Soapy Bill
Member
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.
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.
