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The introduction or shipment for intro into interstate commerce of this misbranded drug breaks section 301(a) of the Act [21 U.S.C. 331(a)] In addition, FDA reviewed your site at the Web address www. earthworkshealth.com and has figured out that you take orders there for the items Diatomaceous Earth Cosmetic Bundle, Goat Milk Soap with Food Grade Diatomaceous Earth, and Nature's Face Mask.

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321(g)( 1 )(B) and/or 321(g)( 1 )(C)] due to the fact that they are intended for use in the cure, mitigation, treatment or avoidance of disease and/or are intended to impact the structure or function of the body. Examples of a few of the site claims that provide proof that your items are meant for usage as drugs consist of:?" [T] reating skin issues like blemishesand acne"?" [C] ontrol acne"? " Learn More Here [an ingredient in your item] (restructuring and pain remedy for acne or cystic acne)" Your products are not generally recognized as safe and efficient for the above referenced usages and, therefore, the items are "new drugs" under area 201(p) of the Act [21 U.S.C.

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New drugs may not be lawfully presented or delivered for intro into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)] FDA authorizes a new drug on the basis of scientific data and info showing that the drug is safe and effective.

342(a)( 2 )(C)(i)] because it is a food additive that is hazardous within the significance of Area 409 of the Act [21 U.S.C. 348] If a substance is not normally acknowledged as safe (GRAS) by qualified specialists for its intended use in food and does not receive any of the other exemptions from the food additive definition, it is a food additive.

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321(s)] defines a food additive as a "compound the meant usage of which results or might reasonably be expected to result, straight or indirectly, in its ending up being a component or otherwise affecting the characteristics of any food. if such compound is not typically acknowledged among experts qualified by scientific training and experience to assess its security, as having been effectively revealed through clinical treatments.