FDA WARNING_LETTER - Organic Heirloom Plants - January 31, 2023

The FDA issued a Warning Letter to Ms. Wiegert of Organic Heirloom Plants (organicheirloomplants.com) following an October 2022 review of their website, promotional literature, and social media (facebook.com/godgivenherbalremedies). The FDA determined that six products—Sarracenia Purpurea, Breathe Rite H2O2 Therapy, Ivermectwin, Nature’s Ancer, Zeolite, and Chaga Mushroom—are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because their claims establish intent for use in the cure, mitigation, treatment, or prevention of disease, including mpox, cancer, COPD, emphysema, HIV, diabetes, and various infections. Examples of violative claims include "Monkey Pox, Sarracenia Purpurea, Herbal Natural Remedy," "Emphysema and Cancer treatment," "Time to kill this Cancer!", "Our herbal alternative to Ivermectin," "Reverses diabetes," and "Prevents and Fights Cancer."

These products are considered "new drugs" because they are not generally recognized as safe and effective for their intended uses, violating 21 U.S.C. 355(a). They are also "misbranded drugs" under 21 U.S.C. 352(f)(1) because they lack adequate directions for use