FDA WARNING_LETTER - Bodyhealth.com, LLC - January 19, 2021

The FDA issued a Warning Letter to Bodyhealth.com after reviewing their website in December 2020. The FDA determined that the products "Healthy-Thin Energize," "Body Detox (Oral Spray)," and "Omega 3 Health" are unapproved new drugs and misbranded under the Federal Food, Drug, and Cosmetic Act.

The products are deemed drugs because website claims indicate they are intended for disease cure, mitigation, treatment, or prevention. Examples include "Healthy-Thin Energize" supporting blood sugar levels and treating diabetes; "Body Detox (Oral Spray)" aiding in removing heavy metals, viral particles, and preventing infections; and "Omega 3 Health" addressing inflammation, improving focus, and alleviating symptoms of ADD, depression, anxiety, mood disorders, and dementia.

These products are considered "new drugs" because they are not generally recognized as safe and effective for their claimed uses, requiring prior FDA approval. Furthermore, they are misbranded because they lack adequate directions for use by a layperson, as their intended uses involve conditions not amenable to self-diagnosis or treatment without professional supervision.

The FDA requires Bodyhealth.com to take prompt action to correct these violations. The company must notify the FDA in writing within fifteen working days of the specific steps taken to correct the violations and prevent recurrence. Failure to comply may result in legal action, including seizure and injunction.