# FDA WARNING_LETTER - New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure - December 31, 2021

Source: https://www.keypedia.com/records/warning_letter/new-earth-healing-essentials-llc-dba-5d-full-disclosure/5632fa04-fc14-4a75-a0f3-8fdaabd26cbd

> FDA WARNING_LETTER for New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure on December 31, 2021. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure
- Inspection Date: 2021-12-31
- Product Type: Drugs
- Office Name: Center for Drug Evaluation and Research
- Summary: The FDA issued a Warning Letter to Mother Nature Natural Essentials, LLC d/b/a Gaia's Whole Healing Essentials, LLC, following a review of their websites (www.5dfulldisclosure.org, which redirects to newearthhealingessentials.ecwid.com) and social media (www.facebook.com/New-Earth-Healing-Essentials-105328171777000/) from November to December 2021.

The FDA determined that the company's "Plasma Colloidal Silver Eyedrops," "Gaia’s Organic Nasal Spray," "Copper Healing Roller," "Plasma Copper Elixer," "Plasma Gold Elixer," "Plasma Gold & Silver Elixer Package," and "Plasma Silver Elixer" products are unapproved new drugs, violating sections 505(a) and 301(d) of the FD&C Act. The "Plasma Colloidal Silver Eyedrops" and "Copper Healing Roller" were also identified as unapproved new animal drugs, unsafe under section 512(a) and adulterated under section 501(a)(5) of the FD&C Act.

The letter cited numerous therapeutic claims on the company's websites and social media, establishing the products' intended use as drugs for humans and animals, despite lacking FDA approval. The FDA expressed particular concern regarding products marketed for children and those applied to

## Related Officers

- [Deputy Director - Drugs and Devices](https://www.keypedia.com/people/cindy-l-burnsteel/6059ccbd-700a-43fe-9629-4b92c88b2c6b)
- [Carolyn E. Becker](https://www.keypedia.com/people/carolyn-e-becker/ad2daae5-dda1-4b9c-a69a-775997e7b60b)

Company: https://www.keypedia.com/companies/new-earth-healing-essentials-llc-dba-5d-full-disclosure/39345b3c-1d39-4877-a52d-0bc78ea77704

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