Dewmar International BMC Inc (DEWM)

[Det_Robert_Thorne]

Nope. Doesn't matter if they call it supplement.

It's very, very simple. Melatonin can be purchased in pill form as a supplement, but you can't add it to a food product.

It is a non-approved food additive.

If you read the letter to the maker of Lazy Larry cakes, you'll see that they tried a variation on that gambit, too, and the FDA saw through it. (bolded for emphasis by me):

The FDCA excludes from the definition of a dietary supplement a product represented for use as a conventional food or as a sole item of a meal or the diet [21 U.S.C. § 321(ff)(2)(B)]. Your use of the term “dietary supplement” in the statement of identity and your use of a “Supplement Facts” panel for nutrition labeling do not make your product a dietary supplement, because your “Lazy Larry” product is represented for use as a conventional food. Examples of factors and information that establish that the product is represented as a conventional food are as follows:

- the product is marketed alongside snack foods;
- the name of a URL, www.mylazycakes.com (accessed 7-14-11), that directs people to your product website, refers to a conventional food (cake);
- the product is described on your website (accessed 7-14-11) as having “the same ingredients your mother uses to make brownies,” which is a conventional food;
- the use of a combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg, and salt, in order of predominance by weight);
- the appearance and packaging of the product as a brownie.

As previously sold, your “Lazy Cakes” product additionally was represented for use as conventional food, for example, by the use of the words “cakes” in the product name and use of the word “brownie” in the statement of identity on the package label.

http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/ucm266129.htm

Now, let's look at Kush Cakes, and how its packaging and marketing parallels the Lazy Larry Cakes:

- Marketed alongside snack foods? Check!
- mykushcakes.com URL name refers conventional food (cake)? Check!
- Same ingredients as mother uses? No ingredients listed, but the word brownie is all over the website.
- Use of combination of ingredients particular to a brownie (including sugar, flour, oil, cocoa, egg, and salt, in order of predominance by weight)? Check! (that's the list from the original Kush Cakes packaging).
- the appearance and packaging of the product as a brownie? Check (it's all over the website, too)

Finally, just like with "Lazy Cakes", the use of the word "cakes" in the product name and the use of brownie in promotional material.

Calling it a herbal supplement ain't gonna help when the FDA comes a-calling.