Nutrition Health Alliance

Nutrition Health Alliance

Parties in the case

Nutrition health alliance is the plaintiff in this case appealing from a judgment made on 15thNovember 2000 by US district court. This is because of the court denying the motion of NHA for summary judgment and granting the defendants cross motion. The defendant on this case is the Food and drug administration (FDA) and the secretary of health and human services. The issue is whether the FDA has the authority from the Congress to regulate packaging of solid dosage dietary supplements and drugs for the reason of poison prevention.

NHA is a dietary supplement manufacturer that is attempting to contest FDA dosage unit regulations for packaging enforcement. The promulgated regulations by FDA required that, the manufactures of drugs and dietary supplements to be distributing products of 30 or more milligrams of iron per dosage unit, in unit dose package. FDA decided to promulgate the regulations so that to decrease the number of child death caused by iron products. NHA has filed a complaint where they were seeking a declaration that the regulations are not valid and have no legal effect or force. They also want a permanent injunction that bars the defendants from enforcing the regulations. NHA claim based on the fact that FDA did not have statutory authority of promulgating and enforcing of poison prevention packaging regulations.

Why was the lawsuit filed?

The lawsuit filed was because the dietary supplement manufactures believed that FDA had gone beyond their scope. This is when they created a regulation on poison prevention packaging, which is not construe under the statute. The dietary supplement manufactures are claiming that the original statute is broad, and it should be narrowly construed. According to NHA, FDA had no authority under the act of issuing and enforcing the regulation for the purpose of poison prevention. This regulation issued in response to the problem of acute iron poisoning that involved death of children below the age of 6 years. The death attributed to overdose of products that contained iron. According to FDA, they explained that they considered the regulations in the attempt of reducing the risk of accidental iron poisoning to young children. It is after FDA made the final rule on the regulation that NHA decided to file complaints. FDA had determined that having individual dosed packaging would help in limiting the number of capsules or the tablets, which the children would consume in case they accidentally gained access to the product.

The role of FDA and policy consideration

The role of FDA was to make sure that there was safety and that the pills would be unadulterated. This means that they would not be contaminated with one another. FDA has the authority of regulating drugs, food, and dietary supplement products (Hartsfield, D, Moulton, D, & Mackie, L. 2007). This is to make sure for the health and safety of the public. FDA assumes the role of making sure it protect the public’s health through assuring that food properly labeled, vaccines and human drugs and medical devices intended for use by human are effective and safe (Harrington, E. 2010). The administration also assures that dietary supplement and cosmetics properly labeled and safe. It also helps the public to get the accurate science based information that they need to use in food and medicine to improve health.  When implementing the regulation, FDA aimed at protecting the lives of children who were dying below the age of 6 years. The policy consideration for the regulation based on safety. The policy based on food, drug, and cosmetic act 21USC section 301. This is the act that has the condition that pertains to packing not injurious to health. This act aims at protecting the health of the public.

Proper resolution

In the resolution of the case, the court reversed and remanded the motion. They returned the case back to the district court because it felt that the conclusion of FDA far beyond the scope and it was also doubtful. This was a correct resolution because the reliance of FDA on the authority that it had to protect against adulterated products misplaced. This was because the public health risk that FDA was seeking to address with the regulation was not similar to the adulterated risks. It is right if FDA would not win the case and the regulation be removed because there argument was not logical. They argued that protective packaging is adulterant. This is not a logical argument because do not cause deleterious change to product. The product that contains iron is not subject to contamination either with packaging or without packaging. It would be best if the regulation established by FDA cancelled as they did not have evidence that would support their arguments. FDA claimed that they had prescribed the unit dose packaging based on the finding that, using other types of packaging would cause deleterious change in the product containing iron.


Hall, M. (2003). The scope and limits of public health law. Perspectives in Biology and Medicine 46 (3)

Harrington, E. (2010). The Health Insurance Reform Debate. Journal of Risk & Insurance, 77(1), 5-38

Hartsfield, D, Moulton, D, & Mackie, L. (2007). A Review of Model Public Health Laws. American Journal of Public Health, 97 p 56-S61

Open Jurist 318 F. 3d 92 -Nutritional Health Alliance v. Food and Drug Administration. Retrieved on 19th November 2012 from

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