WARNING LETTER
Divyata
September 06, 2019
Product:
Drugs
Recipient:
Divyata
United States
Issuing Office:
Center for Drug Evaluation and Research
10903 New Hampshire Avenue
Silver Spring
,
MD
20993
United States
TO: Divyata
FROM: The United States Food and Drug Administration and
The United States Drug Enforcement Administration
RE: Notice of Unlawful Sale of Opioids to
United States Consumers Over the Internet
DATE: September 6, 2019
WARNING LETTER
The United States Drug Enforcement Administration (DEA) has determined that Divyata unlawfully offers to distribute or dispense controlled substances, including opioids, 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, the United States Food and Drug Administration (FDA) has determined that Divyata introduces into interstate commerce misbranded and unapproved new drugs in violation of sections 301(a), 301(d), and 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act) [21 U.S.C. §§ 331(a), 331(d), and 355(a)].
Opioid addiction and abuse have 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 significant risks to U.S. consumers. Accordingly, DEA and FDA request that you immediately cease offering violative drugs for sale to U.S. consumers. This is critical to shielding the American public from harm.
As set forth more fully in this Warning Letter, you are directed to take corrective action immediately and to notify DEA and FDA of the remedial steps that you have taken to address the violations of Federal law. This letter also provides a procedure if you wish to contest DEA’s and FDA’s position with respect to your websites. After 15 working days, DEA and FDA anticipate potentially taking additional measures, including contacting the domain name registrars associated with your websites and informing them of your actions.
Under the RHA, an “online pharmacy” is a “person, entity, or Internet site, whether in the United States 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 Websites
Your websites constitute “online pharmacies” because they are Internet sites that knowingly or intentionally offer 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 websites, 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 United States 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 websites are operating in violation of United States law, which may be enforced through criminal penalties and civil enforcement.
Unapproved New Drugs
As labeled, certain products offered for sale by Divyata 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. These drugs are also 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 for their labeled uses. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in section 505(a) of the FD&C Act [21 U.S.C. § 355(a)]. No approved applications pursuant to section 505 of the FD&C Act are in effect for these products. Accordingly, their introduction or delivery for introduction into interstate commerce violates sections 301(d) [21 U.S.C. § 331(d)] and 505(a) of the FD&C Act.
For example, Divyata offers tramadol, marketed as “Tramadol (Ultram) 100 mg” manufactured by “Dimedics” and described as a “painkiller” and an “agony reliever that ties with receptors of the mind and sensory system to diminish dimensions of torment.” 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 tramadol product manufactured by Dimedics offered by Divyata. FDA-approved tramadol 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 addresses risks including addiction, abuse, misuse, life-threatening respiratory depression (breathing problems), and neonatal opioid withdrawal syndrome (withdrawal symptoms in newborn baby). In addition, when taken in conjunction with other central nervous system depressants, including alcohol, use may result in coma or death.
Misbranded Drugs
A drug is misbranded under section 502(f)(1) of the FD&C Act [21 U.S.C. § 352(f)(1)] if it fails to bear adequate directions for its intended use. “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1) of the FD&C Act [21 U.S.C. § 353(b)(1)] include those that, because of their toxicity or other potentiality for harmful effect, and/or the method of their use, and/or the collateral measures necessary for their use, are not safe for use except under supervision of a practitioner licensed by law to administer them. Prescription drugs, as defined in section 503(b)(1)(A) of the FD&C Act, can only be used safely at the direction, and under the supervision, of a licensed practitioner.
Because the aforementioned drug is a prescription drug intended for a condition 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. Consequently, the labeling for this drug fails to bear adequate directions for its intended use, causing it to be misbranded under section 502(f)(1) of the FD&C Act. In addition, because this drug is not approved in the U.S., it is also not exempt under 21 CFR 201.115(a) from the requirements of section 502(f)(1) of the FD&C Act. By offering this drug for sale to U.S. consumers, Divyata is 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 United States law. It is Divyata’s responsibility to ensure that all products you offer for sale on your websites 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 correct the aforementioned violations. Failure to address these violations 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 of any steps you have taken or will take to correct the noted violations and to prevent their recurrence. 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.
After 15 working days, DEA and FDA may take any additional actions that they determine to be necessary, potentially including contacting the domain name registrars associated with your websites 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 websites, or materials that you have intended for distribution.
If you dispute the allegations set forth in this Warning Letter or believe that you have received it in error, please contact DEA and FDA immediately. Your response to DEA should be sent to the following email 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.
Table of Websites:
Connecting URLs
buying-tramadolonline.com
lionmeds.com
Sincerely,
/s/
Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
/s/
Neil Doherty
Acting Assistant Administrator
Diversion Control Division
Drug Enforcement Administration
Content current as of:
09/30/2019
Regulated Product(s)
Drugs