WARNING LETTER
KetoKerri LLC
MARCS-CMS 598163 —
March 31, 2020
Delivery Method:
Via Overnight Delivery
Product:
Cosmetics
Drugs
Food & Beverages
Recipient:
Recipient Name
Kerri Rivera
KetoKerri LLC
284 E Chilton Dr Ste 11
Chandler
,
AZ
85225
United States
Issuing Office:
Center for Food Safety and Applied Nutrition
United States
WARNING LETTER
March 31, 2020
RE: 598163
Dear Ms. Rivera:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at the Internet address, www.ketokerri.com, in January 2020 and has determined that you take orders there for the products “Dr. Fitt Robynzyme,” “Level Up Clean MCT C8 Oil,” “KK Black Seed Oil,” “KK Breakthrough Vitamin D with CHONDROITIN & OLEIC,” “KK Clean Clay™,” “KK EDTA with Selenium & Minerals,” “KK Humic/Fulvic Minerals & Electrolytes,” and “KK 99.9% Pure Organic Sulfur Crystals MSM.” We have also reviewed your social media website at www.facebook.com/iamketokerri/; this website directs consumers to your website www.ketokerri.com, to purchase your products. Additionally, we reviewed product listings on your Amazon storefront, which you operate under the name, Keto Kerri, as well as the literature accompanying sales of your products.
The claims on your website, social media webpage, Amazon storefront, and literature included with a product sale establish that your 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. As explained further below, introducing or delivering these products for introduction into interstate commerce violates the Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Examples of some of the claims observed on your website, www.ketokerri.com, that provide evidence that these products are intended for use as drugs include the following:
Under the heading for “CLEAN MCT C8 OIL”:
“NATURAL ANTIBIOTIC: used in industry to kill pathogens”
Under the heading for “KK Clean Clay”:
“A pure calcium bentonite green clay, such as KK Clean Clay™ . . . has strong ionic properties that bind (chelate) molecules such as heavy metals, toxins and pathogens and holds them till they are removed from the body.”
“The clay reduces diarrhea”
Under the heading for “KK Humic/Fulvic”:
“Cancer Fighter: the cancer fighting capacity of HA and FA”
ANCIENT ORIGINS The medicinal qualities exhibited by the ancient remedy Shilajit are due to the presence of Humic acid (HA) and fulvic acid (FA) . . . Shilajit has been used in oriental medicine for centuries to treat . . . diabetes, skin diseases, rheumatic pain, kidney stones, heart ailments, leprosy . . . .”
“MICROBIAL MUTAGENIC DEFENSE FA has antimicrobial and antibacterial properties … antiviral properties”
Under the heading for “KK MSM”:
“People take MSM by mouth for chronic pain, osteoarthritis, joint inflammation, rheumatoid arthritis, osteoporosis, inflammation around the joints (bursitis), tendinitis, swelling around the tendons (tenosynovitis), musculoskeletal pain, muscle cramps, hardened skin condition called scleroderma . . . hair loss . . . eye inflammation … gum disease, wounds, cuts, and abrasions/accelerated wound healing, RA (rheumatoid arthritis), carpal tunnel syndrome, asthma, allergies, muscle cramps/pain . . . eczema, rosacea, psoriasis.”
“People also take MSM by mouth for relief of allergies, chronic constipation, “sour stomach”, ulcers, a bowel disease called diverticulosis . . . obesity, poor circulation, high blood pressure, and high cholesterol, type 2 diabetes, liver problems, Alzheimer’s disease . . . lung disorders including emphysema and pneumonia, chronic fatigue syndrome, autoimmune disorders (systemic lupus erythematous), HIV infection and AIDS, and cancer (breast cancer and colon cancer), mucous membrane inflammation, temporomandibular joint (TMJ) problems, leg cramps, migraine, headaches, hangover, parasitic infections of the intestinal and urogenital tracts including Trichomonas vaginalis and Giardia, yeast infection, insect bites, radiation poisoning . . . .”
Your website also includes disease claims in the form of citations to publications or references. When scientific publications or references are used commercially by the seller of a product to promote the product to consumers, such references may become evidence of the product's intended use. For example, under 21 CFR 101.93(g)(2)(iv)(C), a citation of a publication or reference in the labeling of a product is considered to be a claim about disease treatment or prevention if the citation refers to a disease use and if, in the context of the labeling as a whole, the citation implies treatment or prevention of a disease. The following examples of citations on your website used to market “KK Black Seed Oil” and “KK Humic/Fulvic Minerals & Electrolytes” for disease treatment or prevention are evidence of your products’ intended use as drugs:
Under the heading for “KK Black Seed Oil”:
“Diabetes: the anti-diabetic capacity of BSO”
“VERSATILE Black seed oil has been used to treat almost any disease or condition. These include asthma, eczema, inflammation, diabetes, influenza, rheumatism, gastrointestinal issues, cancer, hypertension, neurological issues, and many more”
“MICROBIAL DEFENSE Black seed oil can act as an Antibacterial agent, Antiviral agent, Antifungal agent, Antiparasitic agent”
“Yimer EM, Tuem KB, Karim A, Ur-Rehman N, Anwar F (2019). “Nigella sativa L. (Black Cumin): A Promising Natural Remedy for Wide Range of Illnesses,” Evidence-Based Complementary and Alternative Medicine, vol. 2019, Article ID 1528635, 16 pages, 2019 reviewed 21 studies [referencing footnotes 9-31 on the page] exploring the potential of black seed oil (Nigella sativa [NS] and Thymoquinone [TQ] [a component of black seed oil]) in five specific neurological areas: Alzheimer’s disease, Parkinson’s disease, Depression and anxiety, Epilepsy, and Opioid Dependence and Tolerance. The review concluded NS and TQ held great promise for improvement in these areas [referencing footnote 6 on the page].”
“GUT HEALTH Animal and human studies have shown NS and TQ have broad gastroprotective and restorative potentials [referencing footnotes 3, 5, and 6 on the page]. These include treatments for Celiac disease, dyspepsia, and other common ailments.”
“DIABETES Many of the properties exhibited by black seed oil have the potential to be helpful in the management and treatment of diabetes [referencing footnotes 6 and 7 on the page] . . . it has the potential to reduce bad cholesterol . . ..”
“Aljabre SH, Alakloby OM, Randhawa MA (2015). “Dermatological effects of Nigella sativa,” Journal of Dermatology & Dermatologic Surgery, vol. 19, no. 2, pp. 92–96, 2015 examined all of the current studies and articles relating to NS and TQ as they relate to the skin. The article focused on ten areas of interest: antibacterial properties, the antiviral properties, the antifungal properties, the antiparasitic properties, wound healing, psoriasis … allergic reactions, eczema, and skin cancer. The article concluded, “The published original research articles on the effects of N. sativa and its ingredients strongly indicate its pharmacological potential in dermatology” [referencing footnote 47 on the page].”
“Yimer EM, Tuem KB, Karim A, Ur-Rehman N, Anwar F (2019). “Nigella sativa L. (Black Cumin): A Promising Natural Remedy for Wide Range of Illnesses,” Evidence-Based Complementary and Alternative Medicine, vol. 2019, Article ID 1528635, 16 pages, 2019 reviewed 15 studies [referencing footnotes 32-46 on the page] to assess the role NS and TQ can play in fighting cancer. . . . The review determined that NS and TQ can help alleviate the side effects of conventional therapies and can act on all major cancer markers [referencing footnote 6 on the page].”
On the webpage, www.ketokerri.com/kk-black-seed-oil/, under the header “FOOTNOTES”:
Footnote 30: Sharaf R, Elsayed MN, Mahran L (2014). “Neuroprotective effect of thymoquinone against lipopolysaccharide-induced Alzheimer’s disease in an animal model,” European Geriatric Medicine, vol. 5, no. 1, pp. S83-S158, 2014.
Footnote 35: Gali-Muhtasib H, Ocker M, Kuester D, et al. (2008). “Thymoquinone reduces mouse colon tumor cell invasion and inhibits tumor growth in murine colon cancer models,” Journal of Cellular and Molecular Medicine, vol. 12, no. 1, pp. 330-342, 2008.
On the webpage, www.ketokerri.com/kk-humic-fulvic/, under the header “BIBILIOGRAPHY”:
Cornejo A, Jimenez JM, Caballero L, Melo F, Maccioni RB (2011). “Fulvic acid inhibits aggregation and promotes disassembly of tau fibrils associated with Alzheimer’s disease,” Journal of Alzheimer’s Disease, vol. 27, no. 1, pp. 143-153, 2011.
Moreover, the literature that you enclose with shipped with customer products also contains evidence that your products are intended for use as drugs include the following:
“KK EDTA with Selenium and Minerals . . . Helpful for ASD, Alzheimer’s, heart disease . . .”
“KK Humic/Fulvic Minerals & Electrolytes . . . Crosses the blood brain barrier to remove mercury, heavy metals, and pesticides from the brain and body . . . antiviral, and anti-tumor[,] Reverses arthritis . . .”
Additionally, claims made on your Facebook page, www.facebook.com/iamketokerri/, which links to your website at www.ketokerri.com/product-category/single-items/ where your products can be purchased directly, provide further evidence that your products are intended for use as drugs. For example:
Spanish
November 20, 2019 Post: “Lamentablemente más del 90% de los niños con TEA tienen deficiencia de acido clorhídrico en el estomago. Una deficiencia de ácido clorhídrico puede tener muchas consecuencias, algunas de ellas son: . . . Depresión[,] Asma . . . Anemia . . . ROBYNZYME Incrementa la producción la ÁCIDO CLORHÍDRICO (HCL)”
December 3, 2019 Post: “Aceite de semilla negra: . . . Propiedades/Beneficios: Antidepresivo natural - Antiviral – Antibacteriano- Antiparasitario – Anti fúngico – Antiinflamatorio – Analgésico . . . 21 estudios clínicos exploran el potencial de NS y TQ para ser utilizado en cinco áreas neurológicas específicas: enfermedad de Alzheimer, enfermedad de Parkinson, depresión y ansiedad, epilepsia y dependencia de opioides.”
December 11, 2019 Post: “Hacido Humico/Fulvico con Minerales y Electrolitos …Cruza la barrera hematoencefálica para eliminar el MERCURIO, los metals pesados, los pesticidas y las toxinas del cuerpo y también del CEREBRO! Este es uno de los suplementos más recomendados para la recuperación del autismo”
July 25, 2019 Post: “El informe describe los efectos asociados con la administración de un suplemento constituido por sulfato de condroitina, vitamina D3 y ácido oleico (Rerum) en los síntomas de los trastornos del espectro autista (TEA) . . . mostraron mejoras de moderadas a muy considerable.”
o In a comment of that post, you state “The report describes the effects associated with the administration of a supplement consisting of chondroitin sulfate, vitamin D3 and oleic acid (Rerum) in the symptoms of autism spectrum disorders (ASD) . . . the use of Rerum . . . may be associated with significant improvements of the symptoms of the disease.”
English translation and English claims
November 20, 2019 Post: “Unfortunately more than 90% of children with ASD are deficient in hydrochloric acid in the stomach. A deficiency of hydrochloric acid can have many consequences, some of them are: . . . Depression[,] Asthma . . . Anemia . . . ROBYNZYME Increases production of Hydrochloric acid (HCL)”
December 3, 2019 Post: “Black seed oil: . . . Properties / Benefits: Natural antidepressant - Antiviral - Antibacterial- Antiparasitic – Anti Fungal - Antiinflammatory – Analgesic . . . 21 clinical studies explore the potential of NS and TQ to be used in five specific neurological areas: Alzheimer's disease, Parkinson's disease, depression and anxiety, epilepsy and opioid dependence.”
December 6, 2019 Post: “Edta: . . . Useful for . . . Alzheimer’s, heart disease”
December 11, 2019 Post: “Humic/ Fulvic made with Minerals and Electrolytes … Cross the blood brain barrier to eliminate MERCURY, heavy metals pesticides and toxins from the body and also from the BRAIN! This is one of the most recommended supplements for recovery of autism.”
July 25, 2019 Post: “The report describes the effects associated with the administration of a supplement consisting of chondroitin sulfate, vitamin D3 and oleic acid (Rerum) in the symptoms of autism spectrum disorders (ASD) . . . showed moderate to very considerable improvements.”
Also, a video titled, “Breakthrough Vitamin D” states that your Vitamin D product with CHONDROITIN & OLEIC, “ . . . reduces nagalase which is inflammation caused by virus and cancer cells . . . .It is a macrophage activator. The macrophage are the PAC-MAN of the immune system that gobble up pathogens that are very very microscopic. So, we can basically stop the illness in its tracks. I really like it for autism and lyme, and pretty much anything else that’s small and easy to get. Helps to detoxify chemicals, toxins, cancer.”
Furthermore, you provide product purchase links from your website www.ketokerri.com, to your Amazon storefront, which you operated under the name, Keto Kerri. The product descriptions provide evidence that these products are intended for use as drugs include the following:
On the “KK Humic/Fulvic Minerals & Electrolytes” product listing:
“Fulvic and Humic Acids are the best solution to . . .absorbing the minerals and electrolytes[.] . . . A Few Symptoms That May Indicate Mineral Deficiency: . . . Depression . . .Arthritis . . . Heart Palpitations . . .Allergies . . .Asthma[,] Glucose, Cholesterol, or Anemia Problems[.]”
On the “KK Breakthrough Vitamin D with CHONDROITIN & OLEIC” product listing:
“The latest Breakthrough in Vitamin D supplementation . . . A Few Symptoms That May Indicate Vitamin D Deficiency: . . .Diarrhea . . . Inflammation . . . Fibromyalgia, [and] Chronic Fatigue Syndrome[.]”
Your products “Dr. Fitt Robynzyme,” “Level Up Clean MCT C8 Oil,” “KK Black Seed Oil,” “KK Breakthrough Vitamin D with CHONDROITIN & OLEIC,” “KK Clean Clay™,” “KK EDTA with Selenium & Minerals,” “KK Humic/Fulvic Minerals & Electrolytes,” and “KK 99.9% Pure Organic Sulfur Crystals MSM” 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)]. 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.
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 C.F.R. § 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 products “Dr. Fitt Robynzyme,” “KK Black Seed Oil,” “KK Breakthrough Vitamin D with CHONDROITIN & OLEIC,” “KK EDTA with Selenium & Minerals,” “KK Humic/Fulvic Minerals & Electrolytes,” and “KK 99.9% Pure Organic Sulfur Crystals MSM” 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 products safely for their intended purposes. Accordingly, your “Dr. Fitt Robynzyme,” “KK Black Seed Oil,” “KK Breakthrough Vitamin D with CHONDROITIN & OLEIC,” “KK EDTA with Selenium & Minerals,” “KK Humic/Fulvic Minerals & Electrolytes,” and “KK 99.9% Pure Organic Sulfur Crystals MSM” 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)].
The violations cited in this letter are not intended to be an all-inclusive statement of violations that exist in connection with your products. You are responsible for investigating and determining the causes of the violations identified above 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 the Act and FDA regulations.
You should take prompt action to correct the violations in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and/or injunction.
Within fifteen working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct violations. Include an explanation of each step being taken to prevent the recurrence of violations, as well as copies of related documentation. If you believe that your products are not in violation of the Act, include your reasoning and any supporting information for our consideration. 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.
Your written reply should be directed to Mr. Rob Genzel Jr., 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. If you have any questions, you may also contact Mr. Genzel at rob.genzel@fda.hhs.gov.
Sincerely,
/S/
William A. Correll Jr.
Director
Office of Compliance
Center for Food Safety
and Applied Nutrition
Content current as of:
04/14/2020
Regulated Product(s)
Cosmetics
Drugs
Food & Beverages