WARNING LETTER
Organa International Corp.
MARCS-CMS 613018 —
October 13, 2021
Delivery Method:
VIA UPS
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Larry Mills
Recipient Title
President
Organa International Corp.
533 N 1650 W
Springville
,
UT
84663
United States
Issuing Office:
Office of Human and Animal Food Operations Division West 4
United States
October 13, 2021
WARNING LETTER
Ref: CMS Case #613018
Dear Mr. Mills:
This letter is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address www.organa.net and your social media website at www.facebook.com/organainternational in June 2021. Based on our review, FDA identified significant violations of the Federal Food, Drug, and Cosmetic Act (the Act). You can find the Act and FDA regulations through links on FDA’s home page at
www.fda.gov.
Unapproved New Drugs and Misbranded Drugs
FDA reviewed your website at the Internet address www.organa.net in June 2021 and has determined that you take orders there for your products Copper, Rhodium, Ruthenium, Zinc, Uplift, Immune Boost, Essiac Tea, Gold, Indium, Iron, Magnesium, Manganese, Molybdenum, Palladium, Vanadium, MSM (Methylsulfonylmethane), Relieve Progesterone Cream, and Silver Gel. We have also reviewed your social media website, www.facebook.com/organainternational, which directs consumers to your webpage at www.organa.net to purchase your products. The claims on your websites establish that the products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)] in that 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. As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the Act.
Examples of some of the website claims that provide evidence that your products are intended for use as drugs include:
Organa.net Copper product page
• “Anemia…A copper deficiency can lead to anemia…”
• “Heart Problems…Low intakes of copper may be associated with increased LDL ‘bad’ cholesterol and decreased HDL ‘good’ cholesterol. This may account for low copper levels being a potential contributing factor in heart and circulatory problems, which may lead to full blown heart disease.”
• “Infections: A lack of copper in the diet may lower the body’s immune system. Normal intakes may help to reduce the risk of infection.”
• “Osteoporosis: …[A] mild deficiency of copper may trigger, then worsen, osteoporotic lesions in bones. Boosting…intakes may help reduce the risk of osteoporosis.”
• “Wound and Burn Treatment: …Colloidal copper promotes healing of skin burns and cuts. . .. [C]opper applied directly to the wound promotes faster healing and skin regeneration.”
• “According to researchers…free radicals can offer a “pathway for cancer…and a variety of diseases.” Antioxidants, like those found in Colloidal copper, eliminate free radicals from the body.”
Organa.net Rhodium product page
• Product label: “May be effective in treating HIV and cancer.”
• “Early research has shown that rhodium has a positive effect on tumors in mice… Later research has determined that mismatched DNA is associated with carcinogenesis. Studies have shown that rhodium will bind with mismatched DNA and inhibit the damage associated with these cells.”
Organa.net Ruthenium product page
• Product label: “Reported to neutralize cancer cells.”
• “Antibacterial…Studies have shown that ruthenium particles have antibacterial properties. Studies have shown that ruthenium is more effective against Gram positive and Gram negative pathogenic bacteria.”
Organa.net Zinc product
• Product label: “Essential in wound healing.”
• “Zinc: . . .. Essential in wound healing.”
• “…Zinc deficiency may be contributing to the development or progression of chronic eye diseases, such as macular degeneration . . ..”
• “[T]here is a growing body of evidence that indicates that poor zinc intake is related to…cataract formation; and optic neuritis, the inflammation of the optic nerve.”
• “Many patients who get frequent colds and sore throats have shown a marked decrease in these outbreaks with zinc supplementation.”
Organa.net Uplift product page
• Product label:
o “Uplift is a product designed to target illness. Specific colloidal minerals are added to Organa Mineral Drink to … fight viruses and bacteria.”
o “Silver [an ingredient in Uplift]: A natural antibiotic
o “Zinc [an ingredient in Uplift]: Reduces the duration of colds and illnesses”
o “Gold [an ingredient in Uplift]: Has anti-inflammatory properties”
o “Essential Oil Blend [an ingredient in Uplift]: Antibacterial and antiviral properties…”
• “Uplift is a product which targets the health and wellness of the body as well as the ability to fight off colds and viruses…”
• “A special blend of pure essential oils is added [to Uplift]. These oils together all have anti-bacterial, anti-parasitic, anti-septic...properties.”
Organa.net Immune Boost product page
• Product label:
o “Reduces Allergy Symptoms”
• “… a tool to prevent illnesses from occurring.”
• “sigA antibodies help by trapping bacteria before they cause harm.”
• “When taken consistently, many have reported improvement in chronic allergy conditions, autoimmune problems...”
Organa.net Essiac Tea product page
• Both the website and the images of your product label bear the following claims about ingredients in Essiac Tea:
o “Burdock…May help reduce inflammation.”
o “Slippery Elm…Soothes gastrointestinal … inflammation.”
o “Turkish Rhubarb…May help reduce inflammation...”
Organa.net Gold product page
• “Anti-inflammatory properties: Research shows that colloidal gold can ease the swelling associated with inflammatory conditions like arthritis, bursitis, rheumatism, and tendinitis.”
• “[G]old…may help individuals who are suffering from imbalanced emotional or mental states like anxiety, depression...”
• “Neurological Improvements: Using colloidal gold may help improve neurological diseases in some patients, according to the Meridian Institute’s Health and Rejuvenation Research Center. The Institute followed the case of a woman with essential tremor, a neurological disorder, who found that her symptoms subsided when she took colloidal gold and came back when she stopped taking it.”
Organa.net Indium product page
• “Indium manages the vital functions that are performed by the adrenals, pituitary gland and hypothalamus. These regulate many complex functions of the body, including…perception of pain…inflammations…”
Organa.net Iron product page
• “Iron is an important component of hemoglobin, the substance in red blood cells . . .. A lack of red blood cells leads to anemia.”
• “[I]ron is directly related to brain health and its functions. Proper flow of blood in the brain can … help to create new neural pathways to prevent cognitive disorders like dementia and Alzheimer’s disease . . ..”
Organa.net Magnesium product page
• “[L]ack of magnesium…can result in serious deficiencies which cause illness and make you prone to infection and virus.”
• “Blood Sugar: Magnesium allows your body to regulate blood sugar properly. Diabetes can occur when your body does not properly regulate the amount of sugar in your body.”
• “Headaches: Magnesium has a surprisingly significant effect on migraines and headaches by helping to stop them from happening in the first place.”
• “Depression”
Organa.net Manganese product page
• “Although research has yet to consistently prove that manganese can prevent osteoporosis, it is believed to be one of the contributing factors that slow down the progress of that debilitating disease.”
• “Manganese has been seen to alleviate anxiety…depression….”
• Inflammation and Sprains: Manganese is a widely known remedy for sprains as well as inflammation as it helps in increasing the level of superoxide dismutase. . .. SOD has anti-inflammatory qualities which arthritis sufferers desperately need, so adding manganese back into the body to increase synthesis and function of SOD has been connected with a decrease in symptoms . . ..”
• “Manganese has also exhibited efficiency in controlling the level of sugar in human blood. This may further prevent the occurrence of certain diseases like diabetes. To control the level of sugar in the blood, manganese normalizes insulin synthesis and secretion, and the unpredictable drops in blood sugar can be better regulated, providing a more normal and functional life for diabetics.”
Organa.net Molybdenum product page
• “Fights Inflammatory and Autoimmune Disease: Tetrathiomolybdate, a form of molybdenum with four sulfur atoms, lowers copper levels in the body, which makes it effective in the treatment of fibrotic, inflammatory and autoimmune diseases. . . . [I]n animal studies tetrathiomolybdate dramatically inhibits pulmonary and liver fibrosis, which is thickening and scarring of tissue, helps prevent liver damage from acetaminophen and reduces heart damage from doxorubicin, a bacterial antibiotic. Tetrathiomolybdate also shows a partially protective effect against diabetes.”
Organa.net Palladium product page
• “Palladium …is an anticoagulant…”
Organa.net Vanadium product page
• Product label: “Inhibits the formation of cholesterol.”
• “Vanadium may also help in treating or preventing osteoporosis…”
• “Diabetes: . . . One clinical trial tested the use of vanadium in treatment of diabetes and showed that vanadium had beneficial effects on patients with type 2 diabetes. Vanadium may also improve insulin sensitivity, as well as lower total and LDL, or ‘bad cholesterol,’ levels in people with type 2 diabetes . . ..”
• “Cholesterol: Studies have shown that vanadium helps reduce the cholesterol in the liver cells and decreases blood lipid content . . .. Adequate vanadium content in the brain . . . prevents the development of sclerosis, prevents the risk of cardiovascular disease, hypertension.”
Organa.net MSM (methylsulfonylmethane) product page
• Product label: “Anti-inflammatory”
• “Anti-inflammatory: MSM is a powerful anti-inflammatory”
• "Efficacy of methylsulfonylmethane (MSM) in osteoarthritis pain of the knee: a pilot clinical trial… Assessment of methylsulfonylmethane (MSM) on the development of osteoarthritis (OA): An animal study".
• “It cleans the bloodstream so allergies to food and pollens go away in about three to four days”
Organa.net Relieve Progesterone Cream product page
• “Relieve is a combination of natural ingredients that work in harmony with the body to restore low progesterone levels. . .. Dr. John Lee of Oregon states that balancing the hormones by introducing progesterone through the skin is the first step to curbing osteoporosis. . .. Potential benefits to health: headaches/migraines, depression, PMS prevention relief, mood swings, hot flashes, & osteoporosis.”
Organa.net Silver Gel product page
• Product label: “Use for skin irritations such as . . . cuts, fungus, eczema, psoriasis, and insect bites”
• “Silver Gel aids and promotes natural healing for your skin. . .. The antimicrobial nature of silver makes Silver Gel the perfect solution for all skin irritations. . .. Try Silver Gel for: Eczema, Psoriasis, Razor Burn, Dermatitis, Rosacea, Poison Oak & Ivy, Dry skin, Sunburn, Rashes, Itching, Scrapes, Sunburn, and Acne.”
Organa.net Blog:
Evaluating the Health Benefits of Colloidal Minerals, November 17, 2020
• “Silver has been used for centuries to treat arthritis, cancer, tuberculosis, herpes, and practically anything and everything. Even as medical science has evolved, alternative practitioners worldwide credit colloidal silver for . . . preventing or treating mild to severe infections.”
• “Though there is no evidential proof, Colloidal Silver is thought to help the body heal itself. Other benefits can include:
o “Treat herpes, flue, pneumonia, certain eye infections.”
o “Treatment of cancer and AIDS”
o “Healing wounds: … It is seen when wounds or ulcers are dressed with silver-containing products; the silver particles exhibit antibacterial properties. . .. [C]olloidal silver was also put through scientific test-tube experiments. These studies exhibit antiviral, antifungal, antibacterial, and anti-inflammatory properties.”
Tell Me About Zinc, December 17, 2020
• “Zinc…reduces the risk, severity, and duration of infectious diseases.”
• “Zinc…is needed for natural killer cells which help fight off infections.”
• “A zinc deficiency…causes inflammation.”
• “There have been many articles published recently about zinc and it’s [sic] ability to raise anti-viral resistance.”
In addition, the “Reviews” portion of your website contains evidence of intended use in the form of personal testimonials recommending or describing the use of your products for the cure, mitigation, treatment, or prevent of disease. Examples of such testimonials include:
• Mechel Wall: “I use the nano silver, zinc and minerals daily and have stayed healthy in spite of being exposed to the current virus several times.”
• Lila Turnbull: “I order Essiac tea from Organa after surviving Colon [sic] cancer. It was recommended from a relative whose husband had great results from it after researching its use with cancer and its prevention.”
• Rachel Folkman: “I’ve been using Uplift for two year [sic]. . .. Anytime I start to feel sick I take a capful for a couple of days and it helps kick my sickness.”
• Tracy Mills: “I take the mineral drink everyday along with magnesium & iron. Since doing that I rarely get headaches . . ..”
• Maribel Lopez: “[I]t has helped me for infections, pain, nausea, bleeding, for infected eyes . . ..”
• Maria Lopez: “The colloidal silver of this company is excellent and I am recommending it to everyone I know for how well it has worked for my daughters and my grandson since [sic] for cold or throat infection, skin infection, infection of the eyes . . ..”
• Karina: “I bought it for a friend taht [sic] is undergoing chemotherapy . She is been dringing [sic] Essiac Tea 4 months and she is toleratong [sic] the chemo treatments and her tumors have reduced and some disappeared.”
• A. Perrone: “I had a tooth extraction scheduled because the tooth was badly decayed. 10 days before the surgery I developed an abscess at the tooth site in my palette. I knew the oral surgeon would give me antibiotics and postpone the surgery. I used…Organa 30ppm Colloidal Silver twice daily and after 5 days the abscess was gone. The extraction went off without complication.”
• Courtlin (pertaining to your Magnesium product): “I drink the magnesium and mineral drink and it has greatly helped my gastroenteritis issues. I have been to several doctors that have never seemed to be able to diminish the pain I used to feel in my stomach but to my surprise these have helped drastically.”
In addition, your Facebook page contains evidence of intended use of your products as drugs, including evidence in the form of personal testimonials that you posted recommending or describing the use of your products for the cure, mitigation, treatment, or prevent of disease. Examples of such evidence of intended use includes:
• On June 15, 2020, Organa posted the following: “Rhodium is now being heavily researched as a means to treat cancer…”
• On February 25, 2020, Organa posted the following testimonial from “Annie”: “The Silver has worked wonderfully on cuts, burns, and bugbites [sic]. We all came down with flu symptoms but since we’re all taking silver, it’s Ben [sic] going way [sic] before it can really get started. I began drinking it as soon as I felt the tickle in my thrust [sic] and I’m almost completely better belie [sic] the week is out. I’ve bought two bottles and am ordering one today because it really works and there are no crazy side effects as opposed to pharmesutical [sic] antibiotics.”
• On January 22, 2020, Organa posted the following testimonial from an “Organa Customer”: “I started taking Copper one week ago because of swelling in my legs and pain from a torn ligament. I was taking products for joint support but still had pain and swelling. I RESEARCHED and read that Copper pulls nutrients into ligamints [sic]. I am moving my legs up and down the stairs and bending my legs 80% better after one week! I have suffered with this for 7 years after I had back surgery. I feel this was the missing link and very thankful this product is what they say it is”
• On January 15, 2020, Organa posted the following: “Zinc deficiency may be contributing to the development or progression of chronic eye diseases such as macular degeneration, the major cause of vision loss among older people. In one study, vision loss was reduced by 10 percent in people taking supplements…of zinc . . .. In addition, there is a growing body of evidence that indicates that poor zinc intake is related to . . . cataract formation; and optic neuritis, the inflammation of the optic nerve. Zinc is still 15% off! Head to our website now and get yourself a bottle”
• On December 10, 2019, Organa posted the following: “Many studies have shown that a zinc deficiency can impair a large variety of immune functions and defense mechanisms in animals, and some studies have shown similar effects in humans. These effects include abnormalities and eventual shrinking of the spleen, thymus, and lymph nodes; and impaired production of antibodies-have been found to be correctable with zinc supplementation. Zinc is on sale this month! Make sure you head over to our website to get some before the sale ends!”
Your Copper, Rhodium, Ruthenium, Zinc, Uplift, Immune Boost, Essiac Tea, Gold, Indium, Iron, Magnesium, Manganese, Molybdenum, Palladium, Vanadium, MSM (Methylsulfonylmethane), Silver, Relieve Progesterone Cream, and Silver Gel 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
1
, 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. 331(d), 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective. No FDA-approved application pursuant to section 505 of the FD&C Act [21 U.S.C. 355] is in effect for any of these products. Accordingly, these products are unapproved new drugs marketed in violation of sections 505(a) and 301(d) of the FD&C Act [21 U.S.C. 355(a) and 331(d)].
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 Copper, Rhodium, Ruthenium, Zinc, Uplift, Immune Boost, Essiac Tea, Gold, Iron, Magnesium, Manganese, Molybdenum, MSM, Vanadium, Silver, Relieve Progesterone Cream, and Silver Gel products are intended for prevention or treatment of one or more diseases that are not amenable to self-diagnosis, prevention, or treatment without the supervision of a licensed practitioner. Therefore, it is impossible to write adequate directions for a layperson to use your products safely for their intended purposes. Accordingly, Copper, Rhodium, Ruthenium, Zinc, Uplift, Immune Boost, Essiac Tea, Gold, Iron, Magnesium, Manganese, Molybdenum, MSM, Vanadium, Silver, Relieve Progesterone Cream, and Silver Gel 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)].
Dietary Supplement Misbranding Charges
Even if your Copper, Rhodium, Ruthenium, Zinc, Essiac Tea, Gold, Indium, Iron, Magnesium, Manganese, Molybdenum, Palladium, Vanadium, and Silver were not unapproved new drugs and/or misbranded drugs and described above, they would be misbranded foods under section 403 of the Act, as follows:
1. Your “Copper,” “Gold,” “Indium,” “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” “Palladium,” “Rhodium,” “Ruthenium,” “Silver,” “Vanadium,” “Zinc,” and “Essiac Tea” products are misbranded within the meaning of section 403(s)(2)(B) of the Act [21 U.S.C. § 403(s)(2)(B)] in that the labels fail to identify your products using the term “dietary supplement” in accordance with 21 CFR 101.3(g), which requires that a dietary supplement be identified by the term “dietary supplement” as part of the product’s statement of identity, except the word “dietary” may be deleted and replaced by the name of the dietary ingredient in the product or an appropriate descriptive term. The product labels include a Supplements Facts label, which is evidence of your intent to market the products as Dietary Supplements.
2. Your “Copper,” “Gold,” “Indium,” “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” “Palladium,” “Rhodium,” “Ruthenium,” “Vanadium,” and “Zinc” products are misbranded within the meaning of section 403(q)(1)(A) of the Act [21 U.S.C. § 343(q)(1)(A)] because the serving size on the labels are incorrect. The terms “serving” or “serving size” for a dietary supplement are defined in 21 CFR 101.9(b) and 101.12, Table 2, as the maximum amount recommended on the label for consumption per eating occasion. The labels state the serving size is “1 tsp” while the directions indicate to “Take 2 tsp. once or twice daily as needed.” Furthermore, your “Silver” product is also misbranded because its label fails to include a serving size. The product labels fail to follow the listed “serving size” common measure with the equivalent metric quantity as required by 21 CFR 101.9(b)(7).
3. Your “Copper,” “Gold,” “Indium,” “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” “Palladium,” “Rhodium,” “Ruthenium,” “Vanadium,” and “Zinc” products are misbranded within the meaning of section 403(q)(1)(B) [21 U.S.C. §343(q)(1)B] and 403(q)(5)(F) of the Act [21 U.S.C. §§ 343(q)(5)(F)] because the labels fail to declare the number of servings per container under the serving size on the left hand side of the nutrition label or fails to include this information as part of the net quantity of contents declaration in accordance with 21 CFR 101.36(b)(1)(ii).
4. Your “Copper,” “Gold,” “Indium,” “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” “Palladium,” “Rhodium,” “Ruthenium,” “Vanadium,” and “Zinc” products are misbranded within the meaning of section 403(q)(5)(F) of the Act [21 U.S.C. 343 § (q)(5)(F)] in that the presentation of the nutrition information on the labeling does not comply with 21 CFR 101.36. For example:
a. Your “Copper,” “Gold,” “Indium,” “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” “Palladium,” “Rhodium,” “Ruthenium,” “Silver,” “Vanadium,” “Zinc,” and “Essiac Tea” products fail to enclose the nutrition information (Supplement Facts label) in a box using hairlines and titled with bolded “Supplement Facts” (not “Supplemental Facts” as incorrectly noted on your product labels) set full width, as required by 21 CFR 101.36(e)(1) and (2). Furthermore, all nutrition information within the nutrition label (Supplement Facts label) must utilize all black or one color type, as required by 21 CFR 101.36(e)(3)(ii)
b. The labels for your “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” and “Zinc” products list iron, magnesium, manganese, molybdenum, and zinc, respectively in the nutrition information label. Iron, magnesium, manganese, molybdenum, and zinc are (b)(2)-dietary ingredients (i.e., a dietary ingredient that has a Reference Daily Intake (RDI). Any (b)(2)-dietary ingredient not present, or in amounts that can be declared as zero in 101.9(c), shall not be declared (e.g., amounts corresponding to less than 2 percent of the RDI for vitamins and minerals) in accordance with 21 CFR 101.36(b)(2)(i).
c. The labels for your “Copper,” “Gold,” “Indium,” “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” “Palladium,” “Rhodium,” “Ruthenium,” “Silver”, “Vanadium,” “Zinc,” and “Essiac Tea” products fail to include the subheading “Servings Per Container” as required by 21 CFR 101.36(b)(ii) and 101.36(e)(6)(i). A heavy bar must be placed beneath the subheading “Servings Per Container” except that if “Servings Per Container” is not required and, as a result, not declared, the bar must be placed beneath the subheading “Serving Size”.
d. The labels for your “Copper,” “Gold,” “Indium,” “Palladium,” “Rhodium,” “Ruthenium,” “Vanadium,” “Silver”, and “Essiac Tea” products fail to include a heavy bar beneath the last (b)(3)-dietary ingredient (other dietary ingredient), as required by 21 CFR 101.36(e)(6)(iii).
e. The following product labels are misbranded in that they fail to list “Other ingredients” in a separate “Other ingredients” list outside and immediately below the Supplement Facts label in accordance with 21 CFR 101.4(g):
i. The product labels for Copper and Gold list “Purified Water” within the Supplement Facts label
ii. The product labels for Indium, Iron, Magnesium, Manganese, Molybdenum, Palladium, Rhodium, Ruthenium, Vanadium, and Zinc list “Distilled Water” within the Supplement Facts
iii. The product label for Essiac Tea lists the “Other Ingredients: Distilled Water, Potassium Sorbate, Sodium Benzoate, and Phosphoric Acid” within the Supplement Facts label.
f. The labels for your “Copper,” “Gold,” “Indium,” “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” “Palladium,” “Rhodium,” “Ruthenium,” “Vanadium,” “Silver,” and “Zinc” bear the following or similar statement: “Percent Daily Values based on a 2,000-calorie diet.” This statement is only permitted when the percent of Daily Value is declared for total fat, saturated fat, total carbohydrate, dietary fiber, or protein as required by 21 CFR 101.9(c) and 21 CFR 101.36(b)(2)(iii)(D).
g. Several of your product labels are for persons within more than one group. If a product is for persons within more than one group, the percent of Daily Value for each group must be presented in separate columns, as required in 21 CFR 101.36(b)(2)(iii)(E).
h. The Essiac Tea product label lacks a declaration of % Daily Value. Furthermore, on several of your product labels the statement *“Percentage Daily Value not established” is not linked to a symbol elsewhere in the nutrition information label, as required by 21 101.36 (b)(3)(iv).
i. Your “Copper,” “Gold,” “Indium,” “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” “Palladium,” “Rhodium,” “Ruthenium,” “Silver,” “Vanadium,” and “Zinc,” are misbranded within the meaning of section 403(e)(2) of the Act [21 U.S.C. § 343(e)(2)] because the label fails to accurately declare the net quantity of contents on the principal display panel in accordance with 21 CFR 101.7 and 15 U.S.C.§ 1453(a)(2) of the Fair Packaging and Labeling Act.
j. Your “Copper,” “Gold,” “Indium,” “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” “Palladium,” “Rhodium,” “Ruthenium,” “Silver,” “Vanadium,” and “Zinc,” are misbranded within the meaning of section 403(e)(1) of the Act [21 U.S.C. § 343 (e)(1)] in that each label fails to list the name and place of business of the manufacturer, packer, or distributor in accordance with 21 CFR 101.5.
k. Your Essiac Tea product is misbranded within the meaning of section 403(r)(1)(A) of the Act [21 U.S.C. § 343(r)(1)(A)] because the product label bears a nutrient content claim, but the product does not meet the requirements to make such claim. Under section 403(r)(1)(A) of the Act, a claim that characterizes the level of a nutrient which is of the type required to be in the labeling of food must be made in accordance with a regulation authorizing the use of such a claim. Characterizing the level of a nutrient in the food labeling of a product without complying with the specific requirements pertaining to nutrient content claims for that nutrient misbrands the product under section 403(r)(l)(A) of the Act. Specifically, your Essiac Tea product label bears the claim, “Slippery Elm [an ingredient in your Essiac Tea product]: Rich in . . . antioxidants,” but use of this “antioxidant” nutrient content claim fails to comply with the requirements listed in 21 CFR 101.54(g). These requirements state, in part, that for a product to bear such a claim, a reference daily intake (RDI) must have been established for each of the nutrients that are the subject of the claim [21 CFR 101.54(g)(l)], and these nutrients must have recognized antioxidant activity [21 CPR 101.54(g)(2)]. The level of each nutrient that is the subject of the claim must also be sufficient to qualify for the claim under 21 CFR 101.54(b), (c), or (e), as required by 21 CFR 101.54(g)(3). Further, nutrient content claims using the term "antioxidant" must include the names of the nutrients that are the subject of the claim as part of the claim or, alternatively, the term "antioxidant" or "antioxidants" may be linked by a symbol (e.g., an asterisk) that refers to the same symbol that appears elsewhere on the same panel of the product label, followed by the name or names of the nutrients with recognized antioxidant activity [21 CFR 101.54(g)(4)]. Your claim "[r]ich in antioxidants" is a nutrient content claim, but Essiac Tea does not meet the requirements to bear such a claim because the claim does not include the names of the nutrients that are the subject of the claim or state them on the same panel and link them with an asterisk, as required by 21 CFR 101.54(g).
l. The Essiac product is misbranded within the meaning of section 403(s)(2)(C) of the Act [21 U.S.C. § 343(s)(2)(C)] because the product label fails to identify the part of the plant (e.g., root, leaves) from which each botanical dietary ingredient in the product is derived, as required by 21 CFR 101.4(h)(1).
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.
We also offer the following comments:
• Your “Copper,” “Gold,” “Indium,” “Iron,” “Magnesium,” “Manganese,” “Molybdenum,” “Palladium,” “Rhodium,” “Ruthenium,” “Silver,” “Vanadium,” “Zinc,” and “Essiac Tea” products contain the statement, “This product is not intended to diagnose, treat, or prevent disease. Statements have not been evaluated by the FDA.” This disclaimer is not in accordance with the required text. Per 101.93, the required text should state: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.” Furthermore, this disclaimer is not linked to any specific structure function claim on the product label. The FDA disclaimer statement as noted on your product label must be bolded and set off in a box, and the symbol preceding the disclaimer statement must be linked to the same symbol placed at the end of each structure function statement on the label in accordance with 21 CFR 101.93(d) and (e).
• For your product labels, there is no provision in the regulations for the listing of “Ingredients” as a heading in the Supplement Facts label.
• Your Essiac Tea product label lists the chemical preservatives sodium benzoate, potassium sorbate and phosphoric acid but does not bear labeling stating that fact, in that the label fails to include a separate description of their function as a preservative in accordance with 21 CFR 101.22(j).
• The directions for use statements on your product labels are placed before the nutrition information. Directions for use are considered intervening material. All information appearing on the information panel must appear in one place without other intervening material, as required by 21 CFR 101.2(e).
• The Essiac Tea product label fails to declare the common or usual names of each ingredient used, as required by 21 CFR 101.36 and 21 CFR 101.4. Specifically, “Turkish rhubarb” is not a standardized common name of a botanical dietary ingredient listed in the reference Herbs of Commerce.
Please notify FDA in writing, within 15 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 15 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 Act, include your reasoning and any supporting information for our consideration.
Please send your reply to the Food and Drug Administration, Attention: Hanna L. Potter, Compliance Officer; 6th Ave and Kipling St, DFC Bldg. 20, PO Box 25087, Denver, Colorado, 80225-0087 or via email at hanna.potter@fda.hhs.gov. You may reach Ms. Potter at (303)236-3094 if you have any questions about this matter.
Sincerely,
/S/
E. Mark Harris
Denver District Director & Program Division Director
Office of Human and Animal Food Operations Division West 4
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Even if certain of your products, such as your Indium and Palladium products, are marketed only for nonprescription indications, they would not meet the conditions under section 505G of the FD&C Act [21 U.S.C. 355h] for lawful marketing without an approved application, including because indium and palladium were not active ingredients in any applicable final monograph or tentative final monograph issued under 21 CFR part 330, for purposes of section 505G(a), nor was marketing of these products permitted by an administrative order under section 505G(b). Additionally, these products would be misbranded under section 502(ee) of the FD&C Act [21 U.S.C. 352(ee)] because they would be nonprescription drugs subject to section 505G of the FD&C Act that do not comply with the requirements for marketing under that section and are not the subject of an application approved under section 505 of the FD&C Act [21 U.S.C. 355].
Content current as of:
10/26/2021
Regulated Product(s)
Drugs
Food & Beverages