I don't understand drug claims vs cosmetics

edited May 2020 in General
I am esthetician hence the name, lol, but I am trying to wrap my brain around how cosmetic companies who sell to mostly etheticians like Image, PCA, etc don't have to have all of their products that make claims of "anti aging, anti acne, etc" approved by the FDA. I really want to get into making my own products but I am stuck on the legality of it. My clients are acne clients and the products I sell are for acne prone skin. Benzoyl, AHA's etc. Do they just disregard the rules? Is there a loophole if you sell to skincare professionals? I feel I may have read that somewhere.

I live in the US 

Comments

  • MarkBroussardMarkBroussard Member, Professional Chemist
    @esthetician922:  Yes, if your products are sold only to the Professional market (Estheticians, Dermatologists, etc.) and not to the general public, there are are a different set of labeling requirements.  It's not a "loophole" ... the regulations are designed specifically for the purpose of products sold in the Professional-only market.
    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
  • PerryPerry Administrator, Professional Chemist
    edited May 2020
    If you are selling products to consumers, you have to follow the labeling guidelines that everyone else follows. And if you're selling treatments for acne, then you have to follow the treatments listed out in the Anti Acne product Monograph. https://www.fda.gov/drugs/status-otc-rulemakings/rulemaking-history-otc-acne-drug-products

    Do you have examples of where a brand is doing something you see as breaking the rules?
  • Ok, so just to be clear. If I am a skincare professional selling to other skincare professionals I just need to follow the label criteria and not go through the very expensive process of registering each product I create with the FDA, correct?
  • MarkBroussardMarkBroussard Member, Professional Chemist
    @esthetician922:

    (1)   If the product you are selling contains an ingredient that in designated as an OTC drug active ingredient, such as Benzoyl Peroxide for acne treatment products, then your product is an OTC drug product and must comply with the Acne OTC Monograph regardless of whether or not the product is being sold to the professional market or the consumer market.  If it contains an OTC active, you must comply with the monograph.  OTC products must be registered with the FDA and manufactured in an OTC-approved facility.

    (2)  If your product does not contain an OTC active, it is a cosmetic product.  You can sell cosmetic products to either or both the Professional market and the Consumer market.  You do not have to register cosmetic products with the FDA, it is an optional registration.
    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
    (2)  If your product does not contain an OTC active, it is a cosmetic product.  You can sell cosmetic products to either or both the Professional market and the Consumer market.  You do not have to register cosmetic products with the FDA, it is an optional registration.
    If the product is a cosmetic product that sell through the Professionals but the end users are the general public. It is likely a cosmetic product with more $$ price tag to it.  That's one way to spin a product.
  • MarkBroussardMarkBroussard Member, Professional Chemist
    Selling to the Professional market as opposed to the mass consumer market is a marketing/distribution channel strategy.  Several companies pursue this approach.
    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
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