OR WAIT 15 SECS
FDA and DEA warn four website operators to stop illegally selling opioids.
The US FDA and the US Drug Enforcement Administration (DEA) have issued joint warning letters to four online networks, operating a total of 10 websites, that are illegally marketing unapproved and misbranded versions of opioid medicines, FDA said in a Sept. 30, 2019 press release. The warning letters issued to each of the networks state that they must immediately stop illegally selling these opioids to American consumers. This joint action demonstrates the federal government’s commitment to enhance interagency coordination to respond to the opioid crisis.
Patients who buy prescription medicines, including opioids, from illegal online pharmacies may be putting their health at risk because the products, while being marketed as authentic, may be counterfeit, contaminated, expired, or otherwise unsafe, said FDA in the release. Some offer opioids online without a prescription, which poses significant risks to patients and may further fuel the opioid crisis. As noted in the warning letters, these websites offer for sale opioids that are misbranded and unapproved new drugs, including unapproved tramadol, in violation of the Federal Food, Drug, and Cosmetic Act. FDA-approved tramadol carries a boxed warning, the agency’s most prominent warning, indicating that the drug carries a significant risk of serious or even life-threatening side effects.
According to the press release, the networks also violated the Controlled Substances Act (CSA) by failing to register their online pharmacies with the DEA despite knowingly or intentionally advertising the sale of controlled substances, including opioids. None of the websites are currently registered with the DEA to dispense or distribute controlled substances online, as required by the CSA.
The networks receiving warning letters include Divyata, Euphoria Healthcare Pvt Ltd., JCM Dropship, and Meds4U. FDA and DEA have directed the companies to inform each agency of the specific actions taken to address the violations noted in the warning letters, or they may be subject to legal enforcement action.