Ocular nutritional supplements: are their ingredients and manufacturers' claims evidence-based?

PURPOSE To compare ingredients contained in top-selling brands of ocular nutritional supplements with the Age-Related Eye Disease Study (AREDS) and AREDS2 formulae and investigate the validity of claims made by manufacturers of leading brands of ocular nutritional supplements. DESIGN Descriptive. PARTICIPANTS None. METHODS We examined the 5 top-selling brands of ocular nutritional supplements in the United States according to dollar sales tracked by SymphonyIRI (Waltham, MA) from June 2011 to June 2012. We reviewed the ingredients and manufacturer claims of 11 ocular nutritional supplements on the companies' consumer information websites; the ingredients were compared with those contained in the AREDS and AREDS2 formulae. MAIN OUTCOME MEASURES Proportion of ocular nutritional supplements that contained the same ingredients, in the same doses, as the AREDS or AREDS2 formula; proportion of nutritional supplements with unsubstantiated claims made by the manufacturer. RESULTS All of the ocular nutritional supplements contained the ingredients from the AREDS or AREDS2 formula; 36% (4/11) of the supplements contained equivalent doses of AREDS or AREDS2 ingredients; 55% (6/11) included some information about the AREDS on their consumer information websites. Product descriptions from 4 of the 11 supplements (36%) stated that the supplements were important to maintain general eye health; none of these supplements duplicated the AREDS or AREDS2 formula. All the individual supplements claimed to "support," "protect," "help," or "promote" vision and eye health, but none specified that there is no proven benefit in using nutritional supplements for primary prevention of eye disease. CONCLUSIONS The majority of top-selling ocular nutritional supplements did not contain the identical ingredient dosages of the AREDS or AREDS2 formula and had product description claims that lacked level 1 evidence, underscoring the importance of ophthalmologists educating their patients on the evidence-based role of nutritional supplements in the management of eye health.