After the Department of Veterans Affairs sent an email to all employees mandating that all its health care personnel receive the COVID-19 shots, the Department of Justice (DOJ) issued an absurd Memorandum Opinion (memo) that completely ignores the law.
FDA must ensure that recipients of the vaccine under an EUA are informed, to the extent practicable given the applicable circumstances, that FDA has authorized the emergency use of the vaccine, of the known and potential benefits and risks, the extent to which such benefits and risks are unknown, that they have the option to accept or refuse the vaccine, and of any available alternatives to the product. Typically, this information is communicated in a patient “fact sheet.” The FDA posts these fact sheets on our website. (Addded, B. Jones, Tampa Dispatch)
On July 27, 2021, the DOJ’s Office of Legal Counsel issued a memorandum purporting to outline the legality of the federal government and private employers, educational institutions, and other entities mandating individuals to receive the COVID-19 shots as a condition of employment, education, participation, or use of services. However, the memo, “Whether Section 564 of the Food, Drug, and Cosmetic Act Prohibits Entities from Requiring the Use of a Vaccine Subject to an Emergency Use Authorization,” clearly contradicts the law.
None of the COVID shots are approved or licensed by the FDA. They come under the Emergency Use Authorization (EUA), which means they cannot be forced or required. On page 1 of the DOJ memo, and many times thereafter, the DOJ correctly states that Section 564 of the federal law directs the FDA “to the extent practicable” and as the FDA “finds necessary or appropriate … to impose ‘[a]appropriate’ conditions on each EUA” Section 564 of Food, Drug, and Cosmetics Act (FDCA), 21 U.S.C. §360bbb-3. The memo continues: “Some of these conditions are designed to ensure that recipients of the product are ‘informed’ of certain things, including ‘the option to accept or refuse administration of the product’” (emphasis added).
The memo also states on page 1 that since December 2020, the FDA granted EUAs for COVID shots. “In each of these authorizations, FDA imposed the ‘option to accept or refuse’ condition.” The memo then correctly notes that the FDA Fact Sheet states, “It is your choice to receive or not receive” the COVID shots (emphasis added).
Despite this clear “option to accept or refuse” language, and despite admitting the FDA has publicly affirmed this “option to accept or refuse,” the DOJ memo says it does not mean you have the option to refuse. The “option to accept or refuse,” the DOJ asserts, is met merely by telling people they have the “option to accept or refuse,” and, once told, people can be forced to take these shots. This is akin to interpreting the Miranda Rights to mean once you have been told “You have the option to remain silent,” then you can be forced to talk! This is absurd.
On March 27, 2020, the Health and Human Services (HHS) secretary declared that circumstances exist justifying the authorization of emergency use (EUA) of drugs and biological products for COVID-19. That means people must be told the risks and benefits and they have the right to decline a medication that is not fully licensed. The same section of the Federal Food, Drug, and Cosmetic Act that authorizes the FDA to grant EUA also requires the secretary of Health and Human Services to “ensure that individuals to whom the product is administered are informed … of the option to accept or refuse administration of the product.”
The EUA statute provides that as a condition of receiving authorization governing “the emergency use of an unapproved product,” one requirement is that “individuals to whom the product is administered are informed…of the option to accept or refuse administration of the product, of the consequences, if any, of refusing administration of the product, and of the alternatives to the product that are available and of their benefits and risks” (emphasis added).
The DOJ’s analysis in its memo is fundamentally flawed and the EUA provision cannot be read to permit the government or private entities to mandate an experimental product approved merely for emergency use. In fact, the memorandum even admits multiple times that the EUA law and the FDA require the “option to accept or refuse.”
This memorandum outlines some of the admissions that the DOJ makes and then proceeds to analyze the reasons the analysis is fundamentally flawed in legal terms. The first important admission is, “For the three COVID-19 vaccines, FDA implemented the ‘option to accept or refuse’ condition described in section 564.” Thus, though not required under the statute, the FDA did make the COVID EUAs subject to the option to refuse provision of the U.S. Code. The second admission is that it says the Fact Sheet expressly states you have the “option to accept or refuse.”
In addition, the FDA includes the Nuremberg Code and the Declaration of Helsinki on its website, emphasizing the fact that people cannot be forced to take experimental drugs without their full consent.
The DOJ memo also admits that it did not take into consideration and other federal, state, or local laws that may provide protection for people to refuse the COVID shots.
Liberty Counsel Founder and Chairman Mat Staver said, “The Department of Justice memorandum states that the ‘option to accept or refuse’ does not mean you have the option to refuse the COVID shots. That is absurd. Under the federal Emergency Use Authorization law, these shots cannot be mandated or administered without the free and full consent of the individual. In addition to the plain language of the EUA law and the FDA, employees and students have rights under state and federal laws, including the First Amendment Free Exercise Clause, to refuse injecting a drug into their bodies. It is shocking that the DOJ intentionally deceived the public with its lawless, result-oriented memorandum. We will not allow the law and the people to be trampled by employers, schools or this administration.”