Drug Claims and Lip Balm

I just returned from the 2011 Handcrafted Soapmakers Guild Annual Conference in Miami. It was terrific! This year I went as a speaker and a vendor, and had time to enjoy some of the other speakers and presenters. I loved seeing Barbara Corcoran and had the privilege of having breakfast with her and several of the HSMG directors. Barbara is a fascinating woman, very well-spoken and quite kind.

My Half-Day seminar on Labeling was attended by about 20 people and I believe they all got a good overview and some hands-on experience reviewing and creating labels. All the information covered included in my book Soap and Cosmetic Labeling (except the many anecdotes I have collected over the years about labeling).

Which brings me to the point of this post — drug claims. Many people asked me about what constitutes a “drug claim” and asked me to look at the claims on their labels. Since I’ve come home, I’ve had a few more questions … so here is more information on how a cosmetic can become a drug.

A drug is defined by the FDA as:

Any product that is 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.

We all know that there are many ingredients that are beneficial to the body in some way or another; many have been used for centuries in “traditional” healing.  The fact that they haven’t been “approved by the FDA” doesn’t mean that they don’t work.  Many of us have even made creams, salves, butters and balms for personal use that were blended with essential oils or herbs to help with sore muscles, sprains, aches and pains.

However, to make the CLAIM that a product for sale will cure, mitigate or treat “disease” or affect the structure or function of the body (including relief of sore muscles, sprains, aches and pains) makes the product a drug (and subject to the FDA and all their many, many, many, many regulations.

Drug Claims

So, what constitutes a drug claim?  I went through some of the recent warning letters from the FDA and compiled the following list of examples of drug claims  from websites about products and/or product labels. (These are all topical products – not food or dietary supplements.)

  • Loose your wrinkles!
  • Vitamin C and E [ingredients in the product] help … protect skin cells from free radical damage
  • (Testimonial) Ever since I started using [product] three weeks ago, I have noticed that the wrinkles on my forehead were less deep…
  • Rosehip seed oil [an ingredient in the product] contains Vitamin A, which helps to delay the effects of skin aging … and promotes collagen and elastin levels to increase.  This results in firmer … skin with greater elasticity
  • According to the Centers for Disease Control, ‘In cell cultures, copper complexes cause some types of cancer cells to revert to non-cancerous growth patterns’
  • Our formulation is pH balanced to maintain proper delivery of particles into the skin creating a…healing benefit
  • Topical Vitamin C protects skin against harm caused by exposure to sunlight…
  • Vitamin C has Anti-inflammatory benefits which reduce redness and irritation…
  • Oxygen is a catalyst and energy source for most cellular functions.
  • Oxygen is vital for all cells to sustain proper metabolism [product claiming to include oxygen]
  • Oxygen has a significant role in wound healing, being essential to provide the additional energy source for the repair process. [product claiming to include oxygen]
  • Oxygen is…component of the immune function…component of blood flow…functional element in hormonal mediators…required…during tissue repair process… [product claiming to include oxygen]
  • Relief from: Cuts, burns, sunburns, abrasion, rash, diaper rash, bug bites, shaving, waxing and many types of skin irritations
  • It is excellent for burns, sunburn, and rashes
  • Stops the pain experienced with bikini waxing.
  • (Testimonial) I had a stubborn outbreak of acne on my chin that persisted for 3 months…The acne seems to just be disappearing…
  • Promotes…wound healing and skin conditions such as…eczema and psoriasis.
  • Reduces redness
  • Millions of men and women suffer the stinging embarrassment of chronic facial redness and flushing. . . . Now there’s [product]
  • (Testimonial) After I tried [product], my face wasn’t lighting on fire anymore.
  • [H]elps correct the effects of sun damage on the skin.
  • Stimulates the renewal of skin cells
  • Witch hazel [an ingredient in the product] : eases skin inflammation
  • Employing the universal botanical soother Aloe vera, this formula provides healing support to worn out skin. Legendary for its ability to help the body recover from injury, Aloe actually promotes restoration of the skin, fostering strong ties between your inner skin fibers.
  • Helps to calm, relax and promote restful sleep.
  • Helps skin cells renew and repair themselves…
  • Bruise Relief
  • a patented formulation of essential plant oils proven to kill 99.99% of germs including MRSA, Salmonella, Staph, and E.coli
  • [The] active ingredient is a proprietary, fast-acting, broad-spectrum antimicrobial created from a patented blend of natural thyme and other essential plant oils. . . . The heightened activity and novel combination of oils has proven highly effective at eliminating harmful transient bacteria, while leaving beneficial resident bacteria and soft, healthy skin
  • Use: Sanitize hands when you can’t wash with soap and water

Claims about ingredients

You’ll note that in the above lists there are drug claims made about an ingredient in the product (even when the same claim is not made for the product itself).  That still constitutes a claim for the product.

Location of claims

Obviously, saying “for treatment of eczema” on the actual label on a container of cream would qualify as a drug claim.  What about saying that on the website that sells the product?  Yep, drug claim.  Having an article on the website by someone else that talks about the eczema-curing properties of an ingredient in the cream?  Yep, that’s a drug claim, too.  Putting out a press release on prwire about the healing properties?  Yep, drug claim.  (In fact, one of the warning letters I reviewed was the result of a claim made in a press release!)

Lipstick, lip gloss and lip balm

Lipstick and lip gloss are cosmetics.  They are applied to enhance or color the lips and are purely for increasing beauty and attractiveness (the definition of “cosmetic”).  Lip balms, however, are a different story.

Recently there has been discussion about whether the term “balm” can be used for a cosmetic product – especially a “lip balm”.  While I couldn’t find anything about the term “balm” by itself,  but “lip balm”is referenced in FDA regulations.

“Lip balm” (also called “lip protectant”) is considered drugs in the class of “skin protectants”.  It can be a cream, gel, lotion or ointment.  The approved claims  are “helps prevent”,  “temporarily protects” or “helps relieve” “chapped or cracked lips”, and optionally, “helps prevent and protect from the drying effects of wind and cold weather”.  A lip product which contains sunscreen is also considered a drug under the sunscreen regulations.

In order for a lip balm to qualify as an over-the-counter skin protectant drug, the product must contain at least one of the following:

  • Allantoin, 0.5 – 2 percent
  • Coca butter, 50 – 100 percent
  • Cod liver oil, 5 – 13.56 percent (with restrictions)
  • Dimethicone, 1 – 30 percent
  • Glycerin, 20 – 45 percent

It wouldn’t be hard to make a product that meets the ingredient requirements for a lip or skin protectant.  However, even though you could MAKE it, in order to qualify as an OTC skin protectant drug (and bwe able to use the drug claims noted above), the product must be labeled and manufactured as a drug.

The labeling part isn’t so hard, but qualifying as a drug manufacturer means being registered with the FDA as a drug manufacturer, having an inspected facility and qualifying with all Good Manufacturing Practices at the drug-level standard as specified in the regulations.  In other words, don’t try this at home!

Bottom line

The bottom line is that if you are making a cosmetic product, keep your label and all the accompanying materials (the “labeling”) on track.  Don’t make claims that the product will do ANYTHING other than “cleanse or promote beauty or attractiveness” … even if you know it will.  Be careful about testimonials on your site that make drug claims; even if they aren’t from you, they still count.

Do promote your ingredients; if your product contains arnica and your customer uses it for a sprain or bruise … so be it.  But don’t YOU tell them to do it!

Comments

  1. Nicely written!
    Thank you for all your suggestions, especially the excerpts from the warning letters. I have a few contacts at the FDA and have relied on them several times for their expertise in my labeling questions. With the recent popularity of soap making, and the birth of so many cottage businesses, I have a strong suspicion that many are just not aware of how much regulation exists regarding “Soap” and “Cosmetic Soap.” Blogs like yours help to get the information out there. Thank you! 🙂

  2. I am very confused about the lip balm regulations and wondered if you could help me? I am a very new company (I don’t even have my product entered into my website yet) and I am wanting to sell my fantastic 🙂 lip balm. I have called it “ultra moisturizing.” Is that o.k.? Am I supposed to be jumping through major hoops to sell it, such as FDA approval, etc.? Please help!

    Thanks!

    1. Hi Kelly,

      “Ultra Moisturizing” seems to be a cosmetic claim. Lip products that “protect from chapping” or “heal chapping” are drug claims – so don’t go there. Of course, moist lips are more attractive, so that’s also a cosmetic aspect. The word “balm” seems to lean toward being considered a “drug”, so if you have a different term you can use to describe your product that moisturizes and makes lips more attractive, that would probably be a good idea.

      You don’t need to jump through any hoops at all so long as you stay with a cosmetic product. Get into the realm of drugs and you’re in a complete different (and really uncomfortable and expensive) world.

      Marie

    1. Author

      Based on information I received from the FDA (discussed here), it appears that you can call a product “Lip Balm” if there aren’t any non-cosmetic claims made for it.

      1. can you label it as chapstick, or what can you label it as?

      2. Author

        I think “Chapstick” is a registered trademark. Saying that the product “prevents chapping” or is a “lip protectant” are a drug claims, so that doesn’t work.

        Lip gloss, lip moisturizer … that type of name keeps it in the cosmetic realm.

  3. Can I say my product is vegan? Just so that I’m clear as lone as you don’t say what it is used for you should ok?

    1. Author

      “Vegan” isn’t a regulated term for cosmetics. Using the term is more marketing than anything else – so yes, you can use “vegan” to market cosmetics.

  4. Thank you so much for this Marie, I’m making sure my website, labels and everything are in line with what they should be and your book and website are worth a million bucks! Thank you also to the people above who posted questions that helped my understanding.

  5. I need to go through your book again to check… but may I ask you also ~ I sell a product I call “Homestead Healing Salve” with no claims. It has a number of disclaimers, stating that if the user has a reaction to my salve or any other herbal product, to see their doctor immediately and to take the container with them. Both this product and my Homestead Muscle Rub state “do not use on broken skin” and the disclaimer that nothing on this label was meant to imply the product cured, treated, or prevented any illness.
    Is using the word “HEALING” for the name of the salve – an indication that it specifically heals a condition and thus becomes a medical claim?

    1. Author

      The determining factor in whether it would be a medical claim is whether the consumer, from reading the materials on the package and with the product, comes away with the idea that the intended use is to treat, cure, mitigate or prevent disease. Both “healing” and “salve” have an implication that the product is treating or curing something, as does a “muscle rub” (treating sore muscles). It’s not cut-and-dry, but I would suggest that you be wary and take a hard look at the product and what you are trying to tell the consumer it is for. If you are trying to say that it does, in fact, treat, cure, mitigate or prevent disease or will alter the function or structure of the body, then you should change your wording.

  6. These first 3 lines were taken from U.S. Food and Drug Administration

    The law does not require cosmetic products and ingredients, except for color additives, to be approved by FDA before they go on the market.

    it’s not against the law to manufacture cosmetics in your home.

    FDA does not license cosmetics firms

    This last part was from your on line page

    However, it’s important to note that even though it would be easy to make a product that meets the ingredient requirements, the product must be labeled and manufactured as a drug.

    Please help me understand when it comes to lip balm. Are you saying there is no way to label or sell lip balm without it being classified as a drug. Thanks wicksbee

    1. Author

      It looks like my sentence was a little unclear. I was talking about products that qualify as OTC skin and lip protectants (and therefore OTC drugs). I have revised the sentence to read:

      It wouldn’t be hard to make a product that meets the ingredient requirements for a lip or skin protectant. However, even though you could MAKE it, in order to qualify as an OTC skin protectant drug (and bwe able to use the drug claims noted above), the product must be labeled and manufactured as a drug.

  7. Can you clarify this for me….

    I can’t use the word ‘balm’ or ‘salve’, correct? But I can use the words ‘ointment’, ‘rub’, ‘cream’, ‘lotion’??

    I’m not sure how I can make a salve but not call it a salve.

    Also, if I made a muscle rub with cayanne, can I call it a ‘warming cream’?

    This is all so confusing. Thanks for your help!

    1. Author

      As noted above, the definitions of “balm” and “salve” have changed over time. They were names for healing (and prescription) products and now are much more general.

      Using the either term does not automatically imply the old definition, but it could be a factor in the consumer’s understanding of the product’s use. As always, the determining factor is the intended use – as the consumer understands it.

      A “warming cream” is iffy. Regardless of the actual words used, if the general understanding of consumers is that the product is to relieve sore muscles, then it would be considered a drug in that it is to cure, treat, mitigate or prevent “disease” … or it alters the function or structure of the body. Note that “disease” is used loosely.

  8. Regarding the word ‘balm’, is that just for lip balm? I make a tallow balm and I’m wondering about what I would call that!
    To me, balm just means a waterless, firmer, version of lotion.

    Thanks!

    1. Author

      I think with “balm” there is a case of the vocabulary and word meanings changing over time. Years ago, a “balm” was a healing ointment. Nowadays, though, it’s more like you say … a waterless, firmer, lotion/cream.

      From what I can tell, using the term “balm” does not automatically imply the old meaning of the word (as a healing agent). The key would be what the consumer considers is the intended use of the product based on what you say about it.

  9. Hi Marie,
    I have a question on a soap labeling debate. Another soaper has made beautiful labels for his/her soap and has used words such as “Renew”, “Relieve”, “Refine”, etc. as the actual name of the product. Would this indicate an intention for use as a drug/cosmetic?

    1. Author

      As standalone words, “renew”, “relieve” and “refine” don’t say much about what the product is intended to do (the “intended use”).

      I expect that this would be, in the FDA’s favorite words, “judged on a case-by-case basis”. There isn’t really a hard and fast rule.

      It would depend on what else was on the package …. “relieve” … acne? cancer? dry skin?

  10. Thank you Marie, The labels are just a sample of possible intended packaging. This person was only asking if it may be misconstrued as a “drug”.

  11. Hi Marie,

    In this article you mention that the approved claims are “helps prevent”, “temporarily protects”, or “helps relieve” “chapped or cracked lips”, and optionally, “helps prevent and protect from the drying effects of wind and cold weather”.

    I have a couple of questions:

    1. Do you know of a link to FDA approved claims?

    2. Do you know of reputable FDA consultants that help with creating labels and marketing claims that promote your products for what they do while ensuring to be FDA compliant?

    Thank you much for your assistance.

    1. Author

      The approved claims are from the monograph for over-the-counter skin protectant drugs. It is part of 21 CFR 347.50.

      Keep in mind that these are the specifications for over-the-counter DRUG products. In order to manufacturer and market them, you must be a registered (and inspected) drug manufacturer (and, of course, the product must conform to the specifications in the monograph). The FDA has requirements for drug manufacturers, as do most states. They all are geared towards ensuring that the facility is qualified to produce ANY kind of drugs. Good manufacturing practices are required by regulations and law. It is not a small matter to become approved to manufacture drugs.

      On the other hand, lip and skin products that are intended to have a cosmetic effect (not change the function or sturcture of the body or prevent disease) do not require manufacturer registration or pre-approval.

      I cannot recommend anyone who can assist with labeling and marketing claims for products.

  12. Thank you for this valuable information. Can you give us examples of anything on the market already that would be a muscle balm or salve that did not have to have FDA approval? I see many things that are not allowed but it is confusing as to what is allowed.

    1. Author

      Sometimes it’s easier to look at what’s NOT allowed … any claim that the product with treat, cure, mitigate or prevent disease or will alter the function or structure of the body.

      If the intended use is to somehow address sore muscles, I’m sorry to say that you have already crossed the line.

  13. What about Beard Balm? I’m about to name a product and remembered this article so I’ve re-read it. Great Info.! It sounds like we are now safe using the word “balm” as long as we make no claims per the usual process– following the cosmetic labeling guidelines. My back up is to use the words Beard Butter which I’ve done with Lip products to avoid the word balm. Thanks!

    1. Author

      Based on the information I have received from the FDA, “Beard Balm” would be acceptable, providing no other “medical” or “drug” claims were made for the product.

  14. I was browsing etsy and pretty much every salve maker had claims not approved by the FDA in their description with just a little “Not approved by the FDA” disclaimer at the bottom. My question is How do I stand out in a market with EVERYONE is not following the rules. I was looking for description and labeling inspiration and all I got was discouraged.

    1. Author

      Yes, it can be discouraging. One approach is to go away from how your product can do all these things (that cause it to become an unapproved new drug) and focus on the quality of ingredients, quality of manufacture, how you make the best products, your story, your history, etc. Stand out by being different yourself … think of “Dirty Girl” cosmetics or “Fat Bottomed Girl” cupcakes – those stand out. Quirky marketing, unique product labels, social consciousness – all good ways to stand out.

  15. Hi great info thank you! What about a portmanteau, a blended word for my cosmetic lip balm? Or what about the words ‘primer’ or ‘wax’ (as a noun)? Wax- is that considered listing part of the ingredients in the name- is that allowed? Thanks in advance Marie!

    1. Author

      The regulations just say that the name of an ingredient can’t be included in the name of the product if there are two or more ingredients in the product.

Leave a Comment