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  • Clinical trials questions???

    Posted by Newtoformulating on April 20, 2022 at 4:40 pm

    Hello all! 

    Question…..does clinical trials/performance testing/claims validation testing(whichever you prefer to call it) need to be performed on my product if I make claims such as 24hr hold, no flaking or turning white once applied, for all hair types while advertising or on the product label? My product is an edge control/sculpting gel.  I was quoted $12,000 by on lab and $10,000-$15,000 by another and I don’t want to spend unnecessary money if its not needed. If its needed then I will pay but if I can use the money toward something else that would be great. This is a very small new business with very limited funds. Any advice would help! Thanks!

    Newtoformulating replied 2 years, 6 months ago 4 Members · 6 Replies
  • 6 Replies
  • OldPerry

    Member
    April 20, 2022 at 5:47 pm

    The answer depends on where you are selling your products but in the US there is no specific requirement to do any testing. 

    HOWEVER, it is illegal to make false claims about your product.

    This means that if you are going to make a claim you need to be prepared to defend the truth of your claim in a court of law. Whenever you make any claim answer the question “If I’m sued how will I prove what I’m saying is true?”

    If your defense is your own opinion, you will lose. So, you better have some kind of well-designed study, preferably independently done, that demonstrates you aren’t lying.

    I personally think $10,000 for a test like this is pretty high, but I don’t conduct tests for a living.

  • Newtoformulating

    Member
    April 20, 2022 at 6:02 pm

    @Perry Thanks for this. I thought the prices were pretty steep as well but was unsure of my options. Would you recommend anyone that could possibly direct me to a lab that performs test such as these so that I may price compare or if you can think of an alternative way of getting these claims validated so that I am able to use the data for advertising and also in my defense in court if needed. Thanks so much!

  • Microformulation

    Member
    April 20, 2022 at 7:34 pm
    Be happy with your subjective evaluation and consider perhaps smaller yet informal testing with several testers. It would give you more subjective input. Drop objective claims (24-hour hold) unless you substantiate these measurable claims.
    Not substantiating these claims could put you in the bad graces of the FTC, but more imminently if you do not deliver these metrics, your clients may not repurchase.
  • Newtoformulating

    Member
    April 20, 2022 at 9:07 pm

    @Microformulation thank you!

  • grapefruit22

    Member
    April 21, 2022 at 2:46 pm

    @Newtoformulating The high price may be due to the claims you have chosen to use. No flaking or turning white can be easily scored in a user perception test (if FCA accepts it), but 24hr hold is much more difficult to prove. I would change your claims, e.g. 24hr hold to “hair looks good all day”, it can be confirmed in perception test.
    To confirm “all hair types” claim you should test your product on a sufficiently large number of people with each type of hair. Hair types are difficult to defined, some methodologies indicate 12 hair types, if for each of them you need 15-30 people for testing, it can be really expensive. Additionally you would have to get a positive result for all of these types. I don’t think that anyone, institutions or customers would take the tests on a few people seriously.

  • Newtoformulating

    Member
    April 21, 2022 at 5:57 pm

    @grapefruit22 helpful information! I will definitely make some adjustments in my claims. Do you suggest any labs in particular for this?

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