FDA/FCC Regulation of EO ** Was: Aromatherapist Suppliers- Big Question.

[Guest guest]

Hi Laura,

 

> How are you handling the FDA direction as per your products- as per

> the FDA web site- EO's are regulated and considered as drugs.

 

EO are NOT regulated .. medicinal claims are regulated. If we mix cow

manure with a product and then claim that it will heal the body or mind

or provide this or that relief from a disease or abnormal condition ..

the product can then be classified as a medicine .. a drug .. and our

feet can be held to the fire to prove it is true. If we can't prove it

they can close us down, fine us or take us to court.

 

If a claim is made on the label of the product the FDA (Food and Drug

Administration) is the U.S. federal agency responsible for enforcement.

If the claim is made on a web site or other form of public advertisement

its the FTC (Federal Trade Commission) that can (will?) step in.

 

> Somewhere on a list- I was lead to believe EO's were not regulated -

> but as per the quote below- it appears they are.

 

Don't read too much into it. EO are not regulated .. medicines are

regulated .. and if one claims their product (containing EO or horse

manure) will cause healing in the body or mind or whatever, then they

are selling a medicine (a drug) and it becomes subject to regulation.

 

This is why I have ALWAYS advised folks to STOP using terms like

" Therapeutic Grade " because that smacks of medicine .. " Aromatherapy

Grade " is a better (safer) term .. IF .. folks don't get paranoid and

try to split that term down into micro fibers. Get three lawyers in a

court room dealing with that and you'll get ten opinions .. eleven of

which will probably be wrong opinions. ;-)

 

> Here is the quote straight off their web site:

>

> ..This principal also holds true for essential oils in fragrance

> products. A fragrance marketed for promoting attractiveness is a

> cosmetic. But a fragrance marketed with certain " aromatherapy " claims,

> such as assertions that the scent will help the consumer sleep or quit

> smoking, meets the definition of a drug because of its intended use.

 

Most folks know that .. but many violate it. Some folks dance around

the edges of a " technical " violation on the issue. Note that I avoided

the term " legality " .. I use " violation " because its a bit softer. As

for legality that requires a decision by an authority with the power to

make such decisions .. and even that can be challenged in a court of law

and the decision can be overturned. The big companies hire Silver

Tongue Devils to defend them and they often get out of the hot water.

 

This regulation also holds true for soaps. If one claims their soap is

soap then the FDA/FTC does NOT regulate it. If they sell soaps with a

claim of therapeutic properties .. or even name the soaps in a manner

that would suggest therapeutic value .. like " Psoriasis Soap " or " Eczema

Soap " or whatever, then its no longer a soap .. its a medicinal product

subject to regulation. Check the soap lists and on a daily basis you'll

see many folks walking in harm's way. Why are they not called to task?

In most cases .. its because they are running expensive hobbies .. not

a big business .. if they ever become big business they will probably

get some attention from the FDA/FTC. That is not to say that a small

business can skate .. it depends on the nature of the claim. Experience

shows that the FDA and FTC recognize and maybe even close their eyes

when " technical " violations are not unsafe violations .. but they will

often open their eyes again if a formal complaint is made..

 

Cops don't come running every time folks holler " Wolf. " They don't have

the time or manpower to deal with all violations .. but when a formal

complaint is made they must take the time.

 

However, claims that this or that scientific study has shown that this

or that does this or that is not peddling medicine .. its " technically "

tip toeing thru the tulips and hoping there are no snakes in there. ;-)

 

But we still gotta be careful and not extrapolate the results of an in

vivo or in vitro test because sometimes the manner of introduction of

the therapeutic agent in the experiment will be different than the folks

on this list can perform .. so its a case by case situation.

 

Good it is to quote the credible source when claims are made. Like good

it is to cover our butts with scientifically tested safe dilution for

this and that EO .. as laid out in the Safety Manual " Plant Aromatics " .

http://www.av-at.com/plantaromaticsavnp.html

 

Quoting the opinions found in the vast majority of the Aromatherapy

" novels " out and about is about as useless as udders on a boar hawg

because they are merely opinions .. but reporting dermatology tests,

date of test and who did the test .. as laid out in Plant Aromatics, is

considerably more credible as a defense if one is called to task.

 

We must be careful to avoid blatant advertising and claims .. like those

made by the " Independent " Young Living Distributors. YL has been called

down by the FDA and the FTC .. so they went out to their folks " for the

record " and told them in writing to cease and desist. But at the many

private meetings and get togethers YL leaders fill the " independent "

distributors minds with so much Bovine Excrement overload that they can

not help but spout off some of that data .. which helps to increase the

sales .. but keeps YL leaders out of hot water cause they are on record

telling folks not to do it. Who is left holding the bag? Young Living

" INDEPENDENT " distributors.

 

We must also be careful to avoid paranoia .. if we don't .. then those

who sell/research and report on the safe use of natural products should

not be members of lists like this one or any other list that discusses

Aromatherapy. There would be little learning and safety information put

out .. the lists would become chat groups or rumor mills dominated by

the personalities of the folks who are best at convincing others that

they have their crap together .. lists could become forums where the

blind are leading the blind.

 

By the way .. even though this list is a forum for exchange of opinions,

the List Mama .. and some of her gnomes .. and some other folks who are

knowledgeable and responsible .. often get in and challenge others when

they make claims that we think or know are potentially dangerous. Its

not personal .. its just a matter of needing to maintain some form of

control in order to keep the list from becoming a forum for marketing

hype and unsafe misinformation.

 

The FDA or FTC can also close down a List like this. The List Mama is

responsible to ensure this list does not routinely violate the law.

 

Folks might be surprised to learn how much off list discussion goes down

from time to time when a post from a new member is pending approval.

All new members go on a moderated status until their modus operandi is

clear. If someone makes a post offering " Snake Oil " the List Mama or

one of her gnomes will contact them and ask them to modify the post ..

and if they don't then the post is not approved. This isn't censorship,

its management and without management there is chaos, at best, unsafe or

even dangerous recommendations, at worst.

 

Along with freedom of speech comes a requirement to be responsible. I

think that hollering " Fire " in a crowded theater is no less dangerous

than recommending neat use of EO .. or dermal application of Cinnamon

Bark EO, etc. Somebody is gonna get involved if that happens. Better

it be the List Mama getting involved than it is the FDA or FTC.

 

Ain't no different than it was when I was a military cop. If we saw a

notable trend of conduct prejudicial to good order and discipline in a

particular organization we would tell the commander to tighten up the

reigns .. or we would get involved.

 

> Blessings, Laura

> http://www.purrinlot.com Persians that Purr!

> http://www.castlebaths.com

 

Y'all keep smiling. :-) Butch http://www.AV-AT.com