Dollar Tree Faces FDA Scrutiny

On November 14, the FDA issued a warning letter to Greenbrier International, Inc, who operates as Dollar Tree. Greenbrier International, Inc. is being warned by the Food and Drug Administration for distributing over-the-counter products (marketed in-store as Assured Brand) which are in violation of the FDA’s Current Good Manufacturing Practices (or CGMPs). CGMPs like up-to-date equipment, sterile manufacturing environment, and rigorous product quality testing are how the FDA gauges the quality of drugs sold in the United States marketplace. The FDA does point out that drugs manufactured in non-CGMP-compliant environments are not necessarily dangerous, they just may be less efficacious than advertised. The FDA only takes action against non-compliant manufacturers when it feels that the products may be dangerous to consumers.

In the case of Greenbriar International, Inc’s over-the-counter products, the FDA cited a recent review of imported products (provided through international manufacturers) which contained components that were not tested for microorganisms, component identity, or for drug conformance with specifications. The FDA cited the manufacturers and notified Greenbriar, but noted that Greenbriar continued to purchase OTC products from the manufacturers. As the FDA has been monitoring Greenbriar’s suppliers since the earliest incidents back in 2016, it has given Greenbriar a plan of improvement detailing the need for a system preventing the company from importing adulterated or dangerous drugs.

Not much time has passed to see if Greenbriar will successfully implement the changes outlined by the FDA, but they have announced they will be working with the FDA to avoid these incidents in the future. The Food and Drug Administration has also assured the public they will continue to monitor these products for the safety of consumers.