MASSDEVICE ON CALL — FDA regulators this week issued a letter to online distributors, warning them to obey federal law or face punitive measures.
Healthcare authorities reviewed a series of internet vendors which market decorative contact lenses, which do not help with vision but only change the appearance of the eye.
Even though the lenses don’t provide visual improvement, they do require a prescription by law, FDA regulators noted.
"We advise you to review your websites, product labels and labeling, and promotional materials to ensure that the claims you make do not adulterate or misbrand your products," the FDA said. "Failure to promptly correct violations of the FDCA may result in enforcement action being initiated by FDA without further notice."
"These actions include, but are not limited to, seizure, injunction, and civil money penalties," the federal watchdog agency added.
Failing to take corrective actions could lead to further investigation, including referral to FDA’s Office of Criminal Investigations for possible criminal prosecution for violations of the FDCA and other federal laws.
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