Sonoma Pharmaceuticals Expands Market Reach with FDA Cosmetic Product Facility Registration and Microcyn-Based Cosmetic Product Listing Under MoCRA

Rhea-AI Summary

Sonoma Pharmaceuticals (Nasdaq:SNOA) announced on October 7, 2025 that it has registered its manufacturing facility and listed a Microcyn-based facial spray under the FDA's Modernization of Cosmetics Regulation Act (MoCRA). The MoCRA registration enables Sonoma to manufacture and commercialize Microcyn technology products as cosmetics in the U.S., expanding the company's regulatory footprint beyond its existing FDA medical device establishment registration and 510(k)-cleared portfolio.

The company said this step increases access to U.S. cosmetics and dermatology consumer markets, citing a projected U.S. skin care market near $40 billion by 2030, and positions Sonoma to pursue growth with its patented hypochlorous acid technology.

Positive

• MoCRA registration completed on October 7, 2025
• Microcyn facial spray listed under MoCRA
• Facility already FDA-registered as medical device establishment
• Positions Sonoma to access U.S. cosmetics market projected ~$40B by 2030

Negative

• None.

Insights

Regulatory-commercial strategy expert

MoCRA registration permits U.S. cosmetics manufacturing and listing, expanding commercial channels for Sonoma's Microcyn technology.

Sonoma Pharmaceuticals now holds a MoCRA cosmetic product listing and facility registration, which legally enables the company to manufacture and commercialize its Microcyn-based facial spray in the United States alongside its existing FDA 510(k)-cleared medical device footprint. This materially broadens the company's regulatory permissions across healthcare and consumer categories described in the release.

The primary dependencies remain regulatory compliance and successful commercialization execution under the new cosmetic classification; the company already cites an established FDA medical device registration and a safety record for its technology, which support market entry. Key, disclosed metrics to watch include consumer adoption in the U.S. skin care market projected at $40 billion by 2030 and any concrete commercialization milestones the company reports following the October 7, 2025 registration.

BOULDER, COLORADO / ACCESS Newswire / October 7, 2025 / Sonoma Pharmaceuticals, Inc. (Nasdaq:SNOA), a global healthcare leader developing and producing patented Microcyn^® technology-based stabilized hypochlorous acid (HOCl) products, today announced that it has successfully registered its manufacturing facility and listed its Microcyn-based facial spray under the FDA's Modernization of Cosmetics Regulation Act of 2022 (MoCRA).

The MoCRA registration expands Sonoma's regulatory footprint, enabling the Company to manufacture and commercialize Microcyn technology products as cosmetics in the United States. Sonoma's manufacturing facility is already FDA-registered as a medical device establishment, supporting Sonoma's portfolio of FDA 510(k)-cleared products across wound care, dermatology, eye care, podiatry, and animal health. The MoCRA registration builds on this foundation and provides Sonoma with increased access to the rapidly growing U.S. cosmetics and dermatology consumer markets.

According to industry reports, the U.S. skin care market is projected to reach nearly $40 billion by 2030. Sonoma's patented hypochlorous acid technology, its proven safety record, and its effectiveness for many common skin conditions uniquely address the increased consumer demand for clean, technology-driven skincare solutions.

"Sonoma's robust regulatory expertise allows us to bring safe, effective products to market across multiple healthcare categories," said Amy Trombly, CEO of Sonoma. "This new MoCRA registration positions us to increase our reach in the fast-growing U.S. cosmetics and dermatology markets with Microcyn-based products, creating meaningful opportunities for growth and value creation."

About Sonoma Pharmaceuticals, Inc.

Sonoma Pharmaceuticals is a global healthcare leader developing and producing stabilized hypochlorous acid (HOCl) products for a wide range of applications, including wound, dermatological conditions, eye, oral and nasal care, podiatry, animal health care, and non-toxic disinfectants. Sonoma's products are clinically proven to reduce itch, pain, scarring, and irritation safely and without damaging healthy tissue. In-vitro and clinical studies of HOCl show it to safely manage skin abrasions, lacerations, minor irritations, cuts, and intact skin.

Sonoma's products are sold either directly or via partners in over 55 countries worldwide, and the Company actively seeks new distribution partners. Sonoma's principal office is in Boulder, Colorado, with manufacturing operations in Guadalajara, Mexico. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.sonomapharma.com. For partnership opportunities, please contact busdev@sonomapharma.com.

Forward-Looking Statements

Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Sonoma Pharmaceuticals, Inc. and its subsidiaries (the "company"). These forward-looking statements are identified by the use of words such as "continue," "develop," "anticipate," "expect," and "opportunities," among others.

Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the company's business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the company's products will not be as large as expected, the company's products will not be able to penetrate one or more targeted markets, and other risks detailed from time to time in the company's filings with the Securities and Exchange Commission. The company disclaims any obligation to update these forward-looking statements, except as required by law.

Sonoma Pharmaceuticals™ and Microcyn® are trademarks or registered trademarks of Sonoma Pharmaceuticals, Inc. All other trademarks and service marks are the property of their respective owners.

Media and Investor Contact:
Sonoma Pharmaceuticals, Inc.
Email: ir@sonomapharma.com
Website: www.sonomapharma.com
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SOURCE: Sonoma Pharmaceuticals, Inc.

View the original press release on ACCESS Newswire

FAQ

What did Sonoma Pharmaceuticals announce on October 7, 2025 about MoCRA?

Sonoma announced its manufacturing facility registration and Microcyn facial spray listing under MoCRA on October 7, 2025.

How does the MoCRA registration affect Sonoma Pharmaceuticals (SNOA)?

The registration enables Sonoma to manufacture and commercialize Microcyn-based cosmetics in the U.S., expanding its regulatory footprint.

Which Sonoma product was listed under MoCRA on October 7, 2025?

A Microcyn-based facial spray was listed under MoCRA.

Does Sonoma already have FDA regulatory registrations or clearances?

Yes; the company’s manufacturing facility is FDA-registered as a medical device establishment and supports FDA 510(k)-cleared products.

What market opportunity did Sonoma cite with its MoCRA registration?

Sonoma cited the U.S. skin care market projected to reach nearly $40 billion by 2030.

Will the MoCRA registration immediately change Sonoma's revenue guidance for SNOA?

The announcement did not provide revenue guidance or specific sales timelines tied to the MoCRA registration.