Cost analysis and adherence of over-the-counter supplements to the AREDS2 protocol

Excerpt

The Age-Related Eye Disease Study 1 and 2 (AREDS and AREDS2) nutritional supplements have been shown to decrease the risk of progression from intermediate to advanced age-related macular degeneration (AMD) in large randomized controlled trials. [1, 2] Given the increased risk of lung cancer in smokers with beta-carotene in the original AREDS formula and the possible benefit of lutein/zeaxanthin over beta-carotene in the AREDS2 formula, the AREDS2 formula has become the standard recommended formula for all patients with intermediate AMD. [3] Here, we found that a significant number of supplements containing “AREDS” or “AREDS2” in their label are, in fact, not compliant with the AREDS2 clinical trials formula and are also more expensive than compliant formulas. The Dietary Supplement Health and Education Act (DSHEA) of 1994 considers a supplement misbranded if the supplement “is covered by the specifications of an official compendium” and “fails to so conform.” [4] This suggests that AREDS2-labeled supplements that deviate from the AREDS2 formula may be in violation of federal law. …