# FDA WARNING_LETTER - Natural Adventure, LLC - March 12, 2021

Source: https://www.keypedia.com/records/warning_letter/natural-adventure-llc/3f35b853-56d4-4410-929d-ea1e5f326b89

> FDA WARNING_LETTER for Natural Adventure, LLC on March 12, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: Natural Adventure, LLC
- Inspection Date: 2021-03-12
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: On April 1, 2021, the FDA and FTC issued a Warning Letter to My Natural Adventure regarding unapproved and misbranded products related to COVID-19. The agencies reviewed www.mynaturaladventure.com and associated social media on February 26 and March 12, 2021.

The FDA observed the sale of "Purity Sanitizer with 70% Alcohol" and "Purity Essential Oil Blend" with claims to mitigate, prevent, treat, diagnose, or cure COVID-19. These products are deemed unapproved new drugs under section 505(a) and misbranded drugs under section 502 of the FD&C Act, violating sections 301(a) and (d). The Purity Sanitizer, despite containing ethyl alcohol, does not conform to the 1994 TFM or subsequent amendments due to "anti-bacterial" essential oils not classified for use in consumer antiseptic rubs, nor does it align with temporary FDA policies for hand sanitizers during COVID-19.

The letter demands immediate cessation of sales for all unapproved and unauthorized COVID-19 related products. The company must email COVID-19-Task-Force-CDER@fda.hhs.gov within 48 hours, detailing corrective actions, steps to prevent recurrence, and supporting documentation. Failure to comply may result in legal action, including seizure and injunction, and

## Related Officers

- [Director](https://www.keypedia.com/people/donald-d-ashley/060f0dda-e6e8-4f9c-97e7-f540d523d902)
- [Associate Director](https://www.keypedia.com/people/serena-viswanathan/7d1b292d-1f22-42ff-8452-0bc9673b8326)

Company: https://www.keypedia.com/companies/natural-adventure-llc/e3d09210-1676-4937-9425-a980026672eb

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