I've discovered Neoteric Diabetic Skin Cream due to my weird skin on bottom of my feet and neuropathy as a result of chemo. Countless sources link the results of chemo and diabetes closely together in effect and in how to take care of it. This stuff really does help - somewhat, but definitely somewhat. But FDA can't stand for them to say that it works. They sent a letter to the manufacturer. This harmless cream - they'd like it to be submitted to a 30 million dollar trial and probably subject to being prescribed. No wonder we have the most expensive health care in the world and the lowest longivity rate among all the "advanced" nations.
The details of this statement are distortions of the fact; the closest to the truth is "to treat". But they don't claim to treat the disease, they claim to help mediate the affects of the disease. From the letter dated November 26, 2002 from the FDA in Denver:
"Based on the claims made for these products to affect the structure or function of the body, and-to treat, prevent, and mitigate disease, they are "drugs" within the meaning of section 201(g) of the Federal Food, Drug, and Cosmetic Act (the Act). Moreover, these products are "new drugs" [section 201(p) of the Act] because there is not substantial evidence that these products are generally recognized as safe and effective for their intended uses. Since these products are "new drugs" they may not be marketed in the United States without approved new drug applications [section 505(a) of the Act]. "
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