WARNING LETTER
Organic Heirloom Plants
MARCS-CMS 643997 —
January 30, 2023
Delivery Method:
Via Email
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Wendy Wiegert
Organic Heirloom Plants
51594 Boston Road
Hancock
,
MI
49930
United States
info@organicheirloomplants.com
organicheirloomplants@yahoo.com
Issuing Office:
Center for Food Safety and Applied Nutrition (CFSAN)
United States
WARNING LETTER
RE: CMS # 643997
Dear Ms. Wiegert:
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at the Internet address https://organicheirloomplants.com in October 2022. We also reviewed your promotional literature that accompanies your products and your social media website at https://facebook.com/godgivenherbalremedies, where you direct consumers to your website, https://organicheirloomplants.com, to purchase your products Sarracenia Purpurea, Breathe Rite H2O2 Therapy, Ivermectwin, Nature’s Ancer, Zeolite, and Chaga Mushroom. 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). Furthermore, these products are misbranded drugs under section 502 of the Act, 21 U.S.C. § 352. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
The Department of Health and Human Services (HHS) has determined that a public health emergency exists nationwide involving mpox.
1,2
Therefore, FDA is taking measures to protect customers from products that, without approval or authorization by FDA, claim to mitigate, prevent, treat, diagnose, or cure mpox. As described below, you sell products that are intended to mitigate, prevent, treat, diagnose, or cure mpox in people. We request that you cease the sale of any unapproved and unauthorized products for the mitigation, prevention, treatment, diagnosis, or cure of mpox.
Examples of some of the website claims that provide evidence that your products are intended for use as a drug include the following:
Sarracenia Purpurea
On the product webpage for Sarracenia Purpurea at https://organicheirloomplants.com/shop/ols/products/monkey-pox-sarracenia-purpurea-herbal-natural-remedy-herbal-tincture:
• “Monkey Pox, Sarracenia Purpurea, Herbal Natural Remedy”
• “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.”
The above noted claims are supplemented by metatags used to bring consumers to your website https://organicheirloomplants.com through Internet searches. The metatags include:
• “Monkey Pox, Sarracenia Purpurea, Herbal Natural Remedy”
On your Facebook Social Media page at https://facebook.com/godgivenherbalremedies:
• In a May 30, 2022, post: “Harvesting Pitcher Plant [another name for Sarracenia Purpurea]! Remedy coming soon! #pitcherplant #monkeypox”
Breathe Rite H2O2 Therapy
On the product webpage for Breath Rite H2O2 Therapy at https://organicheirloomplants.com/shop/ols/products/breath-rite-h2o2-therapy-emphysema-copd-fungal-issues:
• “Breath Rite-H2O2 Therapy – Emphysema – COPD [Chronic obstructive pulmonary disease] – Fungal Issues”
• “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.”
• “THIS PRODUCT IS A COMPANION TO OUR NATURAL CANCER PROTOCOL TREATMENT. FOR BEST RESULTS, WE ALSO SUGGEST COMBINING WITH THESE NATURAL CANCER FIGHTING PRODUCTS:”
o “NATURES ANCER: A potent combination of the top Cancer Fighting Herbs ALL IN ONE!”
o “PURE ZEOLITE POWDER: Cleans the Blood and all major organs, even through the Blood brain barrier, removing toxins, parasites, bacteria and viruses. Remedies ALL Cancers.”
o “CHAGA MUSHROOM: A known powerful Cancer Killer.”
• “MORE USES FOR H2O2 THERAPY
1. Chicken pox [Varicella]
2. Parasites
3. Allergies
4. Insect bites infection
5. Headaches
8. Anemia
9. HIV
10. Arrythmia
11. Influenza
12. Bacterial Infections
13. Liver Cirrhosis
14. Bronchitis
15. Lupus
16. Cancers
17. Cardiovascular disease
18. Parkinsonism
19. Diabetes type 11 [sic]
20. Gingivitis
21. Cerebral vascular disease
22. Bronchitis
23. Chronic Pain Prostatitis
…
26. Chancroid”
On your Facebook Social Media page at https://facebook.com/godgivenherbalremedies
• August 31, 2022, post: “H202 Therapy, Breathrite Mouth Spray HERE: https://organicheirloomplants.com. #copd #copdawareness #emphysema #cancer”
Nature’s Ancer
On the product webpage for Nature’s Ancer at https://organicheirloomplants.com/shop/ols/products/cancer-herbal-natures-ancer-cancer-natural-remedy-herbal-cancer-tinture:
• “Cancer Herbal Remedy, Nature's Ancer, Cancer Natural Remedy, Herbal Cancer Tincture”
• “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.”
• “Our Anti-Cancer formula is created only with the purest Organic Herbs . . . pure Anti-Cancer herbs with the highest potency sets the stage for the highest success in healing.”
On your Facebook Social Media page at https://facebook.com/godgivenherbalremedies
• April 7, 2022, post with a picture of your Nature’s Ancer product: “Time to kill this Cancer! HERE!: organicheirloomplants.com #cancer”
Ivermectwin
On the product webpage for Ivermectwin at https://organicheirloomplants.com/shop/ols/products/ivermectwin-immune-support-dietary-herbal-supplement:
• “Our herbal alternative to Ivermectin”
• “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.”
• “It is now clinically proven that most diseases and illnesses are parasitical in nature. This formula kills those parasites within the body . . . These parasites are responsible for C-pneumonia (an actual allergic reaction to parasitical die off), high inflammation in the joints and muscle tissue and prolonged chronic fatigue.”
• “Medicinal Properties: Anti-viral, anti-parasitical, anti-bacterial, antifungal, expectorant, anti-histamine”
The product page for Ivermectwin also contains evidence of intended use in the form of personal testimonials recommending or describing the use of Ivermectwin for the cure, mitigation, treatment, or prevention of disease. Examples of such testimonials include:
• "I have to report after 4 doses and after having confirmed covid 19 for 19 days prior to taking your formula, I have my energy back, brain fog drugged feeling has lifted, and my heart rate has come down to normal. I can feel lungs clearing also, thank you for this medicine."
Zeolite
On the product webpage for Zeolite at https://organicheirloomplants.com/shop/ols/products/zeolite-micronized-clinoptilotite-heavy-metal-detox:
• “Known Benefits of Use:”
o “Supports . . . renal failure”
o “Treats nervous system problems”
o “Treats psoriasis and all skin issues”
o “Treats fibromyalgia”
o “Treats arthritis, bursitis and gout”
o “Treats many herpes viruses”
o “Removes Candida”
o “Normalizes blood pressure”
o “Reverses diabetes”
o “Treats EBV [Epstein-Barr virus] . . . Lymes [sic] and other auto-immune diseases”
Furthermore, promotional literature which accompanies your products includes claims about your Zeolite product, including:
Under the heading, BENEFITS OF ZEOLITE:
 “Pulls out and removes . . . viruses out of the bodies [sic] tissues, blood and gut on a cellular level”
 “[H]as been known to reverse kidney renal failure”
 “Removes/treats all viruses including HIV”
 “Treats Nervous System problems”
 “Treats Psoriasis”
 “Treats Fibromyalgia”
 “Treats Arthritis, Bursitis, Gout by removing all uric acid and inflammation”
 “Treats many Herpes Viruses”
 “Treats Mold Toxicity”
 “Removes Candida and all fungal issues”
 “Normalizes blood pressure”
 “Reverses diabetes”
 “Treats Lymes [sic] disease”
Chaga Mushroom
On the product webpage for Chaga Mushroom Herbal Tincture on https://organicheirloomplants.com/shop/ols/products/chaga-mushroom-herbal-tincture-immune-system-building-fights-inflammation
• “REDUCES INFLAMMATION: Inflammation is a natural response of your immune system that can protect against disease. 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 . . . Chaga extract prevented the growth of cancer in human liver cells. Similar results were observed with cancer cells of the lung, breast, prostate and colon.”
• “Chaga contains the antioxidant triterpene. Test-tube studies reveal that very concentrated triterpene extract can help kill cancer cells”
• “Studies link chaga to lower blood sugar levels. Therefore, it may help manage diabetes”
• “Study in rats with high cholesterol, chaga extract reduced ‘bad’ LDL cholesterol, total cholesterol and triglycerides while increasing antioxidant levels in addition to reducing ‘bad’ LDL cholesterol — chaga increases ‘good’ HDL cholesterol”
On your Facebook Social Media page at https://facebook.com/godgivenherbalremedies:
• In an April 8, 2022, post: “Chaga Mushroom kills Cancer Cells HERE!: organicheirloomplants.com #cancer”
Your Sarracenia Purpurea, Breathe Rite H2O2 Therapy, Nature’s Ancer, Ivermectwin, Zeolite, and Chaga Mushroom products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from FDA, as described in sections 301(d) and 505(a) of the Act, 21 U.S.C. 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
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). “Adequate directions for use” means directions under which a layperson can use a drug safely and for the purposes for which it is intended (21 CFR 201.5). Prescription drugs, as defined in section 503(b)(1)(A) of the Act [21 U.S.C. 353(b)(1)(A)], can only be used safely at the direction, and under the supervision, of a licensed practitioner.
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)]. 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. It is your responsibility to ensure that your firm complies with all requirements of federal law, including FDA regulations.
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.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps you have taken to address these matters. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you cannot complete corrective action within fifteen working days, state the reason for the delay and the time within which you will complete the correction. If you believe that your product is not in violation of the Act, include your reasoning and any supporting information for our consideration.
Your written reply should be directed to Sara Dent Acosta, Compliance Officer, United States Food and Drug Administration, Center for Food Safety and Applied Nutrition, 5001 Campus Drive, Office of Compliance (HFS-608), Division of Enforcement, College Park, Maryland 20740-3835 or via email at CFSANResponse@fda.hhs.gov. If you have any questions, you may also email at CFSANResponse@fda.hhs.gov.
Sincerely,
/S/
Ann M. Oxenham
Director
Office of Compliance
Center for Food Safety and Applied Nutrition
____________________________
1
Secretary of Health and Human Services, Renewal of Determination that a Public Health Emergency Exists (issued Nov. 2, 2022), available at
https://aspr.hhs.gov/legal/PHE/Pages/mpx-renewal-2Nov2022.aspx
.
2
HHS has adopted the World Health Organization’s renaming of monkey pox to “mpox” to reduce stigma. Department of Health and Human Services, Biden Harris Administration Supports the World Health Organization Renaming of Monkeypox to mpox (issued Nov. 28, 2022), available at
https://www.hhs.gov/about/news/2022/11/28/biden-harris-administration-supports-the-world-health-organization-renaming-of-monkeypox-to-mpox.html
.
Content current as of:
01/31/2023
Regulated Product(s)
Drugs
Food & Beverages