This is shocking to read, but only the below nutritional supplements for macular degeneration contained correct formulations according to important NIH based studies for ARMD called AREDS and AREDS2.
1. Bausch + Lomb’s: PreserVision Eye Vitamin AREDS Formula Tablets,
2. Bausch + Lomb’s: PreserVision Eye Vitamin AREDS Formula Soft Gels,
3. Bausch + Lomb’s: PreserVision AREDS2 Formula.
4. Alcon’s ICaps AREDS Formula supplement
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.
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.
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.
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.
Abbreviations and Acronyms
- AMD, age-related macular degeneration;
- AREDS, Age-Related Eye Disease Study
Among the 59% of adults in the United States who take dietary supplements, 7% use a supplement for eye health.1
The Age-Related Eye Disease Study (AREDS) demonstrated that routine supplementation with certain nutrients in people with intermediate or advanced age-related macular degeneration (AMD) in 1 eye or intermediate AMD in both eyes reduces the risk of worsening AMD and severe vision loss by 25% over a 6-year period.2
The AREDS2 demonstrated that a certain combination of carotenoids (lutein and zeaxanthin) is a safe and effective alternative for beta-carotene, an ingredient in the original AREDS formula that has been associated with lung cancer in smokers.3
At present, there is insufficient evidence to support routine use of nutritional supplements for primary prevention of eye diseases such as AMD and cataracts.4 and 5
However, eye supplements continue to be marketed as crucial to maintaining eye health and vision, and sales continue to increase with an annual growth rate of 5%.6
Moreover, recent studies have shown that supplementing the diet of healthy adults with vitamins and minerals had no clear benefit with respect to all-cause mortality, cardiovascular disease, or cancer, and may even be associated with higher mortality.7 and 8
The current study compares ingredients contained in top-selling brands of ocular nutritional supplements with the AREDS and AREDS2 formulae and investigates the validity of claims made by manufacturers of leading brands of ocular nutritional supplements.
We examined the 5 top-selling brands of ocular nutritional supplements in the United States according to dollar sales tracked by SymphonyIRI (Waltham, MA) through U.S. supermarkets, grocery stores, drugstores, and mass merchandisers (excluding Walmart) from June 2011 to June 2012.9
Packaged Facts, a publisher of market research, compiled the sales data from SymphonyIRI and ranked the top 10 eye supplement brands.9
This publicly available Packaged Facts market report was obtained from the Harvard Business School Library’s MarketResearch.com
academic subscription. PreserVision (Bausch & Lomb, Rochester, NY; ranked 1/10), Ocuvite (Bausch & Lomb) (ranked 2/10), and Ocuvite PreserVision (Bausch & Lomb) (ranked 5/10) supplements were categorized in our study into PreserVision or Ocuvite on the basis of Bausch & Lomb’s 2 brand subcategories. ICaps AREDS (ranked 4/10) sales were tracked separately from other ICaps (ranked 3/10), so we categorized them as separate brands. TheraTears (Akorn Inc, Ann Arbor, MI) (ranked 6/10) and Optisource (Nestle HealthCare Nutrition, Florham Park, NJ; ranked 7/10) were omitted from our study, because these brands did not manufacture products that were marketed to provide nutritional support for eye health.
Our analysis includes all the ocular nutritional supplements manufactured by the 5 top-selling ocular nutritional supplement brands. Table 1
lists the 11 ocular nutritional supplements reviewed, their ingredients, and manufacturer claims. The ingredients were compared with the original AREDS (500 mg of vitamin C, 400 IU of vitamin E, 15 mg of beta-carotene, 80 mg of zinc, and 2 mg of copper) and the AREDS2 (500 mg of vitamin C, 400 IU of vitamin E, 10 mg of lutein, 2 mg of zeaxanthin, 80 mg of zinc, and 2 mg of copper) formulae. We obtained information about ingredients and manufacturer claims from the companies’ consumer information websites.10, 11, 12 and 13
The Top Selling Eye Supplement Brands in the United States, June 2011 to June 2012∗
All of the ocular nutritional supplements contained the ingredients from the AREDS or AREDS2 formula. Four of the 11 supplements (36%) contained equivalent doses of AREDS or AREDS2 ingredients; three supplements duplicated the original AREDS formula, and 1 supplement substituted beta-carotene with lutein and zeaxanthin, duplicating the AREDS2 formula.3
One supplement (9%) substituted beta-carotene with lutein only. Four supplements (36%) contained lower doses of all of the AREDS or AREDS2 ingredients (excluding copper). One supplement (9%) added lutein to the AREDS formula but had lower doses of all the other ingredients. One supplement (9%) had a lower dose of just 1 AREDS ingredient: EyeScience Macular Health Formula (EyeScience, Powell, OH) contained 50% of the AREDS zinc dose. Four of the supplements (36%) included additional ingredients to the AREDS formula, such as omega-3 fatty acids, non-AREDS vitamins, non-AREDS minerals, and herbal extracts.
All 5 brands used product descriptions classified by the Food and Drug Administration’s A Dietary Supplement Labeling Guide
as Structure/Function Claims, which describe the role of a nutrient intended to affect the structure or function of the body. 14
Only PreserVision and ICaps brands specified that their supplements were beneficial for patients with AMD and included that their supplements were beneficial for patients with “intermediate to advanced AMD” or “moderate to advanced AMD.”
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. Six of the 11 supplements (55%) included some information about AREDS on their consumer information websites. Product descriptions of 4 of the 11 supplements (36%) stated that taking a supplement is important to maintain general eye health; none of these contained the exact doses of the AREDS or AREDS2 formula.
This study examined the 5 top-selling ocular nutritional supplement brands in the United States and found that although 100% of these supplements contained the ingredients in the AREDS or AREDS2 formula, only 36% (4/11) duplicated the AREDS or AREDS2 formula. Of note, Bausch & Lomb holds patents to both AREDS (2003) and AREDS2 formulae (2013).15 and 16
This does not change the fact that the product descriptions of half of the products included claims that are not supported by level 1 evidence.17
This may be particularly confusing to the elderly, who comprise the majority of supplement users.18
Indeed, more than half of the supplements in our analysis had product descriptions that claimed that their formula was based on AREDS, but only 2 brands specified that the reduced risk of disease progression was in patients with intermediate to advanced AMD.
Under the Dietary Supplement Health and Education Act of 1994, dietary supplements are not evaluated or regulated for efficacy or safety.19
Approval from the Food and Drug Administration is not required for manufacturers to market dietary supplements.19
Use of ocular nutritional supplements is associated with several potential side effects and risks. Of note, there was an increase in genitourinary hospitalizations and self-reported anemia (although measured hematocrits were similar) associated with the use of the AREDS formula.2
Also, beta-carotene may increase the risk of lung cancer in current smokers.20
In addition, the daily dose of vitamin E in the AREDS formulation may increase the risk of prostate cancer among men with high baseline levels of selenium.21
Finally, simultaneous administration of beta-carotene and lutein may suppress serum and tissue levels of carotenoids because of interactions in metabolism and clearance from competitive absorption.22
There are limitations that may affect the rank list of brands of ocular supplements used in this study. First, this analysis was conducted with sales data dating before AREDS2.3
Second, the SymphonyIRI data excluded sales from Walmart, which has the highest revenue of any retail corporation in the United States.23
Although both AREDS and AREDS2 demonstrated the association between exposure to certain nutrients and a reduced risk of progression to and visual loss from advanced AMD, these studies do not address the optimal dose and choice of carotenoids.24
We have not included in our analysis evidence clinicians may find useful to educate patients, such as studies demonstrating the potential visual benefits of supplementation with other nutrients, the potential for nutrient supplementation to reduce progression of other disease processes, such as age-related cataracts, or the potential reduction of ocular disease with a healthy diet.4, 25, 26, 27, 28, 29, 30 and 31
In conclusion, this analysis underscores the importance of ophthalmologists educating their patients on the evidence-based role of nutritional supplements in the management of eye health.