> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# NatureWorks Untitled Letter on Unlicensed Cell Therapy
- URL: https://www.fdaweb.com/natureworks-untitled-letter-on-unlicensed-cell-therapy/
- Published: 2021-06-21T12:00:00.000Z
- Updated: 2026-09-14T17:04:10.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5149579

FDA has sent an[ untitled letter](https://www.fda.gov/media/150204/download?ref=fdaweb.com) to NatureWorks (Poulsbo, WA) after reviewing the Web sites *www.natureworksacupuncture.com* and www.stemcells-washington.com, as well as other information, about its marketing of cellular products derived from human umbilical cords. The letter objects to the products being offered for treating serious or life threatening conditions, such as autism, stroke, diabetes, chronic obstructive pulmonary disease , and Parkinson’s disease because there is no approved biologics application. A written response is required to explain to FDA how the firm intends to comply with FDA regulations.