Unapproved and Misbranded Product Related to Coronavirus Disease 2019 (COVID-19) Functional Remedies, a pioneer in the wellness industry-recognized for creating the highest quality full-spectrum hemp oil and plant-to-body products The endocannabinoid system (ESE) is a biological system composed of endocannabinoids (cannabinoids naturally produced in the body such as anandamide and 2-AG), enzymes that synthesize and degrade the cannabinoids, and cannabinoid receptors (primarily CB1 and CB2) found in the central and peripheral nervous systems. The
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 Announces Rebrand and New Product Line, Synchronicity™
SUPERIOR, Colo.–( BUSINESS WIRE )–Functional Remedies, a pioneer in the wellness industry-recognized for creating the highest quality full-spectrum hemp oil and plant-to-body products using 100% organic and sustainable farming, today announces the launch of its new flagship product line, Synchronicity™. Synchronicity™ defines industry standards and empowers consumers to take control of their health by experiencing the all-natural properties from the highest quality full-spectrum hemp oil products on the market. Full-spectrum hemp oil refers to the utilization of the entire hemp plant and all its possibilities. By comparison, other players in the market use only parts of the plant, or just one molecule of the plant’s hundreds of rich nutrients, thereby limiting its effectiveness.
Functional Remedies’ hemp plant, CBDRx18, is the only hemp plant that’s recognized as the qualifying standard for the cannabis genome sequence by the National Center for Bioinformatics (NCBI), a division of The National Institute of Health (NIH).
It is scientifically proven that the “Endocannabinoid System” in the human body has receptors particularly in the nervous and digestive systems as well as the overall Immune system. Those receptors are activated and receive the phytonutrients from the hemp plant allowing full-spectrum hemp oil and the anatomical makeup of the human body to work together to balance all of these body systems.
“Thanks to the due diligence of Functional Remedies’ President, Dr. Steven Kraus and Chief Scientist, Tim Gordon, this acknowledgment proves that all other cannabis strains are measured by the standard of our hemp plant strain,” says Andrew Campbell, CEO of Functional Remedies. “We now have scientific proof that shows how our nutrient-rich hemp plant products can better sync with your own body. Knowing the molecules and DNA of our plant shows that all the plant’s nutrients are present and is one of many reasons we know how our products work.”
Along with the NCBI registration, Functional Remedies’ proprietary lipid infusion process, LipidTrans™ employs a gentle, hand-pressed, low-heat process that uses cellular bonding to infuse the active beneficial nutrients of the whole hemp plant with a lipid (usually organic coconut oil) while preserving the integrity of the plant molecules and making them truly bioavailable. The result is a more efficacious full-spectrum hemp oil that ultimately delivers The True Entourage™ effect to the human body.
“We have spent over two decades naturally breeding higher-quality hemp plants and meticulously crafting our process to deliver the purest, potent, and safe products to consumers,” says Campbell. “Our new line invites people to experience the difference between a superior brand versus the snake oil CBD and low-quality hemp oil products that flood the market today. Your body is the most reliable source and best authority to answer the question, ‘does this product work for me?’”
The Synchronicity™ product line features a variety of products that can be used throughout the day to best suit your needs:
- Capsules (25 mg and 50 mg)
- Tinctures (500 mg and 1000 mg in natural hemp, peppermint and berry lemonade flavors)
- Aromatherapy (100 mg in peppermint rosemary and lavender chamomile scents)
- Body Oil (200 mg)
- Body Butter (450 mg)
- Body Lotion (1000 mg)
- Sports Balm (2500 mg)
- Facial Cream (250 mg)
- Youth Serum (100 mg)
“Functional Remedies delivers the highest quality products on the market today and sets the industry standard,” says Dr. Joel Kahn, “America’s Healthy Heart Doc”—a bestselling author and world-renowned thought leader in preventive and natural medicine who runs a successful preventive cardiology practice in Detroit, MI. “Their products are truly exceptional and my patients have seen remarkable benefits using them.”
Functional Remedies Pro Full-Spectrum Hemp Oil 500mg
The endocannabinoid system (ESE) is a biological system composed of endocannabinoids (cannabinoids naturally produced in the body such as anandamide and 2-AG), enzymes that synthesize and degrade the cannabinoids, and cannabinoid receptors (primarily CB1 and CB2) found in the central and peripheral nervous systems. The main purpose of the ECS is to maintain homeostasis in the body. Research has shown that introducing external phytocannabinoids could be useful in treating a variety of medical ailments.
Full-spectrum hemp oils are made with whole plant hemp extracts that contain all of the beneficial phytocannabinoids (CBG, CBN, and others), terpenes (beta-caryophyllene, b –pinene, humulene, and limonene), plus flavonoids, polyphenols, and other important hemp-derived phytocompounds. In contrast, some hemp oil products are made from isolate concentrate and do not contain many of the beneficial phytocannabinoids.