What happened
Original notice title
Gaia Arise Farms Apothecary MARCS-CMS 606668, April 13, 2020
From the archived source record
Based on our review, this product is an unapproved new drug 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, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352. We request that you take immediate action to cease the sale of such unapproved and unauthorized product 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 product and misleadingly represent it as safe and/or effective for the treatment or prevention of COVID-19 include: On your product webpage for “True Viral Defense,” below the title “Cases of coronavirus outside China,” you display a color-coded world map with a key indicating the number of coronavirus cases and in the adjactent product description state “True Viral Defense . . . mount a strong defense against whatever Virus you encounter. Approaching 100% inhibition at higher doses!” (internal citations and quotations omitted) [from your website at [see original source] “Elderberry [an ingredient in “True Viral Defense”] - Significantly inhibited replication and blocked viral attachment of Human Coronavirus” (internal quotations omitted) [from a March 19, 2020 post on your Facebook page at www.facebook.com/gafanicole/] You should take immediate action to correct 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. 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 .
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
- 82ec65bf5ce6
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 →