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WARNING LETTER

Date:               March 12, 2021

RE:                  Unapproved and Misbranded Products Related to Coronavirus Disease 2019 (COVID-19)

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 www.ravenscroftescentials.com on March 3, 2021, and March 10, 2021, respectively.  We also reviewed your social media website at www.instagram.com/ravenscroftoils, where you direct consumers to your website, www.ravenscroftescentials.com, to purchase your products.  The FDA has observed that your website offers your “AIR PURIFY AROMAMIST,” “HEALER’s CHAI AROMATEA & BREATH DROPS,” “ELEVATION OF MIND AROMAMIST,” and “ROSE FREQUENCY TONGUE TINCTURE” 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 websites 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:

• “THE 5 BEST ESSENTIAL OILS FOR CORONAVIRUS

CORONAVIRUS ESSENTIAL OILS

Antiviral essential oils . . . are used to help with the treatment of a myriad of health problems. This list will help us understand how essential oils can benefit one’s health and support with coronavirus complications.

So which are the best essential oils when considering coronavirus? Below are the oils we use to build up our immune system and help to rid sickness. This list will explain how these oils can support us when faced with . . . a virus (viral infection).

CINNAMON BARK . . .

A study out of Touro College, New York, suggest it may possess antiviral effects and help prevent infections in humans.

Great benefits include . . .

2. Antiviral” . . .

CARDAMOM OIL . . .

ROSEMARY OIL . . .

Rosemary is one of the best essential oils that helps with headaches and is one of the best essential oils and a good antiviral for coronavirus.

Some of the healing benefits for rosemary include:

1. Antiviral . . .

CLOVE OIL . . .

This essential oil is the best for Covid-19 antiviral support.

We like it for these great benefits:

2. Antiviral . . .

LEMONGRASS OIL

Essential oil benefits of lemongrass are tremendous when fighting viruses.. . .

We have our own special blend of all these organic essential oils in one powerful little bottle: 

Healer’s Chai Aromatea Drops. Try it out and stay safe and healthy! [Followed by a graphic that states “HEALER’SCHAI…Boost your immune system! . . . with this highly antiviral . . . blend. Under tongue or in water”] . . .

We hope you enjoyed this list to help with the coronavirus battle we are facing in the world, utilizing the best . . . antiviral essential oils.

A potent antiviral for Covid. So happy to pass along these coronavirus tips.” [from your webpage https://ravenscroftescentials.com/blogs/blog/5-best-essential-oils-for-coronavirus]

• Under “COLLECTIONS,” you include a category called “Coronavirus Support,” which takes you to a page that states “ANTIVIRAL SUPPORT” and “antiviral…blends.” In this page you list your “AIR PURIFY AROMAMIST,” “HEALER’s CHAI AROMATEA & BREATH DROPS,” “ELEVATION OF MIND AROMAMIST,” and “ROSE FREQUENCY TONGUE TINCTURE” products. [from your webpage https://ravenscroftescentials.com/collections/coronavirus-support]
• A graphic that states: “THE 5 BEST ESSENTIAL OILS FOR CORONAVIRUS

CORONAVIRUS ESSENTIAL OILS

Antiviral essential oils . . . are used to help with the treatment of a myriad of health problems. This list will help us understand how essential oils can benefit one’s health and support with coronavirus complications.

So which are the best essential oils when considering coronavirus?” followed by “ravenscroftoils The 5 Best Essential Oils for the Coronavirus: On our blog now! Link in bio https://ravenscroftescentials.com/blogs/blog/5-best-essential-oils-for-coronavirus.

#coronavirus #covid19

#immunesupport #immunebooster

#antiviral

#antiviralessentialoil” [from an April 24, 2020 post on your Social Media webpage https://www.instagram.com/ravenscroftoils/]

• A graphic that states: “HEALER’SCHAI…Boost your immune system! . . . with this highly antiviral . . . blend. under tongue or in water,” followed by “ravenscroftoils An organic, ingestible antiviral . . .

#coronavirus #antiviral #antiviralherbs

#antiviralessentialoil

#antiviralessentialoils . . . #naturalantiviral” [from a March 11, 2020 post on your Social Media webpage https://www.instagram.com/ravenscroftoils/]

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 products 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].

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 and an order may require that you pay back money to consumers. 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 $43,792 per violation.  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] describing the specific actions you have taken to address the FTC’s concerns. If you have any questions regarding compliance with the FTC Act, please contact Mr. Cleland at 202-326-3088.

Sincerely,

/S/

Donald D. Ashley
Director
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration

Sincerely,

/S/

Serena Viswanathan
Associate Director
Division of Advertising Practices
Federal Trade Commission