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CLARKSBURG, WEST VIRGINIA - A federal grand jury returned an indictment today charging a Jefferson County, West Virginia business, its owner, and its president with distributing medical products without the approval of the U.S. Food and Drug Administration, United States Attorney William J. Ihlenfeld, II, announced.
David B. Phillips, 58, of Charles Town, West Virginia, owns and operates Phillips Technologies and Rebuilder Medical Technologies, Inc. in Jefferson County, West Virginia. Bryan Sheldon, 56, also of Charles Town, West Virginia, 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. Such side effects 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 $250,000.00.
• Four counts of “Introduction into Interstate Commerce of New Drug without Approval." They each face up to three years in prison and a fine of up to $500,000.00 (corporation) or $250,000.00 (individuals) on each count.
• Four counts of “Mislabeling/Misbranding a Drug." They each face up to three years in prison and a fine of up to $500,000.00 (corporation) or $250,000.00 (individuals) on each count.
Under the Federal Sentencing Guidelines, the actual sentence imposed will be based upon the seriousness of the offenses and the prior criminal history, if any, of the defendants.
An indictment is merely an accusation. A defendant is presumed innocent unless and until proven guilty.
Source: U.S. Department of Justice, Office of the United States Attorneys
