NACDS to FDA advisory committee: Curb DXM abuse without impeding appropriate use
ALEXANDRIA, Va. As the Food and Drug Administration’s Drug Safety and Risk Management Committee debated Tuesday on ways to curb abuse of cough suppressants containing dextromethorphan, the National Association of Chain Drug Stores testified that the scheduling of dextromethorphan under the federal Controlled Substances Act is not the right solution.
“Dextromethorphan is consumers’ No.1 choice to treat cough. Depriving consumers of the option to self-medicate with dextromethorphan would have substantial public health consequences because cough and cold are extremely prevalent in the U.S. population, affecting the average adult two to four times per year,” NACDS VP regulatory affairs Kevin Nicholson said to the FDA Drug Safety and Risk Management Committee.
NACDS also urged the committee to consider the approach set forth by Sen. Dick Durbin, D-Ill., in the Dextromethorphan Abuse Reduction Act of 2009, which would prohibit the sale of dextromethorphan to minors.
“Dextromethorphan is the most common ingredient in over-the-counter cough medicines in the United States,” Nicholson stated. “[The] abuse of dextromethorphan is concentrated primarily among teenagers, and this concentration makes possible a targeted and strategic approach to preventing abuse.”
In addition to working on legislative remedies, the association also has worked with the White House Office of National Drug Control Policy and the Drug Enforcement Administration to help raise awareness of the scourge of medication abuse, particularly among young people.
‘C’-ing that scars go away
GUILFORD, Conn. —Mitchell-Vance Labs is in the process of launching a new scar product to add to its ScarAway offering that could appeal to a whole new consumer in search of scar therapy—ScarAway for C-sections.
The therapy may have direct appeal to 1-in-4 new mothers, which is the number of women who give birth by Cesarean section in the United States. According to the March of Dimes, the national weighted average of C-section births is 25.2%, but the percentage of C-sections performed climbs higher than 30% in three states—Mississippi (31.1%), New Jersey (30.9%) and Louisiana (30.4%).
The product features an extended-length, medical-grade silicon scar sheet ideal for placement over C-section cuts.
CRN head counters attacks on industry
MCLEAN, Va USA Today opinion piece published last month regarding a Consumer Reports attack on the dietary supplement industry. —The Council for Responsible Nutrition’s president and CEO Steve Mister supplied the “opposing view” to a
At issue was the public misconception that dietary supplements are unregulated. “While many users believe that sale of unsafe or ineffective supplements must be illegal, it is not,” USA Today opined, citing Consumer Reports. “The public has little protection from useless, fraudulent, dangerous or even deadly products, thanks to special protection Congress gave the industry in 1994.”
“Truth is, the Food and Drug Administration already has ample authority to regulate this industry,” Mister countered. Opinions of regulation aside, Consumer Reports had outlined problems with a dozen considered-to-be-dangerous herbal supplements—none of which would make any mass retailer’s best-seller list.
“The media circus surrounding the latest issue of Consumer Reports implicates the entire aisle of mainstream dietary supplements based on 12 ingredients that, combined, make up less than 1% of the marketplace,” Mister noted. “Yet given the attention, one would think these 12 herbs represent the mainstream dietary supplement aisle at your neighborhood pharmacy. They do not.” Mister added, “If any of these 12 ingredients is truly unsafe, then the FDA should ban its use.”