What happened
Original notice title
Organic Heirloom Plants MARCS-CMS 643997, January 30, 2023
From the archived source record
Based on our review, these products are unapproved new drugs sold in violation of section 505(a) of the Act, 21 U.S.C. § 355(a). Furthermore, these products are misbranded drugs under section 502 of the Act, 21 U.S.C. § 352. We request that you cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of mpox. However, long-term inflammation is linked to conditions like heart disease and rheumatoid arthritis. chaga extract can positively impact immunity by reducing long-term inflammation and fighting harmful bacteria and viruses.” • “Prevents and Fights Cancer” • “Studies show that chaga can prevent and slow cancer growth . . . A drug is misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)] if the drug fails to bear adequate directions for its intended use(s). Accordingly, your Sarracenia Purpurea, Breathe Rite H2O2 Therapy, Nature’s Ancer, Ivermectwin, Zeolite, and Chaga Mushroom products fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act [21 U.S.C. 352(f)(1)]. The introduction or delivery for introduction into interstate commerce of these misbranded drugs violates section 301(a) of the Act [21 U.S.C. 331(a)]. This letter is not intended to be an all-inclusive statement of violations that may exist in connection with your products. You are responsible for investigating and determining the causes of any violations and for preventing their recurrence or the occurrence of other violations. This letter notifies you of our concerns and provides you an opportunity to address them. Failure to adequately address this matter may result in legal action including, without limitation, seizure and injunction. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation.
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
- No closeout listed in FDA table
- Source checked
- Jul 16, 2026
- Record revision
- f9a6d104bf63
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 →