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Texas Woman Charged with Selling Misbranded Drug

OCI BadgeDepartment of Justice
U.S. Attorney’s Office
Eastern District of Michigan

FOR IMMEDIATE RELEASE
Thursday, December 17, 2020

An indictment was unsealed today charging a Texas woman with introducing an unapproved drug into interstate commerce, introducing a misbranded drug into interstate commerce, and introducing an unapproved drug into interstate commerce with the intent to defraud or mislead, announced United States Attorney Matthew Schneider.

Schneider was joined in the announcement by Special Agent in Charge Lynda Burdelik, Federal Drug Administration (FDA). 

Charged was Judith Holloway, 34, of Watauga, Texas

According to the indictment, 2, 4-Dinitrophenol, also known as DNP, is an industrial chemical, with various uses, including in herbicides, dyes, wood preservers, and explosives. The drug is sometimes improperly, and dangerously, used as a weight loss drug, but when ingested is highly toxic to humans. Oral exposure to DNP may cause serious adverse events, including dehydration, cataracts, liver damage, and death. In 1938, the U.S. Food and Drug Administration (FDA) declared DNP to be extremely dangerous and not fit for human consumption. At that time, the FDA announced publicly that it would prosecute those who manufacture and distribute DNP for use as a drug.

According to the indictment, between October 2018 and May 2020, Holloway sold DNP to consumers throughout the United States and in a number of foreign countries and misbranded the substance as a yellow pigment powder.  Holloway purchased bulk DNP and utilized eBay and other websites to market and sell the drug over the internet. Holloway did not label the package as DNP, nor did she include any directions or warnings regarding the use of the drug when she mailed it to consumers.

United States Attorney Schneider stated, “This indictment should send a clear message to those who would profit from the sale of unapproved drugs that we will utilize every tool at our disposal to vigorously prosecute you in order to protect the health and safety of the general public. We urge everyone to refrain from ingesting DNP for any reason."

“Drugs that are produced and distributed outside of the FDA’s oversight present the possibility of harm to consumer health,” said Special Agent in Charge Lynda M. Burdelik, FDA Office of Criminal Investigations Chicago Field Office. “The FDA will continue to work to prevent the illegal sale of dangerous, unapproved drugs and will remain committed to protecting consumers from criminals who put profits above the health and safety of the U.S. public.”

This case is being prosecuted by Assistant United States Attorney Regina R. McCullough. The case was investigated by special agents of the Food and Drug Administration.

An indictment is only a charge and is not evidence of guilt.  The defendant is entitled to a fair trial in which it will be the government’s burden to prove guilt beyond a reasonable doubt.

Topic(s):
Consumer Protection
Component(s):
USAO - Michigan, Eastern

 
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