Seattle District Office
22215 26 th Avenue SE, Suite 210
Bothell, Washington 98021
April 17, 2017
In reply, refer to Warning Letter SEA 17-09
The Vibrant Health Store, LLC
4088 South 2400 West
Weston, Idaho 83286
Dear Mr. Kirk,
This is to advise you that the United States Food and Drug Administration (FDA) reviewed your website at www.drchristophersherbs.com, from which you take orders for the following products: Black Drawing Ointment, Burdock Root, Kid-e-Trac, Liver D-Tox Formula, Rash Ointment, Red Clover Blossoms, Relax-Eze, and St. John’s Wort. As explained further below, introducing or delivering these products for introduction into interstate commerce violates 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.
Based on the labeling claims on your website, your products are drugs under section 201(g)(1) of the Act [21 U.S.C. § 321(g)(1)] because they are articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease. Examples of such disease claims found in the labeling of these products include, but may not be limited to, the following:
Black Drawing Ointment
- “Ailments traditionally used for: . . . Cancer . . . Hemorrhoids . . . Tumor”
- “Traditionally it has been used for . . . boils, scurvy, eczema, psoriasis . . . rheumatism, scrofula, syphilis, leprosy, cancer, gout, pulmonary affections, catarrh . . . hemorrhoids, burns, wounds, eruptions, canker sores, sciatica, gonorrhea, kidney and bladder troubles, colds, fevers, etc.”
- “Ailments traditionally used for: . . . Alzheimer’s Disease . . . Anxiety . . . Cancer . . . Cataracts . . . Convulsions . . . Dementia . . . Depression . . . Fibromyalgia . . . Glaucoma . . . Hyperactivity (ADHD) . . . Impotence . . . Insomnia . . . Kanner’s Syndrome . . . Macular Degeneration . . . Nyctalopia . . . Raynaud’s Disease . . . Retinopathy . . . Senile Dementia (Alzheimer’s Disease) . . .”
Liver D-Tox Formula
- “Ailments traditionally used for: . . . ADD/ADHD . . . Alzheimer’s Disease . . . Anxiety . . . Senile Dementia . . . Austism [sic] . . . Blepharitis . . . Blood Poisoning . . . Cancer . . . Cholecystisis . . . Dementia . . . Depression . . . Gallstones . . . Gastric Ulcer . . . Gastritis . . . Glaucoma . . . Hepatitis . . . Hyperactivity (ADHD) . . . Jaundice . . . Kanner’s Syndrome . . .”
- “Natural Skin Support for Eczema . . . & Other Skin Disorders”
- “Commonly used for poison ivy . . .”
- “Ailments traditionally used for: . . . Cancer . . . Dermatitis . . . Eczema . . . Hemorrhoids . . .”
Red Clover Blossoms
- “Red clover is a very useful and wonderful alterative agent for counteracting scrofulous and skin diseases, as an antidote to cancer, and as an efficient remedy in bronchitis and spasmodic affections.”
- “Ailments traditionally used for: . . . Angina . . . Anxiety . . . Whooping Cough . . . Vertigo . . . Tinnitus . . . Amenorrhea . . . Bronchitis . . . Cancer . . . Carpal Tunnel Syndrome . . . Chronic Obstructive Lung Disease (COLD) . . . Depression . . . Dysentery . . . Epilepsy . . . Paralysis . . . Pleurisy . . . Pulmonary Disease (COPD) . . . Respiratory System (COPD) . . . Upper Respiratory Infection . . .”
St. John’s Wort
- “European clinical research has confirmed the effectiveness of St. John’s Wort in the treatment of depression."
- “[T]reatment of the following: wounds, burns, injured nerves, sciatica, ulcers, anxiety, inflammation, and many other ailments.”
- “Ailments traditionally used for: . . . Alzheimer’s Disease . . . Anxiety . . . Cancer . . . Cataracts . . . Convulsions . . . Dementia . . . Depression . . . Fibromyalgia . . . Glaucoma . . . Impotence . . . Kanner’s Syndrome . . . Macular Degeneration . . . Raynaud’s Disease . . . ”
Your products are not generally recognized as safe and effective for the above referenced uses and, therefore, the 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) and 355(a)]. FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.
Furthermore, your products are offered for conditions that are not amenable to self-diagnosis and treatment by individuals who are not medical practitioners; therefore, adequate directions for use cannot be written so that a layperson can use these drugs safely for their intended purposes. Thus, your products are misbranded within the meaning of section 502(f)(1) of the Act [21 U.S.C. § 352(f)(1)], in that their labeling fails to bear adequate directions for use. It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under 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 assure that you comply with all requirements of federal law and FDA regulations.
You should take prompt action to correct the violations cited in this letter. Failure to promptly correct these violations may result in legal action without further notice, including, without limitation, seizure and injunction.
Within fifteen (15) working days of receipt of this letter, please notify this office in writing of the specific steps that you have taken to correct the 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 complete the correction.
Your response should be sent to U.S. Food and Drug Administration, 22215 26th Avenue SE, Suite 210, Bothell, Washington 98021, to the attention of Compliance Officer Katherine L. Arnold. If you have any questions with regard to this letter, please contact Compliance Officer Katherine Arnold at 425-302-0437.
Miriam R. Burbach
cc: Addison Kirk
The Vibrant Health Store, LLC
P.O. Box 37
Weston, ID 83286
This page was posted on April 30, 2019.