Regulatory Open Forum

Original Message------

Dear colleagues,

FDA does not have a list of claims it deems to be acceptable or not and as such, I struggle with weather our cosmetics, though intended to improve appearance and beautify, could make the claims of "anti-aging" and "rejuvenation".  I understand that these are just words, but are these terms to FDA more of a claim that is intended to affect structure or are these claims reliant on the context or manner in which they are used.  Essentially, what I want to know is whether to FDA these terms by nature do not just beautify or improve lines, but rather are more than just that.

Please advise and thank you as always.

Laura 

As always gentlemen, I cannot thank you enough for the wealth of information you have provided.  David, I have access to the claims list from Canada, and according to them, an anti-aging claim is not an issue.  My question still remains though as to whether we can use the words "anti-aging" and "rejuvenation/rejuvenating" with only cosmetic claims to describe the anti-aging that we are trying to promote or is anti-aging seen as a drug claim in and of itself, for the US that is.  


Thanks so much again.


Laura

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

Original Message:
Sent: 24-Sep-2017 07:15
From: David Steinberg
Subject: "Anti-aging" and "Rejuvenating" claims

For a list to see what may be allowed or not, visit http://www.adstandards.com/en/clearance/cosmetics/Guidelines-for-the-Nonprescription-and-Cosmetic-Industry.pdf

This is what Canada says as acceptable cosmetic claims and what are considered drug claims.

Your major problem is location. Products produced in the US do not go through customs. Imported cosmetics are frequently held at customs for making anti-aging claims. 

There has been little enforcement within the US but that can change at any time. For years using words like helps or may.. . kept you out of trouble. Now the FDA has been sending out Warning Letters saying that these are considered drug claims. Further, you need proof of your claims.

David Steinberg, FRAPS
President
 

SteinbergAndAssociates.net
Office: 609-799-1575
Fax: 609-799-5271 

PPlease consider the environment before printing this email.                         

NOTICE: The contents of this e-mail message and any attachments are confidential and are intended solely for named addressee(s). If you have received this transmission in error, any use, reproduction or dissemination of this transmission is strictly prohibited. If you are not the intended recipient, please immediately notify the sender by reply e-mail or phone and delete this message and its attachments, if any, from your system.

Original Message------

Dear colleagues,

FDA does not have a list of claims it deems to be acceptable or not and as such, I struggle with weather our cosmetics, though intended to improve appearance and beautify, could make the claims of "anti-aging" and "rejuvenation".  I understand that these are just words, but are these terms to FDA more of a claim that is intended to affect structure or are these claims reliant on the context or manner in which they are used.  Essentially, what I want to know is whether to FDA these terms by nature do not just beautify or improve lines, but rather are more than just that.

Please advise and thank you as always.

Laura 

​Hi Laura.

It really depends on the situation more than anything at present.  If you are saying "anti-aging" you are technically making a structure-function claim and FDA and FTC have both taken issue with this in the past, even with cosmetics claims only.  However, the situation is that if the product is being imported to the US, the FDA has significantly more serious response options including things like detention without physical examination and import alert listing.

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Original Message:
Sent: 25-Sep-2017 12:04
From: LAURA HOSHUE
Subject: "Anti-aging" and "Rejuvenating" claims

As always gentlemen, I cannot thank you enough for the wealth of information you have provided.  David, I have access to the claims list from Canada, and according to them, an anti-aging claim is not an issue.  My question still remains though as to whether we can use the words "anti-aging" and "rejuvenation/rejuvenating" with only cosmetic claims to describe the anti-aging that we are trying to promote or is anti-aging seen as a drug claim in and of itself, for the US that is.


Thanks so much again.


Laura

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

Original Message:
Sent: 24-Sep-2017 07:15
From: David Steinberg
Subject: "Anti-aging" and "Rejuvenating" claims

For a list to see what may be allowed or not, visit http://www.adstandards.com/en/clearance/cosmetics/Guidelines-for-the-Nonprescription-and-Cosmetic-Industry.pdf

This is what Canada says as acceptable cosmetic claims and what are considered drug claims.

Your major problem is location. Products produced in the US do not go through customs. Imported cosmetics are frequently held at customs for making anti-aging claims. 

There has been little enforcement within the US but that can change at any time. For years using words like helps or may.. . kept you out of trouble. Now the FDA has been sending out Warning Letters saying that these are considered drug claims. Further, you need proof of your claims.

David Steinberg, FRAPS
President
 

SteinbergAndAssociates.net
Office: 609-799-1575
Fax: 609-799-5271 

PPlease consider the environment before printing this email.                         

NOTICE: The contents of this e-mail message and any attachments are confidential and are intended solely for named addressee(s). If you have received this transmission in error, any use, reproduction or dissemination of this transmission is strictly prohibited. If you are not the intended recipient, please immediately notify the sender by reply e-mail or phone and delete this message and its attachments, if any, from your system.

Original Message------

Dear colleagues,

FDA does not have a list of claims it deems to be acceptable or not and as such, I struggle with weather our cosmetics, though intended to improve appearance and beautify, could make the claims of "anti-aging" and "rejuvenation".  I understand that these are just words, but are these terms to FDA more of a claim that is intended to affect structure or are these claims reliant on the context or manner in which they are used.  Essentially, what I want to know is whether to FDA these terms by nature do not just beautify or improve lines, but rather are more than just that.

Please advise and thank you as always.

Laura 

Original Message------

As always gentlemen, I cannot thank you enough for the wealth of information you have provided.  David, I have access to the claims list from Canada, and according to them, an anti-aging claim is not an issue.  My question still remains though as to whether we can use the words "anti-aging" and "rejuvenation/rejuvenating" with only cosmetic claims to describe the anti-aging that we are trying to promote or is anti-aging seen as a drug claim in and of itself, for the US that is.  


Thanks so much again.


Laura

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

Original Message------

Hi Laura,

I did some anti-aging research in the past.

As for anti-aging claims, one of the cosmetics company settled with the FTC for deceptive claim, anti-aging. The FTC stated "false and unsubstantiated claims.....anti-aging benefits..."

Please be aware of where your claim may lead to!

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

Thank you David and Victor for the feedback.  As always, very good and solid insight.



Regards,
Laura

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

Original Message:
Sent: 26-Sep-2017 08:40
From: David Lim
Subject: "Anti-aging" and "Rejuvenating" claims

Hi Laura,

I did some anti-aging research in the past.

As for anti-aging claims, one of the cosmetics company settled with the FTC for deceptive claim, anti-aging. The FTC stated "false and unsubstantiated claims.....anti-aging benefits..."

Please be aware of where your claim may lead to!

Thank you.

s/ David

______________________________________________

Dr. David Lim, Ph.D., RAC, ASQ-CQA 

REGULATORY DOCTOR

http://www.regulatorydoctor.US

Phone (Toll-Free): 1-(800) 321-8567

E-mail:  David@RegulatoryDoctor.US

NOTICE: This communication (including any attachments) may contain privileged or confidential information intended for a specific individual and purpose, and is protected by law. If you are not the intended recipient, you should delete this communication and/or shred the materials and any attachments and are hereby notified that any disclosure, copying or distribution of this communication, or the taking of any action based on it, is strictly prohibited.

Original Message------

As always gentlemen, I cannot thank you enough for the wealth of information you have provided.  David, I have access to the claims list from Canada, and according to them, an anti-aging claim is not an issue.  My question still remains though as to whether we can use the words "anti-aging" and "rejuvenation/rejuvenating" with only cosmetic claims to describe the anti-aging that we are trying to promote or is anti-aging seen as a drug claim in and of itself, for the US that is.


Thanks so much again.


Laura

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

Original Message------

For a list to see what may be allowed or not, visit http://www.adstandards.com/en/clearance/cosmetics/Guidelines-for-the-Nonprescription-and-Cosmetic-Industry.pdf

This is what Canada says as acceptable cosmetic claims and what are considered drug claims.

Your major problem is location. Products produced in the US do not go through customs. Imported cosmetics are frequently held at customs for making anti-aging claims. 

There has been little enforcement within the US but that can change at any time. For years using words like helps or may.. . kept you out of trouble. Now the FDA has been sending out Warning Letters saying that these are considered drug claims. Further, you need proof of your claims.

David Steinberg, FRAPS
President
 

SteinbergAndAssociates.net
Office: 609-799-1575
Fax: 609-799-5271 

PPlease consider the environment before printing this email.                         

NOTICE: The contents of this e-mail message and any attachments are confidential and are intended solely for named addressee(s). If you have received this transmission in error, any use, reproduction or dissemination of this transmission is strictly prohibited. If you are not the intended recipient, please immediately notify the sender by reply e-mail or phone and delete this message and its attachments, if any, from your system.

​HI Laura.

Just to add to David's claims (we actually have known each other far too many years that it feels like I am finishing his sentences here!) I would honestly say "It depends" to the agency.

Along with where the product is manufactured for US consumption (US or import) you need to remember that the FDA has far more sweeping authority granted by FDCA because they only have to show the appearance of adulteration for imports while they have to prove adulteration for domestic production.

More importantly, what your claims mean will be reviewed in relation to the whole label.  So if your claim is handled correctly with proper wording, and, as David pointed out, proper data to substantiate the claim, you might be OK.  I usually like to use the example of a large red cross on a label.  While the red cross is not "saying" anything (no words at all potentially) the fact that it is a recognized symbol of medical assistance means your product is making an implied claim.  As another example, I remember several years back a company got in some hot water with the FDA over claiming that their product was a "no injection equivalent to Botox" for filling wrinkles (or something like that).  Others have gotten caught up in "face lift" claims.

Finally, just remember, the FDA is not the only problem for you.  FTC looks at all of these claims as well.  More importantly competitors and consumers (plaintiff's lawyers) look at these claims and there have been several actions over the past few years to reign these claims in again both by FTC and by lawsuit.

From the questions you seem to be asking I would also recommend a one-day or two-day conference put on by Independent Cosmetics Manufacturers and Distributors either in CA or NY.  The CA meeting is usually I think 2 days and it comes up in February sometime.  The NY conference is usually in May and is a single day where you will also potentially be able to hear from FDA, FTC, and industry experts in the cosmetics arena.  I have presented at the NY conference and have attended several of these.  Great programs with some of the industry's most knowledgeable folks presenting along side of our regulatory senior staff at FDA and FTC.

------------------------------
Victor Mencarelli
Director - Regulatory Affairs
Hain Celestial Group
United States
------------------------------

Original Message:
Sent: 22-Sep-2017 19:03
From: LAURA HOSHUE
Subject: "Anti-aging" and "Rejuvenating" claims

Dear colleagues,

FDA does not have a list of claims it deems to be acceptable or not and as such, I struggle with weather our cosmetics, though intended to improve appearance and beautify, could make the claims of "anti-aging" and "rejuvenation".  I understand that these are just words, but are these terms to FDA more of a claim that is intended to affect structure or are these claims reliant on the context or manner in which they are used.  Essentially, what I want to know is whether to FDA these terms by nature do not just beautify or improve lines, but rather are more than just that.

Please advise and thank you as always.

Laura 

Hi Laura,

In my current function I do not work with personal care products but I worked in that industry for several years and did a lot of work with advertising and promotion. I have to agree with the overall sentiment in that you have to consider the claim in its overall context. You can walk into any personal care section of a store and see many products with 'anti-aging' even in the name (e.g. anti-aging serum). I think the FDA has taken a non-enforcement stance on this because it has become a claim that is widely used throughout the industry. However, if the overall claims support structure-function then it could be grounds for a Warning Letter, NAD investigation, etc. As well, you are less likely to encounter issues with the FDA if the products are manufactured in the U.S but they could lead to a customs hold if you are importing them from other countries. It can be a delicate balance between trying to meet regulatory objectives while serving the business. I always looked at claims competitors were making, what FDA took issue with, NAD challenges, etc. 


------------------------------
Soyini Wilson
Bio-Rad Laboratories

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

Original Message:
Sent: 22-Sep-2017 19:03
From: LAURA HOSHUE
Subject: "Anti-aging" and "Rejuvenating" claims

Dear colleagues,

FDA does not have a list of claims it deems to be acceptable or not and as such, I struggle with weather our cosmetics, though intended to improve appearance and beautify, could make the claims of "anti-aging" and "rejuvenation".  I understand that these are just words, but are these terms to FDA more of a claim that is intended to affect structure or are these claims reliant on the context or manner in which they are used.  Essentially, what I want to know is whether to FDA these terms by nature do not just beautify or improve lines, but rather are more than just that.

Please advise and thank you as always.

Laura 

Soyini,


Thanks so much for that information.  That is great feedback! 


Thank you!

Laura

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

Original Message:
Sent: 27-Sep-2017 18:16
From: Soyini Wilson
Subject: "Anti-aging" and "Rejuvenating" claims

Hi Laura,

In my current function I do not work with personal care products but I worked in that industry for several years and did a lot of work with advertising and promotion. I have to agree with the overall sentiment in that you have to consider the claim in its overall context. You can walk into any personal care section of a store and see many products with 'anti-aging' even in the name (e.g. anti-aging serum). I think the FDA has taken a non-enforcement stance on this because it has become a claim that is widely used throughout the industry. However, if the overall claims support structure-function then it could be grounds for a Warning Letter, NAD investigation, etc. As well, you are less likely to encounter issues with the FDA if the products are manufactured in the U.S but they could lead to a customs hold if you are importing them from other countries. It can be a delicate balance between trying to meet regulatory objectives while serving the business. I always looked at claims competitors were making, what FDA took issue with, NAD challenges, etc.


------------------------------
Soyini Wilson
Bio-Rad Laboratories


Original Message:
Sent: 22-Sep-2017 19:03
From: LAURA HOSHUE
Subject: "Anti-aging" and "Rejuvenating" claims

Dear colleagues,

FDA does not have a list of claims it deems to be acceptable or not and as such, I struggle with weather our cosmetics, though intended to improve appearance and beautify, could make the claims of "anti-aging" and "rejuvenation".  I understand that these are just words, but are these terms to FDA more of a claim that is intended to affect structure or are these claims reliant on the context or manner in which they are used.  Essentially, what I want to know is whether to FDA these terms by nature do not just beautify or improve lines, but rather are more than just that.

Please advise and thank you as always.

Laura