Dollar Tree issued FDA warning letter

The Dollar Tree has been given a warning letter by the U.S. Food and Drug Administration. The Greenbrier International, Inc. doing business as Dollar Tree has received the warning for receiving over-the-counter (OTC) drugs produced by foreign manufacturers found to have serious violations of federal law. There were various violations outlined in the letter.

Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research says “Protecting patient health and safety is our highest priority, and the FDA continues to investigate and take action against companies that place U.S. patients at risk. Americans expect and deserve drugs that are safe, effective and that meet our standards for quality. The importation and distribution of drugs and other products from manufacturers that violate federal law is unacceptable.”

He added, “In this case, Dollar Tree has the ultimate responsibility to ensure that it does not sell potentially unsafe drugs and other FDA-regulated products to Americans. We will remain vigilant in our efforts to protect the U.S. public from companies who put the health of Americans at risk – whether through the manufacturing and distribution of products we regulate or other means.”

In the warning letter, Dollar Tree’s receipt of adulterated drugs from manufacturers have been identified who were given FDA warning letters in 2018. Some manufacturers had received warning letters between 2016 and 2019 but Dollar Tree uses those manufacturer’s products. The manufacturers that received the warning letters were put on import alert.

The FDA is an agency within the U.S. Department of Health and Human Services. Some of the responsibilities of the body include protecting public health by:

• assuring the safety effectiveness,
• security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices.