Category Archives: Children

FDA: e-cigarettes and children

From today’s American Association for Justice’s TRIAL magazine, FDA focusing on e-cigarette use by minors (see blue text below)

 

Trial

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FDA releases new action plans for medical devices, e-cigarettes

May 2018 – Kate Halloran

a stamper that stamps the word "HEALTH"

The FDA recently announced action plans for medical device safety and reducing sales and marketing of e-cigarettes to children under 18. The “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” outlines the agency’s priorities for addressing safety for the more than 190,000 devices that it regulates, and its Youth Tobacco Prevention Plan aims to hold manufacturers and distributors accountable for illegally selling these devices to children.

The FDA recently announced action plans for medical device safety and reducing sales and marketing of e-cigarettes to children under 18. The “Medical Device Safety Action Plan: Protecting Patients, Promoting Public Health” outlines the agency’s priorities for addressing safety for the more than 190,000 devices that it regulates, and its Youth Tobacco Prevention Plan aims to hold manufacturers and distributors accountable for illegally selling these devices to children.

The medical device action plan highlights five areas: creating a patient safety net, improving the postmarket process for safety-related changes, encouraging development of safer devices, improving device cybersecurity, and enhancing the “total product life cycle” approach to device safety within the FDA.

Many of the plan’s objectives illustrate the role that technology will play in medical device oversight. For example, the patient safety net will rely on the National Evaluation System for Health Technology (NEST), which is run by the nonprofit Medical Device Innovation Consortium. NEST’s goal is to collect electronic health data from a variety of sources—such as medical records, device registries, and patient complaints—to share real-time data among providers and the agency to expose adverse events and safety issues more quickly. As part of its action plan, the FDA intends to devote more resources to its role in NEST and to seek additional funding for the system.

Another example is device cybersecurity, which has garnered increased scrutiny as more medical devices integrate internet-based features that place the device and the patient at risk when there are software vulnerabilities. The FDA’s plan includes possibly adding premarket cybersecurity requirements for medical device manufacturers, such as having to build into devices the ability to update software and address cybersecurity threats and having to disclose to the agency an inventory of the software in a device as part of the premarket submission process—information which also must be made available to the public. Other potential changes include updates to premarket guidance on protecting against cybersecurity risks that pose a danger to patients, developing standards for timely disclosing risks, and creating a separate entity that would oversee device cybersecurity and the response process with manufacturers when a risk is identified.

The agency also announced steps it is taking to address marketing and sales of electronic nicotine delivery systems (ENDS)—often called e-cigarettes—to minors. As part of a ramped-up Youth Tobacco Prevention Plan, the FDA is targeting e-cigarette use among minors to reduce nicotine addiction and to reduce the transition to traditional tobacco products in the next generation. The use of e-cigarettes—known as vaping—has become especially popular with teenagers, partly due to the discreet nature of the devices, which can resemble a USB drive, and the fruit and candy flavors of the liquid used in the devices.

A critical component of the FDA’s plan is increasing enforcement actions against companies that improperly market and sell e-cigarettes to children. One company, JUUL, has become a particular focus: Since March, the agency has sent JUUL 40 warning letters over its sales to minors and has requested documents about the company’s marketing tactics, health and behavioral research that it has conducted on its products, and information about whether design features or ingredients appeal to certain demographics.

Lawrenceville, N.J., attorney Domenic Sanginiti, who handles e-cigarette cases, noted that regulatory efforts initiated when e-cigarettes became popular left a loophole that has impacted minors. “When the FDA extended its tobacco regulation arm to include e-cigarettes, the industry was put on notice that selling and marketing to children under 18 would be banned. The FDA did not, however, issue a similar ban regarding the use of flavors known to appeal to children and young adults—as it did for cigarettes in 2009.” Sanginiti explained that as a result, products that would appeal especially to children “flooded” the marketplace. “JUUL has a sleek design like a flash drive, is easy to hide, and comes in cool colors and fruity flavors. This has caused its popularity in school-age children to skyrocket, prompting some schools to ban flash drives and doctors and educators to condemn JUUL as a major teen health threat,” he said.

Other elements of the FDA’s initiative include collaborating with online retailers such as eBay to remove listings that target children, requesting information from and increasing enforcement against additional manufacturers, and running an online e-cigarette prevention advertising campaign. Sanginiti noted that although these efforts are a step in the right direction, the agency should treat e-cigarettes more aggressively, as it does traditional cigarettes—from banning flavors that appeal to children to lowering and eventually removing nicotine from e-cigarettes.

Sanginiti also pointed out that regulatory rollbacks of the FDA’s “deeming rule” to include ENDS products in its tobacco-regulating authority have exacerbated the situation. “The original deeming rule would have already required e-cigarette companies to file FDA applications for existing and new tobacco products. . . . However, after a comment period, the FDA pushed that requirement out to 2022. Had it not done so, it’s possible that the JUUL product and others would not have been approved without modifications.”

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Run Registration Closes 5/3

From Susan Maritan –

 

New Life 5k

ATTENTION!  There are only 8 days left to register on-line for the New Life 5k!

Do you LOVE the Angel Run? Then we think you’re going to LOVE New Life Furniture Bank’s “1st Annual New Life 5k Trail Run”.

This fundraising event will be held at 9:00 am on Saturday, May 5th at the scenic Medfield State Hospital grounds. The event is open to the public, and all ages are encouraged to RUN, JOG OR WALK in this family-friendly event.

To register or for additional information, go to newlifefb.org.

ON-LINE REGISTRATION CLOSES MAY 3RD. Last minute registration WILL BE open on the morning of the event.

MFi 2018 Summer Camp Fund Appeal

camp fund kids

Medfield Foundation 2018 Summer Camp Fund Appeal

Adults and children throughout Medfield have happy memories of summer camp. From a traditional experience in the woods to skill building or specialized camps, many Medfielders cherish these summer camp experiences and the friends they made there…How would you feel if you were left out of this experience?

Before the summer camp season begins, the Medfield Foundation (MFi) board wants the town to know that there is a highly significant need for assistance by families whose children yearn to attend camp,  but because of difficult financial situations at home they would be unable to attend. It can be challenging to grow up in an affluent community but not have the resources of friends’ families.

The Medfield Foundation encourages you to make a tax deductible donation to help Medfield children attend summer camp! There are easy ways to make your donation or to find out more:

  1. Send your check to the Medfield Foundation, ℅ Medfield Town House, 459 Main Street, Medfield MA 02052. Please make your check out to Medfield Foundation, Inc and then write “CAMP” in the memo line!
  2. Use this link to donate:  http://medfieldfoundation.org/donate/

 

Want more information before donating? Contact

MFi Treasurer, Abby Marble call: 508-361-9825  email: treasurer@medfieldfoundation.org

or Executive Board Member John Byrne call: 860-748-1447  byrne.johnb@gmail.com.

Last year, due to the severity of the need and number of children affected, the Medfield Foundation Board responded by creating the Children’s Camp Fund. Together with the generosity of our Medfield donors, $4,700 was raised which ensured 14 weeks of Medfield’s Parks and Recreation Summer Adventure Camp were enjoyed by a number of children, while others were provided summer swim lessons along with family memberships at Hinkley Pond. As a result of that success the Medfield Foundation Board unanimously voted to make the Children’s Camp Fund an ongoing fund, and this year hope to raise $5,000 so that this summer even more children who would otherwise be unable to go to camp can experience that rite of childhood summers!

 

Did you know…

The Medfield Foundation (MFi) is a 100% volunteer run 501(c)(3) non-profit charitable corporation whose mission is to enrich the lives of Medfield residents, build a stronger community, and facilitate the raising and allocation of private funds for public needs in the town of Medfield. Since its inception in 2001, the Medfield Foundation has raised over $2 million to support community-wide initiatives in Medfield.

MFi was founded based on the realization that some residents were interested in contributing more than town taxes to support projects and services that would enrich life in Medfield. Annual fundraising revenue varies each year as the initiatives and needs in the town change. You are urged to go to http://medfieldfoundation.org/.

New Life 5K Fundraising Run/Walk

From Susan Maritan –

===========================================================

New Life Announces 5K Fundraising Run/Walk

Come join your neighbors and the supporters of New Life Furniture Bank of MA as we host our “1st Annual New Life 5K Trail Run” on the grounds of the scenic Medfield State Hospital in Medfield, MA on Saturday, May 5th at 9 AM. Whether you are an avid runner, jogger, or a strolling dog walker, this fun event is a terrific way to get out of the house and stretch your legs after a long winter.

The event registration is now open: newlifefb.org/5ktrailrun. The race fee, if paid on or before April 5th, is $25; after April 5th it is $30.

 

100% of the proceeds will benefit New Life Furniture Bank of MA.
For those runners interested in getting an official time, RaceWire is providing chip timing, and for those interested in fun and relaxation, there will be post-run refreshments and DJ music!

New Life 5k

New Life’s 5K

This from Susan Maritan –

Registration is Open for New Life’s 5K Fundraising Run/Walk

New Life Furniture Bank is excited to announce its 1st Annual New Life 5K Trail Run. This fundraising event will be held at 9 AM on Saturday, May 5th at the scenic Medfield State Hospital grounds in Medfield, MA.

Come out for a day of competition and fun in the fresh air at a beautiful and natural venue for the area’s most avid runners, walkers and everyone in between. (Pets welcome too!) The New Life 5K Trail Run is open to the public, and all ages are encouraged to run, jog or walk in what promises to be an annual family event not to be missed!

Registration is open now! The first 200 registrants will receive a free t-shirt. To register or for additional information, go to www.newlifefb.org/5ktrailrun.

New Life Furniture Bank is a 501(c)3 non-profit that collects high-quality gently-used furniture and household essentials and makes them available at no cost to individuals and families in extraordinary need.

New Life has made a difference in the lives of thousands of people transitioning from a homeless environment, victims of fire, military veterans and refugees, among others.  Visit us at newlifefb.org.

New Life 5k

Thank You from the 2017 Angel Run Team

From the Medfield Foundation’s ANGEL RUN team –

Thank you from the 2016 MFi Angel Run Team
View this email in your browser
 angel-run-2016

 

Dear Angel Run Nation,

You did it again! You all came out in good cheer and with bells on to make the 2017 MFi Angel Run one for the record books.  With your participation we can know that those in our community who need some extra assistance will have their needs met. The generosity of time, talent and enthusiasm from all is the reason we put this event on year after year. Together we are building a stronger Medfield and truly helping our fellow community members.

MFi has a Flickr site with high resolution photos available for you to download at no charge. Photos will be added as they become available. Be sure to follow us on social media for notifications. And if you have any photos, be sure to upload them so everyone can benefit!

 

 angel run 2017 start
Go to Flickr to see hi-res photos from the 2017 Angel Run

 

 

In addition, RaceWire, the company that provided the timing system at the event, took photos at the finish line. Here is how to see those picures.

  1. Go go: RaceWire.com
  2. Search for 12th Annual Medfield Foundation Angel Run
  3. Click to see photos at the finish line or results

 

Check out the RaceWire.com Photos

 

 angel run 2017 finish line

 

Race Results

If you haven’t already done so, you can view your race results on RaceWire as well.

 

 angel run 2017 results
Check out Race Results on RaceWire.com

 

 

Check out the Angel Run Video!

angel run 2017 santa video

Be sure to check out the 2017 MFi Angel Run video
posted on the Medfield Foundation Facebook page.

 

 

Your Opinion is Important

Don’t forget that the Angel Run survey is still open and we value your feedback. Please reply by 12/31/17 to help us make the race even better for next year.

 

 

We Need Your Help!

A few of our key team members have “retired” and we are looking for people to join the team to help plan the 2018 event. As you know, the Angel Run is fully run by volunteers from the community and we cannot do it without people being generous with their time and skills. Specifically, we know we need volunteers in the areas of Treasurer, Post Race Party Coordination and Marketing and Communications. We have an experienced group of leaders and a great team that work closely together and will help any new volunteers with any questions. We’d love to have your involvement, so be sure to respond in the survey and let us know if you would like to help or if you have any questions at all.

 

 

Thank You and Save the Date

Save the date for the 2018 MFi Angel Run on December 2, 2018. We hope to see you there. Cheers to all and many thanks from the bottom of our hearts,
 
The 2017 MFi Angel Run Committee

 

 

Copyright © 2017 Medfield Foundation, All rights reserved.
You registered for the Medfield Foundation Angel Run

Our mailing address is:

Medfield Foundation

Medfield Town House

459 Main Street

Medfield, MA 02052
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75 High Street

 

Medfield Children's Center bld

I was informed at the Board of Selectmen meeting last night that the owners of the Medfield Children’s Center may be abandoning their planned use of the 75 High Street site (rendering shown above), for which they have been seeking site plan approval from the planning board.  I was told that the owners have located a preferred location for the Medfield Children’s Center that is on Rte. 27, but at the other side of town.