Saturday, July 7, 2012

Question: Why can't we make claims about our products?

In an e-mail, Linda writes: I have been reading your blog in the past few days and find it extremely informative, helpful and generous.  I am currently reading through your e-book on formulating and creating lotions and came across a part where you specifically said not to make any claims for the finished products and this seems to be a consistent message on your blog.  Please elaborate on this point and explain this reasoning.

If you make a medical claim for your cosmetic product, it turns it into a drug, and you have to go through a whole battery of tests to make sure it actually works in that capacity. You can get in huge trouble claiming that your product soothes, cures, fixes, eliminates, or generally makes better a problem you might have.

If you claim your lotion moisturizes your skin, that's a cosmetic claim, and that's fine. But if you claim that your lotion will heal eczema, that's a medical claim. If you want to say your body wash cleans your skin or makes you feel more hydrated, that's fine. If you claim it will soothe itchiness, you can't do that.

I know, I know, there's some woman at your local market who makes a sunscreen or a balm that she claims cures eczema or a bug repellant spray. She's breaking the law. Don't bother trying to convince her that she can't make those claims - she won't listen to you, and your day will be ruined as you clench your teeth to avoid yelling at her! Just walk away and hope that no one gets hurts by her claims. (I say this after attending our Party in the Park last night and having to endure the Kapangi water people, who sell their alkaline water that will prevent cancer. What the heck is a micro-cluster of water? It's nothing, that's what? ARGH! Walk away, Susan. Walk away!)

How do we know what is a cosmetic and what is a drug? The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as "articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance"  The FD&C Act defines drugs, in part, by their intended use, as "articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease" and "articles (other than food) intended to affect the structure or any function of the body of man or other animals"

A few examples from Health Canada...Antidandruff shampoos are drugs since they correct an abnormal physical state of dandruff production, while regular shampoos are cosmetics. Antiperspirants modify the organic function of sweat production and are therefore considered drugs. Deodorants only mask odours and are therefore cosmetics.

If you want to use a nail polish to make your nails look pretty, that's a cosmetic. If you want to make a nail polish that claims to heal split nails and awful cuticles, that's a drug.

This is what the FDA has to say: What about therapeutic claims? Promoting a product with claims that it treats or prevents disease or otherwise affects the structure or any function of the body will cause the product to be considered a drug under the FD&C Act, section 201(g).

This is one of the reasons we don't make sunscreens around here - they're drugs, not cosmetics! 

If you want to say that your lotion moisturizes your skin, that's fine. If you claim that it will soothe dry and itchy skin, that's a drug claim. If you want to claim that women report their skin appeared younger or that they felt younger after using your product, that's fine, but you can't say that women looked younger after using your product. It's a very fine line that a lot of products skirt at their peril, and there are penalties for making these claims.

If you want to sell your products, you will want to make sure you make the cosmetic labelling laws in your country your new favourite book!

Yep, my anti-itch lotion above would violate the rules, but I'm only making it for my husband and named it that so he'd know which one contained the ingredients I hope will reduce his itchiness. If I were to give this to anyone else, I wouldn't call it that! Calling my lotion an "anti-itch lotion" makes it a drug! And my "possibly a dandruff shampoo" definitely falls into the realm of drug...but again, that was labelled that way for a friend so he'd know which of the many shampoos I'd made him contained ingredients that might be helpful for dandruff. I would never sell either of these products with these labels! 

Related posts and links:
Guide to Cosmetic Ingredient Labelling (Health Canada)
Labelling cosmetics (specifically about claims) from Health Canada
Mandatory labelling for cosmetics in Canada (Health Canada)
FDA Cosmetic Labelling guide (USA)
FDA Cosmetic Labelling & Claims
FDA: Is it a cosmetic, a drug, or both? (Or is it soap?)


Mychelle said...

I love the semantic. You can say "for" dry itchy skin but not "heals." You can say "ingredients that soothe" but you can't say "this product soothes." Though I think you can claim anything you want on a product you give away as gifts aren't regulated by commerce laws and the FDA. And yes, this woman is at my market every Sarurday. Mixing creams (note, creams - as in water) as people watch, spooning the unpreserved still-hot bacteria souffle into jars and sending people on their way with promises of cures. Walk away Mychelle.

Robert said...

As a producer of several ‘anti-aging’ type products I am very much involved with label wording and claims. With respect to claims for ‘anti-aging’ products, the phrase ‘This cream reduces wrinkles’ would be considered a drug claim whereas the phrase ‘This cream reduces the look/appearance of wrinkles would place the product in a cosmetic category. I believe the phrase a ‘woman looked younger after using your product’ would still fall into cosmetic category since the word ‘looked’ is subjective and does not suggest any alteration to the functioning of the skin. To be extra cautious, though, perhaps it would be safer to say a ‘woman looked visibly younger’.

melian1 said...

for those interested, there is an extensive thread on the dish about this very subject, with links and explanations. it is a very complex issue, labeling and required semantics. anyone who sells or intends to one day really ought to read that thread.
i don't have the url for it, but if you do a search you'll come up with it. iirc, it was micromom (tho i can't completely swear it was her).

Anonymous said...

Great post and very timely for me. Thanks!!!

Susan Barclay-Nichols said...

I don't think the Dish is up yet (written Sunday, July 8th around 10:30 am PST). But the discussion over there was great!

Susan Barclay-Nichols said...

Hi Mychelle! Ick! And I bet people are just thrilled that they got made just for them, fresh lotion with no preservatives! Blech...

Anonymous said...

Hi Susan,

You asked:
What the heck is a micro-cluster of water?

Possible answer:
A teeny, tiny, super-small water droplet?
Sooooo..... according to their claim, we could save money on their cancer preventing product yet achieve the same results by all standing outside when its foggy, making sure to breathe in the micro-clusters of water all around us.
Makes as much sense as what they're saying.


Anonymous said...

One thing I don't understand about labeling is ingredients, like for example niacinamide which is known for anti aging, or other ingredients that have been researched and tested and are FACTUALLY known to have certain properties, why cant you call a face cream that contains niacinamide and vitamin e "anti aging” or whatever it is your active ingredients do (that is tested and proven)? What about labeling a product: Contains [insert here] ingredient which has anti aging properties” or “contains oat extract, which has soothing properties”. Neither of those would be a lie, or making a claim. Its the truth. The product DOES contain blank ingredient, and blank ingredient DOES have these qualities. Is that within the realm of regulations??

Julie said...

In reply to Mychelle

What?? Why is this woman allowed in there? Why doesnt someone kick her out? If I was there, I'd announce to everyone around her what she is doing and why it's bad, so everyone would know what we know, and then let them make their own informed decision.

Hopefully she has insurance for the inevitable day she gets sued! But based on what I've heard, she probably has her own crazy reasons why you shouldn't use insurance either!