FDA committee recommends additional studies on decongestant
WASHINGTON The Food and Drug Administration’s nonprescription drug advisory committee on Friday recommended the FDA commission additional studies on the decongestant phenylephrine, though in discussions the committee did affirm the safety and efficacy of 10 mg phenylephrine.
“Today, the FDA’s expert panel voted almost unanimously [11-1] that the existing evidence supports the effectiveness of phenylephrine at the 10 mg dose and reaffirms the results of numerous scientific studies and decades of consumer experience,” stated Linda Suydam, president of the Consumer Healthcare Products Association following the meeting. “CHPA and the leading makers of OTC cough, cold, and allergy medicines containing phenylephrine are committed to adding to the existing body of evidence currently supporting the safety and efficacy of phenylephrine. Our goal is to continue to provide consumers with safe and effective therapies, and we are committed to working with FDA to ensure that the scientific data further supports this goal,” she said.
Following the migration of pseudoephedrine from cough/cold aisles to behind the counter, many manufacturers reformulated their cough/cold medicines with PE.
AHPA issues materials to help identify quality of bilberry extract
SILVER SPRING, Md. The American Herbal Products Association earlier this week provided analytical tools and methods to identify adulteration of powdered raw materials labeled as bilberry (Vaccinium myrtillus) extract.
“AHPA is providing methods to help enable proper evaluations of materials where identity and quality issues are known to exist,” stated Steven Dentali, AHPA’s vice president of scientific and technical affairs. “By providing these analytical methods, we will help companies make better ingredient purchasing decisions.”
The methods, along with color images of the results, are on the AHPA website.
Disseminating these quality assurance methods is part of AHPA’s ongoing initiative to provide practical tools that enable the dietary supplements industry to self-regulate.
American Greetings to debut Muhammad Ali cards
CLEVELAND American Greetings has signed an agreement with Muhammad Ali Enterprises that will allow the company to introduce a line of greeting cards featuring the legendary boxer next month.
The Muhammad Ali Collection is due to arrive in stores in January and will include eight cards with a mix of birthday, thinking-of-you and everyday designs that feature iconic photos of Ali. The cards will debut in time for Black History Month in February.
“It’s truly an honor to work with such a respected and revered person like Muhammad Ali,” said Paul Palmer, director of ethnic card marketing for American Greetings. “It’s a natural fit for Ali to be the focal point of cards that inspire and motivate others to reach their goals, persevere through hardship and celebrate the many accomplishments in life.”
The cards will arrive in stores on Jan. 21 priced at $2.99. A line of cards featuring sound bites from Ali is planned for later this year.