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The intro or delivery for introduction into interstate commerce of this misbranded drug breaches 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 identified 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.

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 prevention of disease and/or are intended to affect the structure or function of the human body. Check Here For More of a few of the site declares that offer proof that your items are planned for use as drugs include:?" [T] reating skin issues like blemishesand acne"?" [C] ontrol acne"? "Comfrey Root Powder [an active ingredient in your product] (restructuring and pain remedy for acne or cystic acne)" Your products are not normally recognized as safe and effective for the above referenced usages and, for that reason, the items are "brand-new drugs" under area 201(p) of the Act [21 U.S.C.

New drugs might not be lawfully presented or delivered for introduction into interstate commerce without prior approval from FDA, as explained in sections 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)] FDA approves a brand-new drug on the basis of clinical data and information demonstrating that the drug is safe and effective.

342(a)( 2 )(C)(i)] in that it is a food additive that is risky within the significance of Area 409 of the Act [21 U.S.C. 348] If a compound is not normally acknowledged as safe (GRAS) by certified specialists for its desired use in food and does not get approved for any of the other exemptions from the food additive meaning, it is a food additive.

321(s)] specifies a food additive as a "substance the meant usage of which results or might fairly be anticipated to result, straight or indirectly, in its becoming a component or otherwise affecting the attributes of any food. if such substance is not typically recognized amongst specialists certified by scientific training and experience to evaluate its safety, as having been properly revealed through scientific treatments.