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 that works with relatively new technology, ASEA knew that scientific research data was essential to show the value of redox signaling technology and our products. With this goal in mind, ASEA has invested in third-party research studies for both of its products, ASEA Redox Supplement and RENU 28.
The ASEA safety study was first conducted to show that ASEA Redox Supplement was safe. Participants used the supplement for 12 weeks and reported no adverse effects.
Another step ASEA has taken to substantiate the benefits of the redox signaling molecule its products contain as being vital to help protect, rejuvenate, and keep cells functioning at optimal levels, is with BioAgilytix Labs. BioAgilytix Labs, a leading bioanalytical testing laboratory specializing in immunoassays and cell-based assays, has verified the existence of redox signaling molecules in both ASEA Redox Supplement and RENU 28, providing independent third-party scientific validity of the nature of the company’s products. This validation process helps to ensure that every product made is of the highest quality and endorsed for scientific effectiveness.
These studies, along with ASEA’s facility endorsement and GMP compliance, further show ASEA’s commitment to safety and efficacy. ASEA is dedicated to securing these certifications so consumers can be confident that its products are safe and meet all quality standards the FDA has established for the production and testing of dietary supplements.
*The ASEA production facility is registered with the FDA, meaning that we agree to follow all current GMP guidelines for dietary supplements Section 21 CFR, part 111.