What are health claims?
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thefarmerdaughter
Well-Known Member
Genny,
I'm sorry that happened to your grandfather. I'm sure he's not the only one, and that's unfortunate.
I agree with everything in your post above. I'm trained as a nurse, and even though we are medical professionals, the phrase "You need to speak with your Dr. about X" is drilled into us. (or it should be) It's the reason I'm leery about putting claims on soaps or lotions. And it's the response I plan on using, if I'm ever in that situation.
I'm sorry that happened to your grandfather. I'm sure he's not the only one, and that's unfortunate.
I agree with everything in your post above. I'm trained as a nurse, and even though we are medical professionals, the phrase "You need to speak with your Dr. about X" is drilled into us. (or it should be) It's the reason I'm leery about putting claims on soaps or lotions. And it's the response I plan on using, if I'm ever in that situation.
Genny
Well-Known Member
You absolutely can get your products tested.
http://www.fda.gov/Drugs/DevelopmentApprovalProcess/UCM2007005.htm
You have to make sure that you are following all GMP regulations as well
http://www.fda.gov/Cosmetics/Guidan...PGuidelinesInspectionChecklist/ucm2005190.htm
I have heard that it is incredibly expensive.
Genny
Well-Known Member
They're trying to skirt around the regulations. I've seen many soapers say that it's okay. It's not.
I can't remember which B & B biz got caught by the FDA for doing this, but it did happen not too long ago.
It's still implying that the ingredients in your product can help acne, which is the same thing as saying your product will help acne.
Genny
Well-Known Member
Yeah, sometimes I get a little crazed about it.
I guess I just don't understand why people fight it so much. Makes me wonder what other kinds of laws they have no problem breaking. :think:
paillo
Well-Known Member
We really need someone from the FDA here to explain it all.
So here's another question. I often pull descriptions of ingredients from my reputable suppliers and summarize. How is it OK for them to describe the benefits of an ingredient and not OK for us? Because of the use, e.g. soapmaking may alter the properties of an ingredient? Could an aromatherapist, using one straight essential oil, get away with a description because there is no chemical reaction? But maybe there would be with different bodies. The more I think about this the more conflicted I get...
So here's another question. I often pull descriptions of ingredients from my reputable suppliers and summarize. How is it OK for them to describe the benefits of an ingredient and not OK for us? Because of the use, e.g. soapmaking may alter the properties of an ingredient? Could an aromatherapist, using one straight essential oil, get away with a description because there is no chemical reaction? But maybe there would be with different bodies. The more I think about this the more conflicted I get...
paillo
Well-Known Member
So anyone got any FDA connections? If not I have colleagues who might be able to find someone who might help us. Admins, is it possible to have something like a live Q&A via teleconference or other, with questions that are clearly laid out ahead of time? Personally, I think we have questions we can't answer and need someone -- a real person -- or better/more clear regulations to help us navigate this swamp. And personally I don't like the FDA regs, suspect they haven't updated in forever, due to lack of funding and staff.
melstan775
Well-Known Member
Now this is interesting. One of my posts seems to have disappeared. Genny,. I had offered my condolences on your grandfather's passing, and also commented that your story was poignant and made it's point.
melstan775
Well-Known Member
I agree. Those regs are way out of date. But lately, when the government updates something, it hurts independent business only.
For example, the FCC regulation update a couple years ago mandated that bloggers must disclose when they are given a freebie for review. But news companies did not have to follow the same regulation. This means, Good Morning America does a product review, they don't have to tell you it was given to them for free, nor do they disclose what they get for the kickback when the product's sales go up.
However, Mommy Blogger who was sent a new diaper bag for review has to tell you, "by the way, I'm reviewing this because I got it for free," or "so and so company sent me this to review, and if you click my affiliate link, I will get a little something for that, even though that doesn't affect your purchase price."
If Mommy Blogger fails to have a disclosure on her site, she will face a fine. Good Morning America can continue to plug away with no disclosures and no penalties, even though the practice of reviewing a product is the same.
so while I am in favor of updating regulations, I'm only in favor of it if it's not a classist thing.
For the record, if you make health claims, it just means you have to register your product to the FDA and make sure you have an active ingredient portion on your label, like Clearsil, et al does. I'm not sure, however, what that means in terms of your soaping lab. Since drug companies test on animals a lot, does it mean soapers who make drug claims have to get a cage of white mice? I spose that's really the issue, isn't it, is what regs go with what wording? So complicated. Boo.
thefarmerdaughter
Well-Known Member
I think there is a huge difference between explaining why an ingredient was chosen for use in a product/ giving a description of ingredients VS making claims. The FDA may not agree with me, lol.
Providing legit info to your customers, that could be found for free.... How can the FDA police that?
Providing legit info to your customers, that could be found for free.... How can the FDA police that?
Genny
Well-Known Member
By pretending to be a customer or by someone who knows the laws turning you in. There are people out there that turn in B & B'ers who "provide" info on ingredients. I've heard them talk about it.
I have turned in one B & B maker to the FDA. But, it was a product that was given to me by a friend to use on my child. The product was not preserved and the makers website & labels were drug claim city. The product was a diaper rash cream that contained oils, eo's, lanolin and aloe. Had they left the aloe out, it would have been fine. When I opened it after having it for only 2 weeks, there was mold on the surface. They also listed this cream as being great for c-section incisions. Could you imagine if someone used it on a C-section incision and ended up infecting themselves because of it?
Before turning the person in I actually contacted them and let them know what happened. They immediately blamed me and claimed that I mishandled it in someway. I turned them in to the FDA. About a month later, their shop on Etsy was taken down. I have noticed an eerily similar site on Etsy though that I think may be them, just renamed & such.
Genny
Well-Known Member
I wondered about that once & I asked a supplier. I seriously wish I would have saved the email. But it had something to do with the fact that they are suppliers of the ingredients, while we put together the final product.
I have no idea if that's true or not though.
Genny
Well-Known Member
I just wanted to mention quick that it's the sellers that make the claims and such that will hurt all of us B & B'ers in the end. They're the reason we'll be paying high registration fees and will have prove that we're complying with GMP regulations, it will be very similar to Florida's regulations for making and selling cosmetics. 
Crocoturtle
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I'm curious what you think about my aromatherapy balms. They are just carrier oils, EOs and beeswax. I tell people what part of the body they are for and tell them that they are aromatherapy. I don't claim that it will cure anything but people ask me to make them all the time. I definitely would never suggest someone use aromatherapy of any kind for a condition that hasn't been seen by a doctor.
It's a huge thing here that everyone I know is drinking elderberry syrup. The lady who makes it will call her different blends like "skin blend" or "baby blend" and it's supposed to help allergies and boost immune system. But she also has a statement "not intended to treat or diagnose any disease" and gets away with selling it as a food rather than a drug. Where do you draw the line.
Genny
Well-Known Member
Well here's what the FDA says about aromatherapy products:
http://www.fda.gov/cosmetics/productandingredientsafety/productinformation/ucm127054.htm
What are you exactly saying about what & why they should use your balm?
As far as the elderberry syrup, I honestly have no idea how that goes, because I don't know much about the Food part of the FDA. Although yogurt companies, orange juice companies and milk companies say a lot about the different things that they can help with. So maybe it's okay?
http://www.fda.gov/cosmetics/productandingredientsafety/productinformation/ucm127054.htm
What are you exactly saying about what & why they should use your balm?
As far as the elderberry syrup, I honestly have no idea how that goes, because I don't know much about the Food part of the FDA. Although yogurt companies, orange juice companies and milk companies say a lot about the different things that they can help with. So maybe it's okay?
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Reminds you of elixirs of olden days that would cure all that ailed you.
Crocoturtle
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I guess it's more of an informal thing. I haven't sold any balms in retail or made them ahead of time. The one that most people ask me for is one that has peppermint, rosemary and eucalyptus and people use it for headache. They know I know about EOs and they ask me to make them something. I'm not a health care provider so I can give my friends advice, legally. It's tricky. If I just call it a lotion, I can package it as a cosmetic. Other stuff that people ask me to make like "home made vapo rub" IDK, it's pretty blatant that it's a drug. I think it's best if I keep that as more people paying me for the service of mixing it up rather than selling it as a premade product.
thefarmerdaughter
Well-Known Member
So if a customer asks, "why did you use cocoa butter?" or "can you tell me about cocoa butter?" How does one answer that.
It's like the law doesn't distinguish between someone lying, by making false claims, and an honest B&ber who wants to provide info.
Genny
Well-Known Member
If someone asks me why I use cocoa butter in my soap, and as long as I'm labeling my soaps under cosmetic regulations, I would say, "It helps with a nice stable lather, it helps provide a harder bar of soap and it contains conditioning properties."
If I'm not labeling them under cosmetic regulations, I'd leave out the part about conditioning properties.
Kansas Farm Girl
Well-Known Member
A year or so ago I read that there was new legislation in Washington that, if passed, would require much more from us. The only thing I found today on it was an old post (2008) on Soap queen
http://www.soapqueen.com/business/the-law-with-unintended-consequences-2/
"In a nutshell, the FDA Globalization Act of 2008, is designed to impose stringent monitoring, manufacturing and reporting requirements on all products under FDA purview. The “Cosmetics” portion of the bill is actually very small (1/64th of the entire bill) in relation to the “Food” portion. None the less, the implications for small, home based crafters and cosmetic manufacturers, is concerning."
has anyone heard if this was shot down or still on the table? I know it was long after 2008 that I heard about it, and it was still active then. In searching google for FDA Globalization Act the latest entry I can find is from Jun 2009. I know I heard about it after that because I didn't start soaping until later, and when I heard about it I had been for awhile.
http://www.soapqueen.com/business/the-law-with-unintended-consequences-2/
"In a nutshell, the FDA Globalization Act of 2008, is designed to impose stringent monitoring, manufacturing and reporting requirements on all products under FDA purview. The “Cosmetics” portion of the bill is actually very small (1/64th of the entire bill) in relation to the “Food” portion. None the less, the implications for small, home based crafters and cosmetic manufacturers, is concerning."
has anyone heard if this was shot down or still on the table? I know it was long after 2008 that I heard about it, and it was still active then. In searching google for FDA Globalization Act the latest entry I can find is from Jun 2009. I know I heard about it after that because I didn't start soaping until later, and when I heard about it I had been for awhile.
