Download Ocular Nutritional Supplements

Ocular Nutritional Supplements
Are Their Ingredients and Manufacturers’ Claims
Evidence-Based?
Jennifer J. Yong, MD,1 Ingrid U. Scott, MD, MPH,2 Paul B. Greenberg, MD3,4
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. Ophthalmology 2015;122:595-599 ª 2015 Published by
Elsevier on behalf of the American Academy of Ophthalmology.
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 betacarotene, 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.4,5 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.7,8 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.
2015 Published by Elsevier on behalf of the American Academy of Ophthalmology
595
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) through U.S. supermarkets, grocery stores, drugstores, and mass merchandisers
(excluding Walmart) from June 2011 to June 2012.9 Packaged
596
Table 1. The Top Selling Eye Supplement Brands in the United States, June 2011 to June 2012*
Brand (Company)
PreserVision (Bausch & Lomb,
Rochester, NY)
ICaps (Alcon Laboratories, Fort
Worth, TX)
Compared with
AREDS/AREDS2z
Doses
PreserVision Eye Vitamin AREDS
Formula Tablets
Same
Same
PreserVision Eye Vitamin AREDS
Formula Soft Gels
PreserVision Eye Vitamin Lutein
Formula Soft Gels
PreserVision AREDS2 Formula
Same
Same
þ
þ
þ
þ
þ
þ
Same
Ocuvite Eye Vitamin Adult 50þ
Formula
Beta-carotene
Lutein
Beta-carotene
Lutein
Zeaxanthin
Beta-carotene
Lutein
Zeaxanthin
Omega-3 fatty acids
Same
30% of vitamin C
7.5% of vitamin E
50% of lutein
50% of zeaxanthin
11% of zinc
50% of copper
Ocuvite Lutein and Zeaxanthin Eye Beta-carotene
12% of vitamin C
Vitamin and Mineral Supplements þ Lutein
7.5% of vitamin E
þ Zeaxanthin
50% of lutein/
zeaxanthin
19% of zinc
100% copper
Ocuvite Lutein Eye Vitamin and
þ Lutein
40% of vitamin C
Mineral Supplement
þ Selenium
15% of vitamin E
4% of beta-carotene
20% of lutein
50% of zinc
100% copper
ICaps Eye Vitamin Lutein & Omega-3 þ Vitamin A as retinol 9% of vitamin C
Formula
(beta-carotene)
3% of vitamin E
þ Vitamin B1, B2, B3, 100% of lutein
B6, B9, B12
100% of zeaxanthin
þ Calcium
9% of zinc
þ Selenium
45% of copper
þ Manganese
þ Lutein
þ Zeaxanthin
þ Omega-3 fatty acids
ICaps Eye Vitamin Lutein &
þ Riboflavin
80% of vitamin C
Zeaxanthin Formula
þ Manganese
38% of vitamin E
þ Selenium
26% of beta- carotene
þ Calcium
33% of lutein/
zeaxanthin
75% of zinc
200% of copper
Manufacturer Claims
“The one and only vitamin and mineral supplement formula proven effective
in the National Eye Institute’s AREDS”9
“Proven to reduce the risk of progression in people with moderate-to-advanced
AMD in the National Eye Institute’s AREDS”9
“Based on the original Bausch & Lomb PreserVision Eye Vitamin AREDS
Formula”9
“AREDS-based formula that replaces beta-carotene with lutein. For those who
should avoid beta-carotene, such as smokers”9
“Builds on the original, clinically proven PreserVision AREDS formula”9
“Many people are not getting high levels of many important eye nutrients
through diet alone”10
“Help replenish the vital nutrients your eyes can lose as you age”; “unique
formula to help protect your eye health”10
“Important for proper retinal function and support overall eye health”10
“Important to help maintain eye health”10
“Help replenish essential nutrients to help protect the health of your eyes”10
“Supports macular health by helping filter harmful blue light”10
“Helps keep the macula of the eye healthy, and the macula is critical to your
vision”10
“As we age, lutein is depleted and must be constantly replaced”10
“Work to help protect the health of your eyes”10
“Supports macular health by helping filter harmful blue light”10
“Promotes healthy eyes in people at risk for age-related eye changes”11
“Provides lutein with zeaxanthin to support eye health”11
“Recommended for people who are interested in overall eye health”11
“For people who want to supplement their current multivitamin or are not
currently taking a multivitamin”11
(Continued)
Ophthalmology Volume 122, Number 3, March 2015
Ocuvite (Bausch & Lomb)
Product
Compared with
AREDSy Ingredients
100% of vitamin C
100% of vitamin E
100% of lutein
100% of zeaxanthin
50% of zinc
100% of copper
Vitamin D
Selenium
Vitamin B6, B9
Lutein
Zeaxanthin
Bilberry extract
Alpha lipoic acid
Grapeseed extract
L-Glutathione
MacuGlo
(EyeScience)
proprietary blend
þ
þ
þ
þ
þ
þ
þ
þ
þ
þ
EyeScience Macular Health Formula
Ocular Nutritional Supplements
*Per Packaged Facts (Rockville, MD).
y
AREDS (500 mg of vitamin C, 400 IU of vitamin E, 15 mg of beta-carotene, 80 mg of zinc, 2 mg of copper).
z
AREDS2 (500 mg of vitamin C, 400 IU of vitamin E, 10 mg of lutein, 2 mg of zeaxanthin, 80 mg of zinc, 2 mg of copper).
Manufacturer Claims
Same
Same
Product
ICaps Eye Vitamin AREDS Formula
Brand (Company)
ICaps AREDS (Alcon
Laboratories)
EyeScience Macular Health
Formula (EyeScience, Powell,
OH)
Compared with
AREDS/AREDS2z
Doses
Compared with
AREDSy Ingredients
Table 1. (Continued.)
“Contains the exact formulation used in the AREDS”11
“Supports eye health in people with intermediate to advanced AMD”11
“The most complete ocular supplement designed for those with and without
AMD”12
“For older patients who may already be at an increased risk for AMD, it is better
late than never when it comes to the use of nutraceuticals”12
Yong et al
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.10e13
Results
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.
597
Ophthalmology Volume 122, Number 3, March 2015
Discussion
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).15,16 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
Study Limitations
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.4,25e31
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.
598
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Footnotes and Financial Disclosures
Originally received: July 8, 2014.
Final revision: September 25, 2014.
Accepted: September 27, 2014.
Available online: November 20, 2014.
Manuscript no. 2014-1071.
1
Department of Internal Medicine, Yale-New Haven Hospital-Waterbury
Hospital, Waterbury, Connecticut.
2
Departments of Ophthalmology and Public Health Sciences, Penn State
College of Medicine, Hershey, Pennsylvania.
3
Section of Ophthalmology, Providence VA Medical Center, Providence,
Rhode Island.
4
Division of Ophthalmology, Warren Alpert Medical School of Brown
University, Providence, Rhode Island.
This material is the result of work supported with resources and the use of
facilities at the Providence VA Medical Center. The views expressed in this
article are those of the authors and do not necessarily reflect the position or
policy of the Department of Veterans Affairs or the U.S. government.
Abbreviations and Acronyms:
AMD ¼ age-related macular degeneration; AREDS ¼ Age-Related Eye
Disease Study.
Correspondence:
Paul B. Greenberg, MD, Section of Ophthalmology, Providence VA
Medical Center, 830 Chalkstone Ave, Providence, RI 02908. E-mail:
[email protected].
Financial Disclosure(s):
The author(s) have no proprietary or commercial interest in any materials
discussed in this article.
599