# FDA WARNING_LETTER - The Truth Company, LLC - June 30, 2022

Source: https://www.keypedia.com/records/warning_letter/the-truth-company-llc/924ec8d5-742a-4ce3-8903-07a1ad560b82

> FDA WARNING_LETTER for The Truth Company, LLC on June 30, 2022. Product: Food. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: The Truth Company, LLC
- Inspection Date: 2022-06-30
- Product Type: Food
- Office Name: Division of Human and Animal Food Operations - West IV
- Summary: The FDA issued a Warning Letter to Kinobody, LLC and UMZU, LLC on October 14, 2022, following a June 2022 review of their websites, www.umzu.com and www.kinobody.com. The FDA determined that products sold, including Betaine, Immune, Redwood, Sensolin, Thyrite, zuRelief, Kino Aminos, Kino Collagen Protein, and Kino Gains, are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act (the Act).

The violations stem from website claims that establish the products' intent for use in the cure, mitigation, treatment, or prevention of disease, classifying them as drugs under section 201(g)(1)(B) of the Act. Examples of such claims include "relieve blood clots," "fight inflammation," "reduce depression," "treating osteoarthritis pain," "treating diabetes," "lower your blood sugar and A1C," "reduce varicose veins," "improving blood flow," "reduces viral load of Hepatitis," "prevent bone loss," "control blood sugar levels," "improving cystic fibrosis symptoms," and "Anti-inflammatory properties."

Because these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" under section 201(p) of the Act, requiring prior FDA approval. Furthermore, Betaine, Immune, Redwood, Sensolin

## Related Officers

- [E.](https://www.keypedia.com/people/mark-harris/b51ccb1e-3e75-427e-92da-78eb6f218366)

Company: https://www.keypedia.com/companies/the-truth-company-llc/21039b79-83a5-49ae-96bf-37afbaa3b46e

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iv/683a371a-36d2-4745-90d9-200f1efd4090