FDA WARNING_LETTER - Natural Solutions Foundation - August 31, 2014
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On September 23, 2014, the FDA and FTC issued a Warning Letter to Natural Solutions Foundation regarding products sold on their websites, http://www.drrimatruthreports.com and http://www.nsfinarketplace.com, including "Dr. Rima Recommends? The Silver Solution" (Silver Sol Nano Silver?) and "CBD Organic Dark Chocolate Bars" (High Potency CBD Hemp Oil?). These products are also sold as "Personal Protection Pack" and "Family Protection Pack."
The FDA determined that the websites promote these products for conditions that classify them as drugs under section 201(g)(1)(B) of the Act [21 U.S.C. §321(g)(1)(B)], due to therapeutic claims indicating intent for use in the cure, mitigation, treatment, or prevention of disease. Numerous examples of claims from the websites, YouTube, Twitter, and Facebook pages were cited, asserting the products' effectiveness against Ebola, other communicable diseases, and various pathogens.
These products are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] because they are not generally recognized as safe and effective for their claimed uses. Introducing new drugs into interstate commerce without prior FDA approval violates section 505(a) and 301(d) of the Act [
ID · 75a6edb2-2d75-497f-be0e-f37eb1ee6a24
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