LOW-PROFILE OTC PRODUCTS "NOT IMMUNE" FROM DRUG TAMPERING

LOW-PROFILE OTC PRODUCTS "NOT IMMUNE" FROM DRUG TAMPERING, FDA asserted in a May 25 letter denying a Mentholatum petition for exemption from tamper-resistant packaging requirements. Disputing Buffalo, N.Y.-based Mentholatum's argument that most tampering incidents occur in "high profile products," the agency insisted that "products without 'large volume sales [or] a prominent public profile' are not immune from tampering." FDA said its TRP requirements "are intended to make susceptible over-the-counter drug products more tamper evident, not merely those products with high volume sales or high profiles." In a January petition to FDA, Mentholatum asked that its Red Cross Toothache Medication (eugenol 85%) be exempt from TRP regs ("The Tan Sheet" March 1, In Brief). FDA told Mentholatum that the tape seal mechanism used on the Red Cross product was considered "ineffective" because "tape seals are capable of being removed and reapplied with no visible evidence of entry." The agency said it would not grant Mentholatum's request for a stay of the May 1993 effective date of a rule not recognizing tape seals as an acceptable TRP feature. The agency disagreed with Mentholatum's assertion that Red Cross Toothache Medication is "not the type of product that would be expected to attract the attention of an individual who intends to injure through malicious tampering." FDA said its experience with product tampering "suggests that such incidents are not confined to 'high volume, high profile' products." Those involved in product tampering "may have varying motives, such as extortion, publicity or revenge, or they may be engaging in harmful 'pranks,'" the agency explained. FDA also was not "persuaded that the small recommended dose and limited frequency of use of your product would limit exposure to all harmful substances." FDA said its experience indicates that "poisonous substances do not represent the entire range of harmful substances. Other substances, such as caustic agents, acids, bases and even pathogenic organisms, have been involved in tampering incidents." The agency also questioned Mentholatum's contention that the toothache medication has a characteristic odor that consumers would recognize. FDA cited a recent incident where a "commonly used product" was "discolored, larger than normal and in a resealed package." Despite "visual signs suggesting that the product had been tampered with," FDA said that "a consumer ingested the product and experienced adverse consequences." This incident "indicates that consumers may not always be alert to a product's characteristics," the agency noted, adding that even if long-time users of the Red Cross Toothache Medication recognized its odor, "new consumers may not, and as a result, may be unable to discover that a product has been tampered with." A TRP feature "should help protect all consumers," FDA concluded, "not just those who are already quite familiar with a product."