Safety and Classification of ASEA Products

As the popularity of ASEA’s products grows and the global trend of cellular health increases, it is important...

As the popularity of ASEA’s products grows and the global trend of cellular health increases, it is important to understand how the company has ensured that the products are safe and that they meet the highest level of production standards. How are the ASEA products regulated, and what are the safety standards the production facilities meet?

ASEA and the Food and Drug Administration (FDA)

ASEA Redox Supplement is classified as a dietary supplement in the United States. As a dietary supplement, it is not FDA approved but is FDA regulated. As a company, ASEA cares deeply about following the guidelines set forth by the FDA and always makes sure to stay up to date with any changes in the regulations or manufacturing practices.

The FDA oversees dietary supplements under a different set of regulations than those covering conventional foods and drug products. Dietary supplement manufacturers and distributors are not required to obtain approval from the FDA before marketing their products. Before a company sells a dietary supplement, it is responsible for ensuring that the product it manufactures or distributes is safe, that any claims made about the product are not false or misleading, and that the product complies with the Federal Food, Drug, and Cosmetic Act and FDA regulations in all other respects. (1) These laws apply to topical products as well as to foods and supplements.

Both ASEA Redox Supplement and RENU 28 skin gel follow these guidelines. Additionally, the products are manufactured according to FDA* regulations and best practices, and the company has invested in third-party research studies to prove these products are both safe and effective.

Production and Certification

How a company manufactures a product and the facilities it uses to make the product are equally important to both the FDA and to consumers. The NSF International—a global public health and safety organization that provides food safety and quality assurance services across all food supply chain sectors—certified ASEA’s production center as a GMP (Good Manufacturing Practices) compliant facility. This certification confirms ASEA’s products comply fully with the regulations set forth by the FDA as they relate to the production and testing of dietary supplements with specific standards for safety, quality, and performance.

The corporate leadership at ASEA understood the importance of producing their products independently and controlling the quality process, so they invested more than $1.6 million in building a new, state-of-the-art production facility. Operating a production center of its own also allows ASEA to control the entire process also allows the company to control costs while providing a steady supply of products to consumers and associates alike.

The Proof Is in the Data

As a company working with relatively new technology, ASEA views scientific research data as essential to showing the value of redox signaling technology in our products. With this goal in mind, ASEA has invested in third-party research studies for ASEA® Redox Cell Signaling Supplement and RENU28® Revitalizing Redox Gel.

A safety study was first conducted to show that ASEA Redox can be safely consumed. Participants used the supplement for 12 weeks and reported no adverse effects. Other studies demonstrating the safety and efficacy of ASEA products can be found on the ASEA Global website.

ASEA has also taken the step of establishing partnerships with third-party laboratories to substantiate the presence of redox signaling molecules in its products that help protect, rejuvenate, and keep cells functioning. BQC Redox Technologies, a biotechnology company in Spain, and GLU (Gesellschaft für Lebensmittel- und Umweltconsulting), a chemical-analytical laboratory in Germany, perform regular testing to validate the active redox content in our ASEA Redox and RENU28 Gel products. This validation process helps to ensure that every product sold is of the highest quality and endorsed for scientific effectiveness.

These studies, along with third-party endorsements of our production facilities, which maintain GMP (good manufacturing process) compliance, further show a commitment to safety and efficacy at ASEA. Consumers can be confident in the safety and quality of ASEA products, which meet all standards set by the US Food & Drug Administration (FDA) for the production and testing of dietary supplements.

The ASEA production facility is registered with the FDA, meaning we agree to follow all current GMP guidelines for dietary supplements according to Section 21 CFR, part 111.