October 23, 2018
Registrar R01 LLC
123308 P.O. Box 99
Verisign Global Registry Services
12061 Bluemont Way
Reston, VA 20190
The United States Food and Drug Administration is a consumer protection agency of the United States Government that is, among other things, responsible for regulating and supervising the safety of medical products and enforcing laws regulating medical products. Accordingly, we have determined that the website listed below is offering misbranded and unapproved new drugs for sale to consumers in the United States in violation of the Federal Food, Drug and Cosmetic Act (FD&C Act) found at Title 21, United States Code, § 321, 331, 352, 353 and 355, et. seq and the Controlled Substances Act found at Title 21, United States Code, § 841 et. seq.
The domain names below are registered by your company:
Domains 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.  In 2016, opioids killed more than 42,000 people , surpassing even the number of deaths resulting from traffic accidents in the U.S. .
These websites offer misbranded and unapproved new drugs for sale to U.S. consumers
(e.g. tramadol, marketed as “OL-TRAM” and acyclovir, marketed as “Aciclovir”). These products appear to be new drugs as defined by section 201(p) of the FD&C Act, 21 U.S.C. §321(p), because they are “not generally recognized as safe and effective.” Pursuant to section 505(a) of the Act, 21 U.S.C. §355(a), a new drug may not be introduced or delivered for introduction into interstate commerce unless it is the subject of an approved application. In addition, the introduction or delivery for introduction of such misbranded and unapproved new drug products into U.S. interstate commerce is a prohibited act per section 301 of the Act, 21 U.S.C. §321.
Furthermore, under U.S. law, prescription drugs can be dispensed only pursuant to a prescription from a healthcare practitioner licensed by law to administer prescription drugs. Offering for sale new drugs without requiring a prescription jeopardizes patient safety and misbrands the drug under section 503(b)(1) of the FD&C Act. Dispensing a prescription drug without a prescription is an act which results in the drug being misbranded while held for sale, in violation of section 301(k) of the FD&C Act (21 U.S.C. § 331(k)].
This is an abuse complaint submitted to you under Section 3.18.2 of the 2013 ICANN Registrar Accreditation Agreement (RAA) regarding the use of domain names for illegal purposes. The 2013 RAA contains requirements pertaining to your duty to investigate and respond appropriately to reports of illegal activity (Sections 3.18 and 1.13). An appropriate response to this complaint would be to ensure that this website is not able to sell or otherwise offer for sale any unapproved drugs or uncleared devices, or potentially counterfeit, controlled, adulterated or misbranded products to U.S. consumers in violation of U.S. law.
Thank you for your prompt attention to this matter. This abuse complaint is not intended to be an all-inclusive list of violations. Should your company or the registrant have any questions, please contact me at the contact information below.
Health Fraud Branch
Office of Regulatory Affairs
 Centers for Disease Control and Prevention, Understanding the Epidemic (August 30, 2017),
 Centers for Disease Control and Prevention, Opioid Overdose (October 23, 2017),