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Executive Summary

INTERPRO's MULTI SHIELD SKIN CREAM IS "LIQUID BANDAGE," a Class I medical device, Interpro argues in an April 26 citizens petition to FDA. Disputing the agency's determination that the firm's Multi Shield, Ivy Shield and Dermaffin skin cream products are new drugs, the company maintains that the products fit the definition of a liquid bandage. In a 1980 final rule, FDA classified the liquid bandage as a Class I "sterile device that is a liquid, semi-liquid, or powder and liquid combination used to cover an opening in the skin or as a dressing for burns. The device is also used as a topical skin protectant." Each of Interpro's products "is a cream (semi-liquid) and each is offered for use as a topical skin protectant," the firm says in the April 26 petition. "It is hard to imagine a product which fits that definition more squarely." Interpro is requesting that the FDA commissioner make a final determination as to whether Interpro's products are drugs or devices. The firm also is asking for explanation of the commissioner's decision if a ruling is made that the product does not fit the definition of a liquid bandage. FDA originally informed Interpro that it considers the products to be new drugs in a Jan. 24 regulatory letter. Interpro says that after receiving the reg letter, the firm reviewed the classification systems for drugs and devices and concluded that the three products are devices. The firm subsequently registered with FDA as a medical device firm and listed its products with the device center. Interpro began marketing Multi Shield as a cosmetic in 1985 and in 1989 launched Ivy Shield, describing it as an OTC drug which does not need FDA approval. Dermaffin was introduced early in 1990. In the petition, Interpro states that "obviously any product that is offered for the prevention of skin irritations could fit within the purview of" both the device and drug regulations. However, the firm argues that its products "are more properly within the definition of devices." The firm cites the Food, Drug & Cosmetic Act which states that a device should "not achieve any of its principal intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of any of its principal intended purposes." The company also notes that "these products are offered to prevent exposure, not to cure or alleviate skin irritants." FDA rejected Interpro's arguments in an April 12 letter to the firm. The Interpro creams are not liquid bandages, FDA argues, because "liquid bandages were considered by the device classification panel...(as) those products used to cover skin openings, dressings for burns or otherwise traumatized skin." In addition, FDA maintains that "the lack of metabolic or chemical action in a product does not require that FDA regulate the product as a device." Sunscreens, activated charcoal "and various laxative preparations such as mineral oil" are considered to be drugs even though they "do not achieve their intended purpose through chemical action or by being metabolized," the agency notes. FDA adds that it plans to cancel the firm's registration as a device manufacturer. In addition to the citizens petition, Haverhill, Mass.-based Interpro submitted a petition requesting a stay of any regulatory action against the firm pending consideration of the device/drug question. The firm requests that regulatory action be postponed in order to allow time for the commissioner's determination as well as "a reasonable time thereafter" for the firm to take steps to comply with the commissioner's decision.

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