March 13, 2019
FDA sends warning letters to two entities selling mislabeled and unapproved abortion drugs over the Internet
On Monday, the FDA sent warning letters to two online entities for introducing “Misbranded and Unapproved New Drugs into Interstate Commerce,” specifically mifepristone and misoprostol, the two drugs that make up the “RU-486”abortion technique.
AidAccess.org and Rablon were told to immediately stop selling unapproved versions of the drugs and to “respond to FDA concerns within 15 working days outlining how it will correct its regulatory violations,” according to Julia Belluz of Vox.com.
In its letter to AidAccess, the FDA wrote:
The sale of misbranded and unapproved new drugs poses an inherent risk to consumers who purchase those products. Unapproved new drugs do not have the same assurance of safety and effectiveness as those drugs subject to FDA oversight. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
FDA requests that you immediately cease offering violative drugs for sale to U.S. consumers.
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