Under a proposed administrative consent agreement, Scottsdale, Arizona-based Hi-Health Supermart Corporation will pay a $450,000 fine to the FTC and is banned from claiming that its Premier Formula for Ocular Nutrition-Optim3 product can restore vision or eliminate floaters, unless it has competent, reliable scientific evidence to support the claims.
The commission alleges that the company stated its claims were backed up by nutritional studies in responsible medical journals but, according to the FTC, no such studies have appeared in medical journals.
It draws attention to a statement issued by the National Eye Institute in November 2002, which says: "Claims made about an association between lutein and eye health are speculative and should be viewed with caution. The possible benefits of lutein for the eye remain uncertain."
Although the statement adds that there is little definitive scientific evidence at this time to support claims that taking supplements containing lutein can decrease the risk of developing advanced age-related macular degeneration, a blinding eye disease, or cataract, it concedes the existence of studies examining trends in a population which suggest a link between lutein and decreased risk of eye disease.
A 4-capsule dose of Ocular Nutrition contains 10mg of marigold-derived FloraGLO brand lutein, supplied by Kemin.
Kemin has examined the results of 19 studies carried out in the past few years (a list of which is available on its website) that have linked lutein intake to a decreased risk of developing eye and other health-related disorders. Amongst several key conclusions it drew were that a diet containing 6mg of lutein per day led to a 57 percent lower prevalence of AMD and that lutein protects the retina by blocking out harmful blue light.
The FTC's complaint around a nationwide radio advertising campaign between January 2002 and June 2004, primarily through testimonials and statements read on the Paul Harvey News and Comment show, which is sponsored by Hi-Health.
In addition to the claims surrounding the properties of the products and scientific studies, the FTC alleges the company falsely asserted that 83 percent of ophthalmologists recommend or prescribe it to treat age-related macular degeneration and cataracts.
Hi-Health owner Simon Chalpin could not be reached for comment prior to publication.