November 21, 2001
WASHINGTON--The Food and Drug Administration (FDA) sent a warning letter to R. Scot Hunter, the chief executive officer (CEO) of Corte Madera, Calif.-based ScienceBased Health, telling him that based on the company's Web site claims, MaculaRx(TM) and MaculaRx Plus(TM) fit the definition of a drug under the Federal Food, Drug and Cosmetic Act. In addition, FDA stated that the products had not been approved generally recognized as safe (GRAS) and were misbranded because of label claims that they are safe and effective. FDA gave the company 15 days to reply, noting that if proper actions were not taken in that time, FDA would have the right to seize illegal products and/or issue an injunction against the manufacturer.
Claims specifically singled out by FDA included, "MaculaRx and MaculaRx Plus are state-of-the-art, synergistic multinutrient combinations designed to address different aspects of age-related degenerative conditions of the human eye. MaculaRx is designed for patients diagnosed in the early stages of macular degeneration. MaculaRx Plus is a therapeutic formulation for patients in the later stages of macular degeneration" and "MaculaRx and MaculaRx Plus are effective tools that may help reverse symptoms of macular degeneration and other eye disorders."
According to Hunter, the ScienceBased Health Web site (www.sciencebasedhealth.com) was rewritten to correct the statements specifically mentioned by FDA the day the letter was received. "We have hired an acknowledged and recognized regulatory expert to go over our entire Web site to be sure that we are in compliance," Hunter commented. "That assessment is supposed to be done by November 28, and we will make the changes right away. We think it's important to be in compliance and we will be."
MaculaRx has been on the market for almost two years, and MaculaRx Plus has been on the market for approximately one year. In addition, MaculaRx was recently reformulated according to current science, specifically the Age Related Eye Disease Research Study (AREDS), which was published in the October issue of Archives of Ophthalmology (119,10: 1417-36, 2001) (http://archopht.ama-assn.org). However, in the time these products have been on the market, ScienceBased Health had not had any regulatory contact prior to the Nov. 9 letter. "We have never had any sort of a regulatory notification prior to this," Hunter said. "We actually had hired regulatory people to help us in the past and they had, for the most part, signed off on everything that we've done. When the letter came, we looked for someone who maybe had greater credentials in this realm and have found someone that will do a better job for us."
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