FDA says Dollar Tree imported drugs from firms with “serious violations,” couldn’t assure drug quality
By Kimberly Pierceall - The Virginian-Pilot
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The Food and Drug Administration said Thursday that Chesapeake-based Dollar Tree has been importing drugs for its Assured brand from overseas manufacturers found to have had “serious violations of federal law.” The agency also said Dollar Tree’s independent testing company couldn’t ensure the quality of drugs to be sold in the United States.
Dollar Tree, which also owns Family Dollar, has more than 15,100 stores across the country and in Canada.
The warning letter follows an FDA inspection of Dollar Tree’s Greenbrier International Inc. headquarters in January. In its letter, the agency noted it had sent warnings to more than one of the company’s drugmakers, and placed them on an import alert list, copying Dollar Tree’s chief operating officer at the time, but the retailer’s records showed they were still importing the drugs after those warnings.
According to the agency, Dollar Tree had told the agency it would stop importing drugs from any supplier sent a warning letter and placed on an import alert list.
However, “The import data detailed above demonstrate this is not always the case,” the FDA’s warning letter states.
Among some of the drug makers’ violations, the FDA found the companies weren’t testing raw materials or finished drugs for pathogens and quality.
The products that Dollar Tree imported came from Shanghai Weierya Daily Chemicals Factory and Hangzhou Zhongbo Industrial Company. The agency also said Dollar Tree had a history of importing drugs from other companies that had been found to have significant violations.
The drugs were intended to be sold under the company’s Assured brand. The only product specifically mentioned was an acne treatment pad. Company spokesman Randy Guilar noted Thursday the items referenced in the warning letter were all topical products, not ingestible drugs. He said the company was cooperating with the FDA.
"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,” he said in an emailed statement that did not respond to the agency’s specific claim about its testing agency, Bureau Veritas. “We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards.”
In its warning letter, the agency said that Bureau Veritas representatives asserted that “its test results were not suitable to make release decisions of drug products for distribution into the U.S. supply chain.”
"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,” said Donald D. Ashley, director of the office of compliance in the FDA’s Center for Drug Evaluation and Research, in a statement. “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.
According to an online database published by the FDA, this is the only warning letter issued to Dollar Tree since at least 2014. It’s one of 3,287 warning letters the agency has issued in that time.
Sally Greenberg, executive director of the National Consumers League, a nonprofit advocacy group, said warning letters sent to a retailer are critically important because they represent a warning to all retailers that they need to work with the FDA. “The company is doing a less than adequate job of policing their supply chain,” she said Thursday of Dollar Tree.
“They should pay a price in terms of reputation or goodwill with customers,” she said.
The warning letter requires Dollar Tree to respond in 15 days with what it has done since the FDA’s inspection to correct violations and to prevent them from happening again. The agency also asked for a detailed plan to ensure the company doesn’t import potentially unsafe drugs in the future. Even though it was announced Thursday, the agency sent the retailer the letter on Nov. 6.
The company is scheduled to report its third-quarter earnings on Nov. 26. Dollar Tree’s stock closed Thursday at $108.75 a share, up 35 cents a share from the previous day.
