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Taking A Bite Out of FSMA Compliance: How Upcoming Regulations Will Affect Food and Supplement Manufacturers

Category: Educational Articles

On January 4th 2011, the former President of the United States, Barack Obama, signed into law one of the most innovative and comprehensive revisions to food safety in almost eighty years. The Food Safety and Modernization Act (FSMA) represents a floor to ceiling remodel of how the FDA will approach and regulate food safety practices. This new set of regulations has already started to go into effect, and implementation will continue through 2019.[1]

Coupled with the need to protect America’s food source from potential bioterrorism, part of the reason for the introduction of FSMA was the spike in number and severity of food-borne illness outbreaks in the early 2000s. For example, in 2006 contaminated organic spinach let to the death of 3 people and sickened more than 200 others.  In 2007, contaminated peanut butter sickened more than 600 people; and, in 2008, imported peppers sickened more than 1400 people. In 2009, what could be the most horrific incident in recent history occurred when the Peanut Corporation of America shipped product that tested positive for salmonella, but passed a re-test.  They performed no investigation and did not clean the facility after the results were reported.  This contamination killed 8 people and sickened more than 500 others in 43 different states[2]. The FDA estimates that nearly 1 in 6 people in the USA will get sick this year from foodborne diseases.[3]

The changes posed in the new laws will affect not only traditional food companies, but supplement manufacturers as well. Are you and your team prepared for the upcoming changes?

There are several key ways that the FSMA will affect companies and further empower the FDA.

  1. The idea of proactive rather than reactive contamination efforts.

The FSMA grants the FDA the ability to conduct more thorough prevention-based efforts., requiring companies to put proactive, risked-based, prevention plans in place. For every manufactured product, the company must evaluate hazards, develop a written hazard analysis, validate and monitor preventative controls, and take necessary corrective actions.

  1. Mandatory recall authority.

For the first time, the FDA will be able to mandate companies recall products deemed unsafe. This provision will give the government real “claws” to tackle with potentially serious pathogen outbreaks. 

  1. Tougher importation food safety standards.

All importers now have a stated responsibility to ensure that foreign suppliers have adequate food controls in place. There are several other certifications that will impact quality control for high risk foods. If these requirements are not met, the FDA can block entry of these consumables.

  1. Increased ability to conduct inspections and assure compliance.

To help fulfill this portion of FSMA, the FDA is looking to hire hundreds of additional personnel. These staff members will have an enhanced ability to check-up on manufacturers and sign off on compliance measures.

  1. Increased cooperation between inter-governmental departments.

Washington is pushing for better collaboration between its governing bodies. This means that food safety issues may now be handled and shared between previously separate entities.

In addition to these five changes, the FMSA will also call for food safety plans, food defense plans, biennial registration with the FDA, and a reportable food registry.

Supplement manufacturers must be prepared for these coming changes. Compliance with new FSMA standards is already happening at companies like Deerland Enzymes and Probiotics. Learn more about what you need to do comply here.


About The Expert
Hope Hanley
Vice President of Quality & Regulatory Affairs, Deerland Enzymes & Probiotics

Hope has more than 10 years of experience as VP of Quality and Regulatory Affairs with Deerland Enzymes & Probiotics.

Hope Hanley

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