{"id":575,"date":"2024-03-18T13:59:26","date_gmt":"2024-03-18T13:59:26","guid":{"rendered":"https:\/\/pureoptical.com\/?p=575"},"modified":"2024-04-23T15:25:19","modified_gmt":"2024-04-23T15:25:19","slug":"is-areds2-fda-approved","status":"publish","type":"post","link":"https:\/\/pureoptical.com\/blog\/is-areds2-fda-approved\/","title":{"rendered":"Is AREDS2 FDA Approved?"},"content":{"rendered":"
Among the many supplements out there, the Age-Related Eye Disease Study 2 (AREDS2) formula has received significant attention for its potential to slow the progression of AMD. This article delves into whether the AREDS2 formula is FDA approved, exploring the intricacies of dietary supplement regulation, the evidence behind AREDS2, and what consumers should know.<\/span><\/p>\n Before diving into the specifics of AREDS2, it’s crucial to understand the <\/span>U.S. Food and Drug Administration’s<\/span><\/a> (FDA) role in dietary supplement oversight. Unlike pharmaceuticals, which must receive FDA approval before being marketed, dietary supplements do not require pre-market approval. Instead, the FDA regulates these products under a different set of guidelines established by the <\/span>Dietary Supplement Health and Education Act of 1994<\/span><\/a> (DSHEA).<\/span><\/p>\n Under DSHEA, manufacturers are responsible for ensuring that their products are safe and that any claims made about them are substantiated by adequate evidence. However, they do not need to obtain FDA approval before selling these products. The FDA’s role is primarily to monitor the market for unsafe products and take action against any supplement or claim that poses a risk to consumers or lacks scientific support.<\/span><\/p>\n One must first understand the formula’s origins to fully grasp the discussion surrounding AREDS2<\/a> and FDA approval. AREDS2 is an updated version of the original Age-Related Eye Disease Study (AREDS) formula, which was developed through a major clinical trial funded by the National Eye Institute (NEI), part of the National Institutes of Health (NIH). The original AREDS study aimed to investigate whether certain vitamins and minerals could reduce the risk of developing advanced AMD.<\/span><\/p>\n Following the initial study, AREDS2 sought to refine the formula by testing modifications that might improve its safety and efficacy. The AREDS2 formula typically includes vitamins C and E, zinc, copper, lutein, and zeaxanthin, elements chosen based on their potential antioxidant or eye health benefits.<\/span><\/p>\n The Age-Related Eye Disease Study 2 (AREDS2) is a cornerstone of research in the field of ophthalmology, especially concerning age-related macular degeneration<\/a> (AMD). Conducted by the National Eye Institute, this randomized, multi-center clinical trial was designed to assess the effects of specific nutrients on the progression of AMD and cataracts. The trial followed participants with varying stages of AMD, focusing on whether a modified combination of vitamins and minerals could offer protective benefits against advanced stages of the disease.<\/span><\/p>\nUnderstanding the FDA’s role in dietary supplement regulation<\/span><\/h2>\n
The origins of the AREDS2 formula<\/span><\/h2>\n
Examining the evidence behind AREDS2<\/span><\/h2>\n
What do the study\u2019s findings indicate?<\/span><\/h3>\n