FDA 'GRAS' Statement for Bentonite

Therapeutic clays have been used by the people of the world since before recorded history. In the United States, therapeutic clays were used for their medicinal value by the medical profession prior to the formation of the Food and Drug Administration. To this day, bentonite still enjoys FDA GRAS status (generally regarded as safe).

However, federal law does state that no medical claims may be made about substances that are not approved by the FDA. We can therefore make no medical claims, nor may we recommend clay use for any medical condition. Since we are primarily a wholesale distribution company, we do not label our products for human or animal use.

There have been many books written about the value of therapeutic clays, and we strongly encourage those interested to spend some time researching the wonderful world of clay therapeutics. You'll be glad that you did!

We have links to the most comprehensive information out there. These research article links are available in our RESOURCES section.

  • We specialize in the finest quality therapeutic, homeostatic therapeutic calcium bentonite/montmorillonite in the United States.
  • None of the statements on this website have been reviewed by the FDA. No products presented are designed to diagnose, treat, or cure any illness.
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  • All products are not labeled for human or animal use





§ 184.1155 Bentonite.

(a) Bentonite (Al2O34SiO2nH2O, CAS Reg. No. 1302–78–9) is principally a colloidal hydrated aluminum silicate. Bentonite contains varying quantities of iron, alkalies, and alkaline earths in the commercial products. Depending on the cations present, natural deposits of bentonite range in color from white to gray, yellow, green, or blue. Bentonite's fine particles provide large total surface area and, hence, pronounced adsorptive capability.

(b) The ingredient must be of a purity suitable for its intended use.

(c) In accordance with § 184.1(b)(1), the ingredient is used in food with no limitation other than current good manufacturing practice. The affirmation of this ingredient as generally recognized as safe (GRAS) as a direct human food ingredient is based upon the following current good manufacturing practice conditions of use:

(1) The ingredient is used as a processing aid as defined in § 170.3(o)(24) of this chapter.

(2) The ingredient is used in food at levels not to exceed current good manufacturing practice. Current good manufacturing practice results in no significant residue in foods.

(d) Prior sanctions for this ingredient different from the uses established in this section do not exist or have been waived.

[47 FR 43367, Oct. 1, 1982, as amended at 73 FR 8606, Feb. 14, 2008; 76 FR 59249, Sept. 26, 2011]