Executive Summary

American Cyanamid subsidiary receives April 11 reg letter on promotion of Ocuvite, a zinc supplement for eyes. FDA said the company has been promoting the vitamin and mineral product as a prevention or treatment for such conditions as senile macular degeneration, cataracts, night blindness, severe near-sightedness and injuries to the cornea, which constitute drug claims. Storz said that it would meet with FDA at the beginning of the week of May 7 to discuss the agency's objections. In the meantime, the company has stopped all promotion, including journal ads and mailings, for the product, which is manufactured by Lederle. Storz said that Ocuvite promotions target ophthalmologists to encourage them to recommend the product as a preferred zinc supplement to their patients, and that FDA objections probably were directed at a brochure being distributed that specifically mentioned certain eye conditions.