Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) Functional Remedies offers full-spectrum hemp oil produced with a proprietary, whole-plant lipid infusion process to get phytonutrients out of the plant.
Functional Remedies, LLC D/B/A Synchronicity Hemp Oil MARCS-CMS 627208 — March 28, 2022
This is to advise you that the United States Food and Drug Administration (FDA) and the Federal Trade Commission (FTC) reviewed your website at the Internet address https://synchronicityhempoil.com/ on February 16, 2022, and March 1, 2022, respectively. The FDA has observed that your website offers Full-Spectrum Hemp Oil and cannabidiol (CBD) products for sale in the United States and that these products are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 1 in people. Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352. The introduction or delivery for introduction of these products into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
There is currently a global outbreak of respiratory disease caused by a novel coronavirus that has been named “severe acute respiratory syndrome coronavirus 2” (SARS-CoV-2). The disease caused by the virus has been named “Coronavirus Disease 2019” (COVID-19). On January 31, 2020, the Department of Health and Human Services (HHS) issued a declaration of a public health emergency related to COVID-19 and mobilized the Operating Divisions of HHS. 2 In addition, on March 13, 2020, there was a Presidential declaration of a national emergency in response to COVID-19. 3 Therefore, FDA is taking urgent measures to protect consumers from certain products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure COVID-19 in people. We request that you take immediate action to cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19.
Some examples of the claims on your website that establish the intended use of your products and misleadingly represent them as safe and/or effective for the treatment or prevention of COVID-19 include:
- “Hemp Oil has been shown to possibly reduce viral inflammation, known as a cytokines storm, which can be detrimental and even deadly to a person suffering from a viral infection, such as COVID-19.” [from a November 24, 2020 blog post titled “Can Hemp Oil Combat Inflammation and Viruses?” on your website https://synchronicityhempoil.com/hemp-oil-to-treat-inflammation-andviruses/]
- “Exciting Discoveries: CBD and COVID-19 Research released in May 2020 revealed fascinating findings about the potential effects of cannabis on the COVID-19 virus: ‘Similar to other respiratory pathogens, SARS-CoV2 (COVID-19) is transmitted through respiratory droplets, with potential for aerosol and contact spread . . . ACE2 levels were in fact significantly down-regulated when specific strains of cannabis were introduced, supporting their theory that the anti-inflammatory properties of CBD could inhibit the virus’s ability to successfully bind to a host. Cannabinoids may decrease the number of receptors available to the virus giving your body more of a chance to fight it.” [from a November 24, 2020 blog post titled “Can Hemp Oil Combat Inflammation and Viruses?” on your website https://synchronicityhempoil.com/hemp-oil-to-treat-inflammation-and-viruses/]
You should take immediate action to address the violations cited in this letter. This letter is not meant to be an all-inclusive list of violations that exist in connection with your products or operations. It is your responsibility to ensure that the products you sell are in compliance with the FD&C Act and FDA’s implementing regulations. We advise you to review your websites, product labels, and other labeling and promotional materials to ensure that you are not misleadingly representing your products as safe and effective for a COVID-19-related use for which they have not been approved by FDA and that you do not make claims that misbrand the products in violation of the FD&C Act. Within 48 hours, please send an email to [email protected] describing the specific steps you have taken to address these violations. Include an explanation of each step being taken to prevent the recurrence of any violations, as well as copies of related documentation. Failure to adequately correct any violations may result in legal action, including, without limitation, seizure and injunction.
FDA is advising consumers not to purchase or use certain products that have not been approved, cleared, or authorized by FDA and that are being misleadingly represented as safe and/or effective for the treatment or prevention of COVID-19. Your firm will be added to a published list on FDA’s website of firms and websites that have received warning letters from FDA concerning the sale or distribution of COVID-19 related products in violation of the FD&C Act. This list can be found at http://www.fda.gov/consumers/health-fraud-scams/fraudulent-coronavirus-disease-covid-19-products. Once you have taken actions to address the sale of your unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of COVID-19, and any appropriate corrective actions have been confirmed by the FDA, the published list will be updated to indicate that your firm has taken such corrective actions.
This letter notifies you of our concerns and provides you with an opportunity to address them. If you cannot take action to address this matter completely within 48 hours, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
If you are not located in the United States, please note that products that appear to be misbranded or unapproved new drugs may be detained or refused admission if they are offered for importation into the United States. We may advise the appropriate regulatory officials in the country from which you operate that FDA considers your product(s) referenced above to be unapproved and misbranded products that cannot be legally sold to consumers in the United States.
Please direct any inquiries to FDA at [email protected]
FTC Cease and Desist Demand: In addition, it is unlawful under the FTC Act, 15 U.S.C. § 41 et seq., to advertise that a product can prevent, treat, or cure human disease unless you possess competent and reliable scientific evidence, including, when appropriate, well- controlled human clinical 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 identified above. Thus, any coronavirus-related prevention or treatment claims regarding such products are not supported by competent and reliable scientific evidence. You must immediately cease making all such claims. Violations of the FTC Act may result in legal action seeking a Federal District Court injunction. In addition, pursuant to the COVID-19 Consumer Protection Act, Section 1401, Division FF, of the Consolidated Appropriations Act, 2021, P.L. 116-260, marketers who make deceptive claims about the treatment, cure, prevention, or mitigation of COVID-19 are subject to a civil penalty of up to $46,517 per violation and may be required to pay refunds to consumers or provide other relief pursuant to Section 19(b) of the FTC Act, 15 U.S.C. § 57b(b). Within 48 hours, please send an email to Richard Cleland, Assistant Director of the FTC’s Division of Advertising Practices, via electronic mail at [email protected] certifying that you have ceased making unsubstantiated claims for the products identified above. If you have any questions regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088.
Donald D. Ashley
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
Division of Advertising Practices
Federal Trade Commission
1 As explained in the next paragraph, there is currently an outbreak of a respiratory disease named “Coronavirus Disease 2019” (COVID-19).
Functional Remedies offers full-spectrum hemp oil produced with a proprietary, whole-plant lipid infusion process to get phytonutrients out of the plant in a way that preserves nature’s intended balance of phyto cannabinoids and other compounds. “Everyone seems to know the one term, CBD, which is one molecule among many,” said Tony Tomassini, chief marketing officer at the Superior, Colo.-based company. “Through lipid infusion, what you end up with is a true full-spectrum hemp oil that contains the natural balance of phytocannabinoids, terpenes, polyphenols, flavonoids and other beneficial phytonutrients capable of delivering the entourage effect.” The entourage effect refers to the magnified effect of the individual ingredients because they are all present, a variation of the idea that the whole is greater than the sum of its parts.
For information on the above products or to see what we have in stock stop by our office or call 386.424.9977
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