The U.S. Food and Drug Administration has sent a warning letter to Dollar Tree stores notifying the company that certain over-the-counter medications sourced from Shanghai and other international cities may be defective. The FDA detected flaws at several facilities between 2017 and 2019 and notified both the manufacturers and Dollar Tree that these products may be adulterated. Nevertheless, Dollar Tree continued to receive medications from those manufacturers in violation of the Federal Food Drug and Cosmetic Act.
The warning letter, which was dated Nov. 6, was redacted. The only specific product left un-redacted was Dollar Tree Assured Brand acne treatment pads. According to Dollar Tree, the medicines identified by the FDA are topical, as opposed to ingestible.
“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,” said a Dollar Tree spokesperson.
Yet the FDA’s warning suggests Dollar Tree’s quality assurance programs may not be quite as robust or rigorous as the company claims. According to Bloomberg news, the FDA letter detailed violations by Dollar Tree including:
- Failing to test ingredients before or after products are manufactured to ensure the components are correct
- Failing to ensure the products are made to correct specifications
- Failing to check for objectionable microorganisms
Dollar Tree’s parent company insisted to the FDA it would never have imported products from a manufacturer that was on import alert had it been told. The FDA disputes that assertion.
“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,” stated the director of the FDA’s Office of Compliance in its drugs division.
No actual harm or other adverse events have been reported regarding Dollar Tree’s Assured Brand.
Drug makers increasingly outsourcing to foreign manufacturers
Bloomberg notes that pharmaceutical companies have increasingly been moving their manufacturing abroad due to lower labor costs and less regulation. This is true of both prescription and over-the-counter medicines.
This has pressured the FDA’s inspection and enforcement mechanisms, and the agency has struggled to stay up to date on inspecting foreign facilities manufacturing drugs for use in the U.S.
Is it safe for drug makers to rely on uninspected, lightly regulated facilities in other countries? It may not be. Regardless, manufacturers, distributers and retailers should ensure that no faulty or adulterated drugs are sold to their customers.