Labels with Drug Claims

[AlchemyandAshes]

This.

Of course there are a lot of people that do it, and a lot of people get away with it. That doesn't make it right, and it doesn't make it legal. I'm sorry, but it isn't a "grey area" IMO. The FDA is very clear about what constitutes a drug and how they have to be handled and labeled if selling to the public. The "real world information" that someone is getting away with it is anecdotal at best. What you (the OP and PP) or anyone else chooses to risk is your business, but encouraging others to disregard the regulations is IMO irresponsible.

I am absolutely NOT encouraging others to disregard the FDA regulations, and neither do I do it myself. I am also not insinuating that because others do it and get away with it that it is right. If I wasn't clear, then at least let me clarify that point.

My "grey area" comment is regarding making an herbal product and selling it WITHOUT MAKING ANY MEDICAL CLAIMS either on the label or in marketing. Just making and selling a Calendula Salve and selling it as Calendula Salve - is that considered a drug? Calendula Salve can certainly be used for cosmetic purposes (to moisturize dry skin on heels, for example), but it can certainly be used as an "herbal medicine" also (as a treatment for eczema)...so where does it fall in the FDA categories? Is it only a drug if marketed or labeled that way? If there are no claims made on it's use, either in label or marketing, but it's labeled with the INCI ingredients, is it now a cosmetic? That's the grey area for me. I linked the FDA's stance on labeling/marketing and intended use so that any question about using brochures/flyers to give "medical" information about a product while not labeling your product it as a drug would still be against regulation.

As for the herbalist I contacted - I have no idea of her circumstances, and would not just assume she's not complying with FDA regulations, or that she is. I was only stating that she is an educated and successful business woman in this particular arena, and can possibly share her knowledge or information regarding this topic. It's certainly possible that she's flying in the face of danger, using medical claims, and could care less what the FDA says. I don't know, which is why I contacted her instead of making assumptions. I'm hoping that she has dealt with the FDA regarding her products and can shed a little light. And while she may not be an FDA official, she may have dealt with this exact circumstance and can speak from her experience.

If you had read my previous posts, you would see that I am simply "questioning out loud", stating my opinion and my experience. I am not irresponsible with my labeling or marketing (feel free to check out my Etsy store, FB page, or website), nor encouraging others to be - though I may be encouraging others to think for themselves and ask questions, not just take something found on the internet or forum as fact. Saying that someone finds a loophole and gets away with some illegal activity and wondering how is NOT encouraging others to do so, nor is it stating it's morally or ethically right. It's more a matter of questioning why something hasn't been done about it - if I have to follow strict guidelines, they should, too.

 

[AlchemyandAshes]

Doing something the right way, and having real world experience are not always synonymous unfortunately...

I totally agree with this statement.

I have no idea if the herbalist I contacted is following FDA guidelines or her specific labeling requirements. I did not mean to infer that she is following or not following FDA R&R, just that she sells herbal products with medical claims. She may very well have FDA clearance for her products. She may not. I'm awaiting her answer to hopefully share some pertinent information to this topic from someone who sells this type of product.

I'll share her reply either way. I'm assuming if she does not follow FDA regulations, she may not want to reply and "incriminate" herself...however, she's all over the internet, so if she was trying to "hide", I think they would have "found" her by now...

 

[jcandleattic]

My "grey area" comment is regarding making an herbal product and selling it WITHOUT MAKING ANY MEDICAL CLAIMS either on the label or in marketing. Just making and selling a Calendula Salve and selling it as Calendula Salve - is that considered a drug? Calendula Salve can certainly be used for cosmetic purposes (to moisturize dry skin on heels, for example), but it can certainly be used as an "herbal medicine" also (as a treatment for eczema)...so where does it fall in the FDA categories? Is it only a drug if marketed or labeled that way? If there are no claims made on it's use, either in label or marketing, but it's labeled with the INCI ingredients, is it now a cosmetic? That's the grey area for me.

If it is labeled as Calendula Salve and that is ALL that is said about it, and only the name of the product, and said name is not a claim (like say the name was Healing Beautifying Calendula Salve would be) then, no, it is not a drug or cosmetic, but will still need to be labeled per regulations for the product that it is (lotion, soap, etc.)
Just because there are herbs or what not in it, doesn't automatically make it a medicinal or cosmetic product. It is the claims being made that will differentiate that in most cases. But like everything else there are exceptions to these rules, which is why there are published and updated FDA R&R's.

 

[AlchemyandAshes]

If it is labeled as Calendula Salve and that is ALL that is said about it, and only the name of the product, and said name is not a claim (like say the name was Healing Beautifying Calendula Salve would be) then, no, it is not a drug or cosmetic, but will still need to be labeled per regulations for the product that it is (lotion, soap, etc.)
Just because there are herbs or what not in it, doesn't automatically make it a medicinal or cosmetic product. It is the claims being made that will differentiate that in most cases. But like everything else there are exceptions to these rules, which is why there are published and updated FDA R&R's.

That would be my interpretation of that rule, also...which is why my salves are just labeled as "salve", not "healing" or "bug bite salve" or "acne salve" or any other drug claim - although I think "beautifying" would be a cosmetic claim. I list the ingredients with INCI labeling as you would a cosmetic.

But what about the FDA statement about what a consumer intends to use it for or associates it's use with - "implied use"? Consumer A may think it would be great for her cuticles. Consumer B may think it would be useful for her psoriasis. Consumer C has no idea what a salve is in the first place ...LOL

 

[jcandleattic]

But what about the FDA statement about what a consumer intends to use it for or associates it's use with - "implied use"? Consumer A may think it would be great for her cuticles. Consumer B may think it would be useful for her psoriasis. Consumer C has no idea what a salve is in the first place ...LOL

you can't do anything about what they THINK it's good for. All you can do is if they ask if it's good for your cuticles, or psoriasis, or yada yada yada, all you should reply with is, "that is not it's intended use" and go from there. If they ask what a salve is, be honest. It's a topical product much like lotion only thicker (or whatever) just be very clear that you are not telling them that it can DO anything other than be rubbed onto their skin. Like with soap all you can really 100% get away with is saying is "you can use it to wash yourself with"

 

[AlchemyandAshes]

This is the FDA statement that causes me to wonder:

Intended use may be established in a number of ways. The following are some examples:

Claims stated on the product labeling, in advertising, on the Internet, or in other promotional materials. Certain claims may cause a product to be considered a drug, even if the product is marketed as if it were a cosmetic. Such claims establish the product as a drug because the intended use is to treat or prevent disease or otherwise affect the structure or functions of the human body. Some examples are claims that products will restore hair growth, reduce cellulite, treat varicose veins, increase or decrease the production of melanin (pigment) in the skin, or regenerate cells.


Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

 

[jcandleattic]

This is the FDA statement that causes me to wonder:

A product will only HAVE that reputation of implied usage if you have made claims in the past and established that reputation for your products. (as it says in the very large print you attached)
I really don't know how to make it more clear than the FDA has, and I'm sorry you are confused.
I have been doing this a very long time and am very familiar with the FDA R&R - there is no need to shout them at me. I was only trying to help you.

 

[AlchemyandAshes]

A product will only HAVE that reputation of implied usage if you have made claims in the past and established that reputation for your products. (as it says in the very large print you attached)
I really don't know how to make it more clear than the FDA has, and I'm sorry you are confused.
I have been doing this a very long time and am very familiar with the FDA R&R - there is no need to shout them at me. I was only trying to help you.

Sorry, I didn't mean to shout - I was trying to highlight the part that wasn't clear to me...will go back and fix that.
Just trying to emphasize that part that has me wondering - not the whole quote.
I haven't made any claims on my products. My question is if that statement meant an implied use that the public associates with a TYPE of product (not my particular product), like an herbal salve. If most people associate herbal salves with "medicine", is it considered a drug?

And thank you for your assistance. I apologize if my red bold type came across as shouting.

P.S. The black bolding is from the FDA website, not my own doing.

 

[christinak]

My my, well thanks for the help I think you've all made it very clear that as long as no claims are made on the label or on any brochures that you can pretty much sell what you want and to be on the safe side, label it as a cosmetic. Is there a hard and fast list to the terminology that can be used before crossing a line into the world of drugs?

I also think it's clear (and common sense) that "implied use" is something that is mostly common use across the board, such as aspirin is for headaches. I'm not going to stand on a soapbox (no pun intended) and rant about how I believe government is too involved anyway....and how there's wayyyyy too much "netiquette" now-a-days....but I'm new to this forum and the first thing I thought of when I got here was how refreshing it is to be a part of something with really nice people. I hope that doesn't change. Everyone here is just helping eachother out. Nobody is getting loud or cocky or yelling...we're typing...and nothing is implied. People will always perceive words differently or out of context, it's best to let things roll off your back.

The herbalist in question over the last few posts probably knows more about herbs than any lab coat at the FDA does. The only reason to put one over the other is to not land in jail.

Thanks EVERYONE for your input and keep up the good work!

 

[AlchemyandAshes]

Thanks EVERYONE for your input and keep up the good work!

Hey! Quit shouting at EVERYONE! :eh:

Bwahahaha! Just kidding! :razz:

 

[christinak]

lololol!!!!!!!!

 

[Parke Co. Grapevine]

more labeling Qs, and pine tar Q

I too, have searched online and read here and read there, and ... it all can become quite confusing.

I found the FDA's definition of soap, of course, and this . . .
"Products that meet this definition of soap are regulated by the Consumer Product Safety Commission (CPSC), not by FDA. Please direct questions about these products, such as safety and labeling requirements, to CPSC..."

But could not find anything at the CPSC website about rules and regs or labeling for soap. Rather, the best I could discern is that true 'soap' - like what we make - is an 'unregulated product.' So... no rules for labeling as long it is only 'soap' and not presented as anything else?

We once stayed at a local statepark Inn. The guest soap was boxed and presented as an 'all-natural body cleansing exfoliant' or some such wording. No ingredient label anywhere. We used it and found it to be extremely similar to your basic unscented Walmart bath bar. The lack of labeling info irritated me.

I have sometimes looked at homemade soaps sold by others with very 'skimpy' labeling, IMO. My sister (in another state) claimed that the soaps she buys at her neighborhood soaper were *not* lye soaps because 'lye' was not on the ingredient label ... after sharing a not-well-received brief chemistry lesson, I suggested she just go ask her soapmaker about making soap and using lye. She did :wink:

On our labels, I intentionally call it 'soap' and give a condensed version of our CP recipe and method, and the statement (no lye remains in the final product.) Then I add, "also contains:..." and I list the unsaponifiables or things that I *hope* do not saponify - FOs, EOs, exfoliants, waxes, etc. Things I add at trace. I really want to give the customer accurate information, but clearly state that this is a SOAP.

But Pine Tar . . . is our most demanded and best-selling soap. We label it Pine Tar soap. period. We have never used it for anything but soap (though our sons did have good results controlling athletic fungus with it, lol). It's our customer who will say, "I've been looking everywhere for this for my psioriasis...!" Then, I found this statement at the National Psoriasis Foundation: "Two active ingredients, salicylic acid and tar, are approved by the FDA as treatments for psoriasis."

Noone in our household has psoriasis. We did not know this until our customers told us. Our first customer, who requested pine tar soap, was a lil old lady who remembered always using it as a child and wanted some. Then others bought it. And then we had a crowd . . . it is our #1 item that we cannot keep in stock. Hubby is now retired, we need the income, we are launching our hobby soap business into something fulltime. On my labels, I state the percentage of pine tar in the recipe but no medical claims.

So, there we are with the 'perceived' medical use of our soap, that *we* never intended. I've heard horror stories about this or that soaper who did make cosmetic/medical claims on their soaps, were hit with big fines. But I also see so many others doing it, for years apparently, and like one of you said ... the FDA has 'bigger fish' to worry about? Just looking for input, thanks to all.

(and I agree with Christinak ... labeling becomes a 'pain'

 

[Genny]

Well soap is unregulated by the FDA, but there are still labeling regulations for it since it's a consumable commodity.
http://www.mariegale.com/soap-cosmetic-labeling/quick-labeling-faq

If you put pine tar in your soap, it does not make it a drug. Now, if you call your soap, Pine Tar Soap, then you may have problems. I honestly would just rename them so I didn't have to deal with the hassle & potential legal problems.

I know that a lot of people think, "Who cares? The FDA have bigger things to worry about, they won't come after little old me." That doesn't make it okay. Just because you don't get caught, doesn't make it okay. Millions of people get away with stealing, abuse, ****, murder, etc, but it's still illegal and it doesn't make it okay.

 

[paillo]

Wait, Genny, I don't understand. If you name it Pine Tar soap with no medical claims, how can this be a problem? What am I missing?

 

[Genny]

Wait, Genny, I don't understand. If you name it Pine Tar soap with no medical claims, how can this be a problem? What am I missing?

Because of consumer perception. It's the same reason that if you make whipped shea butter, you have to call it something else, like Whipped Body Butter. Or, if you make Tea Tree Soap, you have to call it something else.




http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm

"How is a product's intended use established?

Intended use may be established in a number of ways. The following are some examples:

Consumer perception, which may be established through the product's reputation. This means asking why the consumer is buying it and what the consumer expects it to do.
Ingredients that cause a product to be considered a drug because they have a well-known (to the public and industry) therapeutic use. An example is fluoride in toothpaste.

This principle also holds true for "essential oils."

 

[Parke Co. Grapevine]

Sigh. OK, so for awhile I was calling our pine tar soap, 'Grampa's Workday Soap' but then we decided to simplify things and changed to just Pine Tar Soap. Do you think the original title is better?

I read that aloe vera helps make a soap whiter, and mild and gentle. We also grow our own Aloe Vera and make (my own recipe of soap with

fresh Aloe Vera, and a touch of EOs - Lavender, Tea Tree, Rosemary, Litsea. And a bit of Kaolin white clay. It smells very fresh and clean and is just wonderful to use. I have never given this soap any name except

fresh Aloe Vera Soap

(cause my daughters actually sit and help me scrape aloe 'snot' for each recipe; we throw in plenty of tiny bits of green leafy stuff cause as it cures, it adds interesting beige-pink flecks in the soap.) Do you see a problem with this one?

 

[SoapPapaw]

Can you say on the label, " Unscented Moisturizing Soap with Shea Butter" or " Unscented Soap with Shea Butter"? Then list Shea butter in the ingredients.

 

[Genny]

Can you say on the label, " Unscented Moisturizing Soap with Shea Butter" or " Unscented Soap with Shea Butter"? Then list Shea butter in the ingredients.

You can't put shea butter in the name of the soap, because of shea butter's widely known "healing properties" and what the potential customer will likely expect it to do. I know, it sounds stupid, because how can we control what a person expects something to do for them? But unfortunately, it is what it is.
Also, unless you are following cosmetic labeling regulations, moisturizing can't be in the title or description either.

 

[Genny]

Sigh. OK, so for awhile I was calling our pine tar soap, 'Grampa's Workday Soap' but then we decided to simplify things and changed to just Pine Tar Soap. Do you think the original title is better?

I'd change it back to Grampa's Workday Soap.

As far as the Aloe Soap, it is an incredibly well known plant around the world used for healing wounds and other skin ailments, so I'm going to assume it would fall into the "Customer perception" rule.
But, when I talked to a FDA officer, I only specifically addressed shea butter, pine tar, certain essential oils, milk, honey and oatmeal. (Oatmeal, honey & milk are okay, by the way). So you may want to contact them yourself to make sure.

Also, for people who are putting customer's testimonials on their websites that talk about helping cure, curing, healing, etc., you might find this interesting:
http://blog.mariegale.com/fda-cracking-down-on-cosmetic-product-claims/

 

[christinak]

This is all very confusing. It seems like making up whimsical names for soap is safer to do that calling it what it actually is. To me it doesn't make sense that a soap cannot be called what it is if it's in the ingredients....WEIRD.