Not allowed to make medical claims

[rkrhome]

Hello everyone,

I am new here but have been reading many of the threads and am very grateful for all of your help. I have a question about medical claims.

I was advertising my Lemon scented soap and this is what I described my soap as....

"Lemon oil is known for its calming properties and helps to relieve anxiety, nervousness and tension. It is also known for its ability to detoxify and and rejuvenate dull skin. It also helps with oily skin which is prone to breakouts.

This is a response I received from someone in the forum and I was wondering if she may be right.

"You are not allowed to make medical claims: Soap cleans, smells good, and that's about it. Soap doesn't relieve anxiety or any other ailment."

Could someone tell me if what I described my soap as is a medical claim or is it ok?

Thank you so much in advance

[Beth]

I'm NO expert, but hopefully someone else will chime in.

If I remember correctly, from when I was reading up on this stuff.... if you list your ingredients & then make a claim as to what they may be known to do- that is the equivalent of a medical claim. Someone correct me if I'm wrong. I think, with soap, you can say that it's "soap" in whatever scent and that's it.

[Candybee]

M&P is listed as a 'cosmetic' and not a true soap. CP is a 'true' soap. Don't get mad at me. Just repeating what I have read re soap and claims made about it.

Check out the CP section as someone recently posted a thread about making claims re soap. Read about it here: http://www.craftserver.com/forums/showthread.php?108514-Huh...Who-Knew-quot-True-Soap-quot-is-exempt-from-FDA-cosmetic-label-regulations...

Edited February 19, 2013 by Candybee

[rkrhome]

Thank you so much!

[Tabitha]

It's all up for interpretation but I believe M&P can be a soap, or a cosmetic, or a drug depending on the ingredients and/or claims made.

It is my understanding that if there are no synthetics in your soap (w/ the exception of color, fragrance, etc) & you make zero claims it is a soap. If it has synthetics &/or you make a claim like 'moisturizing' it is a cosmetic. If you make a medical claim EX) helps clear acne or relieves anxiety then it is a drug.

The first link will help you decide if your soap is a soap, drug or cosmetic. The second will help you label your item properly depending on which category your item falls within.

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

Is It a Cosmetic, a Drug, or Both? (or Is It Soap?)

This is how the FDA defines soap:

"How FDA defines "soap"

Not every product marketed as soap meets FDA's definition of the term. FDA interprets the term "soap" to apply only when

• the bulk of the nonvolatile matter in the product consists of an alkali salt of fatty acids and the product's detergent properties are due to the alkali-fatty acid compounds, and
  
• the product is labeled, sold, and represented solely as soap [21 CFR 701.2017]."
  

http://www.fda.gov/Cosmetics/CosmeticLa ... efault.htm

Summary of Regulatory Requirements for Labeling of Cosmetics Marketed in the United States.

Edited February 22, 2013 by Tabitha

[Guest OldGlory]

Perhaps I am reading this wrong ...

If your quote above is true, then the claim you are making is in reference to Lemon Oil, not soap. If you are referring to a lemon essential oil, I see similar claims all the time. '(such n such) is known to have astringent qualities, etc.' For example, in a CP or M&P bar with oatmeal, I have seen wording on labels about the oatmeal being calming for sensitive skin. The claim is about the oatmeal.

If you were to say your soap contains shea butter and cocoa butter and these 2 ingredients are known to moisturize, that claim is not saying your soap is moisturizing. KWIM?

I would push the envelope in that way, but avoid making claims that my soap or M&P bar is moisturizing/calming/etc.

My thoughts on this might be wrong, but that is how I would do it. And I would be sure I could back up in writing any claim I make.

[Beth]

This is Marie Gale's take on it-

Some common drug claims for soap include: “anti-bacterial,”kills fungi,” “treats or cures eczema,” etc. Note that if a claim is made for an ingredient in the soap it is still considered a claim for the soap itself, so claiming that it contains tea tree oil which is “known to be antibacterial” can make the soap a drug.

http://blog.mariegale.com/ingredient-labels-soap/

Is SOAP a COSMETIC?

IF the soap is "true soap" (made from oil and lye), and the ONLY claims are that it cleanses and is soap, then no, it is not a cosmetics.

HOWEVER, if there are ANY claims that it (or any of the ingredients) moisturizes, soothes, softens, exfoliates or anything other that just "cleans", then it is a cosmetic. As a cosmetic, it requires the ingredients to be listed.

http://www.mariegale.com/soap-cosmetic-labeling/quick-labeling-faq

[Scented]

You can list what is in it, but you have to list everything, including the mess of stuff in the melt and pour. You should refrain from listing anything about what an essential oil does or is claimed to do or help relieve, cause, prevent etc. Unless you are so licensed to do. Eventually you end up making claims. Just because Jane, Jennifer and Moses say what you want to say doesn't make them right either. Stick to it is just soap. If people want to know more about the ingredients in your stuff they can research as long as you put all ingredients on your label. Doing so allows the consumer to learn more about what they are putting on their bodies and allows them to have more information at their fingertips than you will provide. To explain more, lemon has more associations than you have listed so what you say may or may not be true, a partial truth or a lie.

[Guest OldGlory]

Perhaps I am reading this wrong ...

If your quote above is true, then the claim you are making is in reference to Lemon Oil, not soap. If you are referring to a lemon essential oil, I see similar claims all the time. '(such n such) is known to have astringent qualities, etc.' For example, in a CP or M&P bar with oatmeal, I have seen wording on labels about the oatmeal being calming for sensitive skin. The claim is about the oatmeal.

If you were to say your soap contains shea butter and cocoa butter and these 2 ingredients are known to moisturize, that claim is not saying your soap is moisturizing. KWIM?

I would push the envelope in that way, but avoid making claims that my soap or M&P bar is moisturizing/calming/etc.

My thoughts on this might be wrong, but that is how I would do it. And I would be sure I could back up in writing any claim I make.

I'm glad there are very knowledgeable people here. I feel it's important to know the 'right' way to do things.

Having said this, I would still not hesitate to mention the benefits of using certain essential oils or other ingredients I've used in soap. It's not out of a sense of being a rebel, I just like to point out the features of the product I am making. I have always had books on the subject with me when I've done shows or markets, to back up my claims. It's just how I choose to do things.

[Scented]

And it's wrong. Wish it weren't, but it is. Vocally, in print and even having other people make statements that you publish on your website is wrong. If I've made a product with essential oils in it, I'm going to list those essential oils and encourage people to do their research on those oils etc. (and even that is wrong). Doesn't that just take the cake? There are side effects to EOs and we can't per se point those out.

[Candybee]

I always list all my ingredients just to make sure I have covered what may be considered a claim. I do have 'exfoliation' soaps and say so on the label. I simply cannot not say anything about it being an exfoliation soap. How can you sell a scrubby soap and not let your customers know what it is on the label?

So thankfully I have all my ingredients listed. But then I would anyway as some folks are allergic to coconut oil and I use it in every soap I make.

When I sold M&P I always listed the ingredients too. That's how I got in the habit of always listing everything in the soap I sell. Glycerine is the number one ingredient in M&P and believe it or not there are people allergic to glycerine. There is also TD is opaque M&P and people who are allergic to that.

But not being able to say my soap moisturizes just rankles me. I haven't read anything about putting "for dry skin/normal skin/oily skin" types on the label. How are your customers going to know which soap is for dry skin? oily skin? normal skin? baby skin? sensitive skin? etc. I list it anyway and will keep doing that until I'm told to stop.

[ksranch]

I always list all my ingredients just to make sure I have covered what may be considered a claim. I do have 'exfoliation' soaps and say so on the label. I simply cannot not say anything about it being an exfoliation soap. How can you sell a scrubby soap and not let your customers know what it is on the label?

So thankfully I have all my ingredients listed. But then I would anyway as some folks are allergic to coconut oil and I use it in every soap I make.

When I sold M&P I always listed the ingredients too. That's how I got in the habit of always listing everything in the soap I sell. Glycerine is the number one ingredient in M&P and believe it or not there are people allergic to glycerine. There is also TD is opaque M&P and people who are allergic to that.

But not being able to say my soap moisturizes just rankles me. I haven't read anything about putting "for dry skin/normal skin/oily skin" types on the label. How are your customers going to know which soap is for dry skin? oily skin? normal skin? baby skin? sensitive skin? etc. I list it anyway and will keep doing that until I'm told to stop.

Agree - I always list ingredients on all my B&B whether it's required or not. I have a niece who is allergic to aloe - and I have to use a different M&P base for her than I normally use because of it. But, had I not been listing them, her Mom wouldn't have caught it before she used it and it would have been a bad deal.