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Law and Public Health

Law and Public Health

Public health assurance requires an integrative approach that draws the government, communities, and other private stakeholders. One of the government’s strategies in assuring public health is formulating laws and policies that guide practices and tailoring them towards public health attainment. These laws define the functions and mission of the various public health functions and appropriate funding to various public health agencies (Punch & James, 2016). The significance of legal frameworks in public health functionality is evident in their increased effectiveness. This paper seeks to analyze a case involving the Nutritional Health Alliance and the Food and Drug Administration.

The parties involved in this case were the Nutritional Health Alliance, the Food and Drug Administration, and Donna Shalala., the then Secretary U.S. Department of Health and Human Services. The Nutritional Health Alliance was raising an issue on whether Congress had delegated the FDA regulatory authority on solid packaging dosage dietary supplements and drugs to prevent poisoning. The FDA had moved to promulgate regulations requiring drugs and dietary supplements containing more than 30 milligrams of iron to be packed as single-unit dosages to prevent apparent child poisoning. The NHA, in this case, was seeking an injunction that would prevent FDA from enforcing these regulations arguing that they did not have statutory authority to promulgate such poison prevention regulations. They also claimed that the already promulgated regulations were considered invalid and with freedom from legal force and effects.

On the other hand, the FDA argued that its actions were guided by provisions under the FDA act, which are domiciled in the constitution and require that it regulates dietary supplements and drugs for their safety. The FDA further supported their action with provisions from the law that required them to regulate substances that could cause injury to health by the imposition of the single-dose unit rule. This argument was further reinforced by the current good manufacturing practices provided by the law, which required products to maintain safety for their consumers and cause no harm.

This lawsuit was filed to seek a declaration that would consider the FDA regulation invalid and without legality, consequently enabling manufacturers to continue using multiple-dose packaging. The lawsuit also sought a permanent injunction that would prevent FDA from enforcing such regulations. The Nutritional Health Alliance filed the lawsuit. This association consisted of manufacturers and distributors of these dietary supplements and to whom these regulations would adversely affect.

The FDA is a regulatory agency that regulates food products and drugs. Its focus is to protect American public health by ensuring that whatever they consume or utilize is safe and effective. In this regard, it imposes regulations on food, drugs, medical devices, radiation-emitting products, cosmetics, vaccines, blood, biologics, and tobacco products (Cohen, 2018). In this case, FDA had the legal mandate to regulate dietary supplements that formed the basis of contention in the lawsuit. The law provides for the FDA regulatory frameworks and is clearly articulated in the constitution.

The various policy regulations that formed the central focus of this lawsuit, as argued by the FDA, are the authority to regulate dietary supplements and drugs for safety. This authority is granted to the FDA by a law enactment under the FDA Act. It gives several provisions for regulating consumables and ensuring their safety and effectiveness (Nguyen et al., 2019). The detrimental to health provisions stated under this act give the FDA the authority to regulate any substance they deem as having the potential to cause injury to public health. As in this case, the apparent child poisoning evident in multiple-dose containers for the iron-containing dietary supplement is bound for regulation by the FDA. Additionally, the provisions on good manufacturing practices that require manufacturers to ensure the safety of their products were also in contention. The FDA utilized this provision to argue its case, considering the potential harm these manufacturers posed to public health by using multiple-dose containers.

The Nutritional Health Alliance, on the other hand, the FDA’s action was outside their jurisdiction, and Congress transferred the issue under the subject matter to the Consumer Product Safety Act. They argue that this authority was vested in Consumer Product Safety Commission and not the FDA. This means that the FDA acted out of its legal jurisdiction, so their promulgation of this regulation should be invalidated. In resolving this case, the court agreed with the FDA. The court dismissed the NHA’s claim of jurisdictional transfer to the Consumer Product Safety Commission, articulating that this transfer did not eliminate the FDA’s regulation functionalities. The court also stated that the evidence proposed by the appellant did not indicate that Congress intended to entirely transfer these functionalities to this commission (Ozcan & Gurses, 2018). The FDA, in this regard, reserves the right to regulate container packaging of drugs and nutrient supplements upon determination of its potential harm to their consumers.

The facts presented by the FDA were unquestionable. There has been increasing evidence of acute iron poisoning and deaths among children aged six and below (Bateman et al., 2018). These incidences have been attributed to an accidental overdose of these iron-containing nutritional supplements and drugs. The appellant, in this case, did not dispute this fact but instead questioned their legal jurisdiction in handling these situations. The FDA court, by upholding FDA’s verdict on this issue, not only provided justice to the thousands of the victims that had been affected by this but as well prevented thousands of many other lives that would have been affected in the future. The role of the FDA is to ensure the safety and effectiveness of consumable products, is expected to maintain this mandate at all costs, as evident in the case.

Legal frameworks exist that guide public health practices and protect the public against apparent harm. The law mandates the FDA to ensure the consumption of only quality, safe, and effective consumable products. As in the case above, the FDA is expected to carry out its mandate of regulating products deemed potentially harmful to the public. The courts upheld the decision made by the FDA, reinforcing the collaborative approach to public health assurance by the various arms of the government.

References

Bateman, D., Eagling, V., Sandilands, E., Jackson, G., Crawford, C., & Hawkins, L. et al. (2018). Iron overdose epidemiology, clinical features, and iron concentration-effect relationships: the UK experience 2008–2017. Clinical Toxicology, 56(11), 1098-1106. https://doi.org/10.1080/15563650.2018.1455978

Cohen, P. (2018). The FDA and Adulterated Supplements—Dereliction of Duty. JAMA Network Open, 1(6), e183329. https://doi.org/10.1001/jamanetworkopen.2018.3329

Nguyen, H., Shenkar, J., & Griffiths, J. (2019). Industry self-regulatory activities complement FDA’s dietary supplement regulations. Nutraceutical And Functional Food Regulations In The United States And Around The World, 47-60. https://doi.org/10.1016/b978-0-12-816467-9.00004-6

Ozcan, P., & Gurses, K. (2018). Playing Cat and Mouse: Contests over Regulatory Categorization of Dietary Supplements in the United States. Academy Of Management Journal, 61(5), 1789-1820. https://doi.org/10.5465/amj.2015.1221

Punch, M., & James, S. (2016). Researching law enforcement and public health. Policing And Society, 27(3), 251-260. https://doi.org/10.1080/10439463.2016.1205066

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Question 


Law and Public Health

Case Assignment
Review Nutritional Health Alliance v. Food and Drug Administration, and answer the following:

  1. Who are the parties in the case and what are their respective interests?
  2. Why was the lawsuit filed?
  3. What is the role of the FDA and what were the policy considerations for the regulation that served as the central focus of the NHA case?
  4. What was/is the proper resolution of the ultimate issue/question?

Assignment Expectations

Law and Public Health

Law and Public Health

  • Length: Assignment should be from 3 pages (750 words) in length.
  • Assessment and Grading: Your paper will be assessed based on the performance assessment grading rubric that is linked within the course. Review it before you begin working on the assignment.

 

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