# Tepezcohuite Root Powder Soap



## Soapy Bill (Mar 9, 2011)

Reference Mayan Magic Soap Thread

http://soapmakingforum.com/forum/viewtopic.php?t=23478

After Speaking with our Manufacturing Representative in the FDA this morning, some clarification may eliminate some of the perceptions presented in the feedback of this soap.

Let’s be clear, *if *you make this soap to Sell or Market and *intend *to *externally *use it not only for cleansing but *also *to cure, treat, or prevent disease or to affect the structure or any function of the human body, it’s regulated as a drug. In that instance, you do not need a team of Lawyers.  

If a drug claim, such as antibacterial, antiperspirant, or anti-acne, is made on a cleanser or soap, the product is considered a drug, and the label must list all active ingredients, as is required for all drug products.  That’s it!  No paperwork, no licensing, etc.  The best way to be safe is to not make *specific *claims.  As information is readily available to the public via the web on Tepezcohuite, they can make their own distinctions about the ingredient.

In reference to an active ingredient actually having been validated as to effectiveness to be an Anti-Acne “treatment” is a matter of investigation, research, and testing that leads to FDA Approval of that ingredient which in turn may allow a product to be considered “FDA Approved” for that specific condition.  Don’t confuse that with labeling requirements.  In this case, Tepezcohuite is too new to be FDA recognized for any antibacterial, antiperspirant, or anti-acne treatment.  The same is true for popular Anti-Acne treatments like Witch’s Hazel which populate a great many soap formulations and homemade Anti-Acne Soap (interestingly, some have ingredients listed, others don’t).

Even without specific claims, I’d follow the FDA guidelines for Labeling, listing Active ingredients from highest percentage to least.  In reference to the formulation I created above, the listing should look like this…

_Olea europaea (olive) oil, Cocos nucifera (coconut) oil, Aloe Barbadensis Miller, Prunus amygdalus (sweet almond) oil, Elaesis guineensis (palm) fruit oil, Emu oil, Mimosa Hostilis, octadecanoic acid, Phenoxyethanol, Caprylyl Glycol, 2-Hydroxypropanoic acid, yogurt powder, titanium dioxide, Tocopherol, Calendula officinalis._

Sadly, all of this has really caused a loss of focus on the intent of publishing the soap recipe in the first place.  A great soap that the skin loves.  I'm appalled at being attacked and censored for harmlessly trying to share a really nice soap recipe not readily available anywhere else.  I worked very hard on the formulation, it took about 2 years to refine and perfect.  My mistake in thinking soapers would be interested.


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## Genny (Mar 9, 2011)

Soapy Bill said:
			
		

> Reference Mayan Magic Soap Thread
> 
> http://soapmakingforum.com/forum/viewtopic.php?t=23478
> 
> ...



Actually if something is considered a drug, then there is more to it then just listing the ingredients.  With cosmetics, all you have to do is list the ingredients.

Here's a quote from the FDA website on Drugs:
"FDA does not have a premarket approval system for cosmetic products or ingredients, with the important exception of color additives4. *Drugs, however, are subject to FDA approval.* Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded"


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## Genny (Mar 9, 2011)

Forgot to add:
Not to sound snarky.  You weren't attacked or censored for posting the recipe, you were censored for being very rude in your responses.


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## Soapy Bill (Mar 9, 2011)

With the FDA, nothing is ever so simple.  Distinguish between External and Internal drug approval, and the subsequent Regulatory sections that apply.

I'm really tired of doing the battle on the FDA topic.  You're all correct, I'm a noob  - you're the experts.  You win.  Just call it Tepezcohuite Soap and be done with it.  Also, I retract my statement about preservatives occasionly being needed in certain CP formulations dependent upon the oils and decomposible organic content.  Microbes Never survive Saponification - I was wrong.

All I can say is that I don't make medical claims, the root powder is a fun ingredient, and those that use the soap love it.  Right or wrong, they feel it's a great cleanser and have noticed improvements with some skin issues. I sure prefer it over Witches’ Hazel and some others I've seen out there for my skin.


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## carebear (Mar 9, 2011)

Take the chip off your shoulder, Bill, and either participate pleasantly or not at all.


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