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FDA issues draft guidance on pediatric acetaminophen products

BY Michael Johnsen

SILVER SPRING, Md. — The Food and Drug Administration earlier this month issued draft guidance with several recommendations for manufacturers of acetaminophen products, designed to help minimize the risk to consumers of liver damage associated with the use of pediatric liquids containing acetaminophen.
 
"FDA's recommendations are designed to encourage safer use of these products by minimizing the potential for acetaminophen overdosing due to medication errors or accidental ingestion," the agency noted in its announcement. "These recommendations apply to both single ingredient and combination ingredient OTC liquid oral drug products that are labeled for use by children under 12 years of age and contain acetaminophen."
 
According to the Acetaminophen Awareness Coalition, more than 50 million Americans use a medicine that contains acetaminophen — found in more than 600 different over-the-counter and prescription medicines including pain relievers, fever reducers, sleep aids and numerous cough, cold and flu medicines — each week. 
 
Among the recommendations made by FDA: 
 
  • All single-ingredient acetaminophen oral liquids for pediatric use should have a concentration of 160 mg acetaminophen per 5 mL;
  • For single-ingredient acetaminophen oral liquids, the statements “160 mg/5 mL” or “160 mg per 5 mL” should be prominently presented on the principal display panel of the container label and carton labeling immediately below or to the right of the active ingredient name (i.e., acetaminophen) and in the same font size as the active ingredient name;
  • The PDP should clearly indicate the age range and units of age (e.g., months or years) as stated in the Drug Facts Panel under the heading “Directions”;
  • The dosing directions in the Drugs Facts label should be provided only in milliliters (mL); and
  • The product package should include an appropriate dosage delivery device, such as a calibrated and labeled oral syringe or dosing cup that's calibrated in millileters (mL).
The Acetaminophen Awareness Coalition, a diverse group of leading health, healthcare provider and consumer organizations, formed the Know Your Dose campaign to educate consumers about safe acetaminophen use in order to prevent liver damage.
 
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Jolen Creme Bleach celebrates 50 years

BY Antoinette Alexander

NEW YORK — Jolen Creme Bleach is celebrating its 50th anniversary with the first major packaging update since the product first graced the shelves.

While the logo and package color will remain the same, the new package design freshens up the brand’s look and offers two consumer bonuses: 20% more free product and a mixing cup to make it easier for blending the ingredients at home.

“Listening and responding to feedback from our loyal users led to the enhanced packaging,” said Jeff Kossak, VP of Jolen, a privately-held, family owned company headquartered in Fairfield, Conn. “Our popular Jolen Creme Bleach — original and sensitive formulas — will now feature a free bonus of 20% more product at the same price to help women lighten and soften hair on their face, arms and body. We're also providing a nifty, new mixing cup which makes it even easier to prepare the bleach.”
 
Launched in 1964 by entrepreneur and beauty pioneer Evelyn Kossak, who still plays an active role in the company, Jolen remains committed to helping women feel beautiful and confident.

“While our look on the outside has changed a bit, our mission as a company has remained the same over the past 50 years: to help women maximize their natural beauty by empowering them with confidence,” said Jolen president Kossak, who launched Jolen in 1964.
 
Jolen Creme Bleach is available in both original and sensitive formulas (with aloe vera) nationally in most major retailers, including Harmon, Rite Aid, Ulta Beauty, Walgreens and Walmart, as well as select beauty specialty stores and online.
 
Jolen will further mark the occasion with new advertising and promotions, a new website and the development of branded social media communities targeting beauty-focused consumers.

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Giant Eagle exec nominated to USPS Board of Governors

BY Michael Johnsen

WASHINGTON, DC — President Barack Obama on Wednesday announced his intent to nominate Giant Eagle executive chairman David Shapira to the role of governor for the Board of Governors of the United States Postal Service. 
 
The Board of Governors of the U.S. Postal Service is comparable to a board of directors of a private corporation. The board includes nine governors who are appointed by the president, with the advice and consent of the Senate. The nine governors select the postmaster general, who becomes a member of the board, and those 10 select the deputy postmaster general, who also serves on the board. 
 
Shapira has held the position of executive chairman at Giant Eagle since 2012. Previously, he was CEO and chairman of Giant Eagle from 1980 to 2012, and also was the company’s president from 2005 to 2012. He serves as a trustee of Oberlin College and is past chair and a current trustee of Carnegie Mellon University. He is a director of EQT Corporation and a member of the advisory board of Aquatech International. He is a former director of Mellon Bank Corporation. Shapira previously served on the boards of the Pittsburgh Regional Alliance, the Pittsburgh Symphony Orchestra and the Jewish Federation of Greater Pittsburgh.  
 
Shapira received a B.A. from Oberlin College and an M.A. from Stanford University.
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