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351(a)( 5)] You may discover the Act and FDA's regulations through links on FDA's homepage at www. fda.gov. The claims on your internet labeling 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)] because it is meant for usage in the remedy, mitigation, treatment, or avoidance of disease.

Examples of some of the website declares that supply evidence that your product is meant for use as a drug include: Your You, Tube channel Earthworks Health, which notes the site www. earthworkshealth.com where items can be purchased, has a video, "Earthworks Diatomaceous Earth," which includes the claims:? "Internal De-Wormer"? "Great for connective tissue disorders, discomfort, and sleep issues"? "Removes Toxic Substances From The Gut"? "Eliminates a variety of Toxic substance [sic] From the Digestion Tract" Your Facebook page Earthworks Health, which has links to www.

Examples of such reviews consist of:? "I have actually been getting shots in my shoulders and knees for several years. I was arranged for both knees getting changed. I am bone on bone. I took DE and felt results within an hour on my worst knee. I have been taking it considering that mid Jan and no longer get shots.

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I provided some to good friends and household. they [sic] are. practically discomfort complimentary"? "DE is an absolute life saving, discomfort eliminating God send out." Your DE item is not normally recognized as safe and effective for the above referenced uses and, therefore, the product is a "new drug" under section 201(p) of the Act [21 U.S.C.

New drugs might not be legally presented or provided for introduction into interstate commerce without previous approval from FDA, as described in areas 301(d) and 505(a) of the Act [21 U.S.C. 331(d), 355(a)] FDA authorizes a brand-new drug on the basis of scientific data and information demonstrating that the drug is safe and efficient.

352(f)( 1)] if the drug stops working to bear sufficient instructions for its designated usage(s). "Appropriate directions for use" suggests directions under which a layperson can use a drug securely and for the purposes for which it is intended (21 CFR 201. 5). Related Source Here , as defined in section 503(b)( 1 )(A) of the Act [21 U.S.C.