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351(a)( 5)] You may find the Act and FDA's regulations through links on FDA's homepage at www. fda.gov. The claims on your internet identifying establish that your 100% Food Grade Diatomaceous Earth product (DE) is a drug under Section 201(g)( 1 )(B) of the Act [21 U.S.C. 321(g)( 1 )(B)] since it is meant for use in the remedy, mitigation, treatment, or avoidance of illness.

Examples of some of the website declares that offer evidence that your product is meant for use as a drug include: Your You, Tube channel Earthworks Health, which notes the website www. earthworkshealth.com where items can be purchased, has a video, "Earthworks Diatomaceous Earth," which consists of the claims:? "Internal De-Wormer"? "Great for connective tissue conditions, pain, and sleep concerns"? "Gets rid of Contaminants From The Gut"? "Eliminates  Also Found Here  of Toxin [sic] From the Digestive Tract" Your Facebook page Earthworks Health, which has links to www.

Examples of such testimonials include:? "I have been getting shots in my shoulders and knees for many years. I was scheduled for both knees getting replaced. I am bone on bone. I took DE and felt results within an hour on my worst knee. I have been taking it given that mid Jan and no longer get shots.

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I provided some to good friends and household. they [sic] are. essentially pain free"? "DE is an outright life saving, pain easing God send." Your DE item is not typically recognized as safe and effective for the above referenced usages and, for that reason, the item is a "brand-new drug" under area 201(p) of the Act [21 U.S.C.

New drugs might not be legally introduced or provided for introduction into interstate commerce without previous approval from FDA, as explained in areas 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 scientific information and details showing that the drug is safe and reliable.

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352(f)( 1)] if the drug fails to bear appropriate instructions for its intended use(s). "Appropriate directions for usage" means directions under which a layperson can utilize a drug safely and for the functions for which it is planned (21 CFR 201. 5). Prescription drugs, as defined in area 503(b)( 1 )(A) of the Act [21 U.S.C.