| August 23, 2022 | By
The U.S. Food and Drug Administration (FDA) last week issued a warning letter to Tramadol U.S., which is linked to more than two dozen websites that sell opioids and other unapproved and misdirected drugs. labeled to US consumers.
A review of the websites named in the warning letter by Regulatory guidance found that the websites list the same customer service phone number and several use non-existent mailing addresses. Some of the fake websites include yellowxanaxbarsforsale.com, buyadderallpill.com, onlinemedzonline.com and purduepharm.com, whose website is just one letter away from the actual website of opioid maker Purdue Pharma. At the time of publication, the “tramadolus.org” site has been taken down.
On August 23, the FDA announced that it had sent a letter to Tramadol US on August 16, although it is unclear who is running the operation, which runs dozens of websites selling unapproved and misdirected drugs. labeled. In particular, the warning letter does not name any officer or employee of the operation, nor does it indicate an address. The agency does not appear to know in which country the operation is based, as evidenced by this conditional statement later in the warning letter: “If you are not located in the United States, please note that products that appear to be mislabeled or new unapproved drugs may be detained or denied admission.
“The FDA has observed that Tramadol US is introducing unapproved and mislabeled opioid drugs into interstate commerce,” the FDA said. “Opioid addiction and abuse has 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 risks important to American consumers.
“The FDA has also observed that US Tramadol is introducing mislabeled benzodiazepines into interstate commerce,” the agency added. “Benzodiazepines are drug products with recognized abuse potential, and it is important to address the public health impact of their non-medical use.”
Besides the potential for abuse, the agency warns that without regulatory oversight, drugs can be contaminated, counterfeit, contain varying amounts of active ingredients, or contain completely different ingredients.
The agency has asked Tramadol US to immediately stop selling any unapproved or mislabeled drugs in the United States to protect the public from harm.
In addition to not honoring drug applications, the FDA says drugs sold by Tramadol US are mislabeled because they do not include proper labeling, including proper instructions for use, to protect consumers.
“Additionally, the FDA has observed that Tramadol US offers prescription drugs for sale without a prescription,” the agency said in its letter.
The regulators note that the site yellowxanaxbarsforsale.com offers alprazolam marketed as “Yellow Xanax Bars” described as “a moderate strength of alprazolam with 2 mg of active drug.” The site allows consumers to directly order the drug without a prescription as required by law.
“The FDA is sending this warning letter to Tramadol US because of the inherent risks to consumers purchasing mislabeled and unapproved new drugs,” the agency said. “It is your responsibility to ensure that any products you offer for sale comply with FD&C law and its regulations. You must take prompt action to remedy any violation of FD&C law (which may include offering to sell new, similarly branded and/or unapproved drugs other than the drugs mentioned above.) We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you do not misrepresent your products as safe and effective for a use for which they have not been approved by the FDA, and that you do not distribute mislabeled products in violation of the law FD&C.
The FDA gave the operation 15 days to respond, outlining the specific steps it has taken to address any violations and prevent them from happening again. The agency warned Tramadol US that failure to respond could result in legal action that could include “seizure and injunction, without further notice.”
© 2022 Society of Regulatory Affairs Professionals.
