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Teach Soap • View topic - My "MAIN COMPITION" commiting serious FDA no no's

Teach Soap

Soap Making Recipes, Tips and Tutorials
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PostPosted: Wed Mar 13, 2013 12:53 pm 

Joined: Thu Jun 07, 2012 4:10 pm
Posts: 550
Location: Lewisville, NC
Well since I have decided to try to start doing some fairs and markets every one I look into has the same lady. Of corse she is boasting the all natural thing so I went to look at her facebook page and found descriptions of her products like this....

"*Lotions contain no artificial preservatives and do not last as long as conventional lotions but moisturize even better. We suggest keeping lotion in the fridge or another cool dry place. Some separation might occur because we use only natural emulsifier (beeswax) if this occurs just stir the lotion."

" I used my basic lotion recipe and adding Zinc Oxide (for the SPF) making this is the most basic and noninvasive sun protection you can get. Lavender & Vanilla scent is pleasant and refreshing. And Vanilla & Ylang Ylang makes you wish you were at the beach!" ( These she has listed with a SPF20 )

" Grain Alcohol (80-100 proof), Skullcap, Yarrow, Raspberry Leaf and Burdock Root

Tincture can be taken through out menstruation 2-3 times a day or taken when relief is needed from PMS symptoms. Shake well.

1/3 t. for 100 lbs. body weight
1/2 t. for 150 lbs. body weight
1 t. for 200 lbs. body weight
(Do not take if pregnant or nursing)"

"Grain Alcohol (80-100 proof), Echinacea Root and Leaf, Elderberry, Garlic, Ginger Root, Goldenseal Tops and Licorice Root

Tincture helps fight off and cure from cold or flu. Take 2-3 times a day when sick.

Not to be taken regularly. Shake well.

1/3 t. for 100 lbs. body weight
1/2 t. for 150 lbs. body weight
1 t. for 200 lbs. body weight
(Do not take if pregnant or nursing)"

Is it just me or is this not scary as S&%T!!!!!!!! She is even listed on facebook under medical.


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PostPosted: Wed Mar 13, 2013 1:36 pm 
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Joined: Tue Mar 27, 2012 12:14 pm
Posts: 779
Location: Everett, PA
report her to facebook for false advertizing.

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now know as Gwenann's Sudz...


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PostPosted: Wed Mar 13, 2013 2:43 pm 
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Joined: Mon Jan 14, 2008 11:14 pm
Posts: 24336
Location: Mistress Of Lather
That is some crazy Sh*t! If she has a business license, report her to the local city hall or the business office. I'm not sure if FB or the FDA would do anything, but it's worth a try.

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Irena
Closed minds are like faulty parachutes; they refuse to open.


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PostPosted: Wed Mar 13, 2013 4:44 pm 

Joined: Thu Jun 07, 2012 4:10 pm
Posts: 550
Location: Lewisville, NC
Unfortuantly Irena I doubt she has a business licence. When I enquired about it I was told if you are outside the city limits no licence is required. I guess my main thing is now I am nervous to even enter anything now being the "New" girl since she has been around for a couple years. Honestly I am afraid I am not going to be able to keep my mouth shut. Making soaps and lotions is one thing but when you start selling things as holistic medicines I think she is being irresponsable and dangerous. We all know that certain herbs and oils can counteract with medications and health issues and the only warning I have seen her list is do not use if you are pregnant. What about the epileptics and people on blood thinners etc...... The general public doesnt relize that these "natural" products can do serious damage if misused. I guess it just puts me in what I am inticipating to be an "awkard" situation if I do decide to do anything that shes in. I dont know though I guess we will see .


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PostPosted: Wed Mar 13, 2013 4:54 pm 
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Joined: Mon Jan 30, 2012 7:42 am
Posts: 1621
Location: Western WI
You can definitely report her to the FDA. As for reporting her to FB, I don't know if she's doing anything to violate any of their rules.

I say enter whatever you want to enter as long as you know what you're doing and have your ducks in a row. Keep your nose clean & do what you know is the right thing to do. There are quite a few local people like that in my town. At markets when any of them are there also, I do have the occasional person come and ask, "So, what does your soap do?" or "What do you have for my kids eczema?" I'm honest with them, telling them, "My soap cleans." & "Legally I can not sell you anything to help with your child's eczema and anyone doing so is selling you illegal drugs."
The last one's quite shocking to most people since most customers are not aware of FDA regulations.

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PostPosted: Wed Mar 13, 2013 5:01 pm 
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Posts: 24336
Location: Mistress Of Lather
Then I would try AHPA. They might have some suggestions for you. http://www.ahpa.org/Default.aspx?tabid=190

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Irena
Closed minds are like faulty parachutes; they refuse to open.


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PostPosted: Wed Mar 13, 2013 5:07 pm 

Joined: Thu Jun 07, 2012 4:10 pm
Posts: 550
Location: Lewisville, NC
How about this?
http://www.ncagr.gov/fooddrug/consumercoms.htm


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PostPosted: Wed Mar 13, 2013 5:20 pm 
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Location: Western WI

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PostPosted: Wed Mar 13, 2013 7:30 pm 
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Joined: Sun Jan 06, 2013 8:48 am
Posts: 562
Location: North Carolina
Wow, those tinctures sound like something I could use after a hard day at work, minus all those herbs and roots. :lol:

I know you're concerned, and possibly rightfully so, but have you ever talked to her? Have you considered maybe messaging her and asking her about some of your concerns?

I guess I am wondering why not ask her directly rather than just reporting her. If she has no idea she's breaking laws maybe she will take steps to make changes.


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PostPosted: Wed Mar 13, 2013 8:37 pm 
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Joined: Fri Jan 21, 2011 4:03 pm
Posts: 1598
Location: Sum beach, somewhere
I have gone back and forth trying to decide if I was going to chime in on this thread or not. Obviously I have landed on the side of chiming. Lol But I am probably going to ruffle some feathers here, so I am going to write my piece then shut up about it. I am not trying to change anyone's mind, zI just want to offer a different perspective.

Let me start off with saying that I have not looked over this woman's site, have not seen her labels, nor do I know what she sends out with what products. Without that info it is difficult to (really) say how non-compliant she is with regs, if she is. But I see no blatantly "false advertising" except for the word "cure" in the cold/flu tincture. For that, she would get a written letter advising her to alter her word choice and that is all (unless she has failed the correction previously).

I wonder if many of you are reacting to the fact that she sells tinctures and that they have grain alcohol as a prominent ingredient. Tinctures have been made and used as remedies for various maladies for centuries. They are quite effective for many ailments and are always made with grain alcohol, that is normal. Additionally, the amount of alcohol used is pretty much a standardized amount that goes by ratios (they range from 1:1 for fresh herbs and up to 1:4 for dried herbs, depending upon the particular herb).
As for the herbal warnings, some people only use those herbs that are considered safe for all when making their tinctures, which is possibly why there are no warnings. Or, if she does sell some that have properties that could interfere/react with certain conditions or medications, she may label them accordingly. We don't see the actual label, so have no way to know.

As I said, I do take exception to her using the word "cure", as I have never known a tincture to "cure", only to lesson the symptoms, help build immunity to prevent symptoms/ailments, and to help to shorten the length of time that symptoms are present. I think the FDA would approve of that term either, but as I said before, it is just a notice if she hasn't been in trouble before.
Tinctures are sold in many herbal shops, natural food stores, herb festivals/fairs, and even some medical practitioners offices across the country. They are used by the drop(s) and users can drink it straight or mix it in a liquid. Some taste pretty terrible, so mixing them into a tea or juice is best. If you are giving to a child or someone who doesn't want the alcohol part, you just put your drops into hot water and allow the alcohol to evaporate. There are tinctures made/used specifically for infants and children with stomach issues, teething issues and colic. I used them with my kids, and my family used them before me. There is nothing wrong with offering these products. They are an alternative medicine, part of naturopathy and holistic medicine. Just like someone can sell herbal supplements, (which I feel are more likely to be over-used and used without consideration of potential ramifications), they can make and sell tinctures.
She should list the INCI names of the herbs/ingredients, but maybe her labeling does.
The main thing I'd double check before I used one of her tinctures is the dosage amount. They may be correct, but I'd have to study her recipes before I'd go with those amounts. I have always calculated by the drop and so have most of the people I know, which doesn't make her amounts wrong, just not what I am used to seeing.

I am sure you are balking at her indications for the tinctures because we are so strongly ingrained to not make medicinal claims for soap. But if you do make a medicinal claim, it doesn't make your product illegal, it just removes it from the soap category and requires you to then follow the labeling requirements for its new category.

Check out some herbal shops and see how they handle the sale of tinctures. Mountain Rose Herbs is one of my favorite stores. They grow many herbs, wildcraft from their local area, teach, are all organic, and are a leader in their community, as well as the herbal market in general. They make their own tinctures too. Take a look there some time and see how they describe theirs. From what I recall of their site and others I have seen, as well as what was written here about this woman's site, this woman is pretty much describing her products in the same manner.
Without knowing her labeling practices or her background information, I personally would not want to buy from her. But I doubt she is as far off as you all seem to be thinking.

To me, the worst thing I see is the lack of preservative. However, even though I believe that one should always use a preservative when selling water based products, there are people who don't, and people that prefer to buy products without them. It is not against the law to sell un-preserved lotions. Again, her labeling must be correct, expiration date, lot number etc. But since we don't know what her labels look like, we don't know of she is compliant or not. She and her customers need some good education in this area, but I have found that most of those with her mind set are not very open to change in this area. At least she is up front about not using the preservatives, so at least people will know who to sue if their scratch becomes colonized with the bacteria or mold growing in her lotion!

I also find her choice of "emulsifier" interesting. But she is not the only one who does that either.

As for the sunscreen, I am not sure what % of ZO you need to get a spf of 20, so maybe she can offer that. Assuming she can, it is again down to how she labels it. You certainly can purchase the ingredients to make your own sunscreen, and the manufacturers do provide you with the % needed to create various spf levels. So it is possible that she is legally in compliance with her labeling and product.
Personally I don't care to deal with the hassles that are involved in selling a sun screen, and most people I know just make it for their families, but I have known a few that that go all out and sell theirs.

All in all, FB isn't going to care what she sells or how she labels what she sells. The FDA may care, but she is a small fish, so until and unless someone sues her, or many, many people complain about her, she will likely just be ignored. Even if they were to take exception to her labeling she would just get a warning and instruction on what to change if this was a first offense.
As long as she is accurate and compliant with her labeling, the herbal community would not take offense at the little that I have seen from your post. Poppy Swap is an all herbal store website and has many shops that sell similar herbal remedies, including tinctures. They all advertise like this woman. They even have shops with soap, making non soap claims, and they don't even bother with the "the FDA has not ....blah blah blah", yet the AHPA backs and loves this site. In fact, they have won some awards. So I doubt the AHPA will do whatever you are thinking they might.

In the end, without more investigation, I don't think we know enough to say that she is legally non-compliant with anything except using the word "cure" in her description. This woman may be a quack who knows nothing, or she may be a world renown herbalist for all we know. Without discussing anything with her, without investigating her practices more, we have no idea what her background and experience is. Frankly, some of the smartest people I have ever known, people who could whip up salves that would cure you of most anything, if I believed in using the word cure, were backwoods, non-school educated people.

Stepping down off my box now. Let the flogging commence! Lol

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Remember, it's not just that we weather the storm, but how we dance in the rain.

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PostPosted: Wed Mar 13, 2013 9:25 pm 
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Joined: Mon Jan 14, 2008 11:14 pm
Posts: 24336
Location: Mistress Of Lather
"It is not against the law to sell un-preserved lotions". While that's true, this does a great disservice to those that do and do it properly. All it takes is just ONE time for someone to get seriously injured with an unpreserved lotion, where germs. mold and bacteria happily multiply. If you want to see what some of those germs look like, take a look at this testing kit. http://www.lotioncrafter.com/microbial- ... combi.html

No homecrafter would be in compliance with saying their product has an SPF of anything as sunscreens are considered an over the counter drug. It is not soap and it is not a cosmetic. You would need actual testing yourself to make ANY SPF claims. Sure, you can add it, but you cannot claim any sunscreen properties, let alone an SPF.

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Irena
Closed minds are like faulty parachutes; they refuse to open.


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PostPosted: Wed Mar 13, 2013 10:15 pm 
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Joined: Fri Jan 21, 2011 4:03 pm
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Location: Sum beach, somewhere

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Tammy


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PostPosted: Thu Mar 14, 2013 12:05 am 

Joined: Sun Feb 27, 2011 10:42 pm
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PostPosted: Thu Mar 14, 2013 12:47 am 
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Joined: Fri Jan 21, 2011 4:03 pm
Posts: 1598
Location: Sum beach, somewhere
While I can understand why you may think that, in this case, they are referring to the labels and not the actual contents/ingredients. The wording is a bit confusing, but believe me, it is perfectly legal to sell un-preserved products.
You can check through the question/answer section of the FDA website and you will find where they break down the labeling sections and lay it out in slightly more clear words. Have fun! A person can get lost in there for days!

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PostPosted: Thu Mar 14, 2013 8:48 am 
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Joined: Sat Dec 11, 2010 7:14 am
Posts: 6158
Location: Jefferson City, TN
The only thing I'm going to say is that if you sell lotions, then you should educate your customers on why preservatives should be used in lotions. The average person isn't even going to consider why a lotion needs to have a preservative. They hear "all natural" and they're sold. But, if you explained about how quickly bacteria, mold and yeast reproduce in an unpreserved product (even when refrigerated) they might at least stop to think about it and might reconsider their purchase. :D

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I know the voices in my head aren't real, but they sure have some great ideas!



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