The Food Safety Modernization Act: How Effective Is It in 2023?

Food safety is a major concern globally. In some countries, the effects aren’t even tracked sufficiently well to illustrate how dangerous foodborne illnesses can be. In the US, more than 3000 people die from these problems every year, and many more suffer illnesses and become hospitalized. 


Because of these problems, national administrations have struggled to come up with standards that can cover the range of problems that might occur. Following the terrorist attacks of 2001, the US government developed the Public Health Security and  Bioterrorism Preparedness Response Act, which gave the government detention authority over potentially harmful food.


The precise points of what would become the law went through a number of different iterations in Congress before finally becoming law. In 2011, then-President Barack Obama developed the Food Safety Modernization Act. This article will provide an overview of the act and provide a brief assessment of its effectiveness over the last 12 years.


What is the FSMA?


The Food Safety Modernization Act is part of the Food and Drug Administration. It was enacted in 2011 for the purpose of providing methods of preventing food safety problems before they occur. It provided the basis for new authorities to enforce compliance with safety standards among all of the people involved in handling food at different levels. In addition to dealing with food that is produced and sold in the US, it also provides rules for handling imported food.


Although it was conceived in 2011, the FSMA did not finalize all of its details until 2015. Rules had different dates associated with them for compliance, with some sections only having gone into effect as late as 2018. 


Components of the FSMA


The FSMA consists of seven major components related to the prevention of foodborne illness and the punishment of regulation violations.


Food facility preventive control


All food facilities are required to come up with a plan for preventive controls. This includes assessing any hazards within the facility that could have an impact on food safety. In addition, facilities are required to list preventive measures that will be implemented to keep these hazards to a minimum. Plans must include monitoring mechanisms, and means for addressing any issues that might arise in the facility.


Produce safety standards


The FSMA established criteria for the FDA to follow regarding the safety of fruit and vegetable production. These criteria include such things as soil components, as well as conditions to be established during the production process. Conditions include hygienic standards, specifications for packaging, temperature restrictions, as well as the potential for animals that might exist both in the water and in the surrounding area.


Preventing intentional contamination

As there is a continued risk of intentional contamination, the FDA is tasked with developing strategies for protecting the food supply chain and particular points that are known to be vulnerable to contamination. Strategies are to be specific and based upon scientifically proven methods.


Sanitary transportation


Food is to be kept safe from contamination while it is being transported from one place to another. Sub-components of this rule apply to the design and maintenance of transportation equipment, as well as the vehicles used for shipment. It also specifies training requirements for carrier personnel and requires documentation that the training has taken place.


This rule applies to all parties involved in the transportation process, including shippers, loaders, carriers of different types of vehicles, as well as people who receive the food products at their delivery points.

Regular inspections


All food facilities are to undergo inspections on a regular basis. The frequency of the inspections will depend on the level of risk present in any given facility. Newly-opened domestic facilities must be inspected within five years of opening, and every three years after the first inspection. Foreign facilities are to be inspected in increasing numbers over the course of several years.

Record keeping

Food facilities must keep records of safety plans and their implementation, and they must make these records available to the FDA upon inspection.

Accredited laboratory testing


All laboratories must be accredited by the FDA to ensure that food testing meets certain standards. 


Consequences for non-compliance


The FSMA was designed in such a way as to make it clear that consequences for non-compliance are serious. Some of the things that could arise include the following:


  1. The FDA is authorized to order an administrative detention if there is sufficient evidence to indicate a health threat at a given facility.
  2. The FDA has the right to undertake a seizure of a food item if that item poses a clear health threat to consumers.
  3. The FDA is tasked with issuing warning letters in the case of violations of food safety rules. These letters are made public so that both producers and the general public are aware of the potential risks.
  4. In the event that a warning letter is issued, companies have 15 days to respond to it and resolve any issues. After this time, there will be a second inspection. The FDA has the right to collect fees that are commensurate with the costs of re inspection.
  5. The FDA has established an “extended audit and security” mechanism whereby a company that has undergone a recall is subject to closer monitoring for a particular period following the recall.
  6. If a company has problems serious enough that it is considered to pose a major health risk to consumers, the FDA has the right to suspend its registration and potentially shut the facility down. While this regulation always existed in some form, the FSMA has given the FDA powers to act more quickly and with fewer direct causes than before.


How effective is the FSMA?


Given all these new regulations, the next natural question is how effective they are in reality. Studies show that the results are complicated. There are arguments both for and against its effectiveness.




While FSMA enforcement has resulted in a greater number of recalls and penalties for producers who violate the rules, there are also factors pushing in the opposite direction. This has made the program’s effectiveness significantly slower than originally hoped.


First of all, the food industry as a whole has grown increasingly complicated in recent years. The supply chain of food producers, packagers, and shippers is growing increasingly large and more complex every year, and this makes rule enforcement much more difficult. 


At the same time, people’s expectations for fast and efficient delivery are higher than they used to be. So there is more pressure on the food industry to produce and get things out quickly in order to meet consumer demand. 


There is also the argument that offices like the FDA in general have never been particularly effective because they don’t receive sufficient funding or enough staff to sufficiently fulfill their mandates. 


Positive Developments


One of the main arguments given by continued proponents of the system is that it is perfectly normal for something as complex as the FSMA to develop slowly. Because there are so many parties involved and potential for problems on different levels, they contend, there is no way that all of its elements will simply fall into place. Rather, the results will become clear over the course of time.


Also, there have been clear indicators of the program’s effectiveness in some areas. Over the last year, in fact, the number of items recalled as a result of the program implementation increased by over 700%


Last year, the biggest single item recalled was baby formula, which caused a national outcry when it was discovered that formula produced in Abbott Laboratories caused bacterial infections in infants. This led to a massive recall, and many mothers temporarily found themselves without a sufficient supply of baby formula. 


Another big recall that took place in 2022 was peanut butter produced by the popular company JM Smucker’s. The peanut butter started being recalled when it was found that it posed a risk of salmonella poisoning. 


These are just two examples of the work being carried out through the FSMA. There are surely other cases that are more difficult to manage for different reasons, but it does, in fact, look as if the enforcement of the rules is on the increase.




Areas such as food safety are always complicated in every society. Even with strict control measures in place, there will continue to be incidents in which foodborne illnesses cause health problems among populations. However, enacting laws such as the FSMA are making improvements in the public health situation in the US. The question is, will the situation continue to become steadily better, or will new challenges arise that grow faster than the system is able to handle them? The coming decades will determine the answer to this.


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