Archive for the ‘Transparency Posts’ Category

FDA Basics Webinar: Recall Process for FDA-Regulated Products

July 24, 2012 19 comments

Consumers are impacted by FDA-regulated products daily. Food, medicines, and medical devices are examples of FDA-regulated products. What happens when a potentially harmful item is on the market?

Learn more on Thursday July, 26, 2012 at 3 p. m. ET,  in a FDA- hosted webinar ” Recall Process for FDA-Regulated Products.” Recall Coordinator Cecilia Wolyniak of FDA’s Office of Enforcement will discuss the recall process and how recalls are monitored and publicized.

For more information on how to join the webinar, please visit the FDA Basics section of the website.  There are a limited number of spots available. Webinar Slides can viewed before the presentation. Archived material will be available immediately after.

Connect With Us: Using FDA’s Digital Tools to Present, Participate, and Personalize Tobacco Information

June 19, 2012 12 comments

In this short 30 minute webinar, you will learn how the FDA Center for Tobacco Products uses a variety of digital tools to engage and inform you about tobacco laws and the dangers of tobacco use.  From Twitter to texting, digital technology offers countless opportunities to motivate, inspire action and present information in new and interesting ways.

The featured speaker is Michael Murray, a senior social media strategist for the FDA Center for Tobacco Products, who will highlight several innovative tools FDA provides that you can easily use to share information and encourage change.  Michael will be joined by Anait Saakyan, a marketing specialist, who will present a number of ways to connect with us via social media.

After the presentation, there will be an opportunity to ask questions.

For information on how to join the webinar, please visit the FDA Basics website.  There are a limited number of spots available for the Webinar, however Webinar materials will be made available on the FDA Web site.

Materials Available from FDA Basics Webinar on Hearing Aids

June 4, 2012 32 comments

Did you miss the FDA Basics webinar on hearing aids? You can learn about what consumers need to know about hearing loss, hearing aids and the different types, and styles available and how to get the most out of your hearing aids.

Materials from the webinar are now available. We have posted a link to view and listen to the webinar and posted a link to download a copy of the presentation slides.

You can also find materials from past FDA Basics webinars.

Materials Available from FDA Basics Webinar on Steps the FDA is Taking to Address Health Disparities

June 4, 2012 17 comments

Did you miss the FDA Basics webinar about FDA’s Office of Minority Health?  You can learn about health differences that exist between populations and what FDA is doing to address these disparities to achieve the highest standard of health for all.

Materials from the webinar are now available. We have posted a link to view and listen to the webinar and posted a link to download a copy of the presentation slides.

You can also find materials from past FDA Basics webinars.

Hearing Aids: The Basic Information You Need to Know

May 21, 2012 15 comments

Did you know that May is ‘Better Hearing and Speech Month’? Do you have questions about hearing loss and hearing aids?

Learn more Wednesday, May 23, 2012 at 2:00 p.m. ET, when FDA’s Center for Devices and Radiological Health (CDRH) will host a 30-minute Webinar to discuss basic information on Hearing Aids.

The featured speaker Shu-Chen Peng, Ph.D., CCC-A, Audiologist in CDRH’s Office of Device Evaluation, will discuss what consumers need to know about hearing loss, hearing aids and the different types and styles available and how to get the most out of your hearing aids.

After the presentation, there will be an opportunity to ask questions.

For information on how to join the webinar, please visit the FDA Basics website.  There are a limited number of spots available for the Webinar, however Webinar materials will be made available on the FDA Web site.

FDA Basics Webinar: FDA Office of Minority Health – Steps to Address Health Disparities

May 17, 2012 15 comments

Scientific advances and innovative medical technologies have provided Americans with the potential for longer, healthier lives.  However, persistent and well-documented health differences exist between populations.  FDA is dedicated to addressing these disparities and achieving the highest standard of health for all.

Please join us for a webinar by FDA’s Office of Minority Health titled, “Steps to Addressing Health Disparities,” on Monday, May 21st at 2 PM EST.  The featured speaker, Michelle Yeboah, Dr. P.H., is the Acting Director of the FDA Office Minority Health.  Dr. Yeboah will give an overview of the newly established office and answer questions following the presentation.

For more information on how to join the webinar, please visit the FDA Basics website.   There are a limited number of spots available for the webinar, however all materials will be available on the FDA website.

Canadian and U.S. Agencies Partner to Modernize Food Safety

December 12, 2011 32 comments

As Deputy Commissioner for Foods at the Food and Drug Administration, I led a delegation to Ottawa on October 21 to meet with officials from the Canadian Food Inspection Agency (CFIA) and Health Canada to discuss how to best cooperate on our efforts to modernize our respective food safety systems.  I also had the opportunity to hear from Canadian industry representatives on their ideas of how FDA could implement the Food Safety Modernization Act (FSMA) in the most efficient manner as we continue to protect public health.  This trip furthered our efforts to reach out and collaborate with our colleagues abroad who will be our partners as we put FSMA in place, especially those provisions concerning imported food.

The trip also allowed both sides to step back and reflect on the importance of the U.S.-Canadian relationship in achieving the goals that FSMA has laid out for us, in line with FDA’s mission to protect public health.  On the trade front, Canada is the United States’ largest trading partner in terms of agricultural imports.  Because so much food is exchanged across our border every day, our governments share a keen interest in ensuring that this food is safe for our consumers.  However, we also have an obligation to make sure that companies are not unnecessarily burdened.

A major highlight of the trip for me was the industry outreach session where I received comments and questions on FSMA directly from Canadian industry.  We listened as industry described several different types of preventive control programs that they believe could be useful for FDA as we implement FSMA requirements.  Industry also expressed keen interest in the Foreign Supplier Verification Program, especially with regard to its proposed scope and applicability.  We also answered questions on topics ranging from the definition of “importer” to exceptions for small business to user fees.

Our delegation also engaged on a technical level with our Canadian counterparts to investigate areas where we could cooperate on food safety modernization efforts.  Exchanging inspection and compliance information, with a view toward leveraging each other’s resources, was an activity that both sides agreed to pursue.  Also, Canada expressed interest in working with FDA’s FSMA imports implementation team on best practices for import controls, laboratory accreditation and third party certification, among other modernization areas.

The FDA looks forward to continue working with our CFIA and Health Canada counterparts in the months ahead to strategize, prioritize, and exchange ideas on how we can cooperate to accomplish our common public health goals. Our respective food safety systems are already well-developed, but we recognize the need to make continual improvements.  Our modernization efforts will not necessarily be identical, but I know that close cooperation between U.S. and Canadian regulators, such as we had during our trip, will allow us to move forward together to protect public health and continue as strong trade partners.

Michael R. Taylor
Deputy Commissioner for Foods

Talking Food Safety in Minneapolis

November 8, 2011 18 comments

It’s not every day that I have a chance to see first-hand what companies are doing to strengthen their food safety preventive practices, but that’s just what happened on a recent trip to Minneapolis. The facility tour we took is part of FDA’s continuing effort to hear from all stakeholders on the best ways for us to implement the Food Safety Modernization Act (FSMA).

I was joined by several FDA colleagues working hard on implementing the new food safety law, as well as the commissioner and assistant commissioner of the Minnesota Department of Agriculture, the department’s director of the division of dairy and food inspection, and the chief science officer of the Grocery Manufacturers Association.

We met with company executives, plant and shift managers, and those responsible for the safety of our food on a day-to-day basis. A key take away message from our interactions: food safety is a journey that requires sustained leadership and commitment.

We learned about how individual companies have evolved their food safety programs over the past few years. We heard about what works and what challenges they face. We looked at how they verify their suppliers are providing safe products, when and how they conduct environmental monitoring, and how they train employees. All of these efforts are important in preventive control programs. The companies we visited had a lot of experience with preventive controls and are continually improving their systems. The significance of FSMA is that, now, preventive controls will be the norm across the industry.

In two days, we visited Cargill Kitchen Solutions, a marketer of processed liquid and cooked egg products; a Land-O-Lakes feed mill that manufactures feed for a variety of different animal species; a General Mills plant that produces baked goods; Buddy’s Kitchen, a smaller enterprise that prepares ready-to-eat entrees and sandwiches; and a Malt-O-Meal plant that manufactures dry cereal. In the evening we joined a consortium of Minnesota industry leaders and state representatives for a lively dinner that provided additional opportunity for us to hear thoughts on FSMA and food safety.

We saw on our visit to Minnesota the kind of leadership and management commitment to food safety that is the essential foundation for success in providing consumers the safest possible food supply.

Michael R. Taylor
Deputy Commissioner for Foods

Update on Retrospective Review of FDA Regulations

October 26, 2011 36 comments

If you’ve been following this blog you know that earlier this year, President Obama issued Executive Order (EO) 13563 and outlined his plan to create a 21st-century regulatory system that is simpler and smarter and that protects the health and safety of the American people in a pragmatic and cost-effective way.  One of the goals of EO 13563 is to target rules already on the books and revise regulations that are out-of-date, unnecessary, excessively burdensome, or in conflict with other rules.

On June 3, 2011, we announced, as part of the Department of Health and Human Services (HHS) retrospective review plan, that the first of our regulations to be reviewed under this EO would be the “Bar Code Rule.” You can see the HHS plan in its entirety at   The Bar Code regulation, which was finalized in 2004, requires certain human drugs and biological products to have a linear bar code on the label so health care professionals can use bar code scanning equipment to verify that the right drug (in the right dose and route of administration) is being given to the right patient at the right time.

In the seven years since this regulation was issued, there have been advances in alternative technologies.  In addition, it has become increasingly clear from industry, health care providers, and other FDA initiatives, that certain FDA-regulated products present unique bar coding concerns.  For example, the Agency has since learned that certain vaccines present unique challenges in the bar coding context, particularly with respect to compliance with recordkeeping and mandatory adverse event reporting requirements that are specific to the administration of childhood vaccines.

We are pleased to announce that today FDA issued a Federal Register notice seeking public input on the Bar Code rule.  You can see this notice at  We are requesting comments and supporting information on Bar code labeling standards for drugs and biological products and the identification of current alternative technologies for use by industry and others.

To facilitate this discussion with you, in the notice we have included some questions for you to consider.  These questions, which are not meant to be exhaustive, are provided to stimulate public comments that will help us evaluate the Bar Code rule and the accommodation of alternative technologies to the linear bar code requirement.  You are encouraged to address these and/or other related questions, so please review the notice at and submit your comments to our docket.  We look forward to hearing your thoughts and ideas.

Stay tuned as we continue reviewing our regulations at FDA.

Leslie Kux

Assistant Commissioner for Policy


Clark Nardinelli, FDA Chief Economist

Fulfilling the Promise of the Food Safety Modernization Act: The Importance of Stakeholder Engagement

October 24, 2011 29 comments

Recently, I had the good fortune to fill in for an FDA colleague on a panel entitled, “Assuring the Safety of Imported Food” at the National Food Policy Conference, which is organized by the Consumer Federation of America.

Participants at the conference included a broad spectrum of activists, public officials, nutrition professionals, farm and food industry representatives, and scientists who are interested in agriculture, food and nutrition policy.  The Food and Drug Administration Food Safety Modernization Act (FSMA) was one of the key areas of focus at the conference.

Even though I was called from the audience to participate unexpectedly in the panel, I hoped my role as Vice-Chair of FDA’s FSMA Imports Implementation Team would stand me in good stead. Fortunately, the other panelists spoke first, which gave me the chance to organize my thoughts.

My fellow panelists, Caroline Smith DeWaal, from the Center for Science in the Public Interest, Mike Robach, from Cargill, and Eduardo Santos from Allen F. Johnson and Associates spoke eloquently on the challenges and opportunities that the imports provisions of FSMA represent to consumers, industry, and other countries.   They identified various key issues associated with FSMA implementation including the costs associated with implementation, training, capacity building in exporting countries, and ensuring both accountability and fairness.

In addition to emphasizing some of the main features of the FSMA imports provision, I discussed how FDA is approaching the task of developing over 50 deliverables mandated by FSMA, our outreach strategy, the importance of making sure our actions are consistent with our WTO obligations, and the overarching need for stakeholder involvement.

The main message I hoped to leave with the audience was the importance of their role as stakeholders in providing information, practical scenarios, and data as we proceed with FSMA implementation.  FDA’s significant and ongoing effort at early engagement via public meetings has already provided FDA with many useful insights. I encouraged stakeholders to use the “notice and comment” process to continue to provide information and feedback in response to upcoming proposed regulations.

The task before us is huge. Currently, there are over 160 countries exporting hundreds of thousands of FDA regulated food products to the U.S.  How do we collectively assure safety?  How do the import provisions consider domestic provisions? FSMA provides the framework to harness leading business global food safety practices, consumer expectations and importer practicalities, with agency standards and oversight.  We have a long way to go before we fully implement FSMA, but we have the platform on which to build and I am confident that we are up to the task at hand.

During the conference, Secretary of Agriculture Tom Vilsac, CDC Director Thomas Frieden, and FDA Commissioner Margaret Hamburg highlighted the work of their respective agencies in addressing nutrition and food safety issues. They each echoed the importance of food safety and the public imperative for stakeholders to work together to optimize the safety and nutritional adequacy of our food supply.

Dr. Hamburg started her speech with, “Will Rogers liked to say that most political promises are about as solid as applesauce… (and FDA regulates applesauce!)  But some promises are just too important not to keep… like the promise that our food supply will be safe for every American.”

Each of us has a stake in bringing this promise to life.  The National Food Policy Forum was a terrific opportunity to be inspired, to strengthen our resolve, and to keep the stakeholder momentum moving ever forward.

Camille Brewer
Acting Deputy Director for Regulatory Affairs, Center for Food Safety and Applied Nutrition
Senior Advisor for International Affairs, Office of Foods, Office of the Commissioner
U.S. Food and Drug Administration.


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