Drug Information Update- FDA Warns Consumers Not to Use “Best Bentonite Clay”

The Division of Drug Information (DDI)- serving the public by providing information on human drug products and drug product regulation by FDA.

[3/23/16] The U.S. Food and Drug Administration is warning consumers not to use “Best Bentonite Clay,” a product of Best Bentonite, located in Guthrie, Oklahoma. FDA has determined that the product contains elevated lead levels and may pose a lead poisoning risk.

“Best Bentonite Clay” is sold as a fine powder on Amazon.com and on the Best Bentonite website (www.bestbentonite.com). According to the Best Bentonite website, customers mix the product with water and ingest it or apply it to their skin. 

FDA laboratories have found elevated levels of lead in “Best Bentonite Clay.” Exposure to lead can cause serious damage to the central nervous system, kidneys, and immune system. In children, chronic exposure to lead, even at low levels, is associated with cognitive impairment, reduced IQ, behavioral difficulties, and other problems.

Consumers should not purchase or use “Best Bentonite Clay.” Anyone who has used this product or given it to a child should consult a health care professional immediately. FDA has previously warned consumers about the risk of lead poisoning associated with the use of a bentonite clay product (see http://www.fda.gov/Drugs/DrugSafety/ucm483838.htm).

FDA has not confirmed any cases of lead poisoning associated with “Best Bentonite Clay.”

Health care professionals and consumers are encouraged to report any adverse events potentially related to the use of any bentonite product to FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

To view the original communication, please visit: Best Bentonite Clay.