Spongetech Delivery Systems, Inc. (fka SPNGQ)

[loanranger]

MLM,
Thanks, but I believe(?) that your Wiki quote has the following meaning:
Skin care and cosmetic products do not require FDA approval prior to sale.

However, I believe that the FDA is the responsible agency for safety and other considerations once a product is on the market. A few excerpts from the FDA website:

"Does FDA approve cosmetics before they go on the market?

FDA's legal authority over cosmetics is different from other products regulated by the agency, such as drugs, biologics, and medical devices. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. However, FDA may pursue enforcement action against violative products, or against firms or individuals who violate the law."

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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 701.20].

If a cleanser does not meet all of these criteria...

If a product intended to cleanse the human body does not meet all the criteria for soap, as listed above, it is either a cosmetic or a drug. For example:

If a product --

* consists of detergents or
* primarily of alkali salts of fatty acids and
* is intended not only for cleansing but also for other cosmetic uses, such as beautifying or moisturizing,

it is regulated as a cosmetic.

If a product --

* consists of detergents or
* primarily of alkali salts of fatty acids and
* is intended 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 is regulated as a drug.

If a product --

* is intended solely for cleansing the human body and
* has the characteristics consumers generally associate with soap,
* does not consist primarily of alkali salts of fatty acids,

it may be identified in labeling as soap, but it is regulated as a cosmetic.

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Wiki makes it sound a lot easier than it is.
Have a look:
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074201.htm
http://www.fda.gov/Cosmetics/GuidanceComplianceRegulatoryInformation/ucm074162.htm

But please don't forget, I was just GUESSING!