WARNING LETTER
New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure
MARCS-CMS 620001 —
February 01, 2022
Delivery Method:
Via Email
Product:
Animal & Veterinary
Drugs
Recipient:
Recipient Name
Lauryn Suarez and Ashley Peluso
New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure
1290 Raymond Road
Danby
,
VT
05739
United States
newearthhealingessentials@gmail.com
services@gaiaswholehealingessentials.org
Issuing Office:
Center for Drug Evaluation and Research | CDER
United States
WARNING LETTER
February 1, 2022
CC:
Lauryn Suarez, Registered Agent
Mother Nature Natural Essentials, LLC d/b/a Gaia's Whole Healing Essentials, LLC
5 Alcedo Court
Moffat, CO 81143
United States
RE: 620001
Dear Lauryn Suarez and Ashley Peluso:
This letter is to advise you that the United States Food and Drug Administration (FDA) has reviewed your website at https://www.5dfulldisclosure.org/, which redirects to https://newearthhealingessentials.ecwid.com/, from November through December 2021, and has determined that you take orders there for your “Plasma Colloidal Silver Eyedrops,” “Gaia’s Organic Nasal Spray,” “Copper Healing Roller,” “Plasma Copper Elixer,” “Plasma Gold Elixer,” “Plasma Gold & Silver Elixer Package,” and “Plasma Silver Elixer.” We have also reviewed your social media website at https://www.facebook.com/New-Earth-Healing-Essentials-105328171777000/; this social media website direct consumers to your website at https://newearthhealingessentials.ecwid.com/ to purchase products. The claims on your website and social media website establish that your “Plasma Colloidal Silver Eyedrops,” “Gaia’s Organic Nasal Spray,” “Copper Healing Roller,” “Plasma Copper Elixer,” “Plasma Gold Elixer,” “Plasma Gold & Silver Elixer Package,” and “Plasma Silver Elixer” products are unapproved new drugs sold in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act (the FD&C Act), 21 U.S.C. 355(a) and 331(d). FDA has also determined that your “Plasma Colloidal Silver Eyedrops” and “Copper Healing Roller” products are unapproved new animal drugs that are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a) and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). As explained further below, introducing or delivering these products for introduction into interstate commerce violates the FD&C Act. You can find the FD&C Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
The Agency is particularly concerned that you market your “Plasma Colloidal Silver Eyedrops,” “Gaia’s Organic Nasal Spray,” and “Copper Healing Roller” products for use in children. The use of untested drugs can have unpredictable and unintended consequences, especially in vulnerable populations, such as children, who may be at greater risk for adverse reactions associated with certain drug products due to their differences in the ability to absorb, metabolize, distribute, or excrete such drug products or their metabolites.
Further, your “Plasma Colloidal Silver Eyedrops” product is especially concerning from a public health perspective because ophthalmic drug products can pose serious risk of harm to humans and/or animals if toxic substances are introduced directly into the eye because irreversible damage, including vision loss, can result. Your “Gaia’s Organic Nasal Spray” intranasal drug product is also concerning because it may be rapidly absorbed through the highly vascularized nasal mucosa directly into systemic blood circulation, where they may exert undesirable systemic effects such as increased heart rate or elevated blood pressure. If toxic substances are introduced directly into the nose, harmful local effects such as bleeding, ulceration, or nasal septal perforation may occur.
Unapproved New Drug Products
Based on our review of your websites, your “Plasma Colloidal Silver Eyedrops,” “Gaia’s Organic Nasal Spray,” “Copper Healing Roller,” “Plasma Copper Elixer,” “Plasma Gold Elixer,” “Plasma Gold & Silver Elixer Package,” and “Plasma Silver Elixer” products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or intended to affect the structure or any function of the body.
Some examples of claims observed on your website and social media websites that establish the intended use of your products as drugs include, but may not limited to, the following:
From your website https://newearthhealingessentials.ecwid.com/:
From your webpage titled “Plasma Colloidal Silver Eyedrops”:
• “Our Colloidal Silver Eyedrops include a 2oz bottle of our colloidal silver that contains minimal amounts of our turmeric extract so it is safe to be used in the eyes for any infections, irritations, and to protect against any viruses, can be used for children, adults and pets.
These eyedrops provide protection and healing from any infections, bacteria or viruses in the eyes and can be used on-the-go.”
From your webpage titled “Gaia’s Organic Nasal Spray”:
• “Our Gaia’s Organic Nasal Spray assists with clearing out the sinuses which tend to hold a lot of density. This can be used for adults and children.”
• “Our Nasal Spray contains . . . colloidal silver, colloidal copper”
From your webpage titled “Copper Healing Roller”:
• “This serum comes in a roller form for easy application. . . . This roller is perfect for your face & body and can also be used on children & pets to heal skin irritations and scarring.”
From your webpage titled “Plasma Copper Elixer [sic]”:
• “
~Healing Benefits~
. . .
Supports healthy cartilage and tendon regeneration . . .
Relieves Arthritis . . .
Copper . . . is still used in the treatment of wounds and skin diseases, as well as internal diseases, anemia, cancer, rheumatoid arthritis, and heart disease. It is also used for its healing properties in improving circulation of blood, increasing energy and detoxification of the body.
Colloidal Copper has been used as a remedy for . . . burns, arthritis, parasites and viral and bacterial infections.”
From your webpage titled “Plasma Gold Elixer [sic]”:
• “Colloidal Gold . . . has also been known to be effective for easing the pains and swellings of arthritis, rheumatism, bursitis, and tendonitis.”
• “Gold has been used historically to treat digestive disorders, circulatory problems, depression, obesity, and burns. It is a catalyst for endorphin-like hormones as well as the mitochondrial antioxidant enzyme superoxide-dismutase (SOD) as well as having been successful in eliminating tumor and cancer activity, we recommend Colloidal Gold be used in conjunction with Colloidal Silver for cancer treatment and to address the energetic root of any of your illnesses.”
From your webpage titled “Plasma Gold & Silver Elixer [sic] Package”:
• “Colloidal silver it’s [sic] an effective treatment for All types of infections and diseases, ranging from the common cold to cancer. It possesses antibacterial, antiviral, anti-fungal, and anti-inflammatory properties. A number of laboratory and human studies have examined the use of topical silver-contained in dressings on skin ulcers. Studies have found that the silver nano particle-containing dressings exhibited antibacterial effects and were effective against diabetic ulcers, leg ulcers, other types of ulcers, and was effective with healing the wounds of skin graft donors.”
• “To touch on the subject lightly, here is a list diseases Colloidal Silver has been known to treat:
‘Colloidal silver is used to treat infections due to yeast; bacteria (tuberculosis, Lyme disease, bubonic plague, pneumonia, leprosy, gonorrhea, syphilis, scarlet fever, stomach ulcers, cholera); parasites (ringworm, malaria); and viruses (HIV/AIDS, pneumonia, herpes, shingles, warts).
Colloidal silver is also used for lung conditions including emphysema and bronchitis; skin conditions including rosacea, cradle cap (atopic dermatitis), eczema, impetigo, and psoriasis; and inflammation (sometimes due to infection) of the bladder (cystitis), prostate (prostatitis), colon (colitis), nose (rhinitis), stomach (gastritis), tonsils (tonsillitis), appendix (appendicitis), and sinuses (sinusitis).
Other uses include treatment of cancer, diabetes, arthritis, lupus, chronic fatigue syndrome, leukemia, hay fever and other allergies, trench foot, and gum disease. Colloidal silver is also used to prevent flu, H1N1 (swine) flu, and the common cold.
Colloidal silver can be used during pregnancy to aid the baby’s growth and health as well as the mother’s delivery and recovery.
Colloidal silver is applied directly to the skin for acne, burns, eye infections, fungal infections, throat infections, skin infections, and Staphylococcus infections.’”
From your webpage titled “Plasma Silver Elixer [sic]”:
• “Colloidal silver is completely natural and therefore cannot harm you. We recommend starting with one to two filled drops each day and increasing the dose if needed for any viruses or infections.”
From your website’s homepage, under the heading, “Our Mission” as well as on all of your product pages listed above:
• “Our products aid in healing any and all diseases, ailments, energetic imbalances and more, as everything is vibration, we have ensured divine vibration is assimilated into each product”
From a September 3, 2021 post on your Facebook page at https://www.facebook.com/New-Earth-Healing-Essentials-105328171777000/photos/146824010960749:
• On a graphic titled “5D HEALING”:
o “PLASMA COPPER
Can be used to treat wounds and skin diseases . . .”
o “PLASMA SILVER
The most potent anti-biotic in the world . . . it has been shown to cure all types of illness and diseases.
HEALING
-cuts & wounds
-infections (bacterial & viral)
-illnesses
-diseases
-cancer
o “PLASMA GOLD
Shown to have amazing benefits for the brain to assist with damage from vaccines . . .
HEALING
-damaged or loss of neurotransmitters
-brain damage”
Your “Plasma Colloidal Silver Eyedrops,” “Gaia’s Organic Nasal Spray,” “Copper Healing Roller,” “Plasma Copper Elixer,” “Plasma Gold Elixer,” “Plasma Gold & Silver Elixer Package,” and “Plasma Silver Elixer” products are not generally recognized as safe and effective for their above referenced uses and, therefore they are “new drugs” under section 201(p) of the FD&C 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 the FDA, as described in sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. There are no FDA-approved applications in effect for your products.
Unapproved New Animal Drugs
Based on our review of your websites, your “Plasma Colloidal Silver Eyedrops” and “Copper Healing Roller,” products are drugs under section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because these products are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in animals.
Examples of claims observed on your website that show the intended uses of your “Plasma Colloidal Silver Eyedrops” and “Copper Healing Roller” products include, but may not be limited to, the following:
From your website https://newearthhealingessentials.ecwid.com/: Webpage titled – “Plasma Colloidal Silver Eyedrops”
• “Our Colloidal Silver Eyedrops include a 2oz bottle of our colloidal silver that contains minimal amounts of our turmeric extract so it is safe to be used in the eyes for any infections, irritations, and to protect against any viruses, can be used for children, adults and pets.
These eyedrops provide protection and healing from any infections, bacteria or viruses in the eyes and can be used on-the-go.”
From your website https://newearthhealingessentials.ecwid.com/: Webpage titled – “Copper Healing Roller”
• This roller is perfect for your face & body and can also be used on children & pets to heal skin irritations and scarring.
These products are “new animal drugs,” as defined by section 201(v) of the FD&C Act, 21 U.S.C. 321(v), because they are not generally recognized among experts qualified by scientific training and experience to evaluate the safety and effectiveness of animal drugs, as safe and effective for use under the conditions prescribed, recommended, or suggested in the labeling. These products are not the subject of approved new animal drug applications, conditionally approved new animal drug applications, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. 360b, 360ccc, and 360ccc-1. Therefore, these products are unsafe under section 512(a) of the FD&C Act, 21 U.S.C. 360b(a) and adulterated under section 501(a)(5) of the FD&C Act, 21 U.S.C. 351(a)(5). The introduction or delivery for introduction into interstate commerce of these adulterated drugs violate section 301(a) of the FD&C Act, 21 U.S.C. 331(a).
Conclusion
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/or injunction.
Please notify FDA in writing, within fifteen working days of receipt of this letter, of the specific steps you have taken to address any violations. 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 actions within fifteen working days, state the reason for the delay and the time within which you will do so. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration.
Your response should be sent to U.S. Food and Drug Administration, Center for Drug Evaluation and Research/Office of Compliance/Office of Unapproved Drugs and Labeling Compliance by e-mail to FDAADVISORY@fda.hhs.gov.
Sincerely,
/S/
Carolyn E. Becker
Director
Office of Unapproved Drugs and Labeling Compliance
Office of Compliance
Center for Drug Evaluation and Research
Food and Drug Administration
/S/
Cindy L. Burnsteel, DVM
Acting Director
Division of Compliance
Office of Surveillance and Compliance
Center for Veterinary Medicine
Food and Drug Administration
Content current as of:
02/08/2022
Regulated Product(s)
Animal & Veterinary
Drugs