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FDA Cannot Issue Cosmetic Recall

In a previous post entitled “Cosmetics Sold to Consumers with No FDA Screening” the FDA’s lack of authority over consumer cosmetics was discussed. More detail, however, is owed regarding the FDA’s inability to force product recalls.

Regarding the recall policy for cosmetics the FDA’s website reads, “FDA has no authority under the FD&C Act to order a recall of a cosmetic, although it can request that a firm recall a product.”

This places the full responsibility for product safety and recall on the cosmetic firm or manufacturer. But what of harmful products released without proper internal safety screening? Is the FDA truly helpless to enact restrictions? In the case of a voluntary cosmetic recalls the FDA does monitor a recall’s progress and can submit recall request if a firm is otherwise unwilling to withdraw the a known harmful product from the market.

This active involvement assists firms in monitoring cosmetic recalls and taking the appropriate action. Consumers play a large part in reporting cosmetic product failures through MedWatch online. Once discovered, the FDA conducts private testing on cosmetics reported to be potentially harmful. If product testing reveals a safety issue the FDA may seek legal intervention to prohibit further sale of the cosmetic.
Upon the discovery of a damaged or adulterated product, if a company refuses to recall the cosmetic the FDA can pursue legal action through the Department of Justice. The charges brought against a cosmetic firm will vary depending on the health hazard classification and other factors. The FDA may also request a restraining order against the manufacturer or ask that the government seize the contaminated product, thereby removing the product from market by legal force.
Per the FDA’s website legal action may include:
  • Asking a federal court to issue an injunction
  • Requesting that U.S. marshals seize the products
  • Initiating criminal action
  • Refusing entry of an imported cosmetic
  • Requesting that a company recall a product
Though the FDA cannot independently require specific action they work with cosmetic companies and the federal government to safeguard products. Voluntary recalls are the most common occurrence as cosmetic firms partner with the FDA to ensure recalls are effective and thus avoid litigation. The FDA monitors the recall process, privately evaluating the potential hazard, as well as outlining a potential recall strategy and facilitating public notification. These measures are taken as a way to support responsible manufacturing and provide necessary guidance through the recall process and guarantee public awareness.
Cosmetic firms and manufactures should stay ahead of hazards by instating quality protocols, performing correct labeling practices, and finding a contamination testing facility to monitor formula purity. Firms should also know their responsibility during a recall and how to prevent future problems.