New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure

Warning LetterOpen

Lauryn Suarez and Ashley Peluso New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure 1290 Raymond Road Danby , VT 05739 United States newearthhealingessentials@gmail.com services@gaiaswholehealingessentials.orgIssued Feb 1, 2022Center for Drug Evaluation and Research | CDER

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations0

Issue DateFeb 1, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure
Location: Lauryn Suarez and Ashley Peluso New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure 1290 Raymond Road Danby , VT 05739 United States newearthhealingessentials@gmail.com services@gaiaswholehealingessentials.org
FEI Number: N/A
Country: United States
Issue Date: February 01, 2022
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure was cited for marketing unapproved new drugs including Plasma Colloidal Silver Eyedrops, Gaia's Organic Nasal Spray, Copper Healing Roller, and various colloidal elixirs in violation of sections 505(a) and 301(d) of the Federal Food, Drug, and Cosmetic Act. The company sold these products through its website and social media channels with disease claims that established them as unapproved drugs. Additionally, the Plasma Colloidal Silver Eyedrops and Copper Healing Roller were determined to be unapproved new animal drugs that were unsafe and adulterated under sections 512(a) and 501(a)(5) of the FD&C Act.

New Earth Healing Essentials, LLC d/b/a 5D Full Disclosure FDA Warning Letter, February 1, 2022