Archive for the ‘Transparency Posts’ Category

FDA Continues to Issue Warning Letters for Illegal Tobacco Sales to Minors

March 29, 2011 19 comments

Every day nearly 4,000 kids under 18 try their first cigarette and 1,000 kids under 18 become daily smokers. Virtually all new users of tobacco products are under the minimum legal age to purchase such products. Many of these kids will become addicted before they are old enough to understand the risks and will ultimately die too young of tobacco-related diseases.

FDA is working to protect the health of America’s children and ultimately reduce the burden of illness and death caused by tobacco use by enforcing the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act) and Regulations Restricting the Sale and Distribution of Cigarettes and Smokeless Tobacco to Protect Children and Adolescents. This regulation, which took effect on June 22, 2010, limits the sale, distribution, and marketing of cigarettes and smokeless tobacco to protect the health of children and adolescents.

FDA works to inform retailers about these laws through the Break the Chain of Tobacco Addition campaign. FDA will also host a series of Compliance Training for Tobacco Retailers, to be held on March 29, April 26, May 18, June 28, July 26, and September 20, 2011, to provide retailers with training on federal tobacco regulations.

Last year, in order to help enforce these laws, FDA awarded contracts to 15 states to assist in inspecting retail establishments that sell cigarettes and/or smokeless tobacco products. In the upcoming years, FDA plans to award enforcement contracts to all states and U.S. territories to assist with enforcement of the Tobacco Control Act.

The goal of the State Enforcement Program is to improve public health and to protect young people by bringing enforcement action against retailers who violate the law. State inspectors under these FDA enforcement contracts conduct compliance check inspections to determine if retailers comply with the law, including whether the retailer:

  • sells a tobacco product to a minor;
  • requests proper identification;
  • sells prohibited flavored cigarettes or individual cigarettes; and
  • sells tobacco products in a self-service display, like a vending machine, which can be accessed by minors.

We appreciate the efforts and commitment of all states who have contracted with FDA to assist in enforcing the Tobacco Control Act and FDA regulation. More than 95 Warning Letters have been issued to retailers for illegal sales of cigarettes and/or smokeless tobacco to minors. FDA’s website posts Warning Letters that have been issued as well as a list of retailers that have been inspected and where no violations were observed.

We encourage anyone who is aware of retailers who may violate the Tobacco Control Act to report violations to FDA’s Center for Tobacco Products through our website, by email or by phone (1-877-CTP-1373).

Thank you,
Ann Simoneau
Director, Office of Compliance and Enforcement

New Spanish-Language Website Increases Access to FDA Tobacco Information

March 10, 2011 52 comments

I am pleased to announce that many portions of FDA’s Center for Tobacco Products (CTP) website are now available in Spanish. This new resource for the Spanish-speaking community will provide key information to our stakeholders in our common goal of reducing the tremendous toll of illness and death from tobacco use through FDA’s new role in tobacco product regulation. By increasing access to our content to the Spanish-speaking public we not only increase the reach of our message, but also make further in-roads into communities that play a key role in tackling this important public health issue.

Over the last several months, I’ve heard from many stakeholders in a number of ways about the overall need for CTP to provide key tobacco product information in different languages. This was echoed by a request from a woman named Sarah who submitted a request for low-literacy handouts in multiple languages to our CTP Tobacco Ideas Forum (which is a novel way for the public to submit a thought and then have it voted on by other stakeholders). Input like this from the general public, combined with what we’ve learned through many other communication channels, has led to the launch of this Spanish-version website. The first of several plain language handouts similar to what Sarah, and many others have requested, as well as a variety of free resources and tools are now available. These include:

  • The Break the Chain of Tobacco Addiction retailer education campaign web area, which includes translated printed materials that can be ordered online;
  • An digital timeline of the Tobacco Control Act, which highlights past achievements and upcoming deadlines required by the Act;
  • Multiple ways to connect with the us through social media;
  • Federal resources on youth tobacco prevention, effective treatment for nicotine addiction, and tobacco research and statistics;
  • And much more!

I encourage you to check out and let us know what you think. I also hope you will contribute to the CTP Tobacco Ideas Forum. We are listening and want your ideas to improve our efforts to effectively disseminate information about FDA tobacco regulations and to develop innovative ways to educate the public about the dangers of tobacco products use.

Thank you

–Lawrence R. Deyton, M.S.P.H., M.D., Director, FDA Center for Tobacco Products

New Updates on FDA-TRACK, Agency’s Performance Management System

January 12, 2011 24 comments

FDA’s performance management system, FDA-TRACK, allows the public to follow the agency’s progress on a range of measures (see April 7 blog  post).

New performance data from December 2010  is now available on FDA-TRACK.  Check out FDA-TRACK for updates, including complete FY 2010 data for projects related to human drugs and biological products, and animal drug products.

Afia Asamoah, Transparency Initiative Coordinator

Additional Information About Post-Approval Studies Conducted with Medical Devices Now Available

December 22, 2010 17 comments

FDA is taking steps to improve transparency about studies conducted with devices after approval.   The Center for Devices and Radiological Health (CDRH) has a program that oversees studies that are required as a condition of approving certain applications.  The CDRH Post-Approval Studies (PAS) program helps to ensure that well-designed post approval studies are conducted effectively and efficiently and in the least burdensome manner.

CDRH launched a webpage so that the public can keep informed of the progress of each post-approval study.   The webpage displays general information about each post-approval study and now more information is available, including information about the study design, population studied, and data collection methods.  For completed studies, you can find information about final study results, safety and effectiveness findings, strengths and weaknesses of the study, and recommended labeling changes, if any. 

This post will be last one until January 2011.  Happy holidays to all of our readers and best wishes for the New Year!

Afia Asamoah, Transparency Initiative Coordinator

FDA Information is Now on Facebook and Flickr

October 5, 2010 16 comments

FDA has a new Facebook page at:

The page provides regular updates on FDA news and events as well as federal health safety information of interest to the public.  Share this information with your Facebook friends and leave us posts letting us know what you would like to see.

FDA is also taking its public health message to Flickr.  You can see pictures of FDA scientists and investigators working to protect and promote the public health, and more.  Visit FDA’s Flickr photostream and let us know what you think. 

Afia Asamoah, Transparency Coordinator

Tags: ,

FDA’s Center for Devices and Radiological Health (CDRH) Launches Inspections Database

October 1, 2010 8 comments

Yesterday, as part of the FDA Transparency Initiative, CDRH launched the ‘CDRH Inspections Database’.  The database provides information about medical device inspections that were the responsibility of CDRH from 2008 to the present (approximately 25% of the medical device inspections conducted since 2008).  The database contains information about the firms, types of devices and inspections, and links to warning letters (when available).

You can search the inspection database by various parameters, including company name, inspection type, product code, inspection classifaction, inspection action, and date.  You can find the database here.

We encourage your feedback on the database and welcome your suggestions for additional information you would like to see.  You can provide feedback on the FDA Web site.

Afia Asamoah, Transparency Initiative Coordinator

FDA Unveils New Section of the FDA Web site for Recalls Data and Other Agency Data Sets

September 30, 2010 20 comments
As part of making data available through the Department of Health and Human Services (HHS) Open Government Initiative, FDA has created a new section of the FDA Web site for agency data sets. The new section includes all available downloadable data for major recalls from 2009 to present based on information provided by firms in press releases, including data on the recent Shell Egg recall.  The new gateway features data sets in XML format, which allows developers to easily create applications and mashups centered around FDA data.  
You can check out the data sets here.  Let us know what you think by leaving a comment on this blog or sending an email to, subject line “FDA Data Gateway Feedback.”  As we look ahead, we are interested in your ideas about the data provided and how that data is organized.
Afia Asamoah
Transparency Initiative Coordinator

Get every new post delivered to your Inbox.

Join 197 other followers

%d bloggers like this: