FDA calls for new warnings on anti-inflammatory drug labels
BETHESDA, Md. The Food and Drug Administration on Friday issued a final rule to require important new organ-specific warnings and related labeling for over-the-counter acetaminophen and other nonsteroidal anti-inflammatory drugs, to be published in the Federal Register Jan. 26.
The new labeling informs consumers about the risk of liver injury when using acetaminophen and the risk of stomach bleeding when using NSAIDs and applies to both medicines marketed under monograph, as well as those approved through a new drug application.
The rule will become effective Jan. 26, 2010, including products with annual sales less than $25,000.
Hy-Vee adopts NuVal Nutritional Scoring System to help customers determine food’s nutritional content
NEW YORK Hy-Vee has introduced a scoring system to allow customers to determine the nutritional content of the food they buy.
The Midwestern supermarket chain announced Thursday that it had adopted the NuVal Nutritional Scoring System, making it the first chain to do so in the Midwest. Golub Corp., which operates the Price Chopper chain in the Northeast, also has introduced the system, licensed by Braintree, Mass.-based NuVal, a joint venture of Topco Associates and Griffin Hospital in Derby, Conn.
“You really shouldn’t need a Ph.D. in nutritional biochemistry to figure out which kids’ breakfast cereal is more nutritious,” said David Katz, chairman of Griffin Hospital’s Yale Prevention Research Center. “If people want to make good decisions about the foods they buy and eat, then we should give them nutritional information they can understand.”
Hy-Vee plans to introduce the system to its stores in seven states.
Lansinoh acquires Soothies Gel Pads
ALEXANDRIA, Va. Lansinoh Laboratories on Thursday announced the acquisition of Soothies Gel Pads distributed by Puronyx. The acquisition helps expand Lansinoh product line in an effort to become the turnkey brand offering for breastfeeding mothers.
“We will continue to expand our product line through selective acquisitions and internal development to make certain we have a best-in-class product in every category for breastfeeding mothers,” stated Gary Downing, Lansinoh CEO. “Every breastfeeding mother has her own individual needs and preferences. Some mothers will prefer our Lansinoh HPA Lanolin ointment; some will prefer our Soothies Gel Pads. Other moms will prefer to use our gel pads in conjunction with our HPA Lanolin. Whatever their preference, they’ll be able to satisfy it with Lansinoh products.”
Soothies are the natural feeding segment’s bestselling gel pads, Lansinoh stated, and are used by breastfeeding mothers to cool, soothe, and treat sore nipples that can result from breastfeeding. Soothies Gel Pads will be folded into the Lansinoh portfolio of products, and sold nationally as “Soothies by Lansinoh Gel Pads” at a suggested retail price of $12.99.
In 2008, the breast therapies segment, which includes gel pads and topical ointments, contributed nearly 12% to nursing accessories, which is valued at over $83 million, according to Information Resources, Inc. data, as provided by Lansinoh.
In the U.S., the market for breastfeeding products and accessories has grown 40% since 2005, according to IRI. The birth rate in the U.S. has increased to 4.3 million in 2007, up 4% since 2003, according to the Centers for Disease Control. As many as 77% of mothers now initiate breastfeeding, according to the CDC, the highest initiation rate historically in the U.S.
Nursing mothers experiencing nipple pain or discomfort apply Soothies by peeling off the adhesive backing, and placing the three-inch circular hydrogel pad directly over the affected nipple. Soothies’ hydrogel technology and the science of moist wound healing provide instant cooling relief, and soothes sore, cracked, chapped or chafed nipples. Soothies are also the only gel pad that features fabric backing that reduces or eliminates friction against nursing bras or shirts.