# FDA stuff that's giving me one heck of a headache.



## Koshka (Dec 23, 2012)

Hi, it's me again 

I'm writing this in hopes that maybe one of you could shed some light on this mess. Help me, oh wise ones!

So, I have recently moved to Florida and am successfully running my little soap company. Many of my customers are asking for things like bath bombs, lotions, balms, body butters and deodorants. So I dug out this great piece of literature http://blog.mariegale.com/florida-cosmetic-regulations/ Marie explains everything in great detail. How am I supposed to produce them if Florida has extremely strict rules on cosmetics manufacturing? I asked a girl at one of the craft fairs and her answer was: Oh, you just have to label it properly, and that's all. I know there are tons of people here who are also Floridians, and many of you make lotions and such for sale. How do you go about it? 

Did you get a permit? (A permit is required for each person and establishment that intends to operate as a cosmetic manufacturer or repackager in the State of Florida.  However, if the person only labels or changes the labeling of a cosmetic but does not open the container sealed by the manufacturer of the product, a permit is not required.) Are you making that stuff at home or do you have a specific building set up? 

Are you registering your products? (In addition to the manufacturer registration and permits, any person who manufactures, packages, repackages, labels, or relabels a drug or cosmetic in the state of Florida must register that product with the department.)

Once you register you're prone to being inspected by FDA. And then apparently if you don't follow the manufacturing guidelines http://www.fda.gov/Cosmetics/GuidanceCo ... 005190.htm  you are misbranding and adulterating the product.

That's goes not only for FL but all over the US too. (The key factors to any cosmetic being “illegal” falls to the definitions of “adulterated” and “misbranded”.  This is true in all the US as well as in Florida. )

So now what? If I will be making my lotions/potions at home, that would be illegal!? I've called NY, NJ & WA states and the rules/regulations are all the same. Does that make everyone of us, who are making our products at home (except for soaps), and then selling them to public - criminals? 

Please help me figure this out, my head is about to explode


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## AlchemyandAshes (Dec 23, 2012)

Err...ummm... :roll: 
I can't answer any of the questions of legality or such, but to be honest, I doubt you'll find many small batchers who have a manufacturing facility outside their home, or permits/registrations for each product, whether in Florida or any other state, beyond the common business practices and FDA regulatory labeling.
It is my understanding that any of the body products we make fall under the "cosmetics" category, and as long as there are no medical claims made, should be labeled in cosmetic fashion, with the proper INCI names in descending order, weight, and business name and address. Of course the typical business practices should be exercised, such as occupational license, LLC or sole proprietorship, insurance, tax ID, etc
I live in Tampa (born and raised) and have NEVER heard of the state or FDA going after a home based business manufacturer of cosmetics. That's not to say they can't, won't, or shouldn't...just I've never heard it happen, and I've seen plenty of craft show/farmers market vendors that sell lotions, creams, bath salts, bath bombs, etc.
Your best bet would be to call the DBPR and ask them specifically which regulations apply to your products. Make a sandwich and a glass of tea and get comfy...you'll probably be on hold for a long while.
Much of the info you can find online is either outdated, unclear, contradictory, or changes so rapidly that its hard to keep up. I'll do some more research, and if I can make sense of it, I'll post it here.
Hopefully another Floridian cosmetic manufacturer will post with some accurate info...

P.S. Where are you at in Florida?


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## Koshka (Dec 23, 2012)

That's what I've been noticing so far. Everyone makes stuff at home and everyone seems to be ok with that. The problem with me is that I'm not only doing in on craft fair level, I'm also selling my products to the big guys. So, automatically I fall out of that small batch crafting category. I think the best solution to my problem would be to outsource lotion making to a cosmetics manufacturer, so I don't have to worry about anything. 

Shawnee, my business is based out of Space Coast area, but I also have an office in New York.  I've come to the Sunshine State for the winter to keep my old bones warm lol.


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## AlchemyandAshes (Dec 23, 2012)

Koshka said:
			
		

> The problem with me is that I'm not only doing in on craft fair level, I'm also selling my products to the big guys.



Well then, I think part of your answer was pretty much spelled out with concern to selling to "the big guys":
_It doesn’t look like having the actual Certificate of Free Sale is required, but the Dept of Health is asking distributors to request Certificates of Free Sale, so if you plan to sell to Whole Foods or other similar companies, you may need to get one._

Outsourcing may well be a better (or cost effective) solution for lotion as opposed to the set up/maintenance/regulations of a separate manufacturing facility if you're going "balls to the wall"  :wink: 

It sounds like an exciting adventure for you! Good luck!


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## Koshka (Dec 23, 2012)

Alchemy&Ashes said:
			
		

> Koshka said:
> 
> 
> 
> ...



Thanks! I'll let you know in a year if I succeeded or went begging for money on the corner lol. Do you by any chance know any good companies I can outsource to?


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## AlchemyandAshes (Dec 23, 2012)

You could check out these places:
http://www.cosmeticindex.com/private-label-lotion.php
http://allurelabs.com/manufacturing/
http://cosmeticlaboratories.com/
I haven't used them personally, so I can't vouch for their services or products, but at least its a place to start your research  :wink:


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## Koshka (Dec 23, 2012)

Alchemy&Ashes said:
			
		

> You could check out these places:
> http://www.cosmeticindex.com/private-label-lotion.php
> http://allurelabs.com/manufacturing/
> http://cosmeticlaboratories.com/
> I haven't used them personally, so I can't vouch for their services or products, but at least its a place to start your research  :wink:



I heard good things about allurelabs. I'll call them tomorrow and start grilling them  Thanks a bunch!


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## melstan775 (Jan 5, 2013)

hi there! 

I can rally only answer one of these questions, and that is about labeling. 

In general your labels have to state the product name, the amount of product in the bottle or jar, and an ingredient list. Usually ingredients have to have a scientific name, not just a common name. So for example, you might have something that looks like this on a label: 

 Olea europaea (Olive Oil), sodium tetraborate, Tocopheral-E50 (preservative). 

In laymen's, this list is olive oil, borax, and vitamin e capsules. Remember that Borax is actually a product trade name (20 Mule Team Borax), and the correct terms are sodium tetraborate, sodium borate, and sometimes boric acid (which is slightly different then actual sodium borate).  

These small differences are why some products are required to list their scientific names along their common names, but for the record, the FDA doesn't regulate labeling. They allow manufacturers to self-regulate, and simply penalize mislabeled products.  Just promise small and put everything on your label.  

Here's more on FDA labeling requirements: http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/default.htm


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## Koshka (Feb 15, 2013)

Melstan, thank you for clarifying...

I think i got the labeling down, but I'm still confused about the actual production process... There are so many regulations 



melstan775 said:


> hi there!
> 
> I can rally only answer one of these questions, and that is about labeling.
> 
> ...


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## new12soap (Feb 15, 2013)

The state of Florida does not allow ANY cosmetic to be manufactured in a residence.  None. Plain "soap" is not a cosmetic, pretty much anything else is. So yes, with or without any other considerations, making lotions at home that you intend to sell would be illegal. AFAIK Florida is the only state that makes NO allowances for it, whether a small craft business or someone that sells to "the big guys".

The FDA regulations are very specific about what constitutes a cosmetic and how to label it correctly, (including name, size, ingredients, and place of maufacture) and THOSE are the same in NY, NJ, and WA, but have nothing to do with Florida requirements. Florida also requires that each product formulation be registered with the state, not the FDA.

I have not personally known anyone that has been "busted", primarily because I don't know anyone that would chance it, but I have read of a number of people that have been shut down. The "everyone is doing it so what's the big deal?" mentality is a choice you will have to make for yourself, whether the risk is worth it. I think if it were me I would have it manufactured elsewhere as you mentioned, but that is JM2C.


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## Crocoturtle (Feb 15, 2013)

For me the concern with doing other products is that my insurance is currently only to cover soap and soap manufacturing. That's something else to think about.


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