FDA warning letter · Drugs

Organic Heirloom Plants

Issued · Posted by FDA

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

Based on our review, the claims on your websites and promotional literature establish that these products are drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)] because they are intended for use in the cure, mitigation, treatment, or prevention of disease. 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).

Passage 2

Your Sarracenia Purpurea, Breathe Rite H2O2 Therapy, Nature's Ancer, Ivermectwin, Zeolite, and Chaga Mushroom products are intended for treatment of one or more diseases that are not amenable to self-diagnosis or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your product safely for their intended purposes. 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)].

Passage 3

For decades, research has shown the effectiveness of Sarracenia Purpurea (Pitcher Plant) against past outbreaks of small pox [sic] in the 19th Century, found to halt viral replication in viral, derived from the Variola Virus also associated with Monkey Pox.

Passage 4

Emphysema and Cancer treatment. H2O2 is used for. Breaking up infections in the lungs and opens up the small capillaries that allows more oxygen through. If you have cancer, flooding the body with oxygen is crucial for the destruction of cancer cells. . . H2O2 or ozone therapy are two of the best ways to accomplish this.

Passage 5

In formulating this Cancer Herbal Tincture Remedy, we have targeted the very herbs that contain the highest Anti-Cancer properties to not only kill these parasites, but to also support, balance and irradicate them out of your body for optimal healing. Those that include an anti-cancer dietary protocol with these supporting herbs have a higher chance of healing from this disease. The goal is to stop feeding the parasites which many times create Cancers.

Passage 6

The main herb in our formula has been clinically tested and shown to be 38% more effective than it's [sic] chemical counterpart at 99.6% effective against ALL variants and helps in aiding to stop viral replication ON CONTACT with the blood stream on a cellular level.

Passage 7

Harvesting Pitcher Plant [another name for Sarracenia Purpurea]! Remedy coming soon!

Citations in the original letter

As cited in this historical letter, not a statement of current regulatory requirements.

  • 21 CFR 201.5