Supplement Maker Responds to FDA Warning on Claims

Supplement Maker Responds to FDA Warning on Claims

WASHINGTON--The Food and Drug Administration (FDA) sent awarning letter to R. Scot Hunter, the chief executive officer (CEO) of CorteMadera, Calif.-based ScienceBased Health, telling him that based on the companysWeb site claims, MaculaRx and MaculaRx Plus fit the definition of a drugunder the Federal Food, Drug and Cosmetic Act. In addition, FDA stated that theproducts had not been approved generally recognized as safe (GRAS) and weremisbranded because of label claims that they are safe and effective. FDA gavethe company 15 days to reply, noting that if proper actions were not taken inthat time, FDA would have the right to seize illegal products and/or issue aninjunction against the manufacturer.

Claims specifically singled out by FDA included, MaculaRx and MaculaRxPlus are state-of-the-art, synergistic multinutrient combinations designed toaddress different aspects of age-related degenerative conditions of the humaneye. MaculaRx is designed for patients diagnosed in the early stages of maculardegeneration. MaculaRx Plus is a therapeutic formulation for patients in thelater stages of macular degeneration and MaculaRx and MaculaRx Plus areeffective tools that may help reverse symptoms of macular degeneration and othereye disorders.

According to Hunter, the ScienceBased Health Web site (www.sciencebasedhealth.com)was rewritten to correct the statements specifically mentioned by FDA the daythe letter was received. We have hired an acknowledged and recognizedregulatory expert to go over our entire Web site to be sure that we are incompliance, Hunter commented. That assessment is supposed to be done byNovember 28, and we will make the changes right away. We think its importantto be in compliance and we will be.

MaculaRx has been on the market for almost two years, and MaculaRx Plus hasbeen on the market for approximately one year. In addition, MaculaRx wasrecently reformulated according to current science, specifically the Age RelatedEye Disease Research Study (AREDS), which was published in the October issue of Archivesof Ophthalmology (119,10: 1417-36, 2001) (http://archopht.ama-assn.org).However, in the time these products have been on the market, ScienceBased Healthhad not had any regulatory contact prior to the Nov. 9 letter. We have neverhad any sort of a regulatory notification prior to this, Hunter said. Weactually had hired regulatory people to help us in the past and they had, forthe most part, signed off on everything that weve done. When the letter came,we looked for someone who maybe had greater credentials in this realm and havefound someone that will do a better job for us.