What happened
Original notice title
Herbal Amy Inc MARCS-CMS 604813, March 06, 2020
From the archived source record
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. 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. The formulations are preventative as well as specific for acute infections ….” [from your website www.herbalamy.com/product-page/corona-virus-protocol] • “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. 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.
What the official notice says to do
Check the original notice for the instructions that apply to the named product, company, and affected lots.
Read the official notice →Status and source details
- Status recorded in the archive
- Historical warning letter; closeout not established by annual index
- Source checked
- Jul 16, 2026
- Record revision
- e6a164484e70
This is a dated record. Its current status may have changed since the source was captured. A record applies to its stated scope; it is not a safety rating for every product from a company.
Sources, dates, and coverage →