Dollar Tree’s Over-the-Counter Drugs: Cheap, But Potentially Dangerous

Retailer Dollar Tree boasts that everything for sale at its nationwide chain of stores, as well as from its website, costs just one dollar.[1] Among the products sold by Dollar Tree are a wide array of over-the-counter medications, including pain and fever relievers, allergy and cold remedies, antacids, laxatives, antidiarrheal drugs and sleep aids.[2] Many of these drugs are sold under the company’s “Assured” brand.

But a recent warning publicized by the Food and Drug Administration (FDA) suggests that although purchasing these medications from Dollar Tree may appear to be good for your pocketbook, doing so may be dangerous to your health.[3]

On Nov. 14, 2019, the FDA issued a press release stating that the agency had sent a warning letter to Greenbrier International, Inc. — which does business as Dollar Tree — “for receiving over-the-counter…drugs produced by foreign manufacturers found to have serious violations of federal law.”[4] The warning letter, dated Nov. 6, followed January 2019 FDA inspections of Greenbrier International’s corporate headquarters and distribution center warehouse after other FDA inspections revealed serious violations at multiple foreign pharmaceutical manufacturers — several located in China — that supplied drugs sold by Dollar Tree’s network of stores.[5] The inspected drugmakers included contract manufacturers that produced Dollar Tree’s Assured brand drugs.

Specifically, FDA inspectors had found that drug manufacturers used to supply over-the-counter medicine sold by Dollar Tree had violated the FDA’s good manufacturing practices — regulatory standards that are intended to ensure the safety and quality of all over-the-counter and prescription drugs sold in the U.S. When the FDA detects such manufacturing violations, it declares the affected drugs to be “adulterated.” The sale or distribution of adulterated drugs in the U.S. is illegal.

Among the most alarming violations documented by FDA inspectors at contract foreign manufacturers used by Dollar Tree were failures to test raw materials used to make drugs and finished drug products for bacterial contamination and quality.[6]

The FDA also noted that during its January 2019 inspection of Dollar Tree’s headquarters, company executives assured FDA staff that if the company was made aware that a warning letter had been issued to one of its contract drug manufacturers, it would no longer purchase over-the-counter drugs from that manufacturer.[7] But disturbingly, FDA inspectors found that Dollar Tree in some cases had imported drugs from foreign manufacturers that had received FDA warning letters — letters that had been copied to the company’s chief operating officer.

Consumers need to beware of companies like Dollar Tree that sell over-the-counter medications at bargain-basement prices. It’s doubtful that a bottle of safe, high-quality over-the-counter medication can be made consistently in accordance with the FDA’s regulatory standards and still cost only a dollar.
 

References

[1] Dollar Tree homepage. https://www.dollartree.com/. Accessed December 3, 2019.

[2] Dollar Tree. Medicine and treatments. https://www.dollartree.com/health-beauty-supplies/medicine-treatments. Accessed December 3, 2019.

[3] Food and Drug Administration. FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs. November 14, 2019. https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-dollar-tree-stores-receiving-potentially-unsafe-drugs. Accessed December 3, 2019.

[4] Ibid.

[5] Food and Drug Administration. Warning letter to Greenbrier International, Inc dba Dollar Tree. November 6, 2019. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/greenbrier-international-inc-dba-dollar-tree-574706-11062019. Accessed December 3, 2019.

[6] Food and Drug Administration. FDA issues warning letter to Dollar Tree stores for receiving potentially unsafe drugs. November 14, 2019. https://www.fda.gov/news-events/press-announcements/fda-issues-warning-letter-dollar-tree-stores-receiving-potentially-unsafe-drugs. Accessed December 3, 2019.

[7] Food and Drug Administration. Warning letter to Greenbrier International, Inc dba Dollar Tree. November 6, 2019. https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/greenbrier-international-inc-dba-dollar-tree-574706-11062019. Accessed December 3, 2019.