Regulatory Open Forum

Ms. Hoshue:

Your opening statement either was poorly written or is simply wrong.  FDA does regulate cosmetics, although it does not approve them for marketing.  Indeed, the governing law is the Federal Food, Drug, and Cosmetic Act.  For more information, see FDA's website at:  FDA Authority Over Cosmetics: How Cosmetics Are Not FDA-Approved, but Are FDA-Regulated.

Regards,
Michael Swit




------------------------------
______________________________________________
Michael A. Swit, Esq.
Law Offices of Michael A. Swit
San Diego, CA
e: mswit@fdacounsel.com
m: 760-815-4762
www.fdacounsel.com

Note: all postings by me on this forum represent my personal views and are not necessarily those of my law firm or any of our clients. Further, my comments are not intended as legal advice but as the sharing of general knowledge and do not create an attorney-client relationship with any reader.

Please follow me on LinkedIN and Twitter:

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------------------------------

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

Original Message------

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

Hello Laura,

FDA does in fact regulate cosmetics, but not to the extent of drugs and medical devices.  After all, the FDA law is the Food, Drug & Cosmetic Act.  There is a lot of information about cosmetics on the FDA web site (www.fda.gov).  Click on the "Cosmetics" tab and navigate from there and there is a link to "cosmetic labeling".  Cosmetic labeling is covered by regulations under 21 CFR part 701 and 740.  Regarding your specific inquiry about required information on the label, especially when space is limited due to package size, may be addressed as small cosmetic containers are common.  However, without some research, i cannot provide further information on this.  It should be noted that there are provisions for small drug container labeling, such as syringes and ampules. Please utilize the FDA web site.

------------------------------
Peter Smith
Principal
Smith GMP Consulting
Narragansett, Rhode Island
USA
------------------------------

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

Labeling on small packaging can be an issue, but there are ways to meet the intent of the regs. One possible solution is to put a statement on the small package to the effect of "retain all packaging and labeling for instructions and warnings" and then include the instructions / warnings on an insert or the secondary packaging.

------------------------------
Joshua Lust
Quality & Regulatory Affairs Manager
Grand Rapids MI
United States
------------------------------

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

Team,

As Thomas stated, I poorly stated what it is that I wanted to convey.  I do know that cosmetics are regulated, just not to the extent of drugs and medical devices.  That said, I was simply looking for a better resource than the FDA site to refer to for guidance in labeling small containers/packaging etc.  


As always, I thank you for the information.


Regards,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 06-Jul-2018 08:20
From: Joshua Lust
Subject: Cosmetics Regulations - US

Labeling on small packaging can be an issue, but there are ways to meet the intent of the regs. One possible solution is to put a statement on the small package to the effect of "retain all packaging and labeling for instructions and warnings" and then include the instructions / warnings on an insert or the secondary packaging.

------------------------------
Joshua Lust
Quality & Regulatory Affairs Manager
Grand Rapids MI
United States

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

Laura,

It is complicated but FDA does have a lot of resources for Cosmetics labeling on their website.  I have attached the cosmetics labeling guide from that website to get you started.

------------------------------
William Coulston
Quality & Regulatory Affairs
San Antonio TX
United States
------------------------------

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

Hi Laura,

I know that you are looking for a book but I normally just use the guidance. It's been a while since I have done cosmetics, but I know that the type size for cosmetic labels are determined by the total dimensions of the container. Below are links for regulations that you can search for more information.  Hopefully, this will help.

Cosmetic Labeling Guide

Fda		remove preview
Cosmetic Labeling Guide FDA guide to labeling cosmetic products. View this on Fda >

Fair Packaging and Labeling Act

Federal Trade Commission		remove preview
Fair Packaging and Labeling Act Rule Summary: The Fair Packaging and Labeling Act (FPLA or Act), enacted in 1967, directs the Federal Trade Commission and the Food and Drug Administration to issue regulations requiring that all "consumer commodities" be labeled to disclose net contents, identity of commodity, and name and place of business of the product's manufacturer, packer, or distributor. View this on Federal Trade Commission >

Kind regards,

------------------------------
Tracie Waters-Brown
Regulatory Affairs Manager
------------------------------

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

For all the US cosmetics labeling regulations explained, with examples, an excellent reference is the Personal Care Products Council Labeling Manual: A guide to Cosmetic and OTC Drug Labeling and Advertising.  The currently available edition is the Ninth Edition, 2013.
It is quite pricey for non-PCPC members at $650.  This volume presents clear interpretations of the regulations.  It is extensively cross-referenced with the Code of Federal Regulations but it is much easier to find your specific topic of concern then trying to follow all the sub-sub-paragraphs in the CFR.  There is an entire chapter "Special Rules for Small Packages, Samples, Decorative Containers, and Shipping Containers."
Visit the Personal Care Products Council online and check the Bookstore under "Member and Industry Resources" for more information.

------------------------------
Thomas Vichroski
President, CRDR Consulting, Inc.
Huntington Station NY
United States
------------------------------

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

Thank you so much Thomas.  This is great information and as always, I can always count on you seasoned specialists.


Regards,
Laura

------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 07-Jul-2018 18:57
From: Thomas Vichroski
Subject: Cosmetics Regulations - US

For all the US cosmetics labeling regulations explained, with examples, an excellent reference is the Personal Care Products Council Labeling Manual: A guide to Cosmetic and OTC Drug Labeling and Advertising.  The currently available edition is the Ninth Edition, 2013.
It is quite pricey for non-PCPC members at $650.  This volume presents clear interpretations of the regulations.  It is extensively cross-referenced with the Code of Federal Regulations but it is much easier to find your specific topic of concern then trying to follow all the sub-sub-paragraphs in the CFR.  There is an entire chapter "Special Rules for Small Packages, Samples, Decorative Containers, and Shipping Containers."
Visit the Personal Care Products Council online and check the Bookstore under "Member and Industry Resources" for more information.

------------------------------
Thomas Vichroski
President, CRDR Consulting, Inc.
Huntington Station NY
United States

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

Hi Laura.

As many on here have already stated the comment that FDA does not regulate cosmetics couldn't be further from the truth of the situation.  FDA does have authority over cosmetics and has several times in the recent past (this year alone) taken action against cosmetic products both in terms of enforcement (warning letters and import detentions) as well as involvement in many significant recalls that involve what would be considered purely cosmetic products.

As for your question - I am very partial to the FDA's Cosmetic Labeling guide which can be found on the FDA's website.  Whenever I have a question about the situation I am in, that is where I usually start.  As David stated, ICMAD also has a nice simplified adaptation with truly practical examples that is available for something like $250 or $300.  PCPC book that Tom referenced is a bit pricey and honestly probably has no more than the ICMAD book in all honesty (I know many of the editors/authors of different chapters in these books and I can personally vouch for the knowledge and abilities that they bring to the table when discussing their specialties in both books).

The difference is that the FDA guide to cosmetics labeling (available on the FDA's cosmetics website - another indication that the original statement in your post is less than accurate as written) is free to the public.  FTC also has information on the requirements for labeling that are generally expected from their perspective and is also free and available on their website.  The ICMAD and PCPC books are fee-requiring to defray some of the costs of putting the books together but honestly if you are going to "buy" a book, I strongly suggest the ICMAD option because it is generally more cost efficient and contains the same information (in fact, I'm not entirely sure of this but it could be compiled by many of the same authors!).

Finally, I'll put a little bit of a shameless plug in for the Fundamentals of US Regulatory Affairs from RAPS as another source of information.  I know I was honored as one of the authors of the 9th Edition (in fact, I updated the chapter on cosmetics for the 9th edition) and I believe that the Fundamentals text also provides a lot of great insight into other areas of the requirements for all FDA areas as a bonus to getting the cosmetics information you are looking for.
​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States
------------------------------

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

Victor,

Thank you.  I think I stated in the group discussion that as Thomas pointed out, I incorrectly conveyed the intent of my post.  I do know that FDA regulates cosmetics, it is just not to the extent of drugs and medical devices.  That said, I am always grateful for your succinct feedback Victor.  I typically start with the FDA site as my primary resource, but sometimes some of my needs are not so easy to find.  A guide of sorts like the books recommended would be great and I am currently looking into that as one of my resources.

Again, thank you for your very resourceful feedback.

Regards,
Laura 


------------------------------
Laura HoShue
Regulatory Compliance Specialist
Las Vegas, Nevada
USA
------------------------------

Original Message:
Sent: 08-Jul-2018 21:23
From: Victor Mencarelli
Subject: Cosmetics Regulations - US

Hi Laura.

As many on here have already stated the comment that FDA does not regulate cosmetics couldn't be further from the truth of the situation.  FDA does have authority over cosmetics and has several times in the recent past (this year alone) taken action against cosmetic products both in terms of enforcement (warning letters and import detentions) as well as involvement in many significant recalls that involve what would be considered purely cosmetic products.

As for your question - I am very partial to the FDA's Cosmetic Labeling guide which can be found on the FDA's website.  Whenever I have a question about the situation I am in, that is where I usually start.  As David stated, ICMAD also has a nice simplified adaptation with truly practical examples that is available for something like $250 or $300.  PCPC book that Tom referenced is a bit pricey and honestly probably has no more than the ICMAD book in all honesty (I know many of the editors/authors of different chapters in these books and I can personally vouch for the knowledge and abilities that they bring to the table when discussing their specialties in both books).

The difference is that the FDA guide to cosmetics labeling (available on the FDA's cosmetics website - another indication that the original statement in your post is less than accurate as written) is free to the public.  FTC also has information on the requirements for labeling that are generally expected from their perspective and is also free and available on their website.  The ICMAD and PCPC books are fee-requiring to defray some of the costs of putting the books together but honestly if you are going to "buy" a book, I strongly suggest the ICMAD option because it is generally more cost efficient and contains the same information (in fact, I'm not entirely sure of this but it could be compiled by many of the same authors!).

Finally, I'll put a little bit of a shameless plug in for the Fundamentals of US Regulatory Affairs from RAPS as another source of information.  I know I was honored as one of the authors of the 9th Edition (in fact, I updated the chapter on cosmetics for the 9th edition) and I believe that the Fundamentals text also provides a lot of great insight into other areas of the requirements for all FDA areas as a bonus to getting the cosmetics information you are looking for.
​

------------------------------
Victor Mencarelli
Director Regulatory Affairs
United States

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura 

Hi Laura,

I am following this thread since I am also currently reviewing the US labeling for cosmetics. I searched the book Victor mentioned and found out that they are giving 50% discount off the member rate of ($245.00). The link is provided for reference.

- Ginalyn 

The ICMAD Complete Guide to U.S. Cosmetic Regulations and Labeling - ICMAD - Independent Cosmetic Manufacturers and Distributors

Icmad		remove preview
The ICMAD Complete Guide to U.S. Cosmetic Regulations and Labeling - ICMAD - Independent Cosmetic Manufacturers and Distributors As a new member, you will receive a coupon to purchase the updated ICMAD Complete Guide to U.S. Cosmetic Regulations and Labeling at a 50% discount off the member rate! View this on Icmad >

------------------------------
Ginalyn Eusantos
Manteca CA
United States
------------------------------

Original Message:
Sent: 05-Jul-2018 16:59
From: LAURA HOSHUE
Subject: Cosmetics Regulations - US

Team,

While the FDA does not regulate cosmetics, we all know there are certain guidelines and regulations that we ought to follow to ensure that our product is safe etc.  The regulations/guidance however are not detailed as to how we ought to label cosmetics in small containers, as it pertains to what we can and cannot omit.  While some information is mandatory, sometimes real estate on say a small vial may be limited and we may not always be able to capture everything on the inner package.  

Is there a guidance, a book of sorts I can purchase that provides in depth guidance as to how we label, etc. our cosmetics based on size? 

Please advise.....

Thanks,

Laura