There is an apparent trap for those who have a "cream" to market in the US.

Is the "cream" a drug?

Is the "cream" a cosmetic?

Is the "cream" a drug and a cosmetic?

Is the "cream" a food supplement?

Is the "cream" a "nutraceutical?"

Could a "cream" be a "ayurceutical?"

 

If the "cream" is intended (read "promoted" or "claimed") to affect the structure or function of the body, then it is a drug and must comply with the regulations affecting drugs. Generally a "drug" requires all the well-known FDA approval -- generally out of reach for anyone other than a "drug company." Click here for the web page that describes the general gamut of requirements to market a "drug" in the US. The logo above is the "Center for Drug Evaluation and Research."

If the "cream" is NOT intended to affect the structure of function of the body, no claims are made for such, but IS intended to affect the attractiveness of the body, it is a "cosmetic" and must comply with the regulations affecting cosmetics.and the regulations that affect "Fair Labeling."

The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. (quoted from this page)

All cosmetics, whether they are sold on a retail basis to consumers or marketed exclusively for salon or workplace use, are subject to the FD&C Act. (FDA Source on this site)

A "substance" which falls under the category of "cosmetic" is not covered by the DHESA (Dietary Supplement Health and Education Act), and is subject to an FDA regulation calling for "testing" for safety.

Canada has generally had more restrictive regulations on these matters than the US and Canada has further regulations on label requirements for "cosmetics" which do not apply to the US, but could affect sales into Canada.

The question then arises as to whether a "substance" can be regulated under the DHESA (much more liberal than regulations covering drugs and/or cosmetics) when it is a:

Cream?

Skin Nutrient?

Topical Vitamin?

Transdermal Vitamin?

This calls for a revisit to the DHESA and a reconsideration of any marketing or promotion plans or material which might position this cream in a category that would be covered by either the cosmetic or the drug regulations.

To get our cream to be covered by the DHESA it may require some changing in labeling, and certainly probable changes in claims and promotion. More to the point, it appears that we waivered from the early view of Calm Cream as a non-drug source of skin nutrients -- and that is the direction we should return to.

Let's look at some examples of "substances" that have managed to stay under the cover of the DHESA even though they are not the traditional "vitamin."

Link	Description	Comment
Link	Vitamin C Technology used as a "drug."	Medi-Cell Laboratories, Inc. is the first  and only company to combine three different types of Vitamin C with Alpha Hydroxy Acid in non-irritating formulations.
Link	Non Drug Alternative to Viagra
Link	Colored Cosmetics. Are they a medical cover for blemished skin?
Link	Vitamin E is "useless" as a skin nutrient! But, MSM Cream, AyurCream, even so, contains vital and proven skin nutrients -- it is a supplement, not a cosmetic.
Link	Arthritic cartilage has only one-third the level of sulfur concentration of normal cartilage - perhaps that is why MSM has been so effective in treating arthritis.
Link	The non-drug alternative to Ritalin
Link	Sulfur: The vital nutrient for skin, hair and fingernails

 

Click Here

Calm Cream has been marketed as a non-drug skin nourishment.

CLICK HERE for a Slide Show about Calm Cream -- this slide show shows the actual Indian herbs used in this cream -- and also shows future products planned using MSM and the miracles of Ayurvedic Medicine from India.