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May 2023
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Non-Compliance of Over-the-Counter Supplements with the AREDS2 Formulation
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Jeffrey J. Yu, MD, Jason M.L. Miller, MD, PhD, Benjamin K. Young, MD, Mark W. Johnson, MD
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The Age-Related Eye Disease Study 1 and 2 (AREDS and AREDS2) demonstrated the efficacy of nutritional supplements in reducing the risk of progression from intermediate to advanced AMD.1,2 The AREDS2 formula, which replaced beta-carotene with lutein and zeaxanthin, has become the standard recommended formula for all patients with intermediate AMD.3
Since the results of the AREDS clinical trials were published, numerous AREDS-branded supplements have become available to consumers. In our recent study published in Graefe’s Archive for Clinical and Experimental Ophthalmology, we demonstrated that a significant number of supplements available on the online marketplace containing “AREDS” or “AREDS2” in their label are, in fact, not compliant with the AREDS2 clinical trials formula,4 and this finding is consistent with a previously published report on the topic.5 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.”6 This guideline suggests that AREDS2-labeled supplements that deviate from the AREDS2 formula may be in violation of federal law.
In our study, 30.8% of the surveyed products did not adhere to the AREDS2 formula. Compared to the AREDS2 formula, 14.2% were missing at least one ingredient, 13.3% contained less of at least one ingredient, 17.5% contained more of at least one ingredient and 15.8% contained at least one extra ingredient that was not part of the studied AREDS formula (excluding multivitamins).4 The AREDS1 formula was followed in 5.8% of products.4 Our analysis used the ingredients and dosages included in the supplement facts listed on the bottle. We did not perform laboratory confirmation of the listed ingredients. Several non-compliant formulations used the misleading term “AREDS2-based” in their labeling. We also found that, on average, nonadherent products were more expensive per dose than adherent products.
Our analysis treated duplicate or highly similar products as separate entities, the most notable of which were variations of the Bausch + Lomb PreserVision® AREDS2 supplement. Given that this product is compliant with the AREDS2 formula, our results may have been skewed to underrepresent the number of non-compliant formulas. Clinicians should be specific in their recommendation of AREDS2 formulations to avoid inaccurate dosing. Examples of AREDS2-adherent brands that are available online are listed in the table below.
| Bausch + Lomb PreserVision® AREDS2 Formula |
| OJOSLABS Maculabs® AREDS2 Based Formula |
| VITEYES AREDS 2 Based Formula Macular Support |
| Nature Made Vision with AREDS 2 Formula |
| Systane I-Caps® Eye Vitamin & Mineral Supplement AREDS2 |
| Focus Select AREDS2 Based Formula Eye Vitamin & Mineral Supplement |
| Visual Advantage Macular Support |
Brands adherent to AREDS2 formula.
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Reference(s):
- Age-Related Eye Disease Study Research Group. A randomized, placebo-controlled, clinical trial of high-dose supplementation with vitamins C and E, beta carotene, and zinc for age-related macular degeneration and vision loss: AREDS report no. 8. Arch Ophthalmol. 2001;119(10):1417-1436. doi:10.1001/archopht.119.10.1417
- Age-Related Eye Disease Study 2 Research Group. Lutein + zeaxanthin and omega-3 fatty acids for age-related macular degeneration: the Age-Related Eye Disease Study 2 (AREDS2) randomized clinical trial. JAMA. 2013;309(19):2005-2015. doi:10.1001/jama.2013.4997
- Chew EY, Clemons TE, Agrón E, et al. Long-term outcomes of adding lutein/zeaxanthin and ω-3 fatty acids to the AREDS supplements on age-related macular degeneration progression: AREDS2 Report 28. JAMA Ophthalmol. 2022;140(7):692-698. doi:10.1001/jamaophthalmol.2022.1640
- Yu JJ, Miller JML, Johnson MW, Young BK. Cost analysis and adherence of over-the-counter supplements to the AREDS2 protocol. Graefes Arch Clin Exp Ophthalmol. 2022;26(1):37-39. doi:10.1007/s00417-022-05845-w
- Yong JJ, Scott IU, Greenberg PB. Ocular nutritional supplements: are their ingredients and manufacturers’ claims evidence-based? Ophthalmology. 2015;122(3):595-599. doi:10.1016/j.ophtha.2014.09.039
- NIH Office of Dietary Supplements. Dietary Supplement Health and Education Act of 1994. October 25, 1994. Accessed May 8, 2022. https://ods.od.nih.gov/About/DSHEA_Wording.aspx
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About our author(s):
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Jeffrey J. Yu, MD, is an ophthalmology resident at the Kellogg Eye Center, University of Michigan. |
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Jason M.L. Miller, MD, PhD, is an Assistant Professor at the Kellogg Eye Center at University of Michigan. He has a medical retina practice with a strong focus on AMD, and a basic science lab dedicated to exploring dry AMD pathogenesis and treatment via studies on the physiology and metabolism and the retinal pigment epithelium. |
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Benjamin K. Young, MD, is an Assistant Professor of Ophthalmology at the Casey Eye Institute, Oregon Health & Sciences University. He sees patients with both adult and pediatric vitreoretinal disease, and is active in imaging-based research related to dry AMD. |
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Mark W. Johnson, MD, is Professor of Ophthalmology and Visual Sciences and Director of the Retina Service at the University of Michigan Medical School in Ann Arbor. He has served as President of The Macula Society and The Retina Society and as Director of the AAO Retina Subspecialty Day. He lectures widely on and has published more than 200 articles and book chapters. |
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