Florida Regulations, License, and Insurance

[moderncurio]

I'm interested in starting my own business making lotions, balms, and perfume. But I have no idea what I need to sell my items legally.

I know that I need a business license, but I don't know what type. And I read somewhere on this forum that I need insurance and a license to sell cosmetics. Does that mean I have to take classes? I tried looking on the Florida State site, but I couldn't find anything.

Also, what's considered an cosmetic? I know that lip balm is, but soap is not. But I haven't been able to find information on if lotion or perfume is considered a cosmetic.

If someone could give me a quick overview of what I need it would be greatly appreciated. Thanks.

PS. I'm in Hillsborough County if that makes a difference.

 

[TessC]

I don't know the answer to all of your questions, but I do know that Florida is not the most lenient state as far as selling cosmetics, not by a long shot.

The FDA site has some info about cosmetics vs drugs vs soap, as well as the regulations, so that might not be a bad place to start.

Is It a Cosmetic, a Drug, or Both? (Or Is It Soap?)

FDA Authority Over Cosmetics

Good Manufacturing Practice (GMP) Guidelines/Inspection Checklist

Not a complete answer, but hopefully the info at those links will help.

 

[Deda]

In Florida your out of luck, unless you have a separate facility to manufacture your products.

http://www.leg.state.fl.us/Statutes/ind ... PART01.HTM

Read 499.01 - Permits -

(r) A cosmetic manufacturer; Cosmetic manufacturer permit.--A cosmetic manufacturer permit is required for any person that manufactures or repackages cosmetics in this state. A person that only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product is exempt from obtaining a permit under this paragraph.

then read 499.012 - Permit Application Requirements

(b) An establishment that is a place of residence may not receive a permit and may not operate under this part.

Basically, if the FDA rules it a cosmetic, then Florida does, too.

Soapmaking doesn't have the same requirements.
CP anyway, some MP crosses the FDA line into cosmetic by containing surfactants.
I'm not sure how Florida views that.

 

[Tabitha]

Spend some time w/ these links: http://soapmakingforum.com/forum/viewtopic.php?t=4212

Everything you apply will be either soap, a cosmetic or a drug depending on what it is made of & what you 'claim' it will do.

If you 'only' say soap cleans, it is soap.

If you say soap moisturises, it is a cosmetic.

If you say soap aids acne, it is a drug.

At least that is my impression of the FDA guidlines.

 

[Tabitha]

PS: There is no quick overview. I have been doing this for 9 years & am still learning. Lots of trial, error & good note keeping is the best advise you will get. You are going to want to make lots of batches, use each product a few tims and then set them aside for say 6 months then go back in & see how the product has changed with time. That is how you know what to expect when your items sit on shelves, either in a shop or in someone's home.

 

[moderncurio]

Thanks guys. I knew that it was going to be a lot of work to start your own business and sell products. I never realized that there was so much.

I think for the time being I'm going to make candles and soap and learn a little more about the cosmetics side of things before going into that.

 

[ewenique]

Since a permit and separate facility to make or repackage cosmetics is required under Florida law, is it legal to sell M & P soap made from a base that contains Sodium Laureth Sulfate, whether purchased from Michael's or an online distributor? What about lotions made from a wholesaler base?

I've seen both for sale at craft shows/farmer's markets, and in local health food stores, and wonder if the seller even knows the law and has the proper permits. Or is this a case of common senseless government over-regulation?

 

[joeleitz]

It's probably better to stay away from making a product that contains Sodium Laureth Sulfate because there is some debate about potential health risks from that ingredient. I'm surprised that you would see natural soaps at craft fairs that contain that, actually. Personally, I would just leave it out of my product regardless of what the law says.

I'm setting up a small cosmetics shop at the moment and any soaps or shampoos I stock won't have SLS in them. I found a good way to track my inventory when I'm up and running -using a point of sale system and I'm very excited about that. If anyone is interested pos systems specific to beauty products are available at the gci-store. I think that's really going to help streamline things for me.

Since a permit and separate facility to make or repackage cosmetics is required under Florida law, is it legal to sell M & P soap made from a base that contains Sodium Laureth Sulfate, whether purchased from Michael's or an online distributor?

 

[dagmar88]

Since a permit and separate facility to make or repackage cosmetics is required under Florida law, is it legal to sell M & P soap made from a base that contains Sodium Laureth Sulfate, whether purchased from Michael's or an online distributor? What about lotions made from a wholesaler base?

I've seen both for sale at craft shows/farmer's markets, and in local health food stores, and wonder if the seller even knows the law and has the proper permits. Or is this a case of common senseless government over-regulation?

I hope this is of help to you:
How FDA defines "soap"
Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when --

The bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
The product is labeled, sold, and represented solely as soap [21 CFR 701.20].
If a cleanser does not meet all of these criteria...
If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:

If a product --

consists of detergents or
primarily of alkali salts of fatty acids and
is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,
it is regulated as a cosmetic.

If a product --

consists of detergents or
primarily of alkali salts of fatty acids and
is intended not only for cleansing but also to cure, treat, or prevent disease or to affect the structure or any function of the human body,
it is regulated as a drug.

If a product --

is intended solely for cleansing the human body and
has the characteristics consumers generally associate with soap,
does not consist primarily of alkali salts of fatty acids,
it may be identified in labeling as soap, but it is regulated as a cosmetic.

Melt & Pour base containing SLS is considered a cosmetic by the FDA. You'll need to have that permit... Same goed for lotion coming from a wholesaler since you will have to repackage.
People who are selling without a permit will probably be fine most of the time; but when anything goes wrong they're in big trouble :?
Don't look too much at what other people are doing and try to find out how you should do things the right way.

You think YOUR government is over regulating?! Try to start a soap business in Europe... There's a reason there's so little of them

 

[dagmar88]

It's probably better to stay away from making a product that contains Sodium Laureth Sulfate because there is some debate about potential health risks from that ingredient. I'm surprised that you would see natural soaps at craft fairs that contain that, actually. Personally, I would just leave it out of my product regardless of what the law says.

I'm setting up a small cosmetics shop at the moment and any soaps or shampoos I stock won't have SLS in them. I found a good way to track my inventory when I'm up and running -using a point of sale system and I'm very excited about that. If anyone is interested pos systems specific to beauty products are available at the gci-store. I think that's really going to help streamline things for me.

I'm surprised people actually label soap as natural at all.
Please let people make their own choices when it comes to using SLS. Want to discuss it then just open a topic.

 

[Healinya]

I'm in Florida I probably won't be selling bath and body products because of how difficult it would be here - soap is a different story. All the responses above are right, I just want to add that calling your local zoning office and telling them what you want to do, ask what you need to comply with local rules.

Good luck!! If it works out for you, you'll have to tell me how you did it lol.

 

[mcclaren1202]

Florida Regulations

I just went through the Florida Process for permitting. The biggest problem that i encountered is that it is goverened under the pharmacy and medical devices. All the processes are the same.
If any is caught manufacturing any type of products for the skin being soaps lotions and or cosmetics are subject to upwards of a $25,000 fine.

This is what Florida considers a cosmetic:
1. Baby Products
2.Bath Preparations
3.Eye Makeup Preparations
4.Fragrance Preparations
5.Hair Preparations (Noncoloring)
6.Hair Coloring preparations
7.Makeup preparations(not eye)
8.Manicuring preparations
9.Oral hygiene products
10.Personal Cleaniness
a.Bath Soaps and detergents
b.Deodorants
c.Douches
d.Feminine hygiene deodorant
e.Other personal cleanliness products
11.Shaving Preparations
12.Skin Care preparations(creams,lotions,powders and sprays)
12.Suntan and sunscreen preparations.

 

[ewenique]

What!? Even plain ol' soap with no cosmetic claims? Will you post the link with that information, please.

This is what I found: 11) "Cosmetic" means an article that is:

(a) Intended to be rubbed, poured, sprinkled, or sprayed on; introduced into; or otherwise applied to the human body or any part thereof for cleansing, beautifying, promoting attractiveness, or altering the appearance; or

(b) Intended for use as a component of any such article;

except that the term does not include soap.

Here's the link: http://www.flsenate.gov/Statutes/index. ... TM&Title=->2003->Ch0499->Section%20003#0499.003

 

[kara]

I have read this hyperlink 4 times and cannot tell if this applies to bath salts? Any clarification is so appreciated.

 

[donniej]

I have no input on Florida specifically but it's been my experience here in PA that if you call or go to the Labor & Industry people that they will help you figure it out. You can also go to your local State politicians office (State Senate or House) and they will help you as well.