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Home » FDA SAYS DIABETES CREAM NEEDS DRUG APPLICATION
FDA SAYS DIABETES CREAM NEEDS DRUG APPLICATION
July 28, 2006
The maker of a wound lotion that it claims to relieve pain for those suffering from wounds associated with diabetes is in violation of the law for selling unapproved drugs, the FDA said in a warning letter posted July 19.
RAE'lex Circulation Formula, RAE'lex Wound Gel, and RAE'lex Lotion, intended for topical use to treat diabetic neuropathy, are drugs and need to have new drug applications on file with the FDA, the agency said. In addition, the claims the seller makes about the product are false and misleading and violate the FDA's labeling requirements.
"Helps to relief [sic] pain symptoms of diabetic neuropathy," the ads read, as the FDA described them in a letter dated July 12 addressed to Cheryl Good of Guntersville, Ala. Good could not be reached for comment.
RAE'lex's lotions and formulas are made with omega 3, 6, 9 fatty acids -- or "emu oil" -- along with vitamin E, citrus oil and tree oil, according to RAE'lex's website. But because the topical products are intended to prevent, treat or cure disease conditions or affect the structure or function of the body, RAE'lex should be considered a drug, the FDA says.
"For swelling of lower legs, improved circulation, relief of pain symptoms of diabetic neuropathy and for smaller surface diabetic related wounds we recommend RAE'lex Circulation Formula," say the RAE'lex's ads, which were cited in the FDA letters.
The warning letter can be seen at www.fda.gov/foi/warning_letters/g5921d.htm (http://www.fda.gov/foi/warning_letters/g5921d.htm).
KEYWORDS FDAnews Drug Daily Bulletin
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