Food and Drug Regulation in the USA

Food and Drug Regulation in the USA

Every day across the United States, people purchase foods, groceries, eat out and prepare their families’ meals. It is expected that all food is safe, and the role of the FDA is to ensure food safety. The FDA has the authorization of ensuring the safety of the immeasurable range of foods eaten by the Americans, which is about 80% of all the foods that are sold in the Country. The food includes everything except the processed egg products, poultry, and meat that are controlled by the Department of Agriculture in the US. The FDA was given the mandate of developing an integrated and comprehensive FDA Food Protection Plan (Thomas, 2014). The plan was to make sure that the safety supply of the nation’s food from deliberate and unintended contamination. Inspired by the science and the modern technology, the Food Protection Plan aim is to identify the likely hazards and deal with them before they can harm human health. The center of such a progressive effort is the augmented focus on hazard prevention. The Food Protection Plan was developed to create safety measures that address the risks in the entire life cycle of a product, from the time a product is produced to its distribution and consumption. The plan directs the efforts of FDA on the prevention of problems and then applies interventions that are risk-based to make sure that the preventive approaches used are successful (Thomas, 2014). The plan requires a fast response as soon as there is a detection of contaminated food or products or when people or animals are harmed. The policy is a public/social health policy. The purpose analysis of the Food Protection Plan policy is to establish if the plan is effective in accomplishing preventing the problem of food poisoning. The analysis intends to answer the questions of the effectiveness of the policy in the prevention of food poisoning.


Changing demographics and consumption trends

The changing consumption and demographics have raised the susceptibility of consumers to food poisoning. It was approximated that 20% of the American people were 60 years or more (Halabi, 2015). The older people are usually at a higher risk of foodborne diseases. It thus indicates that due to changing demographics the number of susceptible consumers has increased and the factors of convenience mean that small problems can result in great outbreaks. Consequently, there is a need for changes to ensure a high degree of food protection.

Convenience trends

More Americans are now consumers of convenience foods. Foods that are prepared away from home are likely to be cross contaminated from the other foods and contaminated by the food workers (Halabi, 2015). With more Americans eating ready food, it means that vulnerability to foodborne diseases has increased.

The consumption patterns have changed with a large variety of food is eaten all year round. Besides, foods that are eaten raw or with little processing tend to be linked with foodborne diseases. The consumption of fresh fruits in the US has increased by about 36% since 2000 (Halabi, 2015).

Global food supply

The United States imports from over 150 nations. Based on research, about 15% of all the food distributed in the US is from imports. In other food types like fresh vegetables and fruits, a higher proportion is imported (Halabi, 2015). The imported food increases vulnerability to food poisoning due to the transporting conditions and the production conditions that may not meet the standards required by FDA. Whereas most importing countries have well-developed regulatory mechanisms to promote food safety, others have systems that are not well-developed to make sure the imported food is safe.

New threats

Currently, CDC is aware of over 200 foodborne pathogens. These are such as parasites, viruses, bacteria, toxins and potential contaminant of metal and chemicals. The different agents linked to food borne diseases have steadily increased, and it is likely that the list will continue increasing (Thomas, 2014). The emerging of new foodborne pathogens calls for updating of technology to detect their presence in different foods. Consequently, to address the problem of emerging pathogens, there is a need for partnership between the government, industry and research institutions to establish a solution.

Existing policy

The FDA has been responding fast enough to contain problems of food safety. However, while it has maintained that kind of response, it created the plan that was to enhance its response by developing safety into the products right from the production step to encounter the current problem (Thomas, 2014). In the Food Protection Plan policy, it proposes to partner with the private institutions in building on the activities of the food sector to promote food safety.


The policy will be useful in ensuring that the Americans continue benefiting from the safety supplies of food in the world. The food protection office will provide advice and guidelines on local and imported foods (Shames et al., 2015). The FPP will promote corporate responsibility to ensure that food problems do not happen in the first place. The FDA by reviewing the vulnerabilities in the food supply and developing and executing measures to reduce risks, it will be addressing critical weaknesses in food safety (Shames et al., 2015). In the intervention elements, the preventive measures are implemented correctly, ensuring that the existing food safety issues are addressed. The FPP will ensure speed and efficiency by responding to an emergency as soon as it is reported. Whether contamination is deliberate or unintended, fast response is important for the protection of the public.



Although the plan may be viewed as a constructive development, it needs some amendments. Questions have been released since it was released. For example, the Government Accountability Office has pointed weakness on the specifics of the implementation of the Plan. The Food Protection Plan is not clear in its implementation (Shames et al., 2015). The plan lacks details on its efficient targeting of resources in its implementation, budgetary constraints as well as its implementation timeline. Without enough details on the implementation, it is likely that the plan will not be properly implemented.



All people will be affected by the policy especially those who are highly vulnerable to foodborne pathogens like the young children, older adults, and pregnant women. These groups comprise of about 25% of the U.S population. The Food Protection Plan aims at making food safe for all the people through prevention of the likely hazards (Shames et al., 2015).

Food manufacturers

The FDA regulates over 130 registered local food facilities, which includes manufacturers, food processors, food warehouses, restaurants and institutional food establishments. The FDA also oversees the activities of supermarkets and grocery stores.


All the food importers are regulated by the FDA law ensuring that food imported meets the FDA guidelines.

Other Government and Nongovernment Institutions

The FDA in the implementation of the Food Protection Plan is partnering with the other institutions like the Agriculture departments, State Health departments, Universities. Also, the FDA has to work together with governments of the importing nations to ensure the imports meet the required safety standards in the USA.


Alternative policy

In responding to the events related to foodborne illnesses, the United States Congress passed legislation – the Food Safety Modernization Act. The law was meant to move the FDA focus for improved protection of public health by prevention instead of reacting to outbreaks. The FSMA is a large part of the law that was intended to create new practical central food safety system. FSMA changes the role of the FDA from being reactive to being preventive.

In the selection of the best policy between the Food Protection Plan policy and the FSMA, the effectiveness, goals, impacts of each will be measured.

FSMA evaluation


FSMA increases the safety requirements for the food industry and vests FDA with more power to enforce the requirements. Its wide scope affects almost all the food industry members such as importers, producers, manufacturers, distributors, and transporters. The law also requires the foreign suppliers to observe with the FSMA requirements, as it raises the authority of the FDA abroad (Humphrey, 2016). It is intended that the FSMA implementation will apply scientific and risk-based principles that consider the expertise of the existing food safety of the industry.

The effectiveness of the FSMA can be witnessed by the shift towards prevention, which is in the last rules, where the policy requires that all the food consumed in the USA observe the Hazard Analysis standards and Critical Control Points (Humphrey, 2016). Effectiveness is also in the requirement to farms to take certain measures in ensuring prevention of food safety hazards. The foreign suppliers are required to confirm that they have met the specified preventive requirements before their products being accepted in the US. The FDA has conducted frequent meetings with the stakeholders to educate them on FSMA and seek feedback (Humphrey, 2016). Such efforts of the FDA through the new law have proved to increase effectiveness in enhancing food safety in the country.

Problem solving

After a decade of diseases outbreaks, market disruptions and problems with imports’ safety that cost billions of dollars on the food system, the FSMA was developed to prevent problems rather than reacting to problems (Humphrey, 2016). In that manner, it is expected that food safety goals will be achieved.

Also check: Health Assessment