggests to me that any future imports should be labelled as "geranium oil" which is how most geranium oils are labelled for import/export. It's not obvious to me why this was called "rose geranium".
Is there anything that we can do en-masse? I would be willing to help in any way possible. This "Seize" by the FDA is absurd. I will not go into my pov on the politics of this atm. however I re-state, I am willing to help, should you want to proceed.
FDA states in regards to essential oils used for aromatherapy "But if someone tries to market a scent suggesting effectiveness as an aid in quitting smoking, as a sleeping aid, or to treat or prevent any other condition or disease, or otherwise affect the body's structure or function, such a claim may cause the product to be regulated as a drug, requiring premarket approval. The agency will make judgments on a case-by-case basis. The operative word here being "may". I think the same criteria would hold in this case too.
This maroon works for somebody else and has to answer to them, never hesitate to go higher up. Also contact your senator and representative and make them aware of this travesty. Administrative actions can be appealed (I don't know the process) but I do believe it is possible to get an injunction to halt FDA destruction of the rose geranium oil. Not sure how that would be filed and what the time limits are. If there is a good deal of money tied up in this import it would be worthwhile to consult an attorney who is up on such matters.
Has the FDA shown that the intended use for the rose geranium oil by the importer is "diagnosis, mitigation, treatment, or prevention of disease, and intended to affect the structure or any function of the body."? I don't think they have. IMHO, one anon person on a unknown website making a medical claim does not apply to all who use rose geranium oil in their product. It only applies to the person making the claim. I think that is a rather common application of law. It would be like a cop seeing a green car speeding and concluding all green cars must be ticketed for the same offense. This maroon is applying a broad law to a narrow set of facts. Not being a lawyer I can not be sure but I don't think that is how it is supposed to work.
Paula
FDA states in regards to essential oils used for aromatherapy "But if someone tries to market a scent suggesting effectiveness as an aid in quitting smoking, as a sleeping aid, or to treat or prevent any other condition or disease, or otherwise affect the body's structure or function, such a claim may cause the product to be regulated as a drug, requiring premarket approval. The agency will make judgments on a case-by-case basis. The operative word here being "may". I think the same criteria would hold in this case too.
This maroon works for somebody else and has to answer to them, never hesitate to go higher up. Also contact your senator and representative and make them aware of this travesty. Administrative actions can be appealed (I don't know the process) but I do believe it is possible to get an injunction to halt FDA destruction of the rose geranium oil. Not sure how that would be filed and what the time limits are. If there is a good deal of money tied up in this import it would be worthwhile to consult an attorney who is up on such matters.
Has the FDA shown that the intended use for the rose geranium oil by the importer is "diagnosis, mitigation, treatment, or prevention of disease, and intended to affect the structure or any function of the body."? I don't think they have. IMHO, one anon person on a unknown website making a medical claim does not apply to all who use rose geranium oil in their product. It only applies to the person making the claim. I think that is a rather common application of law. It would be like a cop seeing a green car speeding and concluding all green cars must be ticketed for the same offense. This maroon is applying a broad law to a narrow set of facts. Not being a lawyer I can not be sure but I don't think that is how it is supposed to work.
Paula
Your friend needs a lawyer.
I worry about this because I can see the EU going in the same direction. At the moment essential oils have not to my knowledge had this problem but many products have.
Going to get worse before it gets better. Staying aware is vital. Thanks Marge.
May be called rose geranium because that is the plant it is distilled from. Many scented geraniums out there so name may be used to distinguish(?) Are any other scented geraniums being distilled? Is only rose geranium used in aromatherapy?
There can be something done! Want to by pass all the government silliness? Team up with the Native Americans and they can import without going through all the FDA and other silly controls. Go to there website at Oklevueha.org and read more about protecting yourself. Its free. What is there can be easily adapted into your business for complete protection from government interference.
In regards to what can we do.... I am going to post a few links from Natural News, and Health Freedom information. We have to discuss this dark looming issue, and learn from others, like the raw milk farmers, and other practitioner who have been raided, and harassed.
So below are a few articles - related to, but not specific to Marges post. But they may help spark ideas about what and can and will have to do.
So, here are a few things to start reading, .
For those of us going to the AIA Conference in Florida next week - I hope we can dedicate some time to a lively discussion!!
http://www.naturalnews.com/021841_health_freedom_FDA_reform.html
http://www.naturalnews.com/033426_FDA_dietary_ingredients.html
http://www.naturalnews.com/034575_health_freedom_Wisconsin_consumer_choice.html
Unfortunately, like most regulations...the root cause for their being enacted is someone's over zealousness and exaggerated claims.
Supposedly, they are trying to 'protect' the public. Don't laugh.
This is why disclaimers on our websites, products and teaching material needs to be spot on about what we are NOT doing: diagnosing, prescribing and claiming to cure medical conditions.
Thankfully, there are some sites out there like the National Cancer Institute that have given a nod to aromatherapy for SUPPORTIVE care of medicated cancer patients. We must embrace mainstream publications that give us credibility, but more importantly, WE must act credible.
Hmm, maybe it actually works! Next thing you know there will be a new patented US drug based on rose geranium oil!
HA!
I think he needs an attorney. This is ridiculous.
I think its very important now to get good attorneys and ones who can and will be proactively aggressive on behalf of the whole industry enough that government bullies will think twice before picking on any honest legitimate oil company. Also to establish good success records in court and get the facts out there. IMHO.
I highly suggest that you use a tool like http://www.change.org/ to mount a petition for action. This site has been pivotal to highlighting lots of injustices being perpetuated by our state and federal governments, and also in bringing national attention to extreme lapses or abuses in professional procedure, such as has been obviously demonstrated here.
So what action would you like the petition to achieve? Should Sherea Dillon be forced to resign? Should this federal office in Chicago be forced to recall their poorly compiled judgement? this lackadaisy style of governing is dangerous to all of us who rely on government foresight to continue to do business.
If you decide to launch a petition, please update your blog post with this information and I will be more than happy to sign it. Get the word out about this stupidity so it's not allowed to flourish.
I work a lot with government organizations. They are so big that sometime individual employees create these types of problems and not get caught. I wouldn't consider this to be a sign of the times. It is simply a single instance of a government employee/group overstepping bounds and not permitting a GRAS product to be imported. I recommend hiring an FDA attorney if this ever happens again.
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