FDA sends warning letter over Assured Brand


The FDA sent a warning letter to Greenbrier International Inc., also known as Dollar Tree, for selling ‘potentially unsafe drugs’ from Chinese suppliers.

Dollar Tree is under fire for stocking “potentially unsafe drugs” and cosmetics.

The Food and Drug Administration said in a news release on Thursday it sent a warning letter to Greenbrier International Inc., which does business as Dollar Tree, outlining “multiple violations of current good manufacturing practices at contract manufacturers used to produce Dollar Tree’s Assured Brand OTC drugs” and other products sold at Dollar Tree and Family Dollar stores.

“Americans expect and deserve drugs that are safe, effective and that meet our standards for quality,” Donald D. Ashley, director of the Office of Compliance in the FDA’s Center for Drug Evaluation and Research, said in the release. “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.”

In the Nov. 6 letter to Dollar Tree CEO Gary Philbin, the FDA identifies Chinese manufacturers that failed to test products and cited an example where “rodent feces (were) found throughout the manufacturing facility.”

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According to the FDA, Dollar Tree received warning letters between 2016 and 2019, including notification of letters sent to the manufacturers who were placed on “import alert, which are used to prevent potentially violative products from being imported into the U.S. market.”

Randy Guiler, Dollar Tree’s vice president of investor relations, said in a statement to CNBC that the items referenced by the FDA were “topical, not ingestible products.”

“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 said in the statement to CNBC, noting the company was cooperating and plans to meet with FDA in the near future.

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The FDA is asking Dollar Tree to “provide a detailed plan to ensure you do not receive or deliver adulterated drugs in interstate commerce” and a plan to audit suppliers.

Dollar Tree also was asked to schedule a meeting within 15 working days of receiving the letter and to “determine if you have any remaining drugs in your possession, either in your distribution network or in retail stores under the Dollar Tree, Family Dollar or any other retail store brands in your network.”

Follow USA TODAY reporter Kelly Tyko on Twitter: @KellyTyko

Read or Share this story: https://www.usatoday.com/story/money/2019/11/14/dollar-tree-otc-drugs-fda-warning-letter-assured-brand/4199656002/

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