Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1your website www.safalab.com offers the product The Prevention 12 Pak—which you also refer to as the Coronavirus Prevention 12 Pak, and which consists of the products SOUL, CORE, Cellular Detox, Turb-O2, Vitamin C (Anti-Oxidant Assist), Vitamin D3 (Light Assist), Glutathione, Selenium, Zinc, Vitamin A, Melatonin, and Iod Assist (Iodine)—for sale in the United States and that this product is intended to mitigate, prevent, treat, diagnose, or cure COVID-19***1*** in people.
Passage 2Based on our review, this product is an unapproved new drug sold in violation of section 505(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), 21 U.S.C. § 355(a).
Passage 3Furthermore, this product is a misbranded drug under section 502 of the FD&C Act, 21 U.S.C. § 352.
Passage 4The introduction or delivery for introduction of this product into interstate commerce is prohibited under sections 301(a) and (d) of the FD&C Act, 21 U.S.C. § 331(a) and (d).
Passage 5The Prevention 12 PAK – We are all worried about the spread of the Coronavirus (COVID-19) which kills vulnerable people by Acute Respiratory Distress Syndrome (ARDS). The WHO and FDA claim that there is no cure and no prevention. Integrative medical doctors and their informed patients disagree. Here is the essential 12 Pak to buy for each of your family members and loved ones.
Passage 6Here are the Coronavirus 12 Pak items which you can bet your life on.
Passage 7Iodine, at appropriate dosages, kills all pathogens which infect the human body:viruses, bacteria, molds, fungi, yeasts and protozoa.
Passage 8[S]elenium is a potent anti-viral mineral. Selenium facilitates enzymatic processeswhich enhance immune response to viral infections.
Passage 9melatonin is also a powerful anti-viral agent ......This peer reviewed scientific articleis [sic] just one of many which demonstrates the anti-viral benefits of melatonin
Passage 10Melatonin has been found to inhibit the action of an inflammasome known as NLRP3 – one of the primary inflammasomes involved in the exaggerated immune response seen in critical Coronavirus cases.
Passage 11Melatonin plays an important role in your immune function. It has antioxidant and mitochondrial-protective functions, and has been shown to be effective against various bacterial and viral infections
Passage 12Vitamin D3 is an essential pro-hormone which can help you survive the Coronavirus. Studies show that taking vitamin D3 – the active form of vitamin D results in less severe respiratory infections and also required less antibiotic use.
Passage 13Glutathione is a powerful . . . anti-inflammatory agent which is tremendously valuable for people suffering from lung diseases and infections of the lung. The Coronavirus creates inflammation and what lowers native glutathione leading to further damage from inflammation. Once infected with the Coronavirus, you need glutathione . . .
Passage 14A competent medical doctor can rescue you if you are infected with the Coronavirus using intravenous infusion. . . But the minimum responsible protection which everyone should have stockpiled in his or her home is the Coronavirus Prevention 12 Pak available HERE from Safalab, Inc. for $568.
Passage 15PREVENTION PROTOCOL SOUL – take 1 packet first thing in the morning upon arising and one packet immediately before sleep CORE – take 1 packet right before breakfast and right before dinner – can mix in 8 oz cold water for taste Cellular Detox – take 10 drops under the tongue a day Turb-O2™ – take 1 dropper full in water or juice or on food a day AntiOxidant Assist (Vitamin C) 1000mg – take 1 three times a day Melatonin 60mg – take 1 tiny scoop mixed in water or juice a day Acetylglutathione – take 1 capsule take a day Vitamin D3 5000 IU – take 1 a day Methylselenocysteine 200 mcg – take 1 a day IodAssist (iodine/dide blend) – take 1 capsule a day Zinc Monomethionine and Citrate 30mg – take 1 a day A-25 (Vitamin A palmitate) 2500 IU – take 1 a day