Marie Gale

Helping soap and cosmetic handcrafters navigate the rules and regs.

FDA Cracking Down On Cosmetic Product Claims

FDA signage

Based on the warning letters the FDA sent to manufacturers of cosmetics in the last year (especially the last 4 months of 2013), the FDA is starting to crack down on some of the claims being made for cosmetics. I looked through all of the warnings for cosmetics and some of the warnings for food supplements, and made some surprising discoveries.

All of the 2012 warning letters for cosmetics were issued because the products were being promoted for uses that caused the products to be drugs (except one which was for product contamination). In other words, the claims made for the product indicated that they were “intended to affect the structure or any function of the human body,” making them drugs in the eyes of the FDA.

I have to admit, most of the claims were, in fact, claims that the product could change the body function and structure. What was a little surprising was what the FDA referenced as sources of claims.

Source of information

At the beginning of each letter, the FDA states what material(s) they reviewed. Most of them cited “a review of your website at ___,” or the product labeling, (or both) which is to be expected.

What I didn’t expect to see were reviews of invoices sent with products, brochures sent with products, “your amazon.com store,” Facebook posts about the product, and even metatags used in the website. It is apparent that the FDA is digging a little deeper into how and where claims are being made. “Labeling” is not just what you say on the product label itself; it’s everything you’ve said about the product.

Testimonials

In a number of the warning letters, the FDA cited customer testimonials on the site as making drug claims for the product. Some of the examples were:

  • “[M]y grandmother had a horrible case of shingles. Nothing the doctor gave her worked even after months of treatment. I brought down some [product] for her to use and 7 to 10 days later it was completely healed.”
  • “The scars in my upper arms… are getting lighter.”
  • “I started to get severe acne on my face and neck… I feel like I have found a miracle cure.”
  • “[H]ad a patch of psoriasis on the side of one eye for years. Dermatologists gave me medicines for years without success. Four nights of the [product] cleared the psoriasis.”

The moral? Don’t use customer testimonials that state that the product treated, cured, or mitigated any disease” or that it affected the “function or structure of the body.” Even if it’s true!

Citing Research and Articles

One product cited has a page on the website that cited news articles and studies about an ingredient in the product, including studies published in recognized research journals and even the US National Institute of Health. The FDA had this to say:

When scientific publications are used commercially by the seller of a product to promote the product to consumers, such publications may become evidence of the product’s intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered a claim about disease treatment or prevention if the citation refers to a disease use, and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease.

So, even if there are accepted studies that conclusively show that an ingredient has “drug” properties and has been proven to cure, mitigate, or treat a disease or to change the function or structure of the body, those studies cannot be cited as part of the materials on or accompanying the product. It’s completely unfair, but that’s what the regulations are.

Claims for Ingredients in the Product

Some of the content cited as making drug claims was in the form of statements made about a particular ingredient in the product, not the product itself. This was particularly true for claims made about essential oils. Some of the claims cited were:

  • “[L]icorice extract is anti-inflammatory, anti-irritant, anti-microbial… & has a sebum regulation activity.”
  • “Organic Cedarwood… helps to strengthen hair growth… and combat… hair loss.”
  • “Eucalyptus also offers antibacterial, anti-inflammatory benefits and can help to stimulate blood circulation on the scalp, encouraging hair growth….”
  • “Organic Petigraine… antiseptic properties help to clear… blemishes…”
  • “Organic Thyme[,] a potent antimicrobial, antibacterial, and antifungal… recommended for many types of skin disorders.”
  • “Organic Palmarosa… anti-infectious botanical, as well as an antifungal… also helps in treating a range of skin infections while offering antiseptic… benefits.…”
  • “Organic Patchouli… known as… [an] antimicrobial ingredient.…”
  • “Chamomile… celebrated for its… anti-inflammatory properties.…”
  • “Natural B vitamins in the soy and safflower oils help in cell formation and build skin immune functions.”

Of course, anyone who has experience with essential oils or has studied the materials about the various properties of essential oils, knows that many of them DO have “drug-like” properties. Many of these essential oils and the plants from which they are extracted have been used for centuries to treat and cure. However, claiming that in product materials or on the label is a big no-no.

Review Your Product Labels

In light of this information, it might be a good idea to review your product labels and the materials that accompany your products, including your website, Facebook pages, promotional materials, and even your invoices.

Keep in mind that cosmetic products are “products intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance.” Drugs are “products intended for use in the cure, mitigation, treatment or prevention of disease and articles intended to affect the structure or any function of the body.”

The key word here is “intended.” As in, what does the consumer intend to do with your product, based on what you’ve stated the product can do? If the consumer, based on what you’ve told him or her, buys your product because he or she intends to treat or cure something, then you have made drug claims somewhere and should revise your wording to conform with cosmetic regulations.

Soap and Cosmetic Labeling cover

Shameless plug!

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Comments

48 responses to “FDA Cracking Down On Cosmetic Product Claims”

  1. Marizol

    Hi Marie Gale,

    I read your book, it provides fantastic information. I do have a question about a few cosmetic claims on the PDP of a cream jar product that contains tallow: Clarifying, Healing, Nourishing, Hydrating.
    Does any of these claims cross the line?
    There is also a warning disclosure on the packaging that states:
    WARNING:
    The safety of this product has not been determined. The statements made on this product have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
    Is the warning label necessary because the product contains tallow?

    Thanks for all your help!

    Reply
    1. Marie Gale

      Clarifying, nourishing, hydrating are all cosmetic claims. “Healing” is a drug claim.

      As for the warning–no warning is NECESSARY because it contains tallow. You need to make sure the tallow is clean and such, but you don’t need a warning label because of it.

      In fact, do NOT put the “Safety of this product has not been determined.” As part of the new law (MoCRA) you are REQUIRED to have safety substantiation. So you must KNOW it is safe and have documentation to prove it in order to sell it in the first place.

      The “Not evaluated by the FDA” and “Not intended” warnings are completely unnecessary and inapplicable to cosmetics. In the few places where they ARE used, it’s supposed to be on nutritional supplements, not cosmetics.

      You can save a bunch of room on your label by removing all the warning statements you listed there.

      Reply
  2. Lori Sylvester

    Sorry, but I am more confused than ever! Not the sharpest tack in the drawer but not the dullest either! How can one sell ANY products, then? Can’t say ‘purported to,’ ‘thought to,’ or refer to any ingredient in your product that has been investigated and demonstrated effective (like tea tree oil), etc., etc, etc.…AARGH!!! What CAN a product say??? Examples, please!!!

    Reply
    1. Marie Gale

      Unless you are an approved drug manufacturer and you are making a product that has been approved by the FDA, all you can make are cosmetics.

      Cosmetics are intended to ONLY increase attractiveness, beautify, cleanse, or alter the appearance. A cosmetic is all on the surface (moisturizing, exfoliating, etc). You can make any of those sorts of claims for your product and the ingredients. However, you cannot make any claims that state or imply that the intended use of a product or the ingredient will affect the FUNCTION or STRUCTURE of the body (“under the hood” so to speak) because that would make your product an unapproved new drug.

      For ingredients like tea tree oil, you can say what the ingredient IS, but leave it up to the consumer to determine what it DOES (if it’s more than cleansing, beautifying, improving attractiveness, or altering the appearance).

      Reply
  3. Sheryl Wilson

    Can i use the words”dry skin” on a label. There are not any claims.

    Reply
    1. Marie Gale

      “Dry skin” by itself is fine, or say that a product is better for dry skin. If you say “moisturizes dry skin”, it’s a cosmetic. If you say “cures dry skin by increasing your body’s production of new cells” then you have an unapproved new drug.

      Reply
  4. Yera Montoya

    Hi Marie, I am building a brand focused on evening out skin tone for mature, blemish prone skin.. what cosmetic claim could I use in lieu of “lighten skin”?

    Reply
    1. Marie Gale

      Position it in terms of improving appearance. “Evening skin tone” works so long as you are talking about the appearance on the surface, not permanently lightening the skin. There are quite a few products on the market that make similar claims and keep it in the realm of cosmetics. Keep in mind, though, that some products that claim skin lightening are actually over-the-counter drugs. You can tell because they have “active ingredients” listed in the ingredient declaration and may have “drug facts” also on the label. This is a different class than cosmetics, and you have to be an approved, inspected, and licensed drug manufacturer to make over-the-counter drugs.

      Reply
  5. Rob

    Hi! I’ve read through all of the comments in addition to reading the entire article, and this is very helpful information! It seems a lot of products simply make claims that shouldn’t be made to avoid FDA involvement…at least from the research I’ve done. I have not seen any references to use of the word “relief” in a cosmetic sense and I’m curious if that’s a no-no, as well. For example, can a product make a claim that it “provides relief from common issues associated with the skin”. I’m wondering if making a general statement of “relief” without any specific claim would cross the line.

    Reply
    1. Marie Gale

      I would expect that “relief” from non-specific “issues” would be one of those things that the FDA would (as they say) “evaluate on a case-by-case basis.”

      The bottom line is that it comes down to the intended use, and what the FDA considers the consumer would think is the intended use of the product. It’s pretty thin ice to tread, since “common issues associated with the skin” generally tends to mean physical, not appearance, issues; and “relief” generally means some sort of mitigation or treatment. So you leave “cosmetics” and enter into the world of an unapproved new drug pretty quickly.

      Reply
  6. Dawn Mason

    Can I say my lip balm leaves lips softened and smoothed? Is that physically altering your body?

    Reply
    1. Marie Gale

      “Softened” and “smoothed” are cosmetic claims.

      Reply
  7. Christine

    Would you be able to get around this with a disclaimer? Seems like I’ve seen “These claims have not been evaluated by the fda…” type language on pain rubs, diet pills, etc…

    Reply
    1. Marie Gale

      No, the disclaimer doesn’t change the “intended use” of the product and what the FDA uses to evaluate that intended use.

      The “FDA Disclaimer” is actually for dietary supplements and has a very specific use according to the regulations. You can read more about it in the blog post Using an “FDA Disclaimer” on Cosmetics.

      Reply
  8. Miriam Mabrey

    Hello,

    I had a question regarding a body scrub [sugar scrub] that I’m going to be selling. I was wondering whether or not I should use the warning that it “may cause your shower or tub to become slippery”? It’s made with coconut oil, so the tub and shower do tend to get slippery.

    Reply
    1. Marie Gale

      The regulations stipulate that you should include “material facts” that might influence the consumer’s decision to purchase. And, of course, there’s the potential liability for failure to disclose important information. So there’s no regulation that says specifically that you must put that warning on the label—but nothing saying you can’t or shouldn’t either.

      In my opinion, if you feel that there is some risk to your consumers (particularly if you sell to an older population) and it would make you feel better putting the warning on the label, then by all means do so. Personally, I did put that warning on all of my scrubs and in-bath products that contained oils.

      Reply
  9. Stacey Shields

    So then is there no way for a handmade company to make herbal healing salve or muscle rub? These are my two biggest items

    Reply
    1. Marie Gale

      Yup. Anything that claims to treat, cure, mitigate, or prevent “disease” (my quotes added) or that modifies the function or structure of the body is considered a drug. If unapproved for that purpose or produced by an unapproved manufacturer, it is illegal. By definition, a “healing salve” and “muscle rub” (assuming it is to cure or mitigate sore muscles) would likely be in the realm of “unapproved new drug.” Sometimes products like that are marketed as cosmetics without any medical claims in the name, for the ingredients, on the label, or in any attached or accompanying materials. That just relies on the consumer to figure out what to use it for based on their own understanding of the ingredients. You have to be somewhat careful with that approach. The key is the “intended use” of the product.

      Reply
      1. Peggy

        so I have a friend who says immune or pain relief… probably a no no, right? I would assume so. Just trying to get the wording right.

        Much appreciate the article and all the comments. Great food for thought.

      2. Marie Gale

        A product that is promoted for “immune” or “pain” relief would in all likelihood be an unapproved new drug.

      3. Nika

        does this mean the seller can’t offer “muscle rub” even if there is no claims what it does, except one saying – it’s great for your muscles – try and you will know why!
        ?

      4. Marie Gale

        Pretty much, yeah, that’s what it means.

        It’s the INTENDED USE of the product. If you are communicating to the consumer that the intended use is to cure, mitigate, or prevent muscle aches and pains, then it’s an unapproved new drug.

    2. Staci Fuller

      Hello, I am wondering if the FDA can come after you regarding medically proven information section on your website for herbs and oils. Does this not fall under the Freedom Act?

      I studied medicine which lead me to Psychology and then Biological Science. I make essential oil blends, herbs and soap for the mind body and soul. I plan to launch soon but wish to include the medical and mental health benifits backed by science.

      It seems due to the section on my sit showing “drug” classification it would be against FDA. If I write at the top this information is soly for your knowledge or something like that and covered under the freedom act etc……can they still come after me for the linked information as I sell products containing some of the herbs and oils?

      Reply
      1. Marie Gale

        In America, your right of free speech essentially includes the right to say whatever you want about herbs and essential oils.

        HOWEVER, as soon as you start selling products, what you say about the product(s) and their ingredient(s) becomes part of the “labeling” for the products, and is used to determine the intended use of the products.

        If you are making products with the intended use to treat, cure, mitigate, or prevent disease or to alter the function or structure of the body, then you are making drugs. All drugs must be approved by the FDA before they are marketed and sold.

        So the issue is not freedom of speech, the issue is whether you are making and selling unapproved new drugs.

  10. Paula Kochanek

    Please explain how the article you wrote is pasted on FB (not by you) and now gets filtered as this:
    Great artical …. It saddens me that some essential oils are being so exploited by MLMs and more, people are paying exuberant amounts of money for oils that can be had from many places, not just an MLM company. I ably can hope that the general public that is being told these lies by MLMs will read further… If it sounds to good to be true, it is!

    Reply
    1. Marie Gale

      There does seem to be some contention among essential oil folk about some MLM’s that make medical claims for their essential oils and charge prices that are considerably higher than can be found elsewhere.

      Reply
      1. Peggy

        Just have to say that not all EOs are the same. In manufacturing or how they are grown or how they are tested. I see the same thing in hay production on the farm/ranch. Just because a bale of hay is alfalfa doesn’t mean it is all the same. Some bales of hay are ‘a pile of fluff with no nutrition when opened up’. Reason if they are not cut/grown in the right environment and correct bloom and moisture content, the result of that bale of hay is much different. Also in the north where I grew up, with sooo much rain, much of he nutrients are leeched out, in comparison to hay in other drier areas.

        Same thing for EOs.

        Also for example I purchase hay from a few trusted growers, but they don’t test for nutrients. I also purchase other hay from a company who ships world wide. That company tests for nutrients etc. They pay mega bucks for this testing. I choose to feed this way, because then I know my livestock are getting the correct nutrients for their needs. That is just my choice. Its exactly the same thing for EOs.

        Hope this is ok to share here

      2. Marie Gale

        You’re absolutely right that not all EO’s are the same. As with all plant-based products, there are variations because nature is varied. However, regardless of how great an EO is or how much information there might be to support medicinal claims, to do so without the appropriate approvals makes the product carrying the claim(s) an unapproved new drug.

  11. Renee

    Warnings about not using tea tree oil during pregnancy begs another question… If we CAN’T claim the anti-fungal properties of tea tree oil, then are we REQUIRED to add a warning to the label for something tea tree oil might do? Wouldn’t this constitute a drug claim as well??

    Reply
    1. MarieGale

      Just goes to show the oddities of the FDA regulations!

      When it comes to essential oil (or any ingredient) warnings, none are REQUIRED. However, if you feel that warnings should made for certain types of people (i.e., pregnant people or people with allergies to nuts), then by all means put whatever warnings you feel prudent on the label.

      The warning should be simple and not make any reverse claims. Just say, “This contains tea tree essential oil and is not recommended for use by women who are pregnant,” or “Not recommended for women who are pregnant,” or “Contains peanut oil.” Don’t mention the fact that the essential oil is anti-fungal or an abortifactant or whatever it might be (as that MIGHT be construed as a sort of “reverse claim”).

      Reply
      1. Renee

        Thank you for the clarification, Marie… I am REALLY getting a lot out of the book, and am SO happy that I ordered it!
        Thanks for writing it!

  12. Jen

    Good. Thanks. I see now that you’ve explained that above too! My apologies for redundancy.

    Reply
  13. Jen

    If customer testimonials are considered drug claims, is one only responsible for their own publications in that regard? If some one says something in a blog post I’ve never seen that makes a claim about my product, that can’t possibly be held against me right?

    Reply
    1. Marie Gale

      Logic would say that if someone says something about your product (good, bad, claims or whatever) that’s not something you can do something about. However, if you LINK TO or REFERENCE materials on another site, that could be considered “including” the information in your materials.

      Reply
      1. Lisa Farrell

        hmmm, we all have facebook links on our site, I wonder if that counts?

      2. MarieGale

        It’s hard to know where the FDA would draw the line. My GUESS is that they wouldn’t start coming after you just because there were people who made comments on facebook about your product (that had claims in them) that ended up on your feed. But if you came to their attention in some other way AND you were using those comments as a method of selling or promoting your product(s) it might be an issue.

  14. Lisa Farrell

    What about when customers make reviews of your products and state the benefits they have found from them. Even though I never make claims , they do , post on FB and make youtube videos , and it does sell them for me. Am I to worry about that, and how would I control that if I am?

    Reply
    1. Marie Gale

      That’s an interesting question! The warnings that I have seen from the FDA reference the manufacturer/distributor’s labels and “labeling” (website and materials), not what other people say about the product. While they do reference testimonials, they are always testimonials that are on the manufacturer/distributor’s website. I did see one place where the FDA referenced claims made on the manufacturer/distributor’s facebook page.

      Logically, I don’t see how the FDA could require that you control what other people say about your products, except if you are including the information on your website or linking to the comments/videos made by others. Of course, logic and regulation don’t necessarily go hand-in-hand, but you would probably have a pretty good argument. The key would most likely be whether YOU are using (through inclusion or links) the information on other sites as part of the materials used to promote your products.

      Reply
      1. Lisa Farrell

        Thank you for your response:) and I know what you mean about logic;) Ok, I was worried about the reviews, I will breath a little easier on that issue.

        Now for another question. I have always avoided down right claims, but I find it hard to describe what a product is for without making any at all. Like a hair detangler, is that a claim? It is for removing tangles in the hair and it does, but do you know what I mean?
        And as an example, what if it is a base product I purchase and not one of my own recipes handmade, and I use the supplier information about the product, are we liable for just relaying the supplier information and does it make a difference if they have it tested for its claims?
        And, I already changed a while ago my ” Soothing Footbalm” name for a balm I make to ” Old World Footbalm” , but I make it with and without tea tree eo, and explain tea tree is only in the original recipe for anti-fungal reasons and it is replaced with apricot oil for the ” non- tea tree” balm in case you are pregnant , and in that case one who is pregnant should not use it with Tea Tree oil in it. Now is the explanation itself a claim I wonder?

      2. MarieGale

        You hit the nail on the head when you said that it’s hard to describe a product without making any claims! Very difficult indeed.

        The key is to remember that it’s in what is CLAIMED about the product; cosmetics improve APPEARANCE, while drugs make PHYSICAL changes. It doesn’t matter if there is tons of evidence out there that tea tree oil is anti-fungal. If you claim that your product is anti-fungal because it contains tea tree oil (or even that tea tree oil IS antifungal and is an ingredient in the product) then you’re over the line. It sucks, but that’s the way the laws and regulations are.

        Even if the supplier provides information (even if they have a boatload of testing to prove it!) if you use it and it’s a drug claim, you’re again over the line.

  15. Ewenique

    Thank you for staying on top of these regulations and for explaining them in easy to understand terms.

    Reply
  16. Renee

    Was just wondering if it would be a problem if your label said something like: “Organic Cedarwood is PURPORTED to strenghten hair growth, etc…”?

    Reply
    1. Marie Gale

      The guiding factor is what the CONSUMER thinks you are trying to say the product will do. While “purported,” “traditionally used for,” “thought to,” and similar statements don’t make any actual claim, they are giving the impression that the product (because of statement about the ingredient) will do what it’s purported to do. In other words, it’s a roundabout way to make a claim.

      If “white” is no claims at all, and “black” is an out-right claim to cure, then I’d say that saying an ingredient is “purported to strengthen hair growth” is definitely in the gray, probably the dark gray.

      Reply
      1. Peggy

        So basically then, its possibly not advisable to say ‘though to’ or ‘purported’ or things like that? That would be my assumption.

      2. Marie Gale

        Saying that an ingredient is “thought to ____” or “purported to ____” begs the question of WHY you are saying that. Chances are, you are trying to communicate to the consumer that the PRODUCT (because of the inclusion of those ingredients) also has that characteristic. Whatever it might be. It’s a way to try to say what the intended use of the product is, by saying things about the ingredients.

        Remember, the FDA is looking at all of that information (when they do) to determine what the consumer thinks is the INTENDED USE. If the consumer reads what you say and thinks the product will alter the function or structure of the body, or will treat, cure, mitigate, or prevent disease, then you have an unapproved new drug on your hands, not a cosmetic.

  17. Jean Marie Pizzariella

    Hi Marie,

    Thanks so much for this information. I have both of your books and have found them to be very informative and, more importantly, easy to understand and absorb. One thing I’m struggling with is how to describe the function of antioxidants in skin care products without running afoul of the FDA. It seems like any claim about neutralizing free radicals or protecting the skin from damage would be teetering on the edge of a drug claim. Any thoughts or advice you can give would be greatly appreciated!

    Jean Marie

    Reply
    1. Marie Gale

      Hi Jean,

      The FDA seems to have anti-oxidants classed as working internally (as in food), and therefore by default anything you say about how they work would be saying that they affect the “structure and function of the body.” Tricky.

      You might be able to get away with saying that an ingredient IS an anti-oxidant, but unfortunately I doubt that it would be wise to say much else about it.

      On the positive side, if your promotional text describing the cosmetic characteristics of your product is good, the consumer will understand that the product will make them look better which is, after all, what a cosmetic essentially does. Once they are intrigued, they can research the ingredients themselves and will find out (from their own research, not from your site or materials) the benefits of the individual ingredients. The silver lining is that an educated consumer will end up with “third party” verification of the benefits of your product.

      Reply
  18. The Nova Studio

    Wow, this is a great post! Thank you for continuing to keep us all informed on what is going on in the product labeling world.

    Reply

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