FDA Law Blog: House Bill Targets Teenage Dextromethorphan Abuse

FDA Law Blog: House Bill Targets Teenage Dextromethorphan Abuse

House Bill Targets Teenage Dextromethorphan Abuse

Posted: 04 Aug 2015 07:52 PM PDT

By Larry K. Houck –

Representatives Bill Johnson (R-Ohio) and Doris Matsui (D-California), members of the House Energy and Commerce Committee, introduced legislation in Congress on July 28th that seeks to curb teenage dextromethorphan (“DXM”) abuse by restricting its sale to individuals under 18 years old.  The DXM Abuse Prevention Act of 2015 (H.R. 3250) is similar to the Preventing Abuse of Cough Treatments Act of 2014 (H.R. 3969) that Rep. Johnson introduced in January 2014, which was last referred to the Subcommittee on Health in February 2014.  A post on the 2014 bill appeared here on February 5, 2014.

Representative Johnson observed that “[t]eens are taking large doses of cough and/or cold medicine to get high, largely because of its easy availability.”  Dextromethorphan is an antitussive (i.e., cough suppressant) found alone or in combination with other drugs in over 120 over-the-counter cough and cold products.  Dextromethorphan is not a federally-controlled substance, but the Drug Enforcement Administration (“DEA”) has noted that even though abuse is not exclusive to individuals in a specific age group, “its abuse by teenagers and young adults is of particular concern.”  Dextromethorphan, DEA Office of Diversion Control, March 2014.  A handful of states prohibit the sale of dextromethorphan to minors.

The DXM Abuse Prevention Bill would amend the Federal Food, Drug, and Cosmetic Act by:

• Prohibiting the sale of any drug containing dextromethorphan to individuals under 18 years old except with a valid prescription or for military personnel;
• Requiring retailers to verify that they are not selling dextromethorphan to individuals under 18 years old and to implement a verification system through an electronic point-of-sale prompt to verify age, employee training manuals and materials, sales approval by authorized employees, signs or other authorized measures;
• Providing an affirmative defense to retailers who check identification and reasonably conclude that the identification is valid and indicates that the customer is at least 18 years old;
• Creating the following penalties for age violations:  a warning for a first violation; civil penalties of up to $1,000 for a second violation, civil penalties of up to $2,000 for a third violation and civil penalties up to $5,000 for a fourth or subsequent violation;
• Prohibiting possession or receipt of unfinished dextromethorphan by any person not registered, licensed or approved under federal or state law to practice pharmacy, engage in “pharmaceutical production,” or manufacture or distribute drug ingredients;
• Prohibiting the distribution of unfinished dextromethorphan to unregistered or unauthorized persons; and
• Establishing a civil penalty of up to $100,000 for the unfinished dextromethorphan possession, receipt and distribution violations.

In determining civil penalty amounts for violations, the bill would require consideration of whether the retailer “has taken appropriate steps to prevent subsequent violations,” including establishing a documented training program for all employees who sell dextromethorphan.  The bill has received strong support by a number of anti-drug abuse, healthcare and industry organizations including the Consumer Healthcare Products Association, Drug Abuse Resistance Education (“D.A.R.E.”) and Partnership for Drug-Free Kids.  The bill was referred to the Committee on Energy and Commerce the day it was introduced