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Tennessee firms shut down over unproven, unapproved products

September 4, 2019

HENDERSONVILLE, Tenn. (AP) — Two Tennessee-based companies have been ordered to stop unlawfully distributing unapproved drugs and misbranded and contaminated devices and supplements.

The Tennessean reports a federal judge issued an injunction Tuesday against Basic Reset, Biogenyx, owner Fred R. Kaufman III and Kimberly Kaufman.

A Department of Justice statement says the Food and Drug Administration filed a complaint last month accusing the Kaufmans and companies of selling drugs and devices with unproven claims of curing, treating or preventing conditions. One such item is an $80 necklace Basic Reset claims protects the wearer from electromagnetic waves, which it implies can cause leukemia.

The injunction orders the companies to stop production and sales until their products are recalled and examined by qualified experts, and the companies get written FDA approval to resume operations.

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Information from: The Tennessean, http://www.tennessean.com

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