The Food & Drug Administration recently sent warning letters to businesses that are selling abortion pills online that the federal entity deemed unapproved and mislabeled.
The FDA sent a warning letter last week to Aid Access, a website that claims to provide safe abortion pills for “women, girls and trans men.”
Signed by Thomas Christi, director of the Office of Drug Security, Integrity, & Recalls at FDA, the letter says that the website has introduced “misbranded and unapproved new drugs” in “interstate commerce” in violation of federal law.
Two specific examples cited by the FDA were the drugs mifepristone and misoprostol, which were labeled “unapproved,” adding that “they are not generally recognized as safe and effective for their labeled use.”
“Aidaccess.org facilitates the sale to U.S. consumers of unapproved mifepristone in a regimen with unapproved misoprostol labeled for the termination of pregnancy,” states the letter.
“No approved applications pursuant to section 505 of the FD&C Act are in effect for this product. Accordingly, its introduction or delivery for introduction into interstate commerce violates sections 301(d) (21 U.S.C. § 331(d)] and 505(a) (21 U.S.C. § 355(a)] of the FD&C Act.”
Another warning letter was sent last week to Rablon, an online pharmacy network that oversees several websites including some that sell abortion pills.
According to the letter, also signed by Christi, Rablon offered a product known as an “Abortion Pill Pack," which included both mifepristone and misoprostol tablets.
“Because the ‘Abortion Pill Pack’ product contains prescription drugs intended for a condition that is not amenable to self-diagnosis and treatment by a layperson, adequate directions cannot be written such that a layperson can use the product safely for its intended use,” reads the FDA letter.
“By offering this drug for sale to U.S. consumers, Rablon is causing the introduction of a misbranded drug into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].”
Both entities were told by the FDA to immediately cease providing the online abortion pills, being told to contact the FDA office within 15 days of receiving its warning letter.
Dr. Randall K. O’Bannon of the National Right to Life Committee supported the FDA’s action, saying in a statement released Tuesday that it showed “there are still people at the FDA who look at the evidence and see drugs that come with serious risks and require, at a minimum, professional medical management.”
“They also recognize that in their zeal to push these do-it-yourself abortions, these advocates have incautiously partnered with shady or sloppy foreign pharmaceutical companies who manufacture and ship drugs of which the FDA cannot guarantee the purity or safety,” stated O’Bannon.
“That they come without instructions or without clear safety warnings is reason enough for the FDA to halt the import of these drugs.”
Launched last year, Aid Access had reportedly shipped abortion-inducing drugs to approximately 600 women within its first six months of operation.
The FDA began investigating Aid Access last year, noting that mifepristone, which is also called RU-486 or Mifeprex, is not allowed for sale online.