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Use of the word therapy as a cosmetic claim...

  • 1.  Use of the word therapy as a cosmetic claim...

    Posted 13-Dec-2017 16:02
    Hello colleagues, hope everyone is doing well and ready for the holidays and year ahead.  I am just returning from vacation and trying to catch up on the threads. 

    As is always the case, we are back at it again, and today I struggle with whether or not the word therapy could be used as a claim in one of our cosmetic labeling.  By definition, the term means and could imply treatment to an ill, medicinal etc.  The manner in which it is being used for the cosmetic, and I know that the overall content of the claims and product will be taken into consideration, but is it ok to use "hot and cold therapy" as a claim in our cosmetic? 

    I have browsed several claims and products, and have yet to see any with the use of the word therapy in there.

    Any feedback would be most appreciated!


    Happy holidays and cheers to a great new year!


    Laura

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


  • 2.  RE: Use of the word therapy as a cosmetic claim...

    Posted 13-Dec-2017 20:40
    ​Hi Laura,

    I don't work in cosmetics, but your question interested me so I had a quick browse on the FDA website.  From what I can tell, using the word "therapy" may imply that you are marketing a drug, as opposed to a cosmetic product.  I had a quick browse of a few warning letters from 2017 and found a couple of examples that might be of interest to you.

    'Labeling Claims'
    "In addition, if a product is marketed with claims for purposes such as treating or preventing disease, or affecting the structure or function of the body-including the skin-it's a drug according to the law, and it must meet the requirements for drugs, even if it affects the appearance."

    WARNING LETTER CMS# 523208
    "Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:

    ...has been known to have many therapeutic benefits and may help:"

    WARNING LETTER WL# 21-16
    "Even if your products did not have these therapeutic claims, which make them drugs..."

    I would definitely be interested to hear the opinions and experiences of those actually in the industry, but my recommendation would be to err on the side of caution and not include the word "therapy" in any material.

    Best,
    Liz



    ------------------------------
    Elizabeth Goldstein RAC
    Regulatory Affairs Project Manager
    California
    United States
    ------------------------------



  • 3.  RE: Use of the word therapy as a cosmetic claim...

    Posted 14-Dec-2017 11:18
    Liz,

    Thank you so much for the feedback.  I too agree that we err on the side of caution because the word therapy by definition or in essence means treatment for a medical condition.  While the claim simply states "Cold and heat therapy" and there are no medical claims, but cosmetic claims on the overall labeling, I hesitate to give them the "okay" to use the word.  

    I too am interested in hearing what our other colleagues in the industry have to say about this.  To date, in all of my searches of like cosmetic products, I have yet to see any use the word therapy.  

    Thanks again for your feedback Liz.


    Regards and happy holidays!

    Laura

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



  • 4.  RE: Use of the word therapy as a cosmetic claim...

    Posted 14-Dec-2017 06:34
    I usually say that therapy (therapeutic, etc.) and some other words such as treatment, diagnosis, etc., are words that have to be treated carefully in a regulated environment because their misuse can have a great (and usually unwanted) effect in product placing on the market. 

    So I agree to not include these words in any product related material unless you know exactly what you are doing (and can back it up).

    ------------------------------
    Marcelo Antunes RAC
    Regulatory Strategy Consultant
    SQR Consulting
    Sao Paulo
    Brazil
    ------------------------------



  • 5.  RE: Use of the word therapy as a cosmetic claim...

    Posted 14-Dec-2017 11:31
    Totally agreed Marcelo. Thank you for the feedback.  


    Cheers,
    Laura

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



  • 6.  RE: Use of the word therapy as a cosmetic claim...

    Posted 14-Dec-2017 07:08
    Hi Laura,

    Your management really doesn't understand regulations and/or wants to push the envelope.  Any therapeutic claim moves a cosmetic application into either a drug or device, depending on the product being evaluated.  FDA is clear, a therapeutic claim for a cream (or other such product) makes it a drug, a therapeutic claim for an appliance makes it a device.

    I think that you can say "hot and cold treatment", just don't imply therapy or any end result.

    Regards,
    James






  • 7.  RE: Use of the word therapy as a cosmetic claim...

    Posted 14-Dec-2017 11:35
    James,

    Thank you.  It really is challenging since I come from a dental implant background and I am trying to navigate my way through this.  I agree that treatment would be a better word to use as it is widely used in the industry.  Therapy on the other hand isn't and hence the reason I raised the question.  I thank you for your valuable feedback.


    Regards and happy holidays.

    Laura

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



  • 8.  RE: Use of the word therapy as a cosmetic claim...

    Posted 14-Dec-2017 07:42
    You can use the word therapy if it is part of a cosmetic claim: like therapy to smooth the skin or therapy for dry skin. Be careful that permanent claims are avoided.

    David Steinberg, FRAPS
    President
     

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

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  • 9.  RE: Use of the word therapy as a cosmetic claim...

    Posted 14-Dec-2017 09:18
    ​Hi Laura.

    Let me add just one point to David's comment - he is correct that the product claim with the word therapy might be acceptable based on the holistic review of the labeling.  I would caution though that use of "therapy" in relation to dry skin could be a bit more gray than black and white.  Dry skin is to some degree regulated under the skin protectant monograph from FDA so you need to be very careful with that type of claim.

    More importantly, if your company wants to make more aggressive claims, I would strongly suggest doing a gap assessment to understand just how far you are from being able to comply with pharmaceutical cGMPs and if you can make that leap, I would suggest registering as a drug establishment, making the products under pharma cGMPs, creating labeling compliant with both the Drug Facts labeling and the individual monographs, and then providing FDA with your product listing.  This is going to be far more effective than trying to deal with each and every instance where the management wants to extend the claims individually.  It also provides a bit of a safety net in other respects since OTC products have an express preemption clause in the regulations and the FDA is less likely to pull your products up in a general sweep if they are labeled properly, contain acceptable active ingredients as monograph levels, and are listed with the agency than if you are simply "hoping to fly below the radar".

    Just my thoughts.  As always, let me know if I can be of further assistance as this is the area where I actually make my living!

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



  • 10.  RE: Use of the word therapy as a cosmetic claim...

    Posted 14-Dec-2017 11:54
    Victor,

    As always, thank you for such in-depth feedback.  I am certain that the company does not want to go that route of registering as a pharmaceutical company and will avoid any claim that will even remotely suggest they go that route.  That is great feedback to go back to them with as it will serve as a deterrent hopefully for them to avoid any therapeutic claims.

    Thanks so much! :)

    Regards,
    Laura

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



  • 11.  RE: Use of the word therapy as a cosmetic claim...

    Posted 14-Dec-2017 11:51
    Thank you David.  I am appreciative for the feedback as this is one of your area of expertise.  This helps tremendously.


    Regards,
    Laura

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



  • 12.  RE: Use of the word therapy as a cosmetic claim...

    Posted 15-Dec-2017 06:55
    Hi All,

    I agree with David about the use of the word Therapy for a cosmetic.  It's really on the edge of drug claims.  Be safe and look for an alternate.

    All the best,

    Bob

    Robert Schiff, PhD, RAC, CQA, FRAPS
    President and CEO
    Schiff & Company, Inc.
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    West Caldwell, NJ 07006

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