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Specifically: Your website www. earthworkshealth.com, from which your diatomaceous earth items can be bought, states:? "Storing foods. For  View Details  of grains or kept foods please integrate 1 level tablespoon with it. So as you fill your mylar lined 5 gallon bucket with wheat, make sure to dump in 1 level tablespoon every 1 gallon you put into it."? "So next time you start prepping your foods, be prepared with food grade diatomaceous earth and include some service life and NUTRITION to your stored foods for when the time is right!" Using diatomaceous earth for direct addition to food (which is your item's planned usage) is not the topic of any food additive regulations in Title 21 of the Code of Federal Laws (21 CFR) or Normally Recognized as Safe (GRAS) determinations.

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110); 2) a colorant for paper and paperboard (see 21 CFR 176. 170); 3) a colorant for polymers (see 21 CFR 178. 3297); and 4) an optional adjuvant in the production of phenolic resins (see 21 CFR 177. 2410). DE is likewise the topic of threshold of regulation (TOR) exemption 2005? 007 for use as a component of foam trays.

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90); 2) as a carrier for lipase enzyme preparation (see 21 CFR 184. 1420); and 3) it's use in food processing as a purification help as a component of composite purification media is the subject of GRAS Notice 87, to which FDA had no concerns. However, FDA has actually not evaluated the security of making use of DE for direct addition to food and we are not mindful of an independent GRAS decision by certified professionals for this use of DE.

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As such, DE is adulterated under area 402(a)( 2 )(C)(i) of the Act. The introduction of an adulterated food into interstate commerce is an infraction of area 301(a) of the Act [21 U.S.C. 331(a)] FDA also reviewed your site at www. earthworkshealth.com for your product 100% Diatomaceous Earth and Natural Pet Treats.

321(g)( 1 )(B)] Further, as discussed below, these products are unapproved new animal drug and presenting or providing this item for intro into interstate commerce breaks the Act. Examples of some of the claims that offer proof that your items are planned for use as animal drugs are identified listed below. Diatomaceous Earth for Dogs: Website https://www.