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FDA links: soap vs cosmetic vs drug, labeling, claims, etc

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Tabitha

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This comes up a lot so I thought I would make it a sticky.

http://www.fda.gov/cosmetics/guidanceregulation/lawsregulations/ucm074201.htm
Is It a Cosmetic, a Drug, or Both?
(or Is It Soap?)


http://www.fda.gov/Cosmetics/Labeling/Regulations/ucm126444.htm
Summary of Regulatory Requirements for Labeling of Cosmetics Marketed in the United States.

Cosmetic Labeling Regulations as Published in Title 21, Code of Federal Regulations, Sections 701, 740 and Other Pertinent Sections.

Cosmetic Labeling Guide.
 
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Shawn

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Also, do not forget the National Institute of Standards & Technology (NIST) requirements for weights & measures (21 CFR 701.13):

On the "principle display panel" (PDP) the net weight must be in the bottom 1/3 of the label. In addition, there are measurement requirements for the font size, so here are the proportions:

if the PDP area is: -then- the font must be ___ high:
< or = 5sq in. -then- 1/16in
>5 to < or = 25sq in. -then- 1/8in
>25 to < or = 100sq in. -then- 3/16in
>100sq in. -then- 1/4in

Hope this helps!
 

Tabitha

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Common Question:

Do I have to use INCI names on my soap label?

INCI stands for :International Nomenclature Cosmetic Ingredient. It is an international labeling standard required by many countries so a person in China, Spain or California can pick up the same bar of soap or bottle of lotion & be able to decipher the ingredient list in an international language.

Do you personally have to use INCI names? That depends on where you live & what you claim your soap does.

First you have to decide is your soap just soap (free from detergents) and you make no claims other than it cleans. Or is it a cosmetic because A) it contains detergents or B) you make a claim like "moisturizing soap". It may also be a drug if you make a claim like "diminishes acne".

Read here: http://www.fda.gov/cosmetics/guidanceregulation/lawsregulations/ucm074201.htm

After you have made that determination you will need to read the Fair Packaging and Labeling Act (FPLA).

Here: http://www.fda.gov/RegulatoryInformatio ... efault.htm

The FDA operates under the mandate of the Fair Packaging and Labeling Act (FPLA).

For me, I find it MUCH easier to ere on the side of caution & use the INCI names rather than to try & decipher the legal jargon at the 2 links above.

I use INCI names and insert tye comon name in the center which is mentioned & approved on the FDA website.

EX) Ricinus Communis (Castor) Seed Oil
_________________
 
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jessicammorton

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Tabitha said:
Common Question:

Do I have to use INCI names on my soap label?

INCI stands for :International Nomenclature Cosmetic Ingredient. It is an international labeling standard required by many countries so a person in China, Spain or California can pick up the same bar of soap or bottle of lotion & be able to decipher the ingredient list in an international language.

Do you personally have to use INCI names? That depends on where you live & what you claim your soap does.

First you have to decide is your soap just soap (free from detergents) and you make no claims other than it cleans. Or is it a cosmetic because A) it contains detergents or B) you make a claim like "moisturizing soap". It may also be a drug if you make a claim like "diminishes acne".

Read here: http://www.fda.gov/cosmetics/guidanceregulation/lawsregulations/ucm074201.htm

After you have made that determination you will need to read the Fair Packaging and Labeling Act (FPLA).

Here: http://www.fda.gov/RegulatoryInformatio ... efault.htm

The FDA operates under the mandate of the Fair Packaging and Labeling Act (FPLA).

For me, I find it MUCH easier to ere on the side of caution & use the INCI names rather than to try & decipher the legal jargon at the 2 links above.

I use INCI names and insert tye comon name in the center which is mentioned & approved on the FDA website.

EX) Ricinus Communis (Castor) Seed Oil
_________________
Hi Tabitha - I read all of this info, but am a little confused! I have determined that my soaps and products are cosmetics, and in 1 or 2 cases could be considered a "drug." I read that the FDA requires warning labels on products that have not been thoroughly tested: "Warning: The safety of this product has not been determined." The products I make, although classified as drugs and cosmetics, are 100% all-natural and mostly organic, so it kills me to think I have to put a zillion warnings on them for self-protection - for example, because I use essential oils, must I also warn that children cannot use my products? There is no established safe limit for essential oils, just recommendations that children should not use them.

I have a couple of high-end skin care products in front of me right now (closest company to what my brand is modeled after), and in inspecting their PDP and information labels, I see that they do not list any warnings whatsoever, and this is a mass-marketed product. Hmmm.

I know this is kind of detailed, but I just thought I'd ask you - you seem so knowledgable, and your links have been such a help to me! :) Thanks!
 
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cjhays

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Scared Now?

Ok I am just wanting to make bath and body wash and add fragrances colors to it. Does that mean I have to get a license or permit or be tested by the State? Please let me know. Thanks in advance :lol:
 

Tabitha

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Re: Scared Now?

cjhays said:
Ok I am just wanting to make bath and body wash and add fragrances colors to it. Does that mean I have to get a license or permit or be tested by the State? Please let me know. Thanks in advance :lol:
You will need to check w/ your specific ciand ty. county, and state offices to see what is required. Every city, county, state has their own requirements. My requirements are not the same as yours.
 

PuddinAndPeanuts

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This comes up a lot so I thought I would make it a sticky.



http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm

Is It a Cosmetic, a Drug, or Both?

(or Is It Soap?)





http://www.fda.gov/Cosmetics/CosmeticLabelingLabelClaims/default.htm

Summary of Regulatory Requirements for Labeling of Cosmetics Marketed in the United States.



Cosmetic Labeling Regulations as Published in Title 21, Code of Federal Regulations, Sections 701, 740 and Other Pertinent Sections.



Cosmetic Labeling Guide.

Just an FYI- the links don't appear to still be active.
 

The Efficacious Gentleman

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As an addition, anything that claims or is intended for more than just cleaning is no longer a soap, but a cosmetic. Including shaving soap or a bar soap that "nourishes" or "moisturizes"
 
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