FDA warns network of websites for unlawfully selling opioids, benzodiazepines

Regulatory NewsRegulatory News | 23 August 2022 |  By 

The US Food and Drug Administration (FDA) last week sent a warning letter to Tramadol US, which is linked to more than two dozen websites that sell unapproved and misbranded opioids and other drugs to US consumers.
A review of the websites named in the warning letter by Regulatory Focus found that the websites list the same customer service phone number, and several use non-existent mailing addresses. Some of the spurious websites include yellowxanaxbarsforsale.com, buyadderallpill.com, onlinemedzonline.com and purduepharm.com, whose website is only one letter off from opioid maker Purdue Pharma’s actual website. At the time of publication, the website “tramadolus.org” has been taken down.
On 23 August, the FDA announced it had sent a letter to Tramadol US on 16 August, though it is unclear who runs the operation, which runs dozens of websites selling unapproved and misbranded drugs. The warning letter notably does not name any executives or employees of the operation, nor does it list an address. The agency does not appear to know what country the operation is based in, as evidenced by this conditional statement later in the warning letter: “If you are not located in the U.S., please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission.”
“FDA has observed that Tramadol US introduces into interstate commerce unapproved and misbranded opioid drug products,” the FDA said. “Opioid addiction and abuse have created an immense public health crisis, and the death toll is staggering. Given the severity of the opioid epidemic, the easy availability of opioids via the Internet poses significant risks to U.S. consumers.”
“FDA has also observed that Tramadol US introduces into interstate commerce misbranded benzodiazepines,” the agency added. “Benzodiazepines are drug products with an acknowledged potential for abuse, and it is important to address the public health impact of their nonmedical use.”
Besides the potential for abuse, the agency warns that without regulatory oversight, the drugs may be contaminated, counterfeit, contain varying amounts of active ingredients or contain different ingredients altogether.
The agency has asked Tramadol US to cease sales of any unapproved or misbranded drugs for sale in the US immediately to shield the public from harm.
Besides failing to hold drug applications, the FDA says the drugs sold by Tramadol US are misbranded because they fail to include proper labeling, including adequate directions for use, to protect consumers.
“Additionally, FDA has observed that Tramadol US offers prescription drugs for sale without a prescription,” the agency said in its letter.
Regulators note that the site yellowxanaxbarsforsale.com offers alprazolam marketed as “Yellow Xanax Bars” described as “a moderate strength of alprazolam with 2mg of active drug.” The site allows consumers to directly order the drug without a prescription as required by law.
“FDA is sending this warning letter to Tramadol US because of the inherent risks to consumers who purchase misbranded and unapproved new drugs,” the agency said. “It is your responsibility to ensure that all products you offer for sale are in compliance with the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the FD&C Act (which may include the offer for sale of similarly misbranded and/or unapproved new drugs other than the drugs noted above). We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a use for which they have not been approved by FDA and that you are not distributing misbranded products in violation of the FD&C Act.”
The FDA has given the operation 15 days to respond by describing the specific steps it has taken to address any violations and to prevent their recurrence. The agency warned Tramadol US that failure to respond could result in legal action that could include “seizure and injunction, without further notice.”


© 2022 Regulatory Affairs Professionals Society.

Discover more of what matters to you