News

Statement from FDA Associate Commissioner for Regulatory Affairs Melinda K. Plaisier
4/25/19

Voluntary recalls are one of the most important safety tools overseen by the U.S. Food and Drug Administration. They are a vital means to protect public health and typically are the quickest way to remove defective or potentially harmful food, medical, and consumer products from the market. The FDA plays an important role in the recall process, closely overseeing FDA-regulated companies during their voluntary recalls to help ensure public health is protected.  

But our work doesn’t stop there. When it comes to recalls and how quickly they are executed, consumers depend on the FDA to protect their health and we work quickly because it could minimize consumer exposure to a health risk and prevent consumers from being injured. We know that in order for a recall to be effective and timely, it’s crucial that companies be prepared in advance to ...read more...


FDA takes steps to improve ice cream production facility safety
4/24/19

FDA In Brief: FDA takes steps to improve ice cream production facility safety following inspections and environmental sampling effortsThe U.S. Food and Drug Administration today released a report on its findings from inspections and environmental sampling for Listeria monocytogenes and Salmonella at 89 ice cream production facilities in 32 states from Sept. 12, 2016 to Aug. 30, 2017. The agency began the sampling assignment following 16 recalls of ice cream products that occurred from 2013 to 2015 due to the presence of pathogens, and an outbreak of listeriosis linked to an ice cream maker in 2015 that involved three deaths. To read more….


FDA Announces Intentional Adulteration Inspections to Begin March 2020
4/17/19

The U.S. Food and Drug Administration announced during a public meeting that routine inspections to verify compliance with the Intentional Adulteration (IA) rule will begin in March 2020.

The FSMA final rule on intentional adulteration is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause wide-spread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires the food industry to implement risk-reducing strategies for processes in food facilities that are significantly vulnerable to intentional adulteration.

Food facilities covered by the rule will be required to develop and implement a food defense plan that identifies vulnerabilities and mitigation strategies for those vulnerabilities. These facilities will then be required to ensure that the mitigation strategies are working. The first compliance date arrives in July 2019.

FDA has heard from stakeholders that due to the novel nature of the IA rule and its requirements, they believe more time is needed to develop a fully compliant food defense plan. We are working hard to provide resources, including the final portion of draft guidance, which may be helpful to industry. To allow industry time with the forthcoming materials, tools, and trainings, and because the IA rule represents new regulatory territory for all of us, we will be starting routine IA rule inspections in March 2020.

Keeping the compliance dates ensures industry will put in place measures that protect public health while FDA makes additional guidance and resources available. More information about the upcoming compliance date, the recently released draft guidance, and other resources is available in an updated conversation piece featuring FDA food defense experts Ryan Newkirk and Jon Woody.

For More Information

Protecting the Food Supply from Intentional Adulteration, Such as Acts of Terrorism

Constituent Update: FDA Publishes Second Installment of Intentional Adulteration Draft Guidance

Draft Guidance for Industry: Mitigation Strategies to Protect Food Against Intentional Adulteration

FSMA Final Rule on Intentional Adulteration


FDA proposes updated standards for fluoride
4/2/19

FDA proposes updated standards for fluoride added to bottled water to maximize health benefits while avoiding excess exposure. 

The U.S. Food and Drug Administration today released a proposed rule, “Proposed Rule to Revise the Allowable Level of Fluoride in Bottled Water to which Fluoride Has Been Added,” to lower the allowable level of fluoride in bottled water to which fluoride is added by the manufacturer to 0.7 mg/L to be consistent with the 2015 recommendation by the U.S. Public Health Service (PHS) for community water systems that add fluoride for the prevention of dental caries. This action ensures that consumers receive its dental benefits while avoiding unintentional excess exposure.  To read more follow this link…. 

 


FDA Announces Produce Safety Rule Enforcement Discretion Policy for Certain Commodities
3/28/19

The FDA announced today that it intends to exercise enforcement discretion for the requirements of the Produce Safety Rule as they apply to entities growing, harvesting, packing, and holding wine grapes, hops, pulse crops, and almonds. 

  

The Produce Safety Rule establishes science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables for human consumption. The rule does not apply to produce that is considered to be rarely consumed raw (RCR), grown for personal or on-farm consumption, or not a raw agricultural commodity. Commodities considered to be RCR are those that the FDA has determined are typically cooked before consumption. Produce that is otherwise covered by the rule may still be eligible for an exemption if it undergoes commercial processing that adequately reduces the presence of pathogens and certain recordkeeping and documentation requirements are satisfied. 

  

After the Produce Safety Rule was finalized, FDA received feedback from stakeholders that wine grapes, hops, pulses, and almonds should be exempt. After conducting an initial review of the production and use of these commodities, FDA has decided to exercise enforcement discretion with respect to the Produce Safety Rule for entities growing, harvesting, packing, or holding these commodities, while we consider pursuing rulemaking to address the unique circumstances they each present. FDA will continue to enforce the statutory prohibition against introduction or delivery for introduction of adulterated food into interstate commerce.  

  

For more information 

•            FSMA Final Rule on Produce Safety

•            Guidance for Industry: Enforcement Policy for Entities Growing, Harvesting, Packing, or Holding Hops, Wine Grapes, Pulse Crops, and Almonds


FDA's food safety program for 2020 and beyond
3/19/19

Statement from FDA Commissioner Scott Gottlieb, M.D., and Deputy Commissioner Frank Yiannas on new steps to strengthen FDA’s food safety program for 2020 and beyond. To read more….

 


FDA Food Defense Updates
3/12/19

FDA recently published a revised draft guidance designed to support compliance with the Intentional Adulteration (IA) Rule under the FDA Food Safety Modernization Act (FSMA). This second installment adds to and incorporates elements of the previously published guidance. Most of the content from the first installment, published in June 2018, has not been changed in the second installment.  We have indicated new content, mostly located in Chapter Two, Chapter Eight, Appendix 1 and Appendix 4, with brackets stating, “[New March 2019] or [Updated March 2019].” The revised draft guidance, in its entirety, is intended to be a resource that will help the food industry implement the IA provisions in a flexible and cost-effective manner. Stakeholders will have until July 5, 2019 to provide comments on the entire first and second installments of the draft guidance.  In addition, a public meeting on this revised draft guidance is being planned and additional information will be made available in a forthcoming announcement.  To read more…..


USDA and FDA Announce a Formal Agreement to Regulate Cell-Cultured Food Products from Cell Lines of Livestock and Poultry
3/7/19

The U.S. Department of Agriculture’s (USDA) Food Safety and Inspection Service (FSIS) and the U.S. Department of Health and Human Services’ (HHS) Food and Drug Administration (FDA) today announced a formal agreement to jointly oversee the production of human food products derived from the cells of livestock and poultry. To read more…..


Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry
3/5/19

The U.S. Food and Drug Administration today released a revised draft guidance, “Mitigation Strategies to Protect Food Against Intentional Adulteration: Guidance for Industry,” to support compliance with the intentional adulteration (IA) rule set forth under the FDA Food Safety Modernization Act (FSMA). 

The IA rule is designed to address hazards that may be intentionally introduced to foods, including by acts of terrorism, with the intent to cause widespread harm to public health. Unlike the other FSMA rules that address specific foods or hazards, the IA rule requires certain facilities – both domestic facilities and foreign facilities that export to the U.S. – to develop and implement food defense plans that assesses their potential vulnerabilities to such acts of deliberate contamination.  To read more…


Tools to Build a Robust Environmental Monitoring Programs for Food Facilities
3/4/19

Date and Time: Monday, March 25, 2019 9:00 AM Eastern Time (US and Canada)

Description: This FREE 60-minute webinar will summarize the basic elements needed to build a robust environmental monitoring program to control environmental pathogens that could potentially contaminate foods. The webinar will review the most common tools to build, implement and test and environmental monitoring program. Participants will be able to submit questions during the registration. These questions will be addressed during the presentation. The webinar will be recorded and archived in a YouTube channel. 

Presenter: Omar A. Oyarzabal, University of Vermont Extension 

Don’t wait to register for this FREE webinar http://go.uvm.edu/emp