HEALTH

New moms have concerns about feeding their babies, Playtex finds

BY Michael Johnsen

SHELTON, Conn. A recent national survey commissioned by Playtex revealed that 85% of first-time moms have experienced at least one feeding-related problem when caring for their new babies.

“Moms spend more time feeding their babies than any other interaction during the first year,” stated William Sears, pediatrician and Playtex spokesman.  “Feeding a baby is more than simply a means of providing nutrition, it’s an important bonding moment. This bonding time can be interrupted by stress and anxiety when new parents encounter feeding complications.”

Challenges, problems and questions of new moms revealed by the survey included:

  • While first-time moms feel that feeding their baby is an important and enjoyable activity, nearly half of those surveyed (43%) confessed that feeding was a challenge they faced in caring for their new baby;
  • Nearly half of first-time moms (49%) cited gas as their top feeding problem, followed by difficulty breast-feeding (37%), fussiness or difficulty feeding (33%) and problems latching or sucking (32%). The majority of moms surveyed (70%) share a common problem in determining whether or not their baby is eating enough during feedings;
  • As many as 86% of survey respondents agreed time spent feeding their baby is an important bonding moment. In addition, nearly one in four moms (24%) said feeding was their favorite bonding moment during their daily routine; and
  • According to the survey, more than half of first-time moms (56%) ask feeding-related questions during their regular pediatrician appointments; with more than 1-in-4 (26%) doing so at every visit.

To help educate moms around breast feeding, and to offer helpful tips, Playtex has created an online resource at www.playtexbaby.com. “To help educate new moms and encourage further awareness of feeding challenges, Playtex, with our pediatric partners, has developed tips that will provide the solutions parents need to enjoy feeding moments with their baby,” noted Jon Jager, senior brand manager, Playex Infant Care.

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Misrepresented hand-sanitizing gel seized by federal government

BY Michael Johnsen

ROCKVILLE, Md. The Food and Drug Administration ordered the seizure of $230,000 in hand-sanitizing gel last week, the agency announced Friday.

The hand sanitizer, made by Puerto Rico Beverage and distributed by Lord Pharmaceutical/Bee International Distributors, currently is only available for sale in Puerto Rico. The product, which contains benzalkonium chloride, is not approved for sale in the U.S. market, the FDA stated.

The gel was marketed as a product that could kill 99.99% of viruses, bacteria and fungi. However, its safety and effectiveness have not been established. Additionally, the active ingredient, benzalkonium chloride, is not recognized as safe and effective for over-the-counter antifungal use, making it noncompliant with FDA’s final monograph for OTC topical antifungal drug products.

“The safety and effectiveness of the active ingredient in this product have not been demonstrated to the FDA,” stated Michael Chappell, FDA acting associate commissioner for regulatory affairs. “Thus, this product is an unapproved new drug and violates federal law. … This seizure action helps ensure that no consumers are harmed by this product.”

The product also represents that it prevents the disease caused by the H1N1 influenza virus, that it is effective against viruses and provides extended antimicrobial efficacy. The FDA is unaware of any scientific evidence to support these claims.

Moreover, the product, which is not labeled correctly, is misbranded under the law because its packaging does not list all inactive ingredients, and its label fails to contain the place of business of the manufacturer, packer or distributor.

The FDA inspected the product manufacturing facility between Aug. 19 and Sept. 28, 2009, and found numerous violations of U.S. current Good Manufacturing Practice requirements, including failure to have a Quality Control Unit; failure to maintain a clean and sanitary processing, packing and holding area; failure to conduct appropriate lab tests and many other violations.

Following that inspection, the firm agreed to recall and destroy its products but has failed to follow through on its commitments. This failure on behalf of the company led the government to request a seizure of the products.

On March 3, the FDA warned consumers not to use this product because it contained high levels of a bacterium, Burkholderia cepacia, that can cause serious infections in humans.

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Slo-Niacin.com educates visitors about heart disease, cholesterol management

BY Michael Johnsen

MAPLE GROVE, Minn. Upsher-Smith on Monday announced the launch of Slo-Niacin.com, an information portal for cholesterol management.

The site educates visitors about heart disease and includes "Cholesterol Basics," a guide to interpreting cholesterol levels and facts about common heart disease risk factors. The website also reviews recommendations on how to optimize cholesterol management, along with tips to leading a healthy lifestyle, including fitness, nutrition and how the integration of a supplement containing nicotinic acid, like the company’s Slo-Niacin brand, can support overall heart health.

 

"We know how important it is to be informed when it comes to managing overall heart health," stated Tina Fehr, product manager for Slo-Niacin. "The new website gives visitors easy access to credible information about cholesterol management, along with an improved store locator for the ultimate convenience on where to buy Slo-Niacin and how to obtain … coupons."

 

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