U.S. Federal Trade Commission

 FTC News Release,  Feb 15, 2005

Seller of "Ocular Nutrition" Dietary Supplement That Purports to Treat Eye Diseases Settles FTC Charges and Pays $450,000

Hi-Health Supermart Corporation (Hi-Health) and its owner, Simon Chalpin, have settled Federal Trade Commission charges that they made unsubstantiated advertising claims that their product - Premier Formula for Ocular Nutrition-Optim3 (Ocular Nutrition) - can restore vision already lost from age-related macular degeneration and eliminate small specks moving in the field of vision (called “floaters”). The proposed administrative consent agreement bans the respondents from claiming that Ocular Nutrition, or any similar supplement product: (1) restores vision lost from macular degeneration, or (2) eliminates floaters, unless they have competent and reliable scientific evidence to support those claims. It also requires the payment of $450,000 to the FTC.

The FTC’s complaint alleges that Hi-Health, based in Scottsdale, Arizona, and Chalpin promoted Ocular Nutrition through a nationwide radio advertising campaign. From January 2002 to June 2004, the respondents advertised Ocular Nutrition primarily through testimonials and other statements read on the Paul Harvey News & Comment radio show. In their advertising, the respondents promised that Ocular Nutrition would not just preserve eyesight, but actually restore vision lost to macular degeneration. They also claimed that several studies showed that the product could improve cataracts. The FTC’s complaint alleges that the respondents made unsubstantiated claims that Ocular Nutrition restores vision lost from age-related macular degeneration and eliminates floaters, and falsely claimed that nutritional studies in responsible medical journals confirm that the ingredients available in Ocular Nutrition may help individuals with cataracts and/or floaters. According to the FTC, there are no nutritional studies in responsible medical journals that confirm the respondents’ claims. According to the complaint, a statement issued by the National Eye Institute with regard to lutein (one of the active ingredients in Ocular Nutrition) cautions that while a number of studies suggest a link between lutein and decreased risk of eye disease, there is little, if any, definitive scientific evidence at this time to support claims that lutein can decrease the risk of developing cataracts.

In addition, the complaint alleges that the respondents falsely claimed that a study shows that 83 percent of ophthalmologists recommend or prescribe Ocular Nutrition to treat age-related macular degeneration and cataracts.

The proposed consent agreement to settle the charges bans the respondents from claiming that the Ocular Nutrition supplement, or any substantially similar supplement product, restores vision lost from macular degeneration, or eliminates floaters, unless they have competent and reliable scientific evidence to support those claims. In addition, the proposed order prohibits the respondents from making claims about the benefits, performance, efficacy, or safety of any health-related service or program, dietary supplement, food, drug, or device unless they have competent and reliable scientific evidence that substantiates the claims and bans misrepresentations of any test or study. The proposed order requires the respondents to pay $450,000 to the FTC.

The Commission vote to accept the proposed consent agreement was 5-0. The FTC will publish an announcement regarding the agreement in the Federal Register shortly. The agreement will be subject to public comment for 30 days, beginning today and continuing through March 16, 2005, after which the Commission will decide whether to make it final. Comments should be addressed to the FTC, Office of the Secretary, Room H-159, 600 Pennsylvania Avenue, N.W., Washington, D.C. 20580. The FTC is requesting that any comment filed in paper form near the end of the public comment period be sent by courier or overnight service, if possible, because U.S. postal mail in the Washington area and at the Commission is subject to delay due to heightened security precautions.

NOTE: A consent agreement is for settlement purposes only and does not constitute an admission of a law violation. When the Commission issues a consent order on a final basis, it carries the force of law with respect to future actions. Each violation of such an order may result in a civil penalty of $11,000.

The text in this article was prepared by the U.S. Federal Trade Commission.