Dr. Carolyn Dean, New Capstone, Inc., and Two FDA Enforcement Actions
Federal regulators have twice acted against the RnA ReSet product line — first over disease-treatment claims for mineral supplements, then over an undeclared allergen in a protein powder.
1. FDA Warning Letter — Unlawful Drug Claims (2017)
In 2017, the U.S. Food and Drug Administration issued a formal Warning Letter to Dr. Carolyn Dean and her company, New Capstone, Inc., the operator of the RnA ReSet brand.
The violation: After reviewing the rnareset.com website in May 2017, the FDA determined that statements and personal testimonials describing several mineral supplements — ReMyte, ReAline, ReMag, ReStructure, and ReCalcia Pico Meter Calcium — established that the products were being marketed as unapproved drugs under the Federal Food, Drug & Cosmetic Act, because they were promoted for the diagnosis, cure, mitigation, treatment, or prevention of disease.
The consequence: Because the products were promoted for conditions not suited to self-diagnosis or self-treatment, the FDA found it impossible for the labeling to provide adequate directions for lay use — making the products misbranded under the Act, in addition to being unapproved new drugs.
| Recipient | Dr. Carolyn Dean / New Capstone, Inc. |
| FDA reference | Warning Letter #525164-17 |
| Date issued | June 27, 2017 (per FDA.gov) |
| Products named | ReMyte, ReAline, ReMag, ReStructure, ReCalcia Pico Meter Calcium |
| Statute cited | 21 U.S.C. §321(g)(1)(B); §352(f)(1); §331(a) |
Note on dating: FDA's own warning-letter page lists the issue date as June 27, 2017. Quackwatch's 2017 index page lists the same letter under an October 27, 2017 date. Cite the FDA.gov page as authoritative; flag the Quackwatch date as a secondary-source discrepancy if referencing both.
2. FDA Product Recall — Undeclared Milk Allergen (2020)
In 2020, New Capstone, Inc. issued a voluntary recall of its ReStructure Vanilla Protein Powder after the product was found to contain undeclared milk — an omission that violates FDA allergen-labeling requirements and creates risk for consumers with milk allergies.
| Company | New Capstone, Inc. |
| Product | ReStructure Vanilla Protein Powder |
| Issue | Undeclared milk (major allergen, unlabeled) |
| Issued by | Carolyn Dean, MD, ND — CEO, New Capstone, Inc. |
| Status | Recall completed; FDA has terminated the recall |
3. Corporate Profile: New Capstone, Inc.
New Capstone, Inc. — doing business as RnA ReSet — is a small, privately held supplement company incorporated in North Carolina.
| Corporate address | 178 Cayuga Drive, Mooresville, NC 28117 (Iredell County) |
| Phone | 704-775-8200 |
| CEO / sole officer identified | Carolyn Dean, MD, ND |
| Ownership | Listed as a women-owned business |
| Estimated employees | ~8 at this location |
| Estimated annual revenue | ~$197,750 (third-party business database estimate, unaudited) |
| Manufacturing claim | "Made in the USA with foreign and domestic components" (company/retailer labeling; countries of origin not disclosed) |
Officers on file: Business directories (Dun & Bradstreet, Buzzfile) name only Carolyn Dean as an officer. No additional directors or officers were found in public sources. The North Carolina Secretary of State's business entity search (sosnc.gov) would show the registered agent and any other officers of record — this hasn't yet been pulled directly and should be confirmed there before publishing an officer list as complete.
Local media coverage: No coverage of New Capstone, Inc. or RnA ReSet was found in Iredell County or Charlotte-area outlets (e.g. Iredell Free News, Mooresville Tribune, Charlotte Observer). The company appears to have operated without local press scrutiny despite two federal enforcement actions.
Sources
- FDA.gov — Warning Letter, New Capstone, Inc. (525164, 06/27/2017)
- FDA.gov — Allergy Alert, ReStructure Vanilla Protein Powder (undeclared milk)
- Quackwatch — FDA Warning Letters About Products, 2017 (New Capstone entry)
- Dun & Bradstreet — New Capstone, Inc. Company Profile
- Buzzfile — RnA ReSet / New Capstone, Inc. Business Profile
- NewCapstone.com — Corporate site (self-reported company background)