Home Cosmetic Science Talk Formulating Cosmetic Industry FDA requirements - Label vs misleading / misbranding

  • FDA requirements - Label vs misleading / misbranding

    Posted by Paprik on December 16, 2021 at 11:10 pm

    Hello guys,

    I’ll try to keep it short. I had a discussion with one girl, who allegedly wrote a book about FDA requirements after graduating. 

    I advised someone to put 0.01% of Niacinamide in the product if they want to claim the product contains it. (It was for a wash off product, so no point of having more).
    She told me, you can’t claim it on the label, that FDA considers this misleading/misbranding. 
    I told her she has to have it on the label on the correct place if the product contains it. Also, possibly she could have it on the front as a claim - Contains Niacinamide. And it should be all good.

    She’s saying no. I’m not really familiar with FDA, but according to EU, NZ and others I am right, … she is not. 

    What do you think? 

    PhilGeis replied 2 years, 6 months ago 6 Members · 11 Replies
  • 11 Replies
  • PhilGeis

    Member
    December 16, 2021 at 11:21 pm

    Why does she think its misbranding?  
    Please consider Olay Regenerist Micro-Sculpting Cream 
    https://www.olay.com/en-us/skin-care-products/regenerist-micro-sculpting-cream-moisturizer

    • INGREDIENTS LIST

      WATER, GLYCERIN, ISOHEXADECANE, NIACINAMIDE*, DISTARCH PHOSPHATE, ISOPROPYL ISOSTEARATE, DIMETHICONE, PANTHENOL**, PALMITOYL PENTAPEPTIDE-4***, SODIUM HYALURONATE^, CAPRYLIC/CAPRIC TRIGLYCERIDE, ETHYLHEXYLGLYCERIN, HYDROXYACETOPHENONE, DIMETHICONOL, CETEARYL GLUCOSIDE, CETEARYL ALCOHOL, STEARIC ACID, PALMITIC ACID, STEARYL ALCOHOL, CETYL ALCOHOL, BEHENYL ALCOHOL, DISODIUM EDTA, SODIUM ACRYLATES COPOLYMER, PEG-100 STEARATE, TITANIUM DIOXIDE, MICA, PHENOXYETHANOL, FRAGRANCE

  • OldPerry

    Member
    December 16, 2021 at 11:32 pm

    She is not right.  You can find labeling rules here.

    If a company puts niacinamide in their formula, then they have to list it on the label.

    I’ll add that it is not surprising someone who learned everything about the cosmetic industry by doing Google searches and their own research comes to erroneous conclusions. There is a benefit to have actually worked in the cosmetic industry.

  • Paprik

    Member
    December 17, 2021 at 12:08 am

    Thank you guys. Thanks for you. I was hoping @perry would answer, as you live in US right? And you have the most experiences. 

    I seriously have no much energy left trying to convince people, when they are so stubborn. 

    May I have one more question? About this, I’m not sure at all. 
    If the product is named “Aloe Vera Soap”, does it need to contain certain amount of Aloe or is it also not regulated? 

  • MarkBroussard

    Member
    December 17, 2021 at 12:47 am

    @Paprik:

    If you include 0.01% Niacinamide, you must list Niacinamide on your label, and you can even put it as the first ingredient at your 1% line to make it look like your product contains more Niacinamide than other ingredients, even if it is the ingredient included in the smallest amount.  You could even call your product Niacinamide Soap.  Personally, I think the 1% line rule is often abused in this manner.

    Same for Aloe Vera.  Put it one drop and nothing prevents you from calling it Aloe Vera Soap.

  • OldPerry

    Member
    December 17, 2021 at 2:02 am

    Yes, if you want to call something Aloe Vera soap you will need to include some aloe vera in the formula.

  • Pattsi

    Member
    December 17, 2021 at 3:42 am

    Paprik said:

    I’ll try to keep it short. I had a discussion with one girl, who allegedly wrote a book about FDA requirements after graduating. 

    She might be one of those youngsters who think they are right about everything, everything revolves around them.

    There was (I think, my brain is feeling old lately) dog food label as meat but didn’t actually contain meat, FDA issued a letter and the company had to recall their product.

  • Graillotion

    Member
    December 17, 2021 at 10:30 am

    Paprik said:

    Hello guys,

     after graduating. 

     

    After graduating…. graduating from what?  Sounds like she graduated from one of those ‘online courses’ where they get a certificate of guaranteed incompetence. :) 

  • Paprik

    Member
    December 18, 2021 at 2:22 am

    Thanks guys. For all comments. Appreciated. :) 

    The main problem is that she is spreading this incorrect information and confuses people. That’s what drives me crazy. People are asking for help and they get lies. 

  • PhilGeis

    Member
    December 18, 2021 at 11:33 am

    You’ll always have those.  I was in  a legal suit as an expert.  The opposition to the attorney  that hired my had an “expert” consultant whose testimony about micro contamination was crazy - +/-cepacia has never been an issue for cosmetics and thre FDA doesn’t care if its present.
    Pissed me off - but the attorney that brought me in told me to calm down and “watch this”.  He asked - “isn’t it true” that the state of Texas has determined you’re trstimony is unreliable and will are permitted to testify as an expert in state court?

  • Pattsi

    Member
    December 19, 2021 at 7:40 am

    PhilGeis said:

     “isn’t it true” that the state of Texas has determined you’re trstimony is unreliable and will are permitted to testify as an expert in state court?

    ouch ya burnt, didn’t their attorney check their expert’s liability before hand?

  • PhilGeis

    Member
    December 19, 2021 at 9:05 am

    Apparently not - and that is pretty bad too.  As you prob know, attorneys are usually meticulous oin these things.

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