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  1. <br> <br><h1 style="clear:both" id="content-section-0">What Does EARS 1 How the Earth Works - ORC-Catalog Do?<br></h1><br><br> <br><br><br><br> <br><p class="p__0">351(a)( 5)] You may find the Act and FDA's policies through links on FDA's homepage at www. fda.gov. The claims on your internet labeling develop that your 100% Food Grade Diatomaceous Earth item (DE) is a drug under Section 201(g)( 1 )(B) of the Act [21 U.S.C. 321(g)( 1 )(B)] because it is planned for use in the cure, mitigation, treatment, or avoidance of disease.</p><br><br> <br><br><br><br> <br><p class="p__1">Examples of a few of the site declares that provide evidence that your product is meant for usage as a drug include: Your You, Tube channel Earthworks Health, which notes the website www. earthworkshealth.com where items can be bought, has a video, "Earthworks Diatomaceous Earth," which consists of the claims:? "Internal De-Wormer"? "Great for connective tissue conditions, discomfort, and sleep problems"? "Removes Contaminants From The Gut"? "Gets rid of a variety of Toxic substance [sic] From the Digestive System" Your Facebook page Earthworks Health, which has links to www.</p><br><br> <br><br><br><br> <br><p class="p__2">Examples of such reviews consist of:? " https://montoyafink76.livejournal.com/profile have actually been getting shots in my shoulders and knees for years. I was set up 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 actually been taking it because mid Jan and no longer get shots.</p><br><br> <br><br><br><br> <br><div itemscope itemtype="http://schema.org/ImageObject"> <br>  <br>  <br> <span style="display:none" itemprop="caption">Earthwork Contractors - Earthwork Contractor Services Service Provider from Delhi</span> <br>  <br>  <br></div><br><br> <br><br><br><br> <br><br><br><br> <br><h1 style="clear:both" id="content-section-1">The How the Earth Works - Science - HowStuffWorks PDFs<br><br></h1><br><br> <br><br><br><br> <br><p class="p__3">I offered some to loved ones. they [sic] are. virtually discomfort free"? "DE is an absolute life saving, pain eliminating God send." Your DE product is not typically recognized as safe and efficient for the above referenced uses and, therefore, the item is a "new drug" under area 201(p) of the Act [21 U.S.C.</p><br><br> <br><br><br><br> <br><p class="p__4">New drugs might not be legally presented or delivered for intro 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 authorizes a new drug on the basis of clinical information and details demonstrating that the drug is safe and reliable.</p><br><br> <br><br><br><br> <br><div itemscope itemtype="http://schema.org/ImageObject"> <br>  <br>  <br> <span style="display:none" itemprop="caption">Earthwork - MoMA</span> <br>  <br>  <br></div><br><br> <br><br><br><br> <br><br><br><br> <br><div itemscope itemtype="http://schema.org/ImageObject"> <br>  <br>  <br> <span style="display:none" itemprop="caption">Hopeton Earthworks - Hopewell Culture National Historical Park (U.S National Park Service)</span> <br>  <br>  <br></div><br><br> <br><br><br><br> <br><br><br><br> <br><p class="p__5">352(f)( 1)] if the drug fails to bear adequate directions for its designated use(s). "Appropriate instructions for use" means instructions under which a layperson can use a drug securely and for the purposes for which it is meant (21 CFR 201. 5). Prescription drugs, as defined in section 503(b)( 1 )(A) of the Act [21 U.S.C.</p><br><br> <br><br><br><br>
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