On May 29, 2018 FDA posted 9 warning letters to online retailers whose networks offered or introduced into interstate commerce, opioids that are misbranded and unapproved new drugs, in violation of sections 301(a), 301(d), 503(b), and 505(a) of the FD&C Act [21 U.S.C. §§ 331(a), 331(d), 353(b), and 35S(a)].
As reported in the warning letters:
Offering unapproved opioids for sale is particularly concerning given their potential for abuse and dependency, especially amid the growing opioid epidemic in the U.S. On average, 115 Americans die every day from an opioid overdose.1 In 2016, opioids killed more than 42,000 people 2, surpassing even the number of deaths resulting from traffic accidents in the U.S.3
The 9 organizations received warning letters included a significant number of online stores (53 unique URLs were identified). These included:
XLPharmacy 10 online webstores
Instabil ECS-Rx, 4 oneline webstores
Medstore.biz, 8 online webstores
AnonShop, 1 online webstore
Tramado|Hub, 3 online webstores
RxCash.Biz, 14 online webstores
One Stop Pharma, 2 online webstores
RemedyMart, 2 online webstores
Easybuyonline, 9 online webstores
The above facilities were cited for offering unapproved new drugs and for misbranding of drugs.
Examples of Unapproved new drugs include:
For example, XLPharmacy offers tramadol, marketed as “Tramadol Generic (Ultrum)” and described as being “used in cases of moderate to moderately severe pain.” While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Ultrum” offered by XLPharmacy.
For example,Eassybuyonline offers tramadol, marketed as “Citra” and described as a“narcotic-like pain reliever”that is“used to treat moderate to severe pain.” While there are FDA-approved versions of tramadol on the market in the U.S., there are no approved drug applications pursuant to section 505 of the FD&C Act in effect for the “Citra” offered by Eassybuyonline.
Examples of Misbranding include:
Because the aforementioned drug is a prescription drug intended for a condition(s) 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(s). Consequently, the labeling for this drug fails to bear adequate directions for its intended use(s), causing it to be misbranded under section 502(f)(1) of the FD&C Act.
1 Centers for Disease Control and Prevention, Understanding the Epidemic (August 30, 2017),
https://www.cdc.gov/drugoverdose/epidemic/index.html [last visited May 21, 2018]
2 Centers for Disease Control and Prevention, Opioid Overdose (October 23, 2017),
https://www.cdc.gov/drugoverdose/index.html [last visited May 21, 2018]
3 U.S. Department of Transportation, USDOT Releases 2016 Fatal Traffic Crashes Data (October 6, 2017),
https://www.nhtsa.gov/press‐releases/usdot‐releases‐2016‐fatal‐traffic‐crash‐data [last visited May 21, 2018]