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  1. Warning Letters

WARNING LETTER

The Truth Company, LLC MARCS-CMS 611501 —

Delivery Method:
VIA UPS
Product:
Drugs
Food & Beverages
Recipient:
Recipient Name
Nathaneal Mohr
Recipient Title
CEO
The Truth Company, LLC

6325 Spine Rd
Boulder, CO 80301
United States

Issuing Office:
Division of Human and Animal Food Operations West IV

United States

October 14, 2022

WARNING LETTER

Ref: CMS Case # 611501

Nathaneal Mohr, CEO
Kinobody, LLC
6325 Spine Rd
Boulder, CO 80301

Christopher Walker, CEO
UMZU, LLC
6325 Spine Rd
Boulder, CO 80301

Dear Messrs. Mohr and Walker:

This is to advise you that the U.S. Food and Drug Administration (FDA) reviewed your websites at the internet addresses www.umzu.com and www.kinobody.com in June 2022 and has determined that you take orders there for the products Betaine, Immune, Redwood, Sensolin, Thyrite, zuRelief, Kino Aminos, Kino Collagen Protein, and Kino Gains. 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 the Betaine HCl product page at Umzu.com

  •  “Betaine has been shown in research to also improve . . . and even diabetes prevention.”
  •  “Individuals with elevated levels of plasma total homocysteine are at a higher risk of developing cardiovascular disease.”

On the Immune product page at Umzu.com

  •  “Reduce Chance of Catching A Cold”
  •  “According to the NIH, ’Vitamin C deficiency results in impaired immunity & high susceptibility to infections.’ . . . Every serving of UMZU Immune contains a full 500mg of Vitamin C to help you easily hit your daily requirements.”
  •  “In one randomized clinical trial, 60 subjects with flu-like symptoms who took elderberry extract saw symptoms clear up 4 days earlier than placebo. Another clinical study showed positive results for helping clear up cold symptoms for air travelers.”
  •  “Vitamin D3 deficiency can compromise the immune system’s ability to fight off infections . . . Each serving of UMZU Immune contains 10mcg of Vitamin D3.”
  •  “Research shows that echinacea may help shorten the length & severity of colds, as well as upper respiratory infections (URIs).”

On the Redwood product page at Umzu.com

  •  “Clinical research on Isoleucyl-Prolyl-Proline, Valyl-Prolyl-Proline has been shown that it . . . promotes arterial elasticity. . . . inhibiting a particular enzyme that causes blood vessels to shrink.”

On the Sensolin product page at Umzu.com

  •  [on the graphic of the product label] “Lowers Blood Pressure”
  •  “Sensolin is all about helping you control your blood sugar naturally, lower A1C . . . .”
  •  “The unique blend of ingredients in Sensolin help to increase your ability to use glucose properly.”
  •  “The benefits of chromium may include . . . improved blood sugar sensitivity.”

On the Thyrite product page at Umzu.com

  •  “In one study, levels of copper were associated with increased levels of TT3 and TT4.”
  •  “Research also shows that taurine supplementation may play a protective role against the increased oxidative stress resulting from poor thyroid production.”

On the zuRelief product page at Umzu.com

  •  “zuRelief: Reduce Pain . . .”
  •  “I am an MD and there is no product on the conventional over the counter market that approaches the combination of safety and effectiveness of zuRelief for my own joint and muscle aches.”
  •  “Low levels of Vitamin B6 have been associated with increased symptoms in people who suffer from inflammatory conditions.”

On Umzu.com Blog Pages

  • Pain Support - Can Turmeric Relieve Arthritis, Joint Pain & Inflammation?

[Turmeric is described as an ingredient in your zuRelief product]
o “What is Turmeric? . . . This spice is known to relieve blood clots…fight inflammation and even reduce depression.”
o “Curcumin is the main active compound in turmeric. The research behind it suggests it’s one of the best forms of natural anti-inflammatories out there.”
o “A 2009 study . . . revealed that curcumin was comparable to ibuprofen for treating osteoarthritis pain in the knee.”
o “What about rheumatoid arthritis (RA), which tends to affect younger people? . . . In one study, . . .[t]he groups that took the curcumin only saw the most pain relief. The studies show that turmeric, or curcumin more specifically, is effective for treating . . . arthritis.”
o “The Best Solution for Long-Term Pain Relief” . . . turmeric holds tremendous promise as an inflammation reliever . . . it’s one of the active ingredients in our zuRelief supplement . . . inflammation is the root cause of arthritis and other chronic illnesses.”

  • Blood Sugar Support– 10 Ways to Lower Blood Sugar Effectively

o “One small study . . . found that . . . cinnamon [described as an ingredient your Sensolin product] reduced mean fasting serum glucose by 18-29 percent.”
o “GlucoHelp, also known as Banaba leaf [described as an ingredient in your Sensolin product], has been used in natural medicines to treat diabetes for centuries.”
o “Another study, . . . found that chromium [described as an ingredient in your Sensolin product] increased insulin sensitivity in those with diabetes.”
o “Other research has found that taking biotin [described as an ingredient in your Sensolin product] along with chromium is also highly effective at controlling blood sugar. Biotin levels in those with diabetes also tended to be lower compared to those that did not have it.”
o “SENSOLIN . . . proven to help users lower their blood sugar and A1C . . .”

  •  Circulatory Support - How Redwood’s Ingredients Are Proven to Improve Blood Flow and Circulatory Health

o “Boost nitric oxide levels with Redwood . . . Increasing your nitric oxide levels can benefit almost every aspect of your circulatory health from your blood pressure, symptoms of erectile dysfunction, and symptoms of varicose veins.”
o “The active ingredient in horse chestnut extract is called aescin. You should aim to get 100-150mg of this compound to maximize its benefits such as reducing varicose veins and improving blood flow.”
o “[Pine Bark Extract] also has a cardioprotective effects that can lower your risk of developing heart disease.”
o “The biggest benefit of taking a supplement like Redwood is that you can increase blood flow and blood pressure naturally without the negative side effects that many blood pressure medications cause.”

On the Kino Aminos product page at kinobody.com
􀁸 “L-Valine (1,000mg) . . . reduces viral load of Hepatitis (inflammation of the liver).”

On the Kino Collagen Protein product page at kinobody.com
􀁸 “Several studies have found that hydrolyzed collagen reduces both inflammation and pain, and speeds up the healing process in conditions such as . . . osteoarthritis, and tendonitis/ Achilles tendinopathy.”
􀁸 “may prevent bone loss”
􀁸 “may help control blood sugar levels”
􀁸 “collagen seems to have powerful anti-inflammatory effects on injuries”

On the Kino Gains product page at kinobody.com
􀁸 “Deficiency in choline . . . can lead to increased threat of a condition known as Fatty Liver. . . .”
􀁸 “Improving cystic fibrosis symptoms”
􀁸 “Anti-inflammatory properties”

Your Betaine, Immune, Redwood, Sensolin, Thyrite, zuRelief, Kino Aminos, Kino Collagen Protein, and Kino Gains 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 based on 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 Betaine, Immune, Redwood, Sensolin, Kino Aminos, and Kino Gains products are intended for treatment of one or more diseases that are not amendable 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, Betaine, Immune, Redwood, Sensolin, Kino Aminos, and Kino Gains fail to bear adequate directions for their intended use and, therefore, the products are misbranded under section 502(f)(1) of the Act. 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 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 promptly address this matter may result in legal action, including, without limitation, seizure and injunction.

Within fifteen working days of receipt of this letter, please notify this office in writing 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 fifteen 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 reply should be addressed to the U.S. Food and Drug Administration; Attn: 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
Program Division Director
Office of Human and Animal Food Operations – West Division 4

 
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