# FDA WARNING_LETTER - NV Nutrition, LLC - December 07, 2021

Source: https://www.keypedia.com/records/warning_letter/nv-nutrition-llc/ff92e4d7-319d-4ec8-9e3f-05aa4adab919

> FDA WARNING_LETTER for NV Nutrition, LLC on December 07, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: NV Nutrition, LLC
- Inspection Date: 2021-12-07
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Nutrovape and Nutriair on December 1, 2021, following an October 2021 review of their websites (www.nutrovape.com, https://nutriair.com/) and social media. The FDA determined that the "nutrovape vaporizer products" (e.g., B-Complex, Diet, Energy, Focus, Recover) and "nutriair diffuser products" (e.g., Energy, Focus, Immune, Relax, Recover, Sleep) are unapproved new drugs.

The products are marketed with claims establishing their intended use as drugs, such as "cure, mitigation, treatment, or prevention of disease" or "affect the structure or any function of the body." Examples of such claims were found on their websites and social media. Despite some products featuring "Supplement Facts" panels, the FDA stated they are not dietary supplements because they are intended for inhalation, not ingestion, as required by the FD&C Act.

The FDA highlighted safety concerns regarding oral inhalation products, citing potential for laryngospasm, bronchospasm, tissue toxicity, or undesirable systemic effects. As these products are not generally recognized as safe and effective for their claimed uses, they are considered "new drugs" requiring prior FDA approval, which they lack.

The company is required to notify the FDA in writing within fifteen working days of receipt of the letter, detailing steps taken to address the violations and prevent

## Related Officers

- [Carolyn E. Becker](https://www.keypedia.com/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)

Company: https://www.keypedia.com/companies/nv-nutrition-llc/d09a5075-f9a1-4d73-9215-382f07980fe1

Office: https://www.keypedia.com/offices/center-for-drug-evaluation-and-research/cd980d74-1cbf-4226-ba9a-9045324c236c