The Food and Drug Administration fired off a warning letter to Greenbrier International — which does business as the well-known American discount chain, Dollar Tree — for selling “potentially unsafe drugs” from foreign manufacturers with multiple violations.
The Nov. 6 letter to Dollar Tree states that FDA inspections of foreign manufacturers that supplied drug products to Dollar Tree (and Family Dollar stores) — including Dollar Tree’s own over-the-counter drug brand, Assured — were found to have “serious violations of federal law,” including not testing raw materials or finished drugs for pathogens and quality.
The letter warns Dollar Tree about distributing “adulterated drugs from manufacturers that received FDA warning letters in 2018,” and called out several Chinese manufacturers that Dollar Tree uses, including Bicooya Cosmetics Limited for “not testing finished drug products prior to distribution” and for “rodent feces” that was found throughout the manufacturing facility.
Also mentioned: China’s Shanghai Weierya Daily Chemicals Factory, which supplied Dollar Tree with acne treatment pads, and was warned back in 2018 for failing “to test each batch of drug for objectionable microorganisms prior to distribution.” Another manufacturer, Hangzhou Zhongbo Industrial Company, was called out for multiple violations as well.
These manufacturers were all placed on “import alert," which is used “to prevent potentially violative products from being imported into the U.S. market,” according to the FDA.
The FDA says that there’s “a pattern” of drug manufacturers in Dollar Tree’s supply chain with serious violations of what’s known as “current good manufacturing practices.” The agency expects the company to provide “a detailed plan to ensure you do not receive or deliver adulterated drugs in interstate commerce.”
“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,” said Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, in a Nov. 14 news release. “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.”
Ashley 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.”
Dollar Tree responded, with Randy Guiler, vice president of investor relations at Dollar Tree, providing a company statement to CNN: "We are committed to our customers' safety and have very robust and rigorous testing programs in place to ensure our third-party manufacturers' products are safe."
Guiler added: "Each of the items referenced in the report are topical, and not ingestible, products. As always, we are cooperating with the U.S. Food and Drug Administration (FDA). We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards.”
So what can consumers do in the meantime?
The FDA doesn’t list the specific topical products affected, outside of “acne treatment pads” sold at Dollar Tree. The agency does, however, make mention of Dollar Tree importing and selling cosmetics from one of the Chinese manufacturers in violation, Bicooya Cosmetics Limited. While Dollar Tree addresses the violations in its supply chain, customers may want to avoid using acne treatment pads, cosmetics, and other topical products from Dollar Tree’s own Assured products line (here’s a list of their Assured products) in the meantime.
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