Claims-Regulatory Question

I know that the FDA regulates OTC products based on the active ingredients and their monographs, however I have some questions that are in the 'gray area'.  For instance, can a cosmetic product name have the word Eczema in it (for instance, Eczema Cream) if it doesn't claim anything else on the label? What about an Intense Cream used for eczema prone skin?  Is that verbiage appropriate?  If not, are there any ways around marketing a cosmetic product for certain skin types without including an active drug claim?
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Comments

  • abieroseabierose Member
    I could be mistaken but it is my understanding that naming a product "Eczema Cream", even if you are not making any other reference to a claim, it is still leading the consumer to believe that the product will cure or help Eczema. I believe you can still be sued and/or held accountable for not adhering to the FDA labeling laws regarding active and claim statements. @Perry is MUCH better at explaining this than me 😅
  • MarkBroussardMarkBroussard Member, Professional Chemist
    @CB007:

    You cannot use the word "Eczema" in your product name or marketing if your product does not contain a Monograph OTC active for Eczema and it is not an OTC-registered product with the FDA.  There is no "gray area"

    You can call it an Intense Cream, but not refer to your product being for eczema-prone skin.  You simply cannot use the word "Eczema" unless your product is an OTC.

    Generally, No.  A good example is Paula's Choice BHA Exfoliating Lotion ... it contains 2% SA, but is targeted at general exfoliation for anyone and nowhere does it mention the word "Acne" ... But, teen consumers latched on to it and it was selected as the Teen Vogue acne product of the year reader's choice.  That was a consumer's choice, not how Paula's Choice marketed the product.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    See website for details www.desertinbloomcosmeticslab.com
  • PattsiPattsi Member
    It is as @MarkBroussard said. There is no gray area.

    some grayish tricks - don't claim eczema in your own words, you can use intensive or sensitive etc. and wait for consumer's review to come up with the like " I have eczema but this ... cream is good for my skin blah blah" and see if it starts to snow ball or not. Or you can make it happen with money.
    Be aware this could also back fire and effect your whole line. I've seen lines with some success and lines that were totally crushed.

    Huhhh or maybe I shouldn't said this out loud. 
  • MicroformulationMicroformulation Member, Professional Chemist
    Actually the FDA will hold you responsible for any drug claims in your featured reviews if they are on your platform. They feel you have control of the content. I have seen this happen in actual practice and it is often referenced in enforcement letters. I know it was enforced way back when with some Essential oil MLM's.

    markfuller@microformulation.com Microformulation.com Microformulation Cosmetic Consulting provides Custom Formulations for both large Commercial accounts as well as smaller entrepreneurs. We can provide Naturally compliant Formulations under the NSF, NPA, Whole Foods and USDA Organic Certifications. BS.Pharm Albany College of Pharmacy, Union University.
  • PhilGeisPhilGeis Member, Professional formulator
    edited July 3
    Please recall the definition of drug - a produict “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease”.

    Eczema in the name shows intent.
  • MarkBroussardMarkBroussard Member, Professional Chemist
    I've had a client get a letter from the FDA and had to pull it's stock, re-label it's products and correct its marketing language until the FDA-compliant line was completed.  This was for a product that was positioned for Eczema, but was not an OTC.  So, if you want to be too-clever-by-half ... imaginary gray areas can be expensive.

    I am currently working on a baby care line and one of the competitors labels its product container as a Diaper Care Cleanser & Moisturizer and claims that it's 3-in-1 product that can replace Diaper Rash Creams. 

    And, as @Microformulation pointed out, several of their reviews refer to it as a Diaper Rash Cream and their marketing claims that it "prevents Diaper Rash", but it is not an OTC product.

    If the FDA becomes aware of this, they will definitely take action. Hmmm ... I wonder how that might happen?
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    See website for details www.desertinbloomcosmeticslab.com
  • PattsiPattsi Member
    It has to be like Paula's, can't feature in any of your platforms and materials. It has be on their own or third party and unscripted.

    The best way (in my opinion/may differ from other's) is to do honest marketing. Don't plan only one step, also u should think about how to continue ur line too.

    And/or if/when you want to export to where FDA-regis is required, if you mis-label or do false-claimed, it is most likely your product will be dead on arrival.

    You can make a hit without violating regulation if you position your product right while staying in cosmetics lane.

    Also you might not need any relevant claim to eczema, these days >50%  of users in this internet world have eczema with self-diax.

    Is my English readable today?
  • PerryPerry Administrator, Professional Chemist
    Even if a company doesn't market a product as a drug, the FDA still might consider it a drug. I think the Paula's example is in a grey area because it's clear consumers perceive it to be a drug product. One of the ways to determine if something is a drug is "intended use" and on way to determine a product's intended use is by checking with consumer perception of a product.

    "Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.

    https://www.fda.gov/cosmetics/cosmetics-laws-regulations/it-cosmetic-drug-or-both-or-it-soap

    They haven't been called out on it...yet.
  • MarkBroussardMarkBroussard Member, Professional Chemist
    Here's the issue with the Paula's Choice 2% BHA product ... some consumers use it as a general exfoliant, some use it if they have acne.

    There is a category where a product can be considered both a cosmetic and an OTC drug ... this probably falls into that category.
    Chemist/Microbiologist formulating in the Organic & Naturals arena under ECOCert/Natural Products Assn/Whole Foods/National Organic Program guidelines focused skincare & haircare products. 

    See website for details www.desertinbloomcosmeticslab.com
  • PhilGeisPhilGeis Member, Professional formulator
    edited July 6
    In US, there is no unique drug/cosmetic category.  Such products must comply with regulations of both categories.
  • CB007CB007 Member
    Thanks all for your comments.  I am steering this customer away from all claims or using Eczema on her product label.  I don't want to fall into any imaginary gray area that could potentially ruin her line and cost us time and money to fix. 
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