Regulatory Open Forum

I have a question regarding FTC and FDA's regulations and attitude to using actual users comments on products on a company's website.
While I am aware that they frown on any statements from an advertiser that strays from the intended use the product is cleared to, is it different when a customers actual comments are used.

For example if a product is cleared for pain relief and a customer states that they found it has improved their posture also or if a product is cleared to strengthen muscles and a customer states that it makes them fit into lower sized clothes.   
I would love to hear from people with experience in this area
regards
Mike

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Mike Kilkelly
Quality Manager
Galway
Ireland
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Hi Mike.

My general rule has always been that if the advertiser can't say it themselves, then the endorsement can't be used to circumvent that requirement.  So unless the product can be discussed by the company using the same language as the endorser​ then I would steer clear of using the endorser's comments in their entirety because even if you were to place some sort of disclaimer on the website or other advertisement space, the fact that you chose to include the comment is implicit recognition that you are trying to cause the product to be used in that manner potentially without approval or without scientific data to back up the claim.

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Victor Mencarelli
Director Regulatory Affairs
United States
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Original Message:
Sent: 15-Feb-2019 06:48
From: Mike Kilkelly
Subject: Advertising and endorsements

I have a question regarding FTC and FDA's regulations and attitude to using actual users comments on products on a company's website.
While I am aware that they frown on any statements from an advertiser that strays from the intended use the product is cleared to, is it different when a customers actual comments are used.

For example if a product is cleared for pain relief and a customer states that they found it has improved their posture also or if a product is cleared to strengthen muscles and a customer states that it makes them fit into lower sized clothes.
I would love to hear from people with experience in this area
regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

I does not matter to whom you attribute the statement, anything in your advertisement is your statement. For example, social media is a common place for customers to comment on a product, but the industry has an obligation, according to FDA interpretation of the regulations, to correct false and misleading information if they own the page, and FDA or FTC could take action if the manufacturer is "using" their page to include or even encourage statements that are not in line with the approved labeling. I suggest you take a look at the FDA guidances published within the last few years on use of social media for advertising.

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Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States
------------------------------

Original Message:
Sent: 15-Feb-2019 06:48
From: Mike Kilkelly
Subject: Advertising and endorsements

I have a question regarding FTC and FDA's regulations and attitude to using actual users comments on products on a company's website.
While I am aware that they frown on any statements from an advertiser that strays from the intended use the product is cleared to, is it different when a customers actual comments are used.

For example if a product is cleared for pain relief and a customer states that they found it has improved their posture also or if a product is cleared to strengthen muscles and a customer states that it makes them fit into lower sized clothes.
I would love to hear from people with experience in this area
regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Thank you both for your inputs. Much appreciated,

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Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------

Original Message:
Sent: 18-Feb-2019 08:57
From: Glen Park
Subject: Advertising and endorsements

I does not matter to whom you attribute the statement, anything in your advertisement is your statement. For example, social media is a common place for customers to comment on a product, but the industry has an obligation, according to FDA interpretation of the regulations, to correct false and misleading information if they own the page, and FDA or FTC could take action if the manufacturer is "using" their page to include or even encourage statements that are not in line with the approved labeling. I suggest you take a look at the FDA guidances published within the last few years on use of social media for advertising.

------------------------------
Glen Park PharmD
Executive Director, Regulatory Affairs and Quality Assurance
Jersey City NJ
United States

Original Message:
Sent: 15-Feb-2019 06:48
From: Mike Kilkelly
Subject: Advertising and endorsements

I have a question regarding FTC and FDA's regulations and attitude to using actual users comments on products on a company's website.
While I am aware that they frown on any statements from an advertiser that strays from the intended use the product is cleared to, is it different when a customers actual comments are used.

For example if a product is cleared for pain relief and a customer states that they found it has improved their posture also or if a product is cleared to strengthen muscles and a customer states that it makes them fit into lower sized clothes.
I would love to hear from people with experience in this area
regards
Mike

------------------------------
Mike Kilkelly
Quality Manager
Galway
Ireland
------------------------------