WARNING LETTER
LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA
MARCS-CMS 613114 —
November 23, 2021
Delivery Method:
United Parcel Service
Product:
Drugs
Recipient:
Recipient Name
Roger Frantz and Jeremy S. Delk
LIV Health LLC dba INFINIWELL and DEAL Media L.L.C. dba HARMONIA
881 Corporate Drive
Lexington
,
KY
40503
United States
Issuing Office:
Office of Human and Animal Foods Operations‐East V
United States
November 23, 2021
WARNING LETTER 613114
Dear Messrs. Frantz and Delk:
This is to advise you that the Food and Drug Administration (FDA) reviewed your websites at tailormadehealth.com
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and www.infiniwell.com in August ‐ September 2021 and has determined that you take orders at www.infiniwell.com for the products Thyroid Support and DHH‐B. FDA also reviewed your website at https://findharmonia.com/ in August – September 2021 and has determined that you take orders there for the products Balance, Balance+, Clarity, Twilight, and Meditate. The claims on your websites establish that the 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 for such uses 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 website claims that provide evidence that your products are intended for use as drugs include:
On your website www.infiniwell.com ‐
Thyroid Support
On the product page
“Relieves All Of The Symptoms Related To An Under‐Active Thyroid.”
DHH‐B
On the product page:
DHH‐B, dihydrohonokiol‐B, . . . has anxiolytic‐effects [sic]. Treatment with DHH‐B does not cause any significant changes in motor activity or muscle relaxation. Benzodiazepines are some of the most commonly prescribed medications in the United States. These anxiolytics have many well‐known side effects including motor function and more.
On the DHH‐B Education Sheet, which can be accessed by clicking on the hyperlinked text, “View DHH‐B information sheet,” that appears in the “Product Description” section of the DHHB-Product Page
“DHH‐B, dihydrohonokiol‐B, . . . has been researched for . . . anxiolytic effects. Treatment with DHH‐B does not cause any significant changes in motor activity or muscle relaxation. Benzodiazepines are some of the most commonly prescribed medications in the United States. These anxiolytics have many well‐known side effects including motor function and more. That being said, this product has the potential to support mood in people who may be using benzodiazepines for this purpose.”
On your website findharmonia.com ‐
Balance
Under the Details tab on the product page:
“[F]ormulated to ease symptoms of an underactive thyroid”
On the product page, under the section titled “The Support You Need for a Healthy Thyroid”:
“Balance was formulated for those 1 in 8 women with thyroid dysfunction . . .”
“Thyroid disease doesn’t have to rule your life . . . Balance . . . provides . . . ingredients that tackle thyroid dysfunction at the source”
Clarity
On the product page, under the section titled “All‐in‐One Support for Overall Health”
“[R]educe inflammation, reduce plaque build up . . . lowered LDL cholesterol . . .”
Twilight
On the product description page, describing ingredients that your website indicates are in Twilight
“Lemon Balm Extract: Proven to reduce . . . and insomnia”
“Valerian Extract . . . used for sleep disorders.”
“Corydalis Extract . . . Naturally eases symptoms of anxiety and depression”
“Chamomile Extract . . . reduces a number of sleep problems like insomnia . . . hysteria”
“Passion Flower [sic] Extract Another mild sedative that has been known to treat sleep problems, as well as heart arrhythmia . . . and attention‐deficit disorders”
“Magnolia Extract . . . reduce plaque buildup in the body”
“Melatonin . . . Aids in multiple sleep disorders . . .”
Balance+
Under the Details tab on the product page:
“treating higher levels of cholesterol”
“Formulated to . . . supercharge your underactive thyroid and symptoms that follow.”
On the product page, under the section titled “The Support You Need for a Healthy Thyroid”
“Balance was formulated for those 1 in 8 women with thyroid dysfunction . . .”
“Thyroid disease doesn’t have to rule your life . . . Balance+, the all‐natural thyroid support system, provides . . . ingredients that tackle thyroid dysfunction at the source.”
Meditate
Under the Details tab on the product page:
“Meditate’s . . . therapeutic potential has been researched in anxiety, pain, cerebrovascular injury, epilepsy, and cognitive disorders including Alzheimer’s disease”
On the product page, under the section titled “Calm the Mind, Body, and Spirit”
“Feel the effects of an‐all natural anxiolytic that is clinically proven to reduce anxiety, pain, cerebrovascular injury, epilepsy, and cognitive disorders including Alzheimer’s disease.”
Your Thyroid Support, DHH‐B, Balance, Balance+, Clarity, Twilight, and Meditate 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)]. With certain exceptions not applicable here, 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 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 products Thyroid Support, DHH‐B, Balance, Balance+, Clarity, Twilight, and Meditate 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, Thyroid Support, DHH‐B, Balance, Balance+, Clarity, Twilight, and Meditate 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)].
This letter is 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 all products marketed by your firm comply 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.
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 action 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.
Your written reply should be directed to U.S. Food and Drug Administration, Zada L. Giles, Compliance Officer, 404 BNA Drive, Suite 500, Nashville, TN 37217. If you have any questions with regard to this letter, please contact Zada L. Giles, at (615) 366‐7985 or via email at ORAHAFEAST5FirmResponses@fda.hhs.gov.
Sincerely,
/S/
Steven B. Barber
Director, Division V
Office of Human and Animal Foods Operations‐East
__________________________
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When clicking on the “Shop” tab (shop.tailormadehealth.com), your website tailormadehealth.com redirects to your website www.infiniwell.com.
Content current as of:
11/30/2021
Regulated Product(s)
Drugs