Jefferson County business charged with distributing a drug without FDA approval

CLARKSBURG, W. Va. — A federal grand jury returned an indictment Tuesday charging a Jefferson County business, its owner and its president with distributing medical products without the approval of the U.S. Food and Drug Administration

David B. Phillips, 58, of Charles Town, owns and operates Phillips Technologies and Rebuilder Medical Technologies, Inc. in Jefferson County, West Virginia.

Bryan Sheldon, 56, also of Charles Town, is the president of Rebuilder Medical Technologies, Inc.

An FDA investigation revealed that Phillips, Sheldon and their corporate entities were manufacturing and distributing SilverCure Ointment, a product containing colloidal silver for use in treating molluscum, psoriasis and other skin conditions. The FDA has not approved drugs containing colloidal silver due to concerns over its lack of effectiveness and the risk of side effects, which include argyriais, a condition resulting in blue or gray discoloration of the skin resulting from an accumulation of silver or silver sulfide particles in the skin due to the prolonged intake of silver products.

Phillips represented to the FDA that his businesses would discontinue the production and sale of products containing colloidal silver. However, Phillips and his business continued to sell misbranded and unauthorized products containing silver.

Phillips, Sheldon, and Rebuilder Medical Technologies, Inc. are each charged with:

– One count of Conspiracy to Violate the Laws, for which they each face five years in prison and a fine of up to $250,000.

– Four counts of Introduction into Interstate Commerce of New Drug without Approval, for which they each face up to three years in prison and a fine of up to $500,000 (corporation) or $250,000 (individuals) on each count.

– Four counts of Mislabeling/Misbranding a Drug, for which they each face up to three years in prison and a fine of up to $500,000.00 (corporation) or $250,000 (individuals) on each count.





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