HEALTH

Lansinoh launches online tool, social networking for new moms

BY Michael Johnsen

ALEXANDRIA, Va. Lansinoh Laboratories on Wednesday launched its new online community—Lansinohmoms.com—to help connect mothers nationwide.

“Lansinoh has been supporting and nurturing a community of new mothers for more than 20 years, so creating a place where moms can virtually find and share answers, encouragement and support from other moms online is a natural extension,” Kira Wood, director of marketing at Lansinoh, said.

New members to the www.Lansinohmoms.com community will be given the opportunity to create a personal profile, so their new online friends can get to know them and their motherhood experiences. Lansinoh plans to poll those moms on various topics, with the results shared so the members can see how other moms are thinking and feeling.

“Lansinoh was started by a breastfeeding mother who developed a product, Lansinoh Lanolin, that helped solve a problem she was experiencing—sore, cracked nipples—but for which no product existed at the time,” Wood said. “That unique product become a springboard for a whole category of products for breastfeeding women and now, after more than two decades of talking to new moms through Lansinoh’s breastfeeding outreach efforts, we understand that women crave information and love to share their own knowledge and experiences with other moms in similar situations.”

Lansinohmoms.com will also soon feature online guests, including lactation consultants and other breastfeeding experts to take part in discussions about different pressing topics.

“The Lansinoh Community forum will allow moms to candidly discuss their experiences as a mother, share tips with other members and even ask our experts questions related to motherhood,” Wood said.

“With all the new challenges and decisions mothers are faced with each day, we hope this forum will be a meaningful and refreshing pause in their day,” Wood added. “We are really excited about this site and are determined to make this a place where moms will feel confident that they will get the support they need, in addition to the accurate and helpful information they want and deserve.”

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CRN announces webinar to help guide producers through FDA ingredient regulations

BY Michael Johnsen

WASHINGTON The Council for Responsible Nutrition and Virgo Publishing last week announced plans for a new webinar—“Bringing New Ingredients to Market: FDA Guidance and Developments in the New Dietary Ingredient Notification Process”—to be held Dec. 10.

The Food and Drug Administration’s Bill Frankos, director of the Division of Dietary Supplement Programs, is one of the featured speakers and will provide the agency’s perspective on what kind of data is required to file a successful new dietary ingredient notification, as well as offer insight into other expectations from the agency. 

Frankos will be joined by regulatory experts, including George Burdock, president of the Burdock Group; Claudia Lewis-Eng, a partner at Venable; Andrew Shao, vice president, scientific and regulatory affairs, CRN; and Debbie Trinker, vice president of regulatory affairs, Kemin Health.

The webinar will provide a historical analysis of the NDI notification process since its inception by the Dietary Supplement Health and Education Act, and will include a legal review of the process as well as offering practical, actionable approaches for bringing new dietary ingredients to market.         

“There are still a lot of questions surrounding this process including what steps companies should  take in order to make sure they are meeting FDA’s expectations,” stated Shao. “While not everything can be answered in this two hour webinar, it is our goal to provide clarity along with substantive guidance and help companies feel they are up-to-date and well-informed about this process, particularly as we anticipate FDA will soon publish a guidance document on this topic.”

This is the third webinar produced by CRN and Virgo. The first webinar centered on the general aspects of the final good manufacturing practices rule.  The second webinar focused on the specific tools for managing the supply chain and practical approaches to help address safety concerns and ensure GMP compliance.

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CRN backs Bayer combination products as functional health supplements

BY Michael Johnsen

WASHINGTON The Council for Responsible Nutrition last week spoke out against warning letters issued to Bayer Consumer Healthcare by the Food and Drug Administration regarding its dietary supplement/over-the-counter combination products Bayer Aspirin with Heart Advantage and Bayer Women’s Low Dose Aspirin Plus Calcium.

“CRN continues to believe that combination dietary supplement-OTC drug products have a useful and important role to play in integrated health care and wellness,” Steve Mister, president and chief executive officer of CRN said. “Our hope is that the FDA will assist companies attempting to maneuver the regulatory challenges of developing products that combine these ingredients and meet the labeling and formulation requirements of both drugs and dietary supplements, as required by the law.”

CRN noted that the FDA in 1994 stated in the Federal Register that the “FDA does not believe that it would be appropriate to preclude such claims [health claims and OTC drug labeling] under all circumstances. Such claims may be permissible if a firm can demonstrate that dual claims can be made in a manner that will neither misbrand the product nor create a safety problem.” Since then, the FDA has issued a few warning letters addressing specific combinations of supplement and OTC drug ingredients, but has never publicly reversed its view that combination products with dual labeling can be developed that would satisfy the agency’s appropriate concerns for safety.

In its warning letters issued Oct. 28, the FDA charged that the products are unapproved new drugs requiring an approved application for the company to market them. “The FDA considers these products new drugs, and thus, they must undergo the FDA’s drug approval process,” FDA acting associate commissioner for regulatory affairs Mike Chappell said in a statement. “The FDA will take enforcement action against manufacturers found to be violating the law or attempting to circumvent the drug approval process.”

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