Feds Continue Crackdown on Internet Advertisements and Sale of Drugs and Supplements
July 19, 2019
By: Matthew Rubin, Faegre Baker Daniels Consulting
Consistent with ongoing efforts to combat the availability of prescription drugs and controlled substances online, the Food and Drug Administration (FDA) and Drug Enforcement Administration (DEA) have both recently announced significant actions to mitigate threats to public health and patient safety. Capitalizing on hot-button topics such as the opioid epidemic or popular therapeutic classes such as lifestyle or muscle-building drugs, illegal online drug sellers have continued to offer products in violation of state and federal law and pharmacy practice standards.
In late June 2019, FDA issued warning letters to both Cali Botanicals and Kratom NC for the illegal advertisement and sale of unapproved and misbranded drugs containing kratom, a plant indigenous to Southeast Asia. While there are no FDA-approved indications for the use of kratom in medical practice and there are significant concerns about its safety, the organizations sold these products to consumers by way of unapproved product claims. According to the warning letters, Cali Botanicals and Kratom NC made unsubstantiated claims around kratom’s use to treat or cure opioid use disorders, avoid opioid-induced withdrawal, and to help treat other serious medical conditions such as depression, anxiety, or cancer. Through online websites and social media posts, the organizations promulgated dangerous and false information around the products which, in turn, could have significant patient safety impacts on those who might rely on the products. Within 15 days of warning letter receipt, FDA has requested a formal response identifying ways in which the organizations will address the specific violations identified in the warning letters.
Shortly thereafter, DEA announced that three Slovenian nationals are now considered fugitives for their role in a complex, international anabolic steroid importation scheme. Through a network of manufacturers, wholesalers, distributors, and shippers, Mihael Karner allegedly operated a criminal enterprise responsible for the distribution of millions of anabolic steroid dosage units and laundering of money throughout various foreign countries. Karner and his collaborators are alleged to have operated over 200 websites that advertised and sold controlled substances to United States consumers, which incurred scrutiny from DEA officials in the US, Austria, Italy, Croatia, and China. All three individuals referenced in the allegations had been previously indicted on charges related to the illicit importation and distribution of anabolic steroids. The Department of State has offered a $5 million reward for information leading to their arrest.
The easy availability of these products – targeting highly prevalent disease states and in-demand therapeutic outcomes – further underscores the need for a resource that offers consumers and health care providers an opportunity to identify safe sources of medication online. Resources that have been approved as part of the .Pharmacy Verified Websites Program will help to bridge the gap and ensure that both the information and products consumers receive are legitimate and appropriate. Without these resources, consumers remain at risk of being duped – and harmed – by illegal actors like Karner, who simply place profits ahead of patients.