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Claims and Intended Use

customer with product

When describing your product, keep in mind that the whole point of “claims” is that they are providing information to the consumer about the intended use. Technically it’s not the claim, but what the consumer perceives to be the intended use of the product, which determines whether it is a drug or cosmetic.

If your product description, customer testimonials, or ingredient descriptions say it is “good for eczema,1” you are saying that because you want someone to connect your product to “eczema.” By doing so, the implication is that the intended use is for someone with eczema. Otherwise why say it or allow it to be on your website?

You’re not mentioning cancer or liver disease or warts, so obviously (to a new customer) the product has nothing to do with those. But you are mentioning eczema, so … hmmm … “It must have something to do with eczema, and is intended to make it better somehow. Maybe it will cure or help MY eczema,” the customer thinks.  And so the customer now has the idea that the intended use is at least partly to help eczema. Voila! You now have unapproved new drug.

There are probably some very gray areas where things can be said that don’t automatically drop the product into the unapproved new drug status, but those would depend on careful study of past legal cases and FDA interpretations. You’d need an experienced attorney to navigate those waters and even P & G and L’Oreal (who have banks of attorneys) still get occasional warnings from the FDA.

AND, even with all that, if the local FDA Agent gets a whiff of something that he thinks needs to be checked out, you still have an FDA agent in your face, looking through all your processes, procedures, and labels. Even if the “claims” turn out to be a non-issue, who knows what ELSE might end up being an issue.

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  1. On July 15, 2016 the FDA issued a warning letter to a cosmetic manufacturer citing: “[F]or customers suffering from eczema flare-ups” as an example showing the product was intended as an unapproved new drug. ↩︎

Comments

26 responses to “Claims and Intended Use”

  1. Miranda

    What about “soothing sunburn” that is one I am struggling with now that summer is here and I have avoided it due to being unsure.

    Reply
    1. Marie Gale

      “Soothing Sunburn” is really saying that it is to be used to soothe a sunburn, which would be treating a “disease” and/or altering the function or structure of the body—thus making it an unapproved new drug.

      Reply
  2. Bethany Otte

    Hi I just recently bought your book and I have become stumped at the intended use and testimonials bit. If I post my true soap to Instagram and I have customers that post comments about how it moisturized their skin would that cause my product to become a cosmetic? I guess I just want to make sure I understand this correctly rather than assuming and the FDA website has not been helpful in trying to research this info..

    Reply
    1. Marie Gale

      If the intended use of the soap is to moisturize, then it is classed as a cosmetic. The determination of the intended use can be taken from labels and your materials, but also from posts and testimonials from customers. In order to be on the safe side, you can label your soap as a cosmetic. The only difference is that a cosmetic requires the ingredients to be listed on the package; soap that is exempt from the definition of a cosmetic doesn’t require the ingredients to be listed. Both still require the net contents, identity of the product, and the business name and address. The ingredients requirement is the only difference.

      Reply
  3. Kathy Zander

    marie, when listing preservatives, do you list the name of the product or just” presservative”

    Reply
    1. Marie Gale

      The correct way to list is to put ALL of the ingredients of the preservative in the ingredient declaration. For example, according to the Bramble Berry website, the component ingredients of Optiphen ND are phenoxythanol, benzoic acid, and dehydroacetic acid. Assuming you use the preservative at the recommended rate, the percentage of each of the component ingredients should be less than 1% of the whole product. That makes it pretty easy because you can list them with any other ingredients present at 1% or less in any order after all of the ingredients present at more than 1%.

      Listing by “preservative” or by the preservative trade name (such as Optiphen or Germaben) is not allowed.

      Reply
  4. Robi

    Can I write on label only name of the product, lets say “xyz cream” and underneath “skin, muscle, joints”, and I don’t write any uses or any claims, would that be fine?

    Reply
    1. Marie Gale

      “Skin” implies that the product addresses the outside of the body. Since there is no claim otherwise, it would probably be interpreted as a cosmetic.

      If you put “muscle or joint” on the label, it implies that the product is addressing something INSIDE the body. So it is no longer “cleansing, beautifying, or promoting attractiveness,” it has moved into the function or structure of the body (and would probably be interpreted as an unapproved new drug).

      Remember, the determination is based on what the CONSUMER would consider is the intended use of the product. Placing “muscle” or “joint” on the label would be telling the consumer that it’s to be used to address the muscles or joints, making it an unapproved new drug.

      Reply
  5. Ilze

    Would you be able to say “suitable for sensitive skins and skin conditions such as psoriasis and eczema” .You are not making a claims that it will heal or improve these conditions, just that it won’t aggravate these sensitive skin conditions.

    Reply
    1. Marie Gale

      Personally, I would stay away from mentioning “psoriasis and eczema.” By using those words, you definitely are likely to raise red flags. But if you do go that route, make sure the wording makes it VERY clear that it’s not to TREAT, but is a product that people with those skin conditions could safely use.

      Reply
  6. Kelsey

    So what CAN we say if we believe our product *soap* and *cream* helps relieve eczema, psoriasis etc. ?? Is there any way to word it for it not to be a claim?

    Reply
    1. Marie Gale

      In order to be legal, you must be making soap or cosmetics. If you are trying to say that your products can or may help relieve exzema or psoriasis, then you are making a new drug. An unapproved new drug. Made in an unapproved drug manufacturing facility.

      In other words, there is nothing you can say about your product helping eczema, or psoriasis, or anything else. As soon as you do, you have changed the intended use to that of a drug, and have stepped well over the line.

      Reply
  7. Lora

    Thank you Marie! You are always such a blessing to us! Thanks for all you do!

    Reply
  8. Lora

    I was wondering more about people with allergies to certain things that might be used in soap. Could you put a statement like “Please check ingredients carefully if you have allergies or sensitivities. If irritation occurs discontinue use.” All ingredients would be listed on soap label as well.

    Reply
    1. Marie Gale

      Allergy statements are not required on soap or cosmetics. That said, if you use ingredients that are common allergens, or if your particular market includes many people with allergies, or if you just think it’s a good idea, you can always include a statement about it. Your suggestion is good, directing the consumer to check the ingredients.

      Reply
  9. Shay Signoretti

    I’m concerned because on my Etsy feedback I have many that claim that my salves healed or helped them with other ailments. I also get comments on my social media posts with the like. Am I required to remove them all?

    Reply
    1. Marie Gale

      If you want to stay in compliance with the FDA, then yes, you should remove them; or at least edit them so there isn’t a mention of a specific illness/disease/physical problem cured.

      Reply
  10. Stacey W

    What do you think about the word “detoxifying?” It’s an adjective really, just like moisturizing, skin-loving, etc. Thoughts?

    Reply
    1. Marie Gale

      “Detoxifying” when used as an adjective, implies that the item being described will remove toxins (as in “detoxifying lotion”). Removing toxins is altering the function or structure of the body and/or curing, treating, preventing, or mitigating disease.

      “Detoxifying” is much different than “moisturizing” (which is considered on the surface and thereby not affecting structure or function).

      Reply
  11. Arice Miranda

    Thank you Marie! I appreciate your time and advice! I do have your book and recommend it to anyone who creates soap and skin care products for sale. 🙂

    Reply
  12. Arice Miranda

    Is it necessary to have a latex allergy warning on shea butter product label regarding the common chemistry between shea butter and latex? Or is it ok to just have a cautionary statement on the website? I am private labelling for another company and want to cover me arse. 🙂

    Reply
    1. Marie Gale

      As far as I know, there are no latex allergy warnings required for shea butter. While (I think) shea butter would fall under the nut allergy warnings for FOOD, there are no similar warnings required for cosmetics.

      I did a quick search and most of the information I found about the shea/latex relationship was just forwarded on various sites selling skin care. I did find a newsletter from the American Latex Allergy Association which has some actual scientific information in it. It’s worth a read.

      That all said, if you feel that the science is sufficient and the public for your products may would have a high enough risk (say, if the product is specifically for people who tend toward latex allergies) then a warning may be a moral/ethical issue for you (rather than legal). If you do decide to put a warning on the label, you might want to check with an attorney to ensure that whatever wording you use does, in fact, cover your arse. If nothing else, you might just put some information on your website and link to the studies.

      Bottom line though, I’ve never seen or heard of a shea/latex allergy warning on a cosmetic product. Doesn’t mean that no one has done it, but it must be pretty rare if so. With all the shea butter being used in products by big commercial cosmetic companies, you’d think their attorneys would have a say in it if it was a real threat.

      Reply
  13. Tracy

    What about when you don’t make a claim, but the customer believes your product does something, anyway? I have customers who swear by my products for certain uses. I realistically can’t stop customers from telling their friends that my products “cured” or “significantly improved” a dermatological condition for them. (Certainly, if I’m present when they say it, I disavow the claim!) Some of the ingredients I use have been proven in clinical (medical) trials in other formulations to benefit medical conditions (oats, for example). I include them for reasons like “powdery feel on application” (and formulated with them before I ever saw them in a “drug” product formulation). Or – every non-compliant soap maker claims that tea tree or willow bark or goat milk improve acne; am I at risk of being a drug if I include those ingredients in a product simply because other brands have convinced customers of a medical “intended use” that I don’t claim?

    Reply
    1. Marie Gale

      Of course you can’t stop word of mouth. BUT, if the word-of-mouth is forwarded by you (as on your website as a testimonial), then you are the one that is presenting the claim in order to communicate to your potential customers what the intended use of the product is.

      Adding an ingredient such as oats or goat milk which are known to be beneficial to certain medical conditions doesn’t automatically make the product an unapproved new drug. However, if you tout those benefits (or even put links to studies that say the ingredients have those benefits) then you are implying or outright claiming that the intended use of YOUR product is to treat those medical conditions. So you are back to having an unapproved new drug.

      The best you can do, really, is to include whatever ingredients you want to include and then (using marketing text) claim that you have those ingredients (“with oatmeal,” or “contains tea tree oil”) without EVER saying what those ingredients are for, what they do or linking to places that make claims for them.

      If a consumer thinks that tea tree oil is antibacterial, so be it. There are plenty of websites and books that make all sorts of claims (proven and unproved, valid and invalid) for all sorts of foods and cosmetic ingredients. The point is that they aren’t trying to sell a product based on that information.

      You can encourage your customers to “research all cosmetic ingredients” and promote how proud you are of your ingredient selections because they are natural, beneficial, have been historically used in cosmetics, are pure, etc., etc. But you can’t tell them that the product or ingredient(s) will cure, treat, mitigate, or prevent a disease. You are ultimately responsible for what consumers consider to be the intended use of the product.

      Reply
  14. Mark Fuller

    Great blog post Marie! You really explained the issues and made a good case for caution.

    Reply
    1. Marie Gale

      Thanks.

      Reply

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