Date: April 6, 2020
RE: Unapproved and Misbranded Products Related to Coronavirus Disease 2019 ( COVID-19)
This is to encourage you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) evaluated your site at the Web address https://farm2pharmacy.com on March 25, 2020 and April 2, 2020, respectively. The FDA has actually observed that your site provides cannabidiol (CBD) items, in some cases referred to as hemp products on your sites, for sale in the United States and that these products are meant to reduce, avoid, treat, diagnose, or cure COVID-19 in individuals.
There is presently an international outbreak of breathing illness triggered by an unique coronavirus that has actually been named “severe intense respiratory syndrome coronavirus 2” (SARS-CoV-2). For That Reason, FDA is taking urgent measures to protect consumers from certain items that, without approval or authorization by FDA, claim to reduce, avoid, treat, detect, or treatment COVID-19 in individuals.
Some examples of the claims on your sites that establish the designated usage of your items and misleadingly represent them as safe and/or efficient for the treatment or prevention of COVID-19 include:
- ” Marijuana Indica speeds up Recovery from Coronavirus … Serious intense breathing syndrome (SARS) is a viral respiratory illness triggered by the SARS coronavirus (SARS-CoV) … Curing coronavirus infection prevents clinical SARS. Cannabis indica accelerate healing … 2 plants Marijuana sativa and Cannabis indica Their [sic] resins contain hundreds of cannabinoids. I suggest just marijuana indica extracts which are not psychoactive … ‘Marijuana indica resin is antiviral and prevents cell expansion'” [from the blog section of your website https://farm2pharmacy.com – published on March 20, 2020]
- ” Do Not Fear the #CoronaVirus BATTLE it with us! Soap, immune enhancing oils & more!” [from a March 12 post on your Facebook social media website https://www.facebook.com/NativeRootsHemp/]
- ” ESSENTIAL CORONA VIRUS UPGRADE (COVID 19)
Please be advised that our team at Native Roots Hemp takes the infection seriously … We have offered FREE full-spectrum hemp oil to all staff member to help with keeping their Endocannabinoid System healthy, which handles our body’s immune system.” [from a March 16 post on your social media website https://www.facebook.com/NativeRootsHemp/]
- ” Hemp/CBD increases your immune system.
#FightTheVirus [from a March 14 post on your Facebook social media website https://www.facebook.com/NativeRootsHemp/]
You need to take instant action to correct the infractions mentioned in this letter. This letter is not implied to be an all-encompassing list of violations that exist in connection with your items or operations. It is your responsibility to guarantee that the items you offer remain in compliance with the FD&C Act and FDA’s carrying out guidelines. We recommend you to evaluate your sites, product labels, and other labeling and promotional products to guarantee that you are not misleadingly representing your products as safe and effective for a COVID-19- associated usage for which they have actually not been authorized by FDA and that you do not make claims that misbrand the products in infraction of the FD&C Act Within 48 hours, please send out an e-mail to COVID-19- [email protected] describing the specific steps you have taken to remedy these infractions. Consist of an explanation of each step being required to prevent the recurrence of infractions, as well as copies of related documents. Failure to instantly remedy the violations mentioned in this letter may lead to legal action, including, without constraint, seizure and injunction.
FDA is encouraging customers not to acquire or utilize particular products that have not been approved, cleared, or authorized by FDA which are being misleadingly represented as safe and/or effective for the treatment or avoidance of COVID-19 Your company will be added to a released list on FDA’s site of firms and sites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related items in infraction of the FD&C Act. This list can be found at http:// www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19- items When you have actually taken restorative actions to stop the sale of your unapproved and unauthorized products for the mitigation, avoidance, treatment, diagnosis, or treatment of COVID-19, and such actions have actually been confirmed by the FDA, the released list will be updated to indicate that your firm has taken appropriate restorative action.
If you can not finish corrective action within 48 hours, state the reason for the delay and the time within which you will complete the corrections. If you believe that your products are not in offense of the FD&C Act, include your reasoning and any supporting information for our factor to consider.
If you are not located in the United States, please note that items that seem misbranded or unapproved new drugs undergo detention and rejection of admission if they are used for importation into the United States. We may advise the proper regulative officials in the nation from which you run that FDA considers your items referenced above to be unapproved and misbranded products that can not be lawfully sold to customers in the United States.
Please direct any inquiries to FDA at COVID-19- [email protected]
In addition, it is unlawful under the FTC Act, 15 U.S.C. 41 et seq., to promote that a product can prevent, deal with, or cure human illness unless you have competent and reliable clinical proof, including, when proper, well-controlled human medical research studies, substantiating that the claims are true at the time they are made. For COVID-19, no such study is currently known to exist for the products recognized above. Therefore, any coronavirus-related avoidance or treatment claims regarding such products are not supported by proficient and trustworthy clinical proof. You should immediately cease making all such claims. Violations of the FTC Act may result in legal action looking for a Federal District Court injunction and an order might need that you pay back cash to customers. Within 48 hours, please send an email to Richard Cleland, Assistant Director of the FTC’s Department of Advertising Practices, through electronic mail at [email protected] explaining the specific actions you have actually required to deal with the FTC’s issues. If you have any questions relating to compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088
Donald D. Ashley
Workplace of Compliance
For Drug Examination and Research Study
Food and Drug Administration
Richard A. Quaresima
Acting Associate Director
Division of Advertising Practices
Federal Trade Commission