Labelling Requirements (therapeutic) and Expiration Dates

[vickgould]

Can someone clear up what I need to put on my lotions and oils jars for compliance? I have
Caution: For Adult use only. External use only. We are not responsible for misuse and/or allergic reaction to this product. Not intended for use in the diagnosis, cure, mitigation, treatment, or prevention of any disease.
Does that cover me? I am making lotions for antifungal, eczema, etc, so they are therapeutic.

Also, what's the rules for expiration dates? I see that sometimes there's dates on stuff (like at the store -- bath and body works, walmart, target) and sometimes there's not. When do I have to put an expiration date?

Thanks!
Vickie

 

[dagmar88]

This might be of help.

http://www.fda.gov/Cosmetics/CosmeticLa ... efault.htm
http://www.fda.gov/Cosmetics/GuidanceCo ... 074201.htm

and here some examples of caution & warning statements:

http://law.justia.com/us/cfr/title21/21 ... 2.1.1.html

The most important thing is proper insurance though; you'll still be liable, even with caution/warning statements. So, no, that doesn't cover you :wink:

Not intended for use in the diagnosis, cure, mitigation, treatment, or prevention of any disease.
I am making lotions for antifungal, eczema, etc, so they are therapeutic.

As you'll see in the link, therapeutic = drug.
And although I'm not familiar with FDA guidelines, as I'm not US based; I think it would be conceived as misleading information to state you sell antifungal & eczema products in one place (or tell your customers so) and say the product is not intented for treatment in the other.

 

[vickgould]

I have read through those pages before.... that's why it's so hard to figure out. I was hoping that someone with experience in this would let me know what they put on their labels. After all, there are a ton of people on Etsy selling similar things. They seem to all have different cautions on their label. I just want to know which one I should use.
Thanks for your response.

Vickie

 

[dagmar88]

It is hard to figure out. And the answer depends on your marketing strategies and product; drug or cosmetic.
People on Etsy selling similar 'theraputic' products either have an FDA Drug approval (which doesn't seem likely for products produced at home/on such a small scale); or they're just doing what they think is most appropriate.
In fact, I'd be very happily surprised if any forum member was able to meet the drug approval requirements

For cosmetics:
-the principal display must state the name of the product and the nature of the product must be identified either by a discriptive name or illustration.
-The weight of your product.
-Business name and location (street adress, city, state, zipcode)
-Ingredient declaration (ingredients mus be declared in descending order of predominance, color ingrediens and ingredients used at less than one % may be declared without regard for predominance)
-All label statements must be in English and must be placed in a way customers are readily able to read and understand them.
-manufactures have the responsibility to determine shelf-life for their products. The voluntary shelf-life guidelines suggest a minimum of 18 to 24 months.
There are no regulations or requirements under current US laws that require cosmetic manufacturers to print expiration dates on their labels.
However, if you fail to set an appropriate experation date, FDA might consider this to cause a product to be adulterated or misbanded.

-Cosmetics which may be hazardous to consumers when misused must bear appropriate warnings and directions for safe use. (some cosmetics, like cosmetics in self-pressurised containers, do have specific warning/caution labels; others do not. You can find those who do in regulation 21 CFR 740)

 

[Tabitha]

If you state they are for "antifungal or eczema," your cosmetic has become a drug & your labels will need to comply w/ the FDA's standards on drugs. Your best bet is to consult your lawyer. Though asking around may be a good starting point, I would never take advice found on a forum as the gospel.

 

[Zenobiah]

Aaah!!! You have to put your complete address on the label? That is kind of scary when you make the products at home. Would a postbox do?

Thanks for clarifying the mystic FDA requirements. I am still in the research phase and this helps.

 

[Deda]

The rule for addresses on labels state that your FULL STREET ADDRESS must be printed on the label, unless your BUSINESS is listed BY NAME in your local telephone directory.

It's a RULE, not a Guideline.

http://www.fda.gov/Cosmetics/CosmeticLa ... 4.htm#clgi

 

[dagmar88]

No, BUT, if you don't want to put your full address on the label, your business has to be listed in the telephone book.
People will easily be able to trace your address when you've officially registered your business anyway.

What th FDA says:
The name and place of business of the firm marketing the product must be stated on an information panel of the label (21 CFR 701.12). The address must state the street address, city, state, and zip code. If a firm is listed in a current city or telephone directory, the street address may be omitted. If the distributor is not the manufacturer or packer, this fact must be stated on the label by the qualifying phrase "Manufactured for ......" or "Distributed by ......" or similar, appropriate wording.

 

[Tabitha]

It's so they can find you easily if there is an allergic reaction & they need more info or wish to take you to court.

 

[carebear]

It's not easy to make and sell from home. But the rules exist to protect us.

 

[dagmar88]

Sorry Deda, I was posting but something came in between; hadn't seen you posted he same thing in that time

 

[Deda]

no worries Dagmar, Great minds think alike...