ASEA works hand in hand with the FDA to ensure our ASEA Redox Supplements are safe and effective. But what exactly is the FDA, and what is their role?
The Food and Drug Administration (FDA) is a federal agency that operates within the U.S. Department of Health and Human Services. It consists of core functions including Medical Products and Tobacco, Foods and Veterinary Medicine, Global Regulatory Operations and Policy, and Operations.
What Is The FDA Responsible For?
As a substantial government program, the FDA has many responsibilities, including:
- Except for meat from livestock, poultry and some egg product, the FDA is responsible for ensuring that foods are safe, wholesome, sanitary and properly labeled for the general public to enjoy.
- They are responsible for ensuring human and veterinary drugs, vaccines, and other biological products and medical devices are safe and effective.
- It’s the FDA’s duty to protect the public from electronic product radiation.
- They must assure cosmetics and dietary supplements are safe and properly labeled.
- The FDA is responsible for regulating tobacco products.
- It is also the duty of the FDA to advance public health by helping the speed product innovations.
Uniquely, the FDA’s responsibilities aren’t restricted to just that of the 50 states, but also to the District of Columbia, Puerto Rico, Guam, the Virgin Islands, American Samoa, and all other U.S. territories and global interests.
How Does The FDA Regulate Its Products?
In order to properly evaluate and regulate drugs, the FDA uses process called the Strategic Action Plan for Risk Communication. While this is the first of many steps the FDA uses to determine if products are safe, it is also one of the most important. They regulate drugs in six steps:
- If a company is seeking approval for their new product, they must first submit an Investigational New Drug Application, which the FDA will review before they begin testing on humans.
- The company must then perform a series of clinical human tests. These tests must be issued in three different phases. The FDA monitors every phase to ensure the drug in testing is both effective and safe.
- Thirdly, the company must send all data to the FDA’s Center for Drug Evaluation and Research (CDER) in a New Drug Application (NDA). From here a team of physicians, statisticians, toxicologists, pharmacologists, chemists and other scientists review the data. If accepted, the experts then propose the product for labeling.
- If the panel of experts deems the product’s benefits outweigh the risks, the product is then approved for sale.
- The FDA continues to monitor the product after it reaches the market. They review consumer feedback, as well as feedback and information from health care practitioners and pharmaceutical companies. They also have access to several different databases that collect information from prescription drug use and health outcomes. This helps FDA staff learn more about the side effects and benefits of the product.
- Even after the FDA has approved the product, they continue to monitor its safety and efficacy. If a health risk is detected, a Drug Safety Communication is relayed to both consumers and healthcare professionals. The product is then labeled with a statement stating the concern.
Oftentimes a product will be removed from distribution if the risks begin to outweigh the benefits for the general public. Even with careful observation and thorough testing, the biggest test the product undergoes is when it hits shelves. It’s during this time that members of the FDA are often forced to make judgment calls.
To learn more about the FDA in regards to ASEA Redox Supplements, read this in-depth article on the scientific research and effectiveness of ASEA products.