Federal court enjoins New Jersey company from distributing unapproved COVID-19 treatment

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Federal court enjoins New Jersey company from distributing unapproved COVID-19 treatment

Luke Torrance | U. Pittsburgh School of Law, US

December 29, 2021 05:00:43 pm

The United States District Court for the District of New Jersey ordered a company and ints principals to cease distribution of a product touted as a COVID-19 treatment on Tuesday, according to the Department of Justice (DOJ), because the product was misbranded and unapproved.

The DOJ said that the company Natural Solutions Foundation and its trustees, Ralph Fucetola and Dr. Rima Laibow, agreed to settle a lawsuit against it and be bound by a consent decree imposing a permanent injunction. In a complaint filed at the request of the US Food and Drug Administration (FDA) last month, the DOJ alleged that Natural Solutions Foundation and its two principals violated the Federal Food, Drug, and Cosmetic Act (FDCA). The complaint alleged that Fucetola and Dr. Laibow had introduced a new COVID-19 drug into interstate commerce without gaining approval, and that the drug had been misbranded under the act.

According to the complaint, Natural Food Solutions distributed a “nano-silver” product that it claimed would help prevent, treat and cure COVID-19. These drugs, which purportedly contained silver particles in a solution, were marketed through several websites with names like drrimatruthreports.com and truthaboutcoronavrius.com and were sold starting in January 2020. But the DOJ argued that such solutions are not generally recognized as safe or effective by qualified experts. Further, the DOJ stated that the company’s claims were not backed by sufficient, credible scientific evidence and that they were mislabeled as drugs because their labeling failed to bear adequate directions for use, as required by the FDCA.

Acting Deputy Director Greg Noonan of the FDA’s Office of Dietary Supplement Programs said in a statement that “[t]he FDA will continue to aggressively pursue and hold accountable those who jeopardize public health.” Noonan also applauded the outcome of this case, saying that the “consent decree demonstrates that [the DOJ] will use all of [its] authority to stop companies that prey on the public during a global pandemic by selling unapproved new drugs.”

The consent decree permanently enjoins Natural Food Solutions, Fucetola and Dr. Laibow from committing further FDCA violations and requires it to submit a recall plan to the FDA by January 2 for the “nano-silver” product. Once the FDA approves, they will have 22 days to complete the recall. They must then destroy any nano-silver products in their possession under the FDA’s supervision.

Natural Food Solutions, Fucetola and Dr. Laibow must also give the FDA advance notice if they plan to distribute any drugs in the future and must continue to allow the FDA to inspect their procedures and facilities.

Martin Luther King Jr. wrote his Letter from Birmingham Jail

On April 16, 1963, an incarcerated Martin Luther King, Jr. (arrested for demonstrating in defiance of a court order) wrote his Letter from Birmingham Jail in response to a published statement by eight fellow clergymen from Alabama.

Part of the letter read: We have waited for more than 340 years for our constitutional and God-given rights. The nations of Asia and Africa are moving with jetlike speed toward gaining political independence, but we stiff creep at horse-and-buggy pace toward gaining a cup of coffee at a lunch counter. Perhaps it is easy for those who have never felt the stinging dark of segregation to say, "Wait." But when you have seen vicious mobs lynch your mothers and fathers at will and drown your sisters and brothers at whim; when you have seen hate-filled policemen curse, kick and even kill your black brothers and sisters; when you see the vast majority of your twenty million Negro brothers smothering in an airtight cage of poverty in the midst of an affluent society; when you suddenly find your tongue twisted and your speech stammering as you seek to explain to your six-year-old daughter why she can't go to the public amusement park that has just been advertised on television, and see tears welling up in her eyes when she is told that Funtown is closed to colored children, and see ominous clouds of inferiority beginning to form in her little mental sky, and see her beginning to distort her personality by developing an unconscious bitterness toward white people; when you have to concoct an answer for a five-year-old son who is asking: "Daddy, why do white people treat colored people so mean?"; when you take a cross-county drive and find it necessary to sleep night after night in the uncomfortable corners of your automobile because no motel will accept you; when you are humiliated day in and day out by nagging signs reading "white" and "colored"; when your first name becomes "nigger," your middle name becomes "boy" (however old you are) and your last name becomes "John," and your wife and mother are never given the respected title "Mrs."; when you are harried by day and haunted by night by the fact that you are a Negro, living constantly at tiptoe stance, never quite knowing what to expect next, and are plagued with inner fears and outer resentments; when you are forever fighting a degenerating sense of "nobodiness" then you will understand why we find it difficult to wait. There comes a time when the cup of endurance runs over, and men are no longer willing to be plunged into the abyss of despair. I hope, sirs, you can understand our legitimate and unavoidable impatience. Read the full text of the Letter.