Re: EPA & the Insect Repellent Registration Saga Continues...

[Guest guest]

,

Your attorney gave you excellent advice... money well spent.

No, you can not sell this bug repellant if you in any way imply that

it will keep bugs away, act as a repellant, deter insects, or any

round about way of implication that this is insecticide or

repellent. This is also why Avon sold their SSS Skin So Soft as BATH

OIL for many years until they passed the EPA hurdles to actually

sell their concoction as repellant.

You can not label, promote, claim, insinuate, or advertise this

product as being insect repelling, bug repelling, bug be gone,etc..

or you will be engaging in product misbranding and subject to

everything you have of this being seized.

http://www.epa.gov/oppfead1/labeling/lrm/chap-02.htm#claims

(Claims. If a person who distributes or sells the product claims,

states or implies by labeling or otherwise (such as, advertising,

collateral literature, or verbal statements), that the product can

or should be used as a pesticide or that the product contains an

active ingredient and that it can be used to manufacture a

pesticide, then the product is a pesticide. 40 CFR 152.15(a).

Composition. If a product is composed of one or more active

ingredients that have no other significant commercially valuable use

other than for a pesticidal purpose or for use in manufacturing a

pesticide then the product historically has been considered to be a

pesticide. 40 CFR 152.15(. For example, a company markets a

granular product that has labeling identifying the presence of 2,4-

D, directions to apply it to lawns at a certain dosage rate, and

warns the user about over-application, but does not claim that broad-

leaved weeds will be killed, is the product a pesticide? Most

likely, the product is a pesticide because 2,4-D is a well-known

herbicide and has no other significant commercially valuable use.

Knowledge that the substances will be used as a pesticide. Even if

pesticidal claims are not made for the product, if the person who

distributes or sells the substance has actual or constructive

knowledge that the substances will be used, or is intended to be

used, for a pesticidal purpose, the product is a pesticide product

required to be registered. 40 CFR 152.15©. )

It will not be your small manufacturer competitors that turn you

in.. it will be the big boys that have already paid their $750,000

and done their scientific lab testing, and paid to have their

product registered in the states they sell it in, as well as their

Multi Million Dollar Market Focus Studies Groups and Advertising

campaigns. They will not just sit back and let any of use pimp

similar products without having to jump through the same hoops,

comply with the same rules and regulations. They WILL report you. I

don't remember the name.. but within the last few years their was a

small manufactuer reported and fined $70,000 by the EPA for this..

I am including a PDF link to a document that I give to people

asking about this ...:

http://www.epa.gov/opp00001/regulating/fifra.pdf

Be sure to click on the Section #2 Definitions, para q, Misbranding.

also para U, Pesticide (definition).

Registration of Pesticides:

http://www.epa.gov/opp00001/regulating/fifra.pdf

Here is the EPA Labeling Manual also:

http://www.epa.gov/oppfead1/labeling/lrm/

Hope that helps... Suncreens, Insecticides, and Baby Care items are

things that in my opinion carry too high a liability risk unless you

have the huge capital resource to conduct proper testing...

Bloom

Southern Soapers Fragrances ~ " We Have No Common Scents! "

http://www.southernsoapers.com

[Guest guest]

> American I just want to throw up. This draws a very clear, deep, dark

> line between the " have's " and the " have-nots. " Those that can't pay

> upwards of $200,000 (after testing etc., ) need not apply, Thank you

> very much.

Remember the AVON " Skin-so-soft " bath oil? It worked as an insect

repellant, too...but the company never had it tested nor had it

registered as one, so it was just marketed as a bath oil...and

people " whispered " about the side benefits!

I think the issue is, insects spread potentially fatal diseases, and if

you make a claim and the product doesn't work, someone could put

themselves in harm's way.

The other issue is, this is a billion $++ industry, repelling insects.

If you want a piece of the pie...you have play with the big boys.

Why not just market the product as a cosmetic and just like plenty of

cosmetics have medical effects/benefits, your product works as a

repellant? And just like the cosmetics's makers cannot legally make

medicinal claims, but they still sell with a whole lot of " hints " . Sue

[Guest guest]

There's got to be a legal loophole somewhere. If it's all about a word.. then

focus your attention on that. Don't give up. I wouldn't even bother with the

government. Just follow their rules their way. Don't lie. Don't play on their

grounds or speak their language or take offense and try to play their games

their way.

Why can't the product name have a totally different twist that makes sense to

everyone.

who needs the word repellent. Surely our language can contribute something more

descriptive. Maybe our industry just needs its own word. The herbal community

found a way to cut thru this same type of red tape. I think it's important that

so many are allergic to natural plant extracts.. People also love their pets for

example, more than themselves. Everyone is too afraid of lawsuits while too

quick to put in and on the body what the gov. has deemed safe or okay?... yeah,

that's a problem bigger than just skin care products.

If " I " worked for the EPA and really cared, I would be more concerned about

warnings I feel our customers need the most. it's up to the end customer to test

for themselves.

i.e.....

NEW! Safe the environment. All natural BUG STOP. Bugs and insects hate it. We

Use only 100% natural ingredients that God gave us to use to protect us against

all the pesty pests.

I think we are also safe to quote bible scriptures that say there is healing in

the leaves without saying " our products heal " . yet it would clearly get the

message out.

cc

EPA & the Insect Repellent Registration Saga

Continues...

Dear Group,

>>>>>>>>>>....

One of the main reasons I am so disgusted (well besides the

ridiculously exorbitant amount of money) is the fact that we have many

other products that have the same exact natural ingredients, that are

not called " repellents " and we have no problems whatsoever. All of our

products are listed, without a hitch, with the FDA. Your thinking,

well don't call it a repellent then. But why do we have to lie about

it to get thru the gates (and live in fear that maybe the gate will

one day come slamming back and hit you in the a$$)? My point is that

these products are 100% natural, do not contain any harsh synthetic

chemicals (that I ABSOLUTELY believe should be regulated, DEET etc.,

etc. cancer-causing water pollutants) and are the same as any other

natural product out there. Just the word " repellent " makes them

different?

>>>>>>>>>>>>>>>............

If the point of the EPA (Environmental Protection Agency) is to

protect our environment and water supply etc., etc. from chemicals

etc., etc. then shouldn't every single cosmetic/ product on earth be

registered with the EPA? Not just the ones that " repel " insects, but

every single product out there has the potential to pollute and be

destructive to the environment.

Frustratedly yours,

R. Lorenti Jr.

mlorenti@...

www.sensatia.com

YM id: sensatia_botanicals

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[Guest guest]

Hi ,

Well you are sure a wealth of information. Wow!!!! Thank you very much.

But, In any event I intend on pushing this further. I COMPLETELY and

utterly disagree with these regulations. No matter what (and this is

the major point of my argument) THE INGREDIENTS ARE THE SAME wether a

product is called a repellent or not. Allow Avon to call skin so soft

a repellent, everyone knows it is anyway, so what's the big deal. What

the difference if a product is on the shelf as a repellent or simply

as a lotion and the ingredients are the same??? The point is to

protect the environment isn't it?

I am just trying to be honest and take care of this directly & openly

( & legally) and instead I am completely stupefied by the system. If

the point of the EPA is to protect and regulate toxins being released

into the environment thru regulation of chemicals etc., then their

concern should be ONLY the ingredients not wether they are called a

repellent or not. Should this mean that every product that contains

rosemary oil should be regulated by the EPA? Lavender oil? Patchouli?

Peppermint? Lemon Myrtle? If yes, thats fine, we all have alot of work

to do. But if not, then why on earth should this even be an issue???

Anyway , I truly just can't believe it, and I am still in shock.

But anyway, I definitely intend on pushing further. I am not happy

accepting this as it is and think there definitely needs to be some

changes made to this regulation. I am considering starting a petition.

Do you have any idea of how many thousands of natural insect

repellents are out there currently in violation of the EPA regs???

Practically every handmade/ homemade cosmetic company has a something

for the skeeters. It boggles my mind.

Anyway, I want to try and effect change. Seems like an old republican-

crony made law.

Have a great day,

R. Lorenti Jr.

mlorenti@...

www.sensatia.com

YM id: sensatia_botanicals

[Guest guest]

Uh.. the EPA is very clear.. IMPLICATION or IMPLIED use by the name

of the product, word of mounth, advertising is all part of how they

determine misbranding. So, you can put Sexy Lady Cream on the label,

and just only use word of MOUTH to promote it as a bug repellant..

and you will be looking at MISBRANDING litigation and fines.

It is because the active ingredients in your " Sexy Lady " product are

not REGISTERED and TESTED with the EPA.

Of course you can do whatever you please... but if you loose your

house and business defending your right to not follow the laws it

does you no good at all.. and it only benefits your competition. I

firmly believe that even if we do not LIKE the regulations, that is

more intelligent to abide by them... because PISSING IN THE WIND

only gets YOU wet.

Bloom

Southern Soapers Fragrances ~ " We Have No Common Scents! "

http://www.southernsoapers.com

>

> There's got to be a legal loophole somewhere. If it's all about a

word.. then focus your attention on that. Don't give up. I wouldn't

even bother with the government. Just follow their rules their way.

Don't lie. Don't play on their grounds or speak their language or

take offense and try to play their games their way.

>

> Why can't the product name have a totally different twist that

makes sense to everyone.

> who needs the word repellent. Surely our language can contribute

something more descriptive. Maybe our industry just needs its own

word. The herbal community found a way to cut thru this same type of

red tape. I think it's important that so many are allergic to

natural plant extracts.. People also love their pets for example,

more than themselves. Everyone is too afraid of lawsuits while too

quick to put in and on the body what the gov. has deemed safe or

okay?... yeah, that's a problem bigger than just skin care

products.

>

> If " I " worked for the EPA and really cared, I would be more

concerned about warnings I feel our customers need the most. it's up

to the end customer to test for themselves.

>

> i.e.....

> NEW! Safe the environment. All natural BUG STOP. Bugs and insects

hate it. We Use only 100% natural ingredients that God gave us to

use to protect us against all the pesty pests.

>

> I think we are also safe to quote bible scriptures that say there

is healing in the leaves without saying " our products heal " . yet it

would clearly get the message out.

>

> cc

>

[Guest guest]

HINTS are IMPLIED USE.. and make your product subject to

misbranding ... and the fines associated with that. There truly is no

way or loop hole around this. One should not jeopardize the rest of

their successful business by risking shut down over promoting this

type of product illegally. I would instead PATENT the formula or sell

the formula for a huge fee to a big boy that is will and able to pay

and follow the enormous costs associated with putting this type of

product properly on the market.

I saw something last month on Essential Wholesale's website... Kayla

is a member here so she might step in and point you to this.. But EW

is soliciting for a few really good business ideas to invest in and

helpt take to the next lelel. I would take this idea to them, get a

non disclosure first, and let them evaluate if this would qualify as

one of the good ideas that they might be interested in.

If that is not workable, than I would contact Burts Bees.. they

recently were puchased by Clorox and they have the capital and

interest to take something like this and get it in distribution

channels properly. Remember, Tom's toothpast and tinctures started

this way too... Venture Capital is good if you define who you are

willing to help, only give up the goods for this one item, and

negotiate. You will need an attorney to represent YOUR best interest

regardless of WHO you approach though, but you do have one so you

should have no problems.

Bloom

Southern Soapers Fragrances ~ " We Have No Common Scents! "

http://www.southernsoapers.com

make a claim and the product doesn't work, someone could put

> themselves in harm's way.

>

> The other issue is, this is a billion $++ industry, repelling

insects.

> If you want a piece of the pie...you have play with the big boys.

>

> Why not just market the product as a cosmetic and just like plenty

of

> cosmetics have medical effects/benefits, your product works as a

> repellant? And just like the cosmetics's makers cannot legally make

> medicinal claims, but they still sell with a whole lot of " hints " .

Sue

>

[Guest guest]

Hi Sue,

I agree with you, especially in regards to making claims. But I think

that decision should ultimately be left to the educated consumer. For

example, We have all bought products or goods or even services for

that matter that didnt work. Did we buy them again? This is not a cure

for cancer, it is only a product that possibly protects us from

mosquitoes. There are no 100%'s out there but it would definitely be

better than nothing at all, and you even get to smell nice, hehehehe

Take care Sue, thanks for the input ;-)

Have a great day,

R. Lorenti Jr.

mlorenti@...

www.sensatia.com

YM id: sensatia_botanicals

On Mar 15, 2008, at 12:50 PM, greengirlh2 wrote:

> > American I just want to throw up. This draws a very clear, deep,

> dark

> > line between the " have's " and the " have-nots. " Those that can't pay

> > upwards of $200,000 (after testing etc., ) need not apply, Thank you

> > very much.

>

> Remember the AVON " Skin-so-soft " bath oil? It worked as an insect

> repellant, too...but the company never had it tested nor had it

> registered as one, so it was just marketed as a bath oil...and

> people " whispered " about the side benefits!

>

> I think the issue is, insects spread potentially fatal diseases, and

> if

> you make a claim and the product doesn't work, someone could put

> themselves in harm's way.

>

> The other issue is, this is a billion $++ industry, repelling insects.

> If you want a piece of the pie...you have play with the big boys.

>

> Why not just market the product as a cosmetic and just like plenty of

> cosmetics have medical effects/benefits, your product works as a

> repellant? And just like the cosmetics's makers cannot legally make

> medicinal claims, but they still sell with a whole lot of " hints " . Sue

[Guest guest]

what if you said similar to Avon's skin so soft...

or is it now a bug repellant...

Just curious.

Willow

--- " R. Lorenti Jr. " <mlorenti@...>

wrote:

> Hi ,

>

> Well you are sure a wealth of information. Wow!!!!

> Thank you very much.

>

> But, In any event I intend on pushing this further.

> I COMPLETELY and

> utterly disagree with these regulations. No matter

> what (and this is

> the major point of my argument) THE INGREDIENTS ARE

> THE SAME wether a

> product is called a repellent or not. Allow Avon to

> call skin so soft

> a repellent, everyone knows it is anyway, so what's

> the big deal. What

> the difference if a product is on the shelf as a

> repellent or simply

> as a lotion and the ingredients are the same??? The

> point is to

> protect the environment isn't it?

>

> I am just trying to be honest and take care of this

> directly & openly

> ( & legally) and instead I am completely stupefied by

> the system. If

> the point of the EPA is to protect and regulate

> toxins being released

> into the environment thru regulation of chemicals

> etc., then their

> concern should be ONLY the ingredients not wether

> they are called a

> repellent or not. Should this mean that every

> product that contains

> rosemary oil should be regulated by the EPA?

> Lavender oil? Patchouli?

> Peppermint? Lemon Myrtle? If yes, thats fine, we all

> have alot of work

> to do. But if not, then why on earth should this

> even be an issue???

>

> Anyway , I truly just can't believe it, and I

> am still in shock.

> But anyway, I definitely intend on pushing further.

> I am not happy

> accepting this as it is and think there definitely

> needs to be some

> changes made to this regulation. I am considering

> starting a petition.

> Do you have any idea of how many thousands of

> natural insect

> repellents are out there currently in violation of

> the EPA regs???

> Practically every handmade/ homemade cosmetic

> company has a something

> for the skeeters. It boggles my mind.

>

> Anyway, I want to try and effect change. Seems like

> an old republican-

> crony made law.

>

> Have a great day,

> R. Lorenti Jr.

> mlorenti@...

> www.sensatia.com

> YM id: sensatia_botanicals

>

>

[Guest guest]

,

I support your frustration and desire to make the govt create

changes 100%... You will be a " change maker " ... it is a hard row to

hoe, but it can be done with determination and preserverance. I am

going to wish you the absolute best of luck because if you are

sucessful you will be breaking ground for the rest of us small

indies also,

Bloom

Southern Soapers Fragrances

http://www.southernsoapers.com

>

> Hi ,

>

> Well you are sure a wealth of information. Wow!!!! Thank you very

much.

>

> But, In any event I intend on pushing this further. I COMPLETELY

and

> utterly disagree with these regulations. No matter what (and this

is

> the major point of my argument) THE INGREDIENTS ARE THE SAME

wether a

> product is called a repellent or not. Allow Avon to call skin so

soft

> a repellent, everyone knows it is anyway, so what's the big deal.

What

> the difference if a product is on the shelf as a repellent or

simply

> as a lotion and the ingredients are the same??? The point is to

> protect the environment isn't it?

>

> I am just trying to be honest and take care of this directly &

openly

> ( & legally) and instead I am completely stupefied by the system.

If

> the point of the EPA is to protect and regulate toxins being

released

> into the environment thru regulation of chemicals etc., then

their

> concern should be ONLY the ingredients not wether they are called

a

> repellent or not. Should this mean that every product that

contains

> rosemary oil should be regulated by the EPA? Lavender oil?

Patchouli?

> Peppermint? Lemon Myrtle? If yes, thats fine, we all have alot of

work

> to do. But if not, then why on earth should this even be an

issue???

>

> Anyway , I truly just can't believe it, and I am still in

shock.

> But anyway, I definitely intend on pushing further. I am not

happy

> accepting this as it is and think there definitely needs to be

some

> changes made to this regulation. I am considering starting a

petition.

> Do you have any idea of how many thousands of natural insect

> repellents are out there currently in violation of the EPA

regs???

> Practically every handmade/ homemade cosmetic company has a

something

> for the skeeters. It boggles my mind.

>

> Anyway, I want to try and effect change. Seems like an old

republican-

> crony made law.

>

> Have a great day,

> R. Lorenti Jr.

> mlorenti@...

> www.sensatia.com

> YM id: sensatia_botanicals

>

[Guest guest]

>This is also why Avon sold their SSS Skin So Soft as BATH

> OIL for many years until they passed the EPA hurdles to actually

> sell their concoction as repellant.<

Actually the original SSS bath oil is still just sold as bath oil, but

they added other ingredients to the items in the SSS line that they

sell as repellants. When the kids were little the bath oil was all I

would use on them for bugs, my husband HATED the smell so much he

waited until he was bitten before he'd put any on. I hated the smell

too...but everyone's personal chemistry is a bit different and I tend

to attract all the bugs while everyone else in my family is FINE! My

husband says it is because I am so sweet! HA HA!! [not] Sue

[Guest guest]

> Hi Sue,

>

> I agree with you, especially in regards to making claims. But I think

that decision should ultimately be left to the educated consumer.<

First, the thing about products with " active ingredients " , activity is

based on proof. And once an ingredient is legally determined to be

an " active ingredient " the government steps in to regulate it's use.

You may not WANT your formula to be legally recognized as a repellant

because then ANY use of those same ingredients might be subject to the

laws regarding the sale of a " repellant " !

Secondly, There are libraries full of books, herbalists with decades of

experience handed down to future herbalists, aromatherapists, etc. Are

the ingredients in your product something " no one " has ever combined

before with the intent to repel insects, or is the formula based on

historical use of the herbs and/or essential oils? You can't patent or

own something that has been used before for the same purpose. So the

originality of your product would be what determined whether anyone

would want to invest in taking it to the " next level " .

Sue

[Guest guest]

Yes absolutely. That is why I contacted the EPA in the first place, to

hopefully clear things up and travel the path of the straight &

narrow.... and in the end I figured out that in order to make it legal

you would have to come up with a few hundred thousand dollars, just

insane!!! I dont see the logic in trying to make an after-sun evening

lotion that everybody knows is an insect repellent. I wanted to call

it like it is. But in the end it just doesn't make sense that the same

product made of the same ingredients does not have any of those

regulations unless it is called repellent. The same non-repellent

product doesn't have any regulation. Can you see me smacking my

forehead going Duuuhhhhh?

> It is because the active ingredients in your " Sexy Lady " product are

> not REGISTERED and TESTED with the EPA.

So what is the excuse for all of the other natural ingredients that we

all use every day? None of those are tested and regulated by the EPA.

What makes a lavender/ rosemary/ lemon myrtle bar of soap or body oil

made of almost the same ingredients NOT have to undergo the same

testing as an " intended " repellent????

Have a great day,

R. Lorenti Jr.

mlorenti@...

www.sensatia.com

On Mar 15, 2008, at 10:10 PM, Southern Soapers Fragrances wrote:

> Uh.. the EPA is very clear.. IMPLICATION or IMPLIED use by the name

> of the product, word of mounth, advertising is all part of how they

> determine misbranding. So, you can put Sexy Lady Cream on the label,

> and just only use word of MOUTH to promote it as a bug repellant..

> and you will be looking at MISBRANDING litigation and fines.

>

> It is because the active ingredients in your " Sexy Lady " product are

> not REGISTERED and TESTED with the EPA.

>

> Of course you can do whatever you please... but if you loose your

> house and business defending your right to not follow the laws it

> does you no good at all.. and it only benefits your competition. I

> firmly believe that even if we do not LIKE the regulations, that is

> more intelligent to abide by them... because PISSING IN THE WIND

> only gets YOU wet.

>

> Bloom

> Southern Soapers Fragrances ~ " We Have No Common Scents! "

> http://www.southernsoapers.com

>

>

> >

> > There's got to be a legal loophole somewhere. If it's all about a

> word.. then focus your attention on that. Don't give up. I wouldn't

> even bother with the government. Just follow their rules their way.

> Don't lie. Don't play on their grounds or speak their language or

> take offense and try to play their games their way.

> >

> > Why can't the product name have a totally different twist that

> makes sense to everyone.

> > who needs the word repellent. Surely our language can contribute

> something more descriptive. Maybe our industry just needs its own

> word. The herbal community found a way to cut thru this same type of

> red tape. I think it's important that so many are allergic to

> natural plant extracts.. People also love their pets for example,

> more than themselves. Everyone is too afraid of lawsuits while too

> quick to put in and on the body what the gov. has deemed safe or

> okay?... yeah, that's a problem bigger than just skin care

> products.

> >

> > If " I " worked for the EPA and really cared, I would be more

> concerned about warnings I feel our customers need the most. it's up

> to the end customer to test for themselves.

> >

> > i.e.....

> > NEW! Safe the environment. All natural BUG STOP. Bugs and insects

> hate it. We Use only 100% natural ingredients that God gave us to

> use to protect us against all the pesty pests.

> >

> > I think we are also safe to quote bible scriptures that say there

> is healing in the leaves without saying " our products heal " . yet it

> would clearly get the message out.

> >

> > cc

> >

>

>

>

[Guest guest]

Hi ,

I have a question that maybe you can help with. So far I understand

the complications with Insect repellents, and sunscreens/ blocks. But

what other body care items would you say are a hassle to deal with and

better to just avoid??? I want to make a toothpaste from aloe vera

juice in the future, is that a headache too???? I mean i was thinking

because it is going in your mouth that maybe that is another huge ball

of wax.

Looking forward to waht you have to say on the matter. Sincerely,

Have a great day,

R. Lorenti Jr.

mlorenti@...

www.sensatia.com

YM id: sensatia_botanicals

On Mar 15, 2008, at 6:35 AM, Southern Soapers Fragrances wrote:

> ,

> Your attorney gave you excellent advice... money well spent.

>

> No, you can not sell this bug repellant if you in any way imply that

> it will keep bugs away, act as a repellant, deter insects, or any

> round about way of implication that this is insecticide or

> repellent. This is also why Avon sold their SSS Skin So Soft as BATH

> OIL for many years until they passed the EPA hurdles to actually

> sell their concoction as repellant.

>

> You can not label, promote, claim, insinuate, or advertise this

> product as being insect repelling, bug repelling, bug be gone,etc..

> or you will be engaging in product misbranding and subject to

> everything you have of this being seized.

>

> http://www.epa.gov/oppfead1/labeling/lrm/chap-02.htm#claims

> (Claims. If a person who distributes or sells the product claims,

> states or implies by labeling or otherwise (such as, advertising,

> collateral literature, or verbal statements), that the product can

> or should be used as a pesticide or that the product contains an

> active ingredient and that it can be used to manufacture a

> pesticide, then the product is a pesticide. 40 CFR 152.15(a).

>

> Composition. If a product is composed of one or more active

> ingredients that have no other significant commercially valuable use

> other than for a pesticidal purpose or for use in manufacturing a

> pesticide then the product historically has been considered to be a

> pesticide. 40 CFR 152.15(. For example, a company markets a

> granular product that has labeling identifying the presence of 2,4-

> D, directions to apply it to lawns at a certain dosage rate, and

> warns the user about over-application, but does not claim that broad-

> leaved weeds will be killed, is the product a pesticide? Most

> likely, the product is a pesticide because 2,4-D is a well-known

> herbicide and has no other significant commercially valuable use.

>

> Knowledge that the substances will be used as a pesticide. Even if

> pesticidal claims are not made for the product, if the person who

> distributes or sells the substance has actual or constructive

> knowledge that the substances will be used, or is intended to be

> used, for a pesticidal purpose, the product is a pesticide product

> required to be registered. 40 CFR 152.15©. )

>

> It will not be your small manufacturer competitors that turn you

> in.. it will be the big boys that have already paid their $750,000

> and done their scientific lab testing, and paid to have their

> product registered in the states they sell it in, as well as their

> Multi Million Dollar Market Focus Studies Groups and Advertising

> campaigns. They will not just sit back and let any of use pimp

> similar products without having to jump through the same hoops,

> comply with the same rules and regulations. They WILL report you. I

> don't remember the name.. but within the last few years their was a

> small manufactuer reported and fined $70,000 by the EPA for this..

>

> I am including a PDF link to a document that I give to people

> asking about this ...:

>

> http://www.epa.gov/opp00001/regulating/fifra.pdf

>

> Be sure to click on the Section #2 Definitions, para q, Misbranding.

> also para U, Pesticide (definition).

>

> Registration of Pesticides:

> http://www.epa.gov/opp00001/regulating/fifra.pdf

>

> Here is the EPA Labeling Manual also:

> http://www.epa.gov/oppfead1/labeling/lrm/

>

> Hope that helps... Suncreens, Insecticides, and Baby Care items are

> things that in my opinion carry too high a liability risk unless you

> have the huge capital resource to conduct proper testing...

>

> Bloom

> Southern Soapers Fragrances ~ " We Have No Common Scents! "

> http://www.southernsoapers.com

[Guest guest]

> Hi ,

>

> I have a question that maybe you can help with. So far I understand

the complications with Insect repellents, and sunscreens/ blocks. But

what other body care items would you say are a hassle to deal with and

better to just avoid??? <

I'm not but the answer to these questions are found on the FDA

website, not the EPA. The FDA is the government agency that governs

cosmetics. You need to under stand the rules governing the use of the

term " organic " if you are using any " food " ingredients in your product,

and that is covered by the USDA.

Ingredients that have activity other than cosmetic need to be not only

used with caution by the manufacturer, but also the consumer.

The only way the " uneducated " consumer knows what to use the product

for, is by reading the label. Anyone can mix up a batch of pretty much

anything and call it a lotion, cream, body oil...whatever. That's why

ingredients need to be listed, the manufacturer MUST have product

liability insurance, and the product should be tested for shelf

stability and safety.

Sue

[Guest guest]

> > It is because the active ingredients in your " Sexy Lady " product are

> > not REGISTERED and TESTED with the EPA.<

It concerns me that you think any cosmetic is regulated by the EPA.

I hope you are not mistaking the FDA for the EPA!

Sue

[Guest guest]

> I want to make a toothpaste from aloe vera juice in the future, is

that a headache too???? I mean i was thinking because it is going in

your mouth that maybe that is another huge ball of wax.<

It is. First, I just went to your website and my heart is literally

racing. One of the most gorgeous websites I have ever seen! I'd buy

your products based on the beautiful color scheme alone!

That said, you do make some medicinal claims on your website. But,

since you are not located in the USA, I don't think you have to

follow the FDA laws. It's a new area but if you were breaking the

law and the FDA had issues, they'd send you a letter and you would

just have to amend the wording. You could add some language

like " traditionally known for " curing acne, rather than saying the

ingredient " cures acne " . Unless you say " cures acne " on the PRODUCT

label itself, I think you are fine. Do you know what I mean?

Here is the web page with the basics:

http://www.cfsan.fda.gov/~dms/cos-218.html

" The Food, Drug, and Cosmetic Act (FD & C Act) defines cosmetics by

their intended use, as " articles intended to be rubbed, poured,

sprinkled, or sprayed on, introduced into, or otherwise applied to

the human body...for cleansing, beautifying, promoting

attractiveness, or altering the appearance " [FD & C Act, sec. 201(i)].

Among the products included in this definition are skin moisturizers,

perfumes, lipsticks, fingernail polishes, eye and facial makeup

preparations, shampoos, permanent waves, hair colors, toothpastes,

and deodorants, as well as any material intended for use as a

component of a cosmetic product. "

So toothpaste is a cosmetic. BUT...

" How can a product be both a cosmetic and a drug?

Some products meet the definitions of both cosmetics and drugs. This

may happen when a product has two intended uses. For example, a

shampoo is a cosmetic because its intended use is to cleanse the

hair. An antidandruff treatment is a drug because its intended use is

to treat dandruff. Consequently, an antidandruff shampoo is both a

cosmetic and a drug. Among other cosmetic/drug combinations are

toothpastes that contain fluoride, deodorants that are also

antiperspirants, and moisturizers and makeup marketed with sun-

protection claims. Such products must comply with the requirements

for both cosmetics and drugs. "

So, no active ingredient like fluoride, and you are making a cosmetic

and all you have to do is follow the labeling requirements for

cosmetics.

" How is a product's intended use established?

Intended use may be established in a number of ways. Among them are:

Claims stated on the product labeling, in advertising, on the

Internet, or in other promotional materials. Certain claims may cause

a product to be considered a drug, even if the product is marketed as

if it were a cosmetic. <snip> An example is fluoride in toothpaste.

This principle 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. "

Sue

[Guest guest]

Hi Sue,

Thanks for your email. Yes, I am very aware of the rules & regs. We

already have registered all of our products with the FDA. One would

think after successful registration with the FDA that one would be

fine as long as labeling is all correct according to their

regulations. This is what I find so strange about my EPA saga. We

successfully registered Sensatia Botanicals Botanical Bug-Off Insect

repellent with the FDA and there was no mention of this product

possibly having to be then registered with the EPA. Its not a problem,

I am over it, but i still intend on creating a petition to send to the

EPA requesting leniency for small scale producers with annual sales

reports less than 1 million dollars. Stay tuned if you would like to

be part of it ;-)

Have a great day,

R. Lorenti Jr.

mlorenti@...

www.sensatia.com

On Mar 16, 2008, at 11:17 PM, greengirlh2 wrote:

> > Hi ,

> >

> > I have a question that maybe you can help with. So far I understand

> the complications with Insect repellents, and sunscreens/ blocks. But

> what other body care items would you say are a hassle to deal with and

> better to just avoid??? <

>

> I'm not but the answer to these questions are found on the FDA

> website, not the EPA. The FDA is the government agency that governs

> cosmetics. You need to under stand the rules governing the use of the

> term " organic " if you are using any " food " ingredients in your

> product,

> and that is covered by the USDA.

>

> Ingredients that have activity other than cosmetic need to be not only

> used with caution by the manufacturer, but also the consumer.

>

> The only way the " uneducated " consumer knows what to use the product

> for, is by reading the label. Anyone can mix up a batch of pretty much

> anything and call it a lotion, cream, body oil...whatever. That's why

> ingredients need to be listed, the manufacturer MUST have product

> liability insurance, and the product should be tested for shelf

> stability and safety.

>

> Sue

>

>

>

[Guest guest]

Hi Sue,

Wow! Thanks so much. Our site was definitely a labour of love. And it

sure feels nice to hear when someone notices. I really appreciate it.

Thank you.

Thanks Sue for all the great info. I will definitely look a bit deeper

now that we are setting our sites on Whole Foods Markets. I have to

make sure everything is completely in check. Actually Sue, I am

definitely affected by the rules & regs in the States because we are a

US Corporation, but we produce and I live in Bali. So, for example

with the current Insect repellent issue we just dont sell that product

to the states. We sell quite a bit to Australia and Singapore, even

here in Indonesia we sell a reasonable amount. So my point is that,

yes I definitely like to keep up on getting as organized as possible

so that when we do finally hit the states that we are prepared and I

dont have to do any reprinting.

Thanks also for the tip about the info in the site. I remember trying

to stay as neutral as possible when writing the info for the site but

it became such a monster that at one point I am sure I just tried to

blaze on through it. Thanks for bringing that to my attention, I will

start the daunting task of going thru each page and making sure that i

dont make any claims.

Thanks very much for the heads up, much appreciated. Sincerely,

Have a great day,

R. Lorenti Jr.

mlorenti@...

www.sensatia.com

[Guest guest]

, I have no knowledge about toothpaste so I am of no help

there. My experience is anything that has 'active' ingredients in

it, like deodorants, suncreen, repellants, etc are best avoided

unless you have deep pockets. Other things that require 'claims' to

market them (healing, cures eczema, psoriasis, etc, some herbal

products that require self diagnosis, etc) are best avoided to. When

I make Pine Tar soap, I do NOT imply anywhere that it is for skin

problems. I just let the historical record of what pine tar soap has

been used for speak for it. Label just simply says Pine Tar Soap.

Baby Care products. That is because the American public is so

ignorant to science and cause & effect. They may feed their kid a

new formula and use a new baby care product at the same time. Kid

breaks out with a rash.. but YOU, the maker of the baby care product

will be who they hammer first... because it is a homemade or indie

product and YOU will be suspect before the jar of carrots...

So... Sunscreen, Insect repellant, any product with " claims " needed

to promote it, and Baby Care products. I avoid. I used to sell a

NEW MOMS gift basket with lavender and unscented products. Lotion,

soap, balm. It was marketed to NEW MOMS and they could do with it

for baby if they wanted to. or not wanted to. I dont even do that

anymore.

Bloom

Southern Soapers Fragrances

http://www.southernsoapers.com

[Guest guest]

> Thanks Sue for all the great info. I will definitely look a bit

deeper now that we are setting our sites on Whole Foods Markets.<

One avenue you might try is contacting an individual Whole Foods

store [mine! mine!].

I have shopped at a number of them and one thing I've noticed is that

there is a certain amount of buying that happens at a local level.

Ours opened just last week [see www.gogreenct.wordpress.com the blog

I write for!] Our store carries soap by 3 Sisters which is a soap

business out of Essex, here in CT.

When I have been to the West Hartford, CT store I noticed handmade

soap and cosmetics from other local CT businesses. So while you may

not be local...it does indicate to me a certain flexibility in the

freedom the buyers have to not just shelf the national lines seen at

each and every Whole Foods store.

I can find the buyer for our store if you'd like. I went to

the " Grand Opening " and much to my surprise walked right into the

homeopath who used to have an office at the Wholistic Health Care

Center I ran, working in the bath, beauty, vitamin area! FREAKED me

out because she looked EXACTLY the same, and it's been 16 years since

she last treated my family. So good, NATURAL, skincare is nothing

short of amazing!

Sue Apito

[Guest guest]

I think you are jumping in here without reading the previous posts and

replies, No, cosmetics are NOT governed by the EPA, however

PESTICIDES are... and if you make a cosmetic that is also a repellant,

than you fall under the purview of regulations related to the

repellant, which IS the EPA... and if you do NOT follow those

guidelines regarding your cosmetic that is a repellant, than you ARE

engaging in misbranding.

Please read the info.

Bloom

Southern Soapers Fragrances

http://www.southernsoapers.com

>

> > > It is because the active ingredients in your " Sexy Lady " product

are

> > > not REGISTERED and TESTED with the EPA.<

>

> It concerns me that you think any cosmetic is regulated by the EPA.

>

> I hope you are not mistaking the FDA for the EPA!

>

> Sue

>

[Guest guest]

>

> I think you are jumping in here without reading the previous posts

and replies, <

No, I read them in this thread...but when the example of the " Sexy

Lady Lotion " not needing to be OK'd by the EPA, I thought he was

unaware of the FDA. His post [and website for that matter] cleared

that up.

I'm impressed he has registered his cosmetics with the FDA. I don't

know of many cosmetics companies that have done so, and that really

does speak well of the professionalism of this company, IMHO.

Here in CT, we take insect repellents very seriously because of the

potentially fatal diseases that are in our geographic area. So, if

an herbalist or cosmetics manufacturer sold a product with an implied

claim, and the customer ends up with a disease, or worse, dead...you

can only imagine the impact on the entire herbal/natural cosmetic

industry! The future of the handmade/handcrafted/natural/organic and

for that matter even the handmade/handcrafted/synthetic industry is

only strong as their weakest link. Sue

[Guest guest]

Hi Sue,

Yep, thanks for the suggestion, but i have a friend in Boulder

Colorado that will go straight to Whole Foods Markets, " World

Domination " office so we can get distribution happening to all the

WFM's. Now, if this happens or not, I am not sure, but i think

everything is in place (almost) and there is no good reason why they

wouldn't bite. Part of my problem is that if we produced in the states

then it would be easier to approach shop by shop, but because we

produce in Bali, Indonesia that we really need to send containers of

the stuff to the states in order to make it worthwhile.

Thats pretty cool to hear about your Homeopath, if we could all be so

lucky right? Thanks Sue, Talk to you soon,

Have a great day,

R. Lorenti Jr.

mlorenti@...

www.sensatia.com

YM id: sensatia_botanicals

On Mar 18, 2008, at 9:37 AM, greengirlh2 wrote:

> > Thanks Sue for all the great info. I will definitely look a bit

> deeper now that we are setting our sites on Whole Foods Markets.<

>

> One avenue you might try is contacting an individual Whole Foods

> store [mine! mine!].

>

> I have shopped at a number of them and one thing I've noticed is that

> there is a certain amount of buying that happens at a local level.

>

> Ours opened just last week [see www.gogreenct.wordpress.com the blog

> I write for!] Our store carries soap by 3 Sisters which is a soap

> business out of Essex, here in CT.

>

> When I have been to the West Hartford, CT store I noticed handmade

> soap and cosmetics from other local CT businesses. So while you may

> not be local...it does indicate to me a certain flexibility in the

> freedom the buyers have to not just shelf the national lines seen at

> each and every Whole Foods store.

>

> I can find the buyer for our store if you'd like. I went to

> the " Grand Opening " and much to my surprise walked right into the

> homeopath who used to have an office at the Wholistic Health Care

> Center I ran, working in the bath, beauty, vitamin area! FREAKED me

> out because she looked EXACTLY the same, and it's been 16 years since

> she last treated my family. So good, NATURAL, skincare is nothing

> short of amazing!

>

> Sue Apito

>

>

> .

>

>

[Guest guest]

I've been looking around and a LOT of people sell some kind of " bug

off " " bug away " EO product and no mention of the EPA. I posted on

another list to ask how they got around the issue...here is a link:

http://www.siblinggroup.com/

The owner publishes an herbal magazine so she is very knowledgeable

about the issues, and she herself sells a " bug off " product. Maybe she

can help you!

Sue

[Guest guest]

Turns out the person selling was just hoping to fly under the radar,

but another herbalist gave some great advice. She said; " you can claim

it's a bug deterrant or that bugs don't like it, but you can't claim

it's a bug repellant. Wording is the big thing. "

I hope this helps! Sue