CIRS Supports Magic Health in Securing U.S. GRAS for PQQ!

Magic Health’s flagship ingredient, PERFQUQ™ (Pyrroloquinoline Quinone Disodium Salt), has officially earned Self-GRAS (Generally Recognized as Safe) status in the United States following unanimous approval from an independent expert panel. This key regulatory milestone confirms the ingredient's safety for use in U.S. foods and beverages, marking a significant step forward in Magic Health’s international expansion. CIRS Group provided end-to-end support throughout the GRAS assessment.

What Is GRAS?

GRAS (Generally Recognized as Safe) is an important category within the U.S. food regulatory framework. A substance may be considered GRAS when qualified experts with appropriate scientific training and experience conclude, through scientific procedures, that it is safe under its intended conditions of use.

For ingredient manufacturers, obtaining GRAS notification not only supports market access in the United States but also demonstrates international recognition of the ingredient’s safety and quality.

About PQQ

PQQ possesses two key biological properties: potent antioxidant activity and the ability to promote mitochondrial biogenesis. It can effectively scavenge free radicals while supporting the formation of new mitochondria and the maintenance of mitochondrial function. These properties give PQQ potential value across multiple health applications, including skincare, sports nutrition, brain health, and cardiovascular health. In skincare, PQQ may help protect against oxidative damage and delay skin aging. For physically active individuals, it may support energy metabolism and exercise performance. It may also help protect neuronal cells and support cognitive function, while contributing to vascular health and cardiovascular well-being. As the human body cannot synthesize PQQ, it must be obtained through dietary intake. PQQ disodium salt is a commonly used, stable form of PQQ. Following ingestion, it can be converted to PQQ in the body, thereby exerting its associated biological activities.

PERFQUQ™ from Magic Health offers several advantages in manufacturing and application:

Specialized microbial fermentation: Produced using a proprietary microbial fermentation process, with optimized fermentation, extraction, and purification procedures. Multistage separation and purification help ensure consistent product quality and regulatory compliance.

Comprehensive quality control: Manufactured in strict accordance with cGMP standards, with an end-to-end quality control system covering strain selection, fermentation control, purification, refining, and finished-product testing.

Versatile formulation compatibility: Suitable for a range of finished dosage forms, including powders, tablets, and functional beverages, supporting diverse formulation development needs.

Proprietary PQQ-BAup sustained-release solution: Featuring a distinctive release structure designed to deliver the active ingredient gradually and consistently. Testing has demonstrated a release duration of up to 12 hours. This technology is designed to address practical challenges associated with oral PQQ formulations, including slow absorption and insufficient stability.

About Magic Health

Established in 2021, Magic Health Technology Co., Ltd. is a professional comprehensive health-tech enterprise co-invested by Huadong Medicine and Angel Group. The company integrates independent research and development, project incubation, industrial production and commercial operation of health and medical aesthetic product lines. Adhering to the dual development strategy of technological core competitiveness and international industrial layout, we focus on the research and development and production of functional nutritional raw materials as well as personal care and medical aesthetic active ingredients, empowering high-quality and sustainable development of the global health industry through continuous technological innovation. Email: business@maiggic.com

How CIRS Can Help

CIRS Group is a leading global product safety and regulatory consulting firm. Our technical experts assist food, beverage, and supplement companies with U.S. FDA compliance—including GRAS notice, New Dietary Ingredient (NDI) notifications, and global market access strategies spanning China, Japan, South Korea, and the European Union.

Our services include but not limited to:

• Application for “Three New Foods (new food additives, new food raw materials and new food-related products” in China;
• U.S. GRAS, NDI, and CAP;
• EU Novel Food, food additives, and food enzymes applications; and
• Application for new feed ingredients and feed additives in China, the U.S., and the EU.