Pink Sheet is part of Informa PLC

This site is operated by a business or businesses owned by Informa PLC and all copyright resides with them. Informa PLC’s registered office is 5 Howick Place, London SW1P 1WG. Registered in England and Wales. Number 8860726.

This copy is for your personal, non-commercial use. For high-quality copies or electronic reprints for distribution to colleagues or customers, please call +44 (0) 20 3377 3183

Printed By



This article was originally published in The Tan Sheet

Executive Summary

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."

You may also be interested in...

People In Brief

Perrigo promotes in pricing, planning

In Brief

Combe sells most of its OTC brands

Supplement GMP Warning Letters Make Modest Debut In 2010

Finalization of a settlement between the Federal Trade Commission and Rexall Sundown regarding unsupported cellulite treatment claims for the firm's Cellasene dietary supplement hinges upon approval of two related class action settlements pending in California and Florida, according to FTC





Ask The Analyst

Please Note: You can also Click below Link for Ask the Analyst
Ask The Analyst

Your question has been successfully sent to the email address below and we will get back as soon as possible. my@email.address.

All fields are required.

Please make sure all fields are completed.

Please make sure you have filled out all fields

Please make sure you have filled out all fields

Please enter a valid e-mail address

Please enter a valid Phone Number

Ask your question to our analysts