WARNING LETTER
Dr Jen Hartley/Healing Artistry, LLC
MARCS-CMS 590265 —
October 29, 2019
Product:
Animal & Veterinary
Drugs
Recipient:
Dr Jen Hartley/Healing Artistry, LLC
Healing Artistry, LLC
6650 West 44th Avenue, Suite #1
Wheat Ridge
,
CO
80033
United States
Issuing Office:
Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road
Irvine
,
CA
92612-2506
United States
WARNING LETTER
October 29, 2019
Dear Dr. Hartley:
This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your website at Internet address www.drjenhartley.com in 2019, and has determined that you take orders there for the products “Colloidal Silver,” “Chronic Pain Tincture,” “Heart Health Tincture,” “Insulin Balance Tincture,” and “Intestinal Restore Tea.” The claims on your website establish that the products are drugs under section 201(g)(1) of the Federal Food, Drug, and Cosmetic Act (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 diseases in human or animals.
As explained further below, introducing or delivering these products for introduction into interstate commerce for such uses violates the FD&C Act. You can find the Act and FDA regulations through links on FDA’s home page at www.fda.gov.
Products Intended for Use in Humans
On your website and under the heading “Products” and “Tinctures & Herbal Supplements,” the following are examples of products and claims observed that provide evidence that these products are intended for use as drugs which include, but are not limited to, the following:
Heart Health Tincture
? “Lowers Cholesterol & Blood Pressure, Prevents Stroke & Heart Disease (Stop All Statin or HBP Drugs NOW)”
? “Do you have Cardiovascular Disorders that run in the family? Did your doctor just inform you that you have too high of cholesterol or blood pressure? Do you think that Statins or blood pressure medication for the rest of your life…”
? “Tags: atherosclerosis…”
Insulin Balance Tincture
? “Diabetes, Hypoglycemia”
? “Is insulin regulation always on the back of your mind? Then this is the Tincture for you! Herbs are carefully selected to help the body learn to naturally regulate it’s (sic) blood sugar and insulin levels. This tincture can decrease experience of hypoglycemia, prevent diabetes or decrease your need for insulin”
Chronic Pain Tincture
? “Reduces Systemic Inflammation & Pain”
? “Do you have pain that seems to migrate EVERYWHERE? Are you tired of relying on prescription painkiller or anti-inflammatories? Then it may be time to go back to your natural roots, and give our high quality, pain relief tincture a try!”
Intestinal Restore Tea
? “Do you suffer from gastric distress, Chrone’s (sic), IBS or Leaky Gut? Then this is the tea for you. Our tea is designed to be gentle enough even with the worst intestinal disorders, but will give you support.”
Your 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 FD&C 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.
Products Intended for Use in Humans and Animals
Colloidal Silver
On your website page for your “Colloidal Silver” product, you promote it for use in humans and animals. Specifically, you state, “It can be used internally or externally, for all ages and even the family pet,” and “…add it to the doggie water bowl.” FDA has determined that your firm’s “Colloidal Silver” is a drug under section 201(g)(1) of the FD&C Act, 21 U.S.C. § 321(g)(1), because it is 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 of man or other animals.
Examples of claims from the website that establish the intended use of “Colloidal Silver” include, but are not limited to, the following:
? “Tags: Acne, antibacterial, antifungal, burns, cold and flu, cuts, gas . . . infection.”
? “Nature’s Antibiotic, Antiviral, AntiCancer”
? “Kills All Infections”
? “[I]t can be used for colds/flu, UTIs, yeast infections, Digestive disorders including parasites and leaky gut, and many more!”
? “External applications can be for acne, sunburns, wounds/cuts, dandruff, psoriasis, eczema, athlete’s foot, ear and eye infections, gangrene and other skin conditions.”
These statements also appear on the website product page for your “Acne Protocol,” which includes “Colloidal Silver” as one of several components of the protocol.
Your “Colloidal Silver” product is also a “new drug” under section 201(p) of the FD&C Act, 21 U.S.C. § 321(p), because it is not generally recognized as safe and effective for use under the conditions prescribed, recommended, or suggested in its labeling. Under
section 505(a) of the FD&C Act, 21 U.S.C. § 355(a), new drugs may not be introduced or delivered for introduction into interstate commerce without prior approval from FDA. No approved application pursuant to section 505 of the FD&C Act, 21 U.S.C. § 355, is in effect for this product. Accordingly, the introduction or delivery for introduction into interstate commerce of this product violates sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. §§ 331(d) and 355(a).
In addition, this product is a new animal drug, as defined by section 201(v) of the FD&C Act, 21 U.S.C. § 321(v), because it is 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. The product is not the subject of an approved new animal drug application, conditionally approved new animal drug application, or index listing under sections 512, 571, and 572 of the FD&C Act, 21 U.S.C. §§ 360b, 360ccc, and 360ccc-1. Therefore, the product is unsafe within the meaning of 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).
Your “Colloidal Silver” product is also misbranded within the meaning of section 502(f)(1) of the FD&C Act, 21 U.S.C. § 352(f)(1), in that its labeling fails to bear adequate directions for use. “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. Your “Colloidal Silver” product is 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 this drug safely for its intended purposes. FDA-approved prescription drugs that bear their FDA approved labeling are exempt from the requirements that they bear adequate directions for use by a layperson. However, your product is not exempt from the requirement that its labeling bear adequate directions for use, 21 CFR 201.100(c)(2) and 201.115, because no FDA-approved application is in effect for it. It is prohibited to introduce or deliver for introduction into interstate commerce a misbranded drug under section 301(a) of the FD&C Act, 21 U.S.C. § 331(a).
Further, according to 21 CFR 310.548, any OTC drug product containing colloidal silver ingredients that is labeled, represented, or promoted for the treatment and/or prevention of any disease is regarded as a “new drug” within the meaning of section 201(p) of the FD&C Act, 21 U.S.C. § 321(p), for which an approved application is required for marketing, without which such product is also misbranded under section 502 of the FD&C Act, 21 U.S.C. § 352.
This letter is not intended to be an all-inclusive review of your products. It is your responsibility to ensure that all of your products are in compliance with the Act and its implementing regulations. Failure to promptly correct the violations specified above may result in enforcement action without further notice. Enforcement action may include seizure of violative products and/or injunction against the manufacturers and distributors of violative products.
You should notify this office, in writing, within fifteen (15) working days of the receipt of this letter of the steps you have taken to bring your firm into compliance with the law. Your response should include any documentation necessary to show that correction has been achieved. If corrective action cannot be completed within fifteen (15) working days, state the reason for the delay and the date by which the corrections will be completed. Include copies of any available documentation demonstrating that corrections have been made.
Send your electronic reply to ORAPHARM4_Responses@fda.hhs.gov or mail your reply to:
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
19701 Fairchild Road
Irvine, CA 92612
Please identify your response with unique identifier 590265.
If you have questions regarding any issues in this letter, please contact CAPT Matthew R. Dionne, Compliance Officer, at (303) 236-3064, or Matthew.Dionne@fda.hhs.gov.
Sincerely,
/S/
CDR Steven E. Porter, Jr.
Director, Division of Pharmaceutical Quality Operations IV
Content current as of:
11/05/2019
Regulated Product(s)
Animal & Veterinary
Drugs