WARNING LETTER

Date: March 6, 2020

TO: amy@herbalamy.com – Amy Weidner, Herbal Amy Inc.

12575 Anakate Ln.

Nampa, ID 83686

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.herbalamy.com on February 18, 

2020 and February 25, 2020, respectively. We have also reviewed your social media page at 

https://www.facebook.com/HerbalAmyInc/, where you provide a link your website www.herbalamy.com to 

purchase your products. The FDA has determined that your website offers “Coronavirus Protocol” products 

(Coronavirus Boneset Tea, Coronavirus Cell Protection, Coronavirus Core tincture, Coronavirus Immune 

System, and Elderberry Tincture) for sale in the United States and that these products are intended to 

mitigate, prevent, treat, diagnose, or cure COVID-191 in people. FDA has determined that 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 section 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and 

(d).

The Secretary of Health and Human Services, under section 319 of the Public Health Service Act, 42 

U.S.C. § 247d, has determined that a public health emergency exists nationwide as a result of confirmed 

cases of COVID-19. 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. We request that you take prompt action to cease the sale of such unapproved and

unauthorized products for 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: 

• “Corona virus treatment. Stephen Buhner has analyzed how corona viruses infect tissues, what 

tissues they infect, and the herbs that are useful to interrupt that process, as well as the herbs useful 

to shut down the cytokine cascade they create. Here is his protocol. ... [T]his is a rather extensive 

protocol because the particular corona virus that is now spreading world wide is exceptionally 

potent in its impacts. All the herbs are specific in one way or another for this virus. A number of the 

herbs are strongly antiviral for corona viruses ..... The formulations are preventative as well as 

specific for acute infections ....”

[from your website www.herbalamy.com/product-page/corona-virus-protocol]

 1 COVID-19 is the official name for the disease that is causing the 2019 novel coronavirus outbreak, first identified 

in Wuhan, China.
Herbal Amy Inc. – (continued) Page 2 of 3 pages

• “Stephen Buhner has used this with other corona virus infections, including SARS, it works well.”

[from your website www.herbalamy.com/product-page/corona-virus-protocol]

You should take immediate action to correct the violations cited in this letter. The violations cited in this 

letter are not meant to be an all-inclusive list. 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 

representing your products 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 COVID-19-Task-Force-CFSAN@fda.hhs.gov describing the specific steps

you have taken to correct these violations. Include an explanation of each step being taken to prevent the 

recurrence of violations, as well as copies of related documentation. Failure to immediately correct the 

violations cited in this letter 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 www.fda.gov/consumers/healthfraud-scams/fraudulent-coronavirus-disease-covid-19-products. Once you have taken corrective actions

and such actions have been confirmed by the FDA, the published list will be updated to indicate that your 

firm has taken appropriate corrective action.

If you cannot complete 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 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 are subject to detention and refusal of 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) listed 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 COVID-19-

Task-Force-CFSAN@fda.hhs.gov.

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. To make or exaggerate such claims, whether directly or indirectly, through the use of a product 

name, website name, metatags, or other means, without rigorous scientific evidence sufficient to 

substantiate the claims, violates the FTC Act. 

There currently are no vaccines, pills, potions, lotions, lozenges or other prescription or over-the-counter 

products available to treat or cure coronavirus disease 2019 (COVID-19). Thus, the claims cited above are 

not supported by competent and reliable scientific evidence. You must immediately cease making all such 

claims. In addition, you are advised to review all claims for your products and immediately cease making 

claims that are not supported by competent and reliable scientific evidence. 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. Within 48 hours, please send an email to Richard Cleland, Assistant Director of 
Herbal Amy Inc. – (continued) Page 3 of 3 pages

the FTC’s Division of Advertising Practices, via electronic mail at rcleland@ftc.gov 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,

William A. Correll

Director

Office of Compliance

Center for Food Safety

 and Applied Nutrition

 Sincerely,

 

 

 

 Richard A. Quaresima 

 Acting Associate Director

 Division of Advertising Practices 

 Federal Trade Commission