- The FDA sent a warning letter to the Dollar Tree over certain OTC drugs.
- The letter details the company’s use of foreign manufacturers that had received warning letters.
- The company said they’re working with the FDA to get the issues resolved.
The FDA has sent a warning letter to Greenbrier International, Inc., doing business as Dollar Tree, for receiving over-the-counter (OTC) drugs made by foreign manufacturers that were found to have serious violations of federal law.
According to the warning
Firms inspected by FDA included contract manufacturers used to manufacture Dollar Tree’s Assured Brand drugs.
The FDA inspections of these foreign facilities revealed significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals.”
The letter details that although the company had limited manufacturing operations at their corporate headquarters, the violations that the agency identified at Dollar Tree’s foreign-based OTC drug supplier facilities caused products manufactured there to be adulterated under the
“We have a standard that we expect drugs to meet in the U.S. and when they’re not met, certain things can happen. When we have violations of this standard, there certainly should be an investigation as to why that happened and what steps are being taken to correct it,” Glenn Hardesty, DO, emergency medicine physician, Texas Health Presbyterian Hospital Plano, told Healthline.
The FDA letter also details the company’s use of manufacturers that had received warning letters for similar problems between 2016 and 2019.
Those manufacturers had already been placed on an import alert, which is used to prevent products that potentially violate federal standards from being imported for sale in the U.S. market.
According to a
Hardesty emphasized that the Dollar Tree products may have been adulterated in even other ways.
In the FDA definition of adulterated, it can mean being “contaminated with filth,” among other issues.
If it’s “contaminated under unsanitary conditions and the products had become contaminated with filth or rendered injurious to health, including the topical products, we can use our imaginations on what filth means. Does it mean dirt? Does it mean human or animal waste?” Hardesty said.
“It raises the question: What do they mean by unsanitary and contaminated with filth? That drew my attention.”
A Dollar Tree representative emphasized that their third-party manufactured products are subject to stringent safety testing and that the OTC drugs in question are intended for topical use only.
“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. Each of the items referenced in the report are topical, and not ingestible, products,” Randy Guiler, vice president, investor relations, Dollar Tree, Inc told Healthline in an emailed statement. “As always, we are cooperating with the U.S. Food and Drug Administration. We plan to meet with the FDA in the near future and expect that our plans will satisfy their requirements in all regards.”
Dollar Tree received a warning letter from the FDA regarding products manufactured for them by foreign manufacturers.
The complaint alleges that drug products manufactured for Dollar Tree by foreign-based companies may be adulterated under the Federal Food, Drug, and Cosmetic Act.
Experts emphasize that when this happens, the public should be informed of the reasons why, and what products are affected, as soon as possible.
A Dollar Tree representative confirmed that the company is cooperating with the FDA, and plans to meet with the agency to discuss their plans to resolve this issue.