WARNING LETTER
kubapharm.com
MARCS-CMS 622051 —
March 30, 2022
Product:
Drugs
Recipient:
kubapharm.com
United States
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
TO: www.kubapharm.com
FROM: The United States Food and Drug Administration and The United States Drug Enforcement Administration
RE: Notice of Unlawful Sale of Schedule II Stimulants to United States Consumers Over the Internet
DATE: March 30, 2022
WARNING LETTER
This is to advise you that based on the United States (U.S.) Drug Enforcement Administration’s (DEA) review, www.kubapharm.com unlawfully offers to distribute or dispense stimulants that are Schedule II controlled substances, including amphetamine drug products, and advertises their sale in violation of the Ryan Haight Online Pharmacy Consumer Protection Act (RHA), P.L. 110-425 (October 15, 2008), as codified at 21 U.S.C. § 841(h) and § 843(c). In addition, based on the U.S. Food and Drug Administration’s (FDA) review, the FDA has observed that www.kubapharm.com introduces into interstate commerce amphetamine drug products that are misbranded in violation of sections 301(a), 301(k), and 503(b) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(k), and 353(b)].
Schedule II stimulants have an acknowledged high potential for abuse, and it is important to address the public health impact of their diversion and nonmedical use. Diversion is the primary source of prescription stimulants for nonmedical use, and nonmedical use is most frequent among young adults and college students. Polysubstance use is common among those who use prescription stimulants nonmedically, with individuals frequently co-using illicit drugs and/or prescription opioids. These concerns come against a backdrop of rising mortality from psychostimulant-involved overdoses, which involve illicit stimulants the vast majority of the time, but sometimes involve prescription stimulants.
The easy availability of these stimulants via the Internet poses additional significant risks to U.S. consumers. Additionally, the sale of misbranded drugs, including misbranded stimulants, poses an inherent risk to consumers who purchase those products. Drugs that have circumvented regulatory safeguards may be contaminated, counterfeit, contain varying amounts of active ingredients, or contain different ingredients altogether.
As set forth more fully in this Warning Letter, we request that you take any necessary corrective action and notify DEA and FDA of any remedial steps that you have taken to address any violations of Federal law. This letter also provides a procedure if you wish to contest this Warning Letter with respect to your website(s). After 15 days, failure to adequately address this matter may result in further action by DEA and FDA including potentially contacting the domain name registrar(s) associated with your website(s) and informing them of your actions.
Under the RHA, an “online pharmacy” is a “person, entity, or Internet site, whether in the U.S. or abroad, that knowingly or intentionally delivers, distributes, or dispenses, or offers or attempts to deliver, distribute, or dispense, a controlled substance by means of the Internet.” 21 U.S.C. § 802(52)(A) (emphasis added). It is unlawful to knowingly or intentionally “deliver, distribute, or dispense a controlled substance by means of the Internet, except as authorized [by the Controlled Substances Act (CSA)],” or to knowingly or intentionally aid or abet such activity. 21 U.S.C. § 841(h)(1). This includes, for example, knowingly or intentionally “delivering, distributing, or dispensing a controlled substance by means of the Internet by an online pharmacy that is not validly registered” with a modified DEA registration authorizing such activity, see 21 U.S.C. § 841(h)(2)(A), or knowingly or intentionally serving as an “agent, intermediary, or other entity that causes the Internet to be used to bring together a buyer and seller to engage in the dispensing of a controlled substance” without a modified DEA registration. 21 U.S.C. § 841(h)(2)(C).
In addition, under the RHA, it is also unlawful “for any person to knowingly or intentionally use the Internet, or cause the Internet to be used, to advertise the sale of, or to offer to sell, distribute, or dispense, a controlled substance where such sale, distribution or dispensing is not authorized by [the CSA] or by the Controlled Substances Import and Export Act” (CSIEA). 21 U.S.C. § 843(c)(2)(A). Examples include “knowingly or intentionally causing the placement on the Internet of an advertisement that refers to or directs prospective buyers to Internet sellers of controlled substances” who do not possess a valid modified DEA registration. 21 U.S.C. § 843(c)(2)(B) (with limitations described in 21 U.S.C. § 843(c)(2)(C)).
No Modified DEA Registration Exists for Your Website(s)
Your website(s) constitutes an “online pharmacy” because it is an Internet site that knowingly or intentionally offers to deliver, distribute, or dispense a controlled substance by means of the Internet. 21 U.S.C. § 802(52). Moreover, as the owner and domain name subscriber responsible for operation of the website(s), you are serving as an agent or other entity that causes the Internet to be used to bring together buyers and sellers for the purpose of dispensing a controlled substance. DEA has determined that you are not in possession of a modified DEA registration authorizing you to engage in such activity. Accordingly, your actions constitute a violation of U.S. law, which are subject to criminal penalties and civil enforcement.
In addition, you knowingly or intentionally use the Internet to advertise the sale of controlled substances by directing prospective buyers to Internet sellers of controlled substances who do not possess a valid modified DEA registration. You do not possess a valid modified DEA registration authorizing such activity, and your actions do not fall into the exceptions of 21 U.S.C. § 843(c)(2)(C). Therefore, your website(s) is operating in violation of U.S. law, which may be enforced through criminal penalties and civil enforcement.
Misbranded Drug(s)
Certain products offered for sale by www.kubapharm.com are drugs within the meaning of section 201(g) of the FD&C Act [21 U.S.C. § 321(g)] because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or because they are intended to affect the structure or function of the body.
For example, www.kubapharm.com offers an amphetamine drug product for sale listed as “Buy Adderall Online Now.” Adderall is the brand name of an FDA-approved drug for the treatment of attention deficit hyperactive disorder (ADHD) and narcolepsy that is only available by prescription. Using the brand name of the drug product Adderall indicates that this product is intended to treat ADHD and narcolepsy. FDA-approved Adderall bears a boxed warning, commonly referred to as a “black box warning,” which is the strongest warning FDA requires, indicating that the drug carries a significant risk of serious or even life-threatening adverse effects. The boxed warning indicates that amphetamines, including Adderall, have a high potential for abuse and dependence.
The FDA-approved product Adderall is a stimulant medication. All stimulants that have been approved for marketing by FDA are limited by an approved new drug application to use under the supervision of a licensed practitioner to administer such drugs. Therefore, Adderall is a prescription drug as defined in section 503(b)(1)(A) of the FD&C Act (21 U.S.C. § 353(b)(1)(A)), because, in light of its toxicity or potential for harmful effects, the method of its use, or the collateral measures necessary for its use, it is not safe for use except under the supervision of a practitioner licensed by law to administer such a drug. By offering the aforementioned drug without requiring a prescription, www.kubapharm.com 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)]. By offering this drug for sale to U.S. consumers, www.kubapharm.com is also causing the introduction of a misbranded drug into interstate commerce in violation of section 301(a) of the FD&C Act [21 U.S.C. § 331(a)].
This letter is not intended to identify all the ways in which your activities might be in violation of U.S. law. It is your responsibility to ensure that all products you offer for sale on your website(s) are in compliance with Federal law, including but not limited to the RHA and its implementing regulations, as well as the FD&C Act and its implementing regulations. You should take prompt action to address any violations of the RHA and the FD&C Act. Failure to adequately address this matter may result in legal action, including but not limited to, seizure, injunction, and/or temporary restraining order without further notice. Nothing in this letter should be deemed to preclude any other action, criminal or civil, by U.S. authorities.
Please notify DEA and FDA, in writing, within 15 working days of receipt of this letter describing the specific steps you have taken or will take to address any violations and to prevent their recurrence. Include an explanation of each step being taken to remedy and prevent the recurrence of any violations, as well as copies of related documentation. If the corrective action(s) cannot be completed within 15 working days, state the reason for the delay and the time within which the corrections will be completed. This letter notifies you of our concerns and provides you with an opportunity to address them. If you believe that your products are not in violation of the RHA and FD&C Act, include your reasoning and any supporting information for our consideration within 15 working days.
After 15 days, DEA and FDA may take any additional actions that they determine to be necessary, potentially including contacting the domain name registrar(s) associated with your website(s) and informing them of your actions. Please note that the transmission of this Warning Letter does not prohibit DEA or FDA from taking any or all other actions permitted by law, including the initiation of civil or criminal proceedings against you, your website(s), or materials that you have intended for distribution.
If you are not located in the U.S., please note that products that appear to be misbranded drugs may be detained or refused admission. FDA may advise the appropriate regulatory officials in the country from which you operate that your products referenced above appear to be misbranded products that cannot be legally sold to consumers in the U.S.
Your response to DEA should be sent to the following e-mail address: DEA.Online.Pharmacy.Request@usdoj.gov. Your response to FDA should be sent to the following e-mail address: FDAInternetPharmacyTaskForce-CDER@fda.hhs.gov. Please direct any inquiries regarding this letter to DEA and FDA at the e-mail addresses provided.
Sincerely,
/S/
Wendy C. Woolcock
Special Agent in Charge
Special Operations Division
Drug Enforcement Administration
/S/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Content current as of:
04/12/2022
Regulated Product(s)
Drugs