Selected passages from the FDA letter
Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.
Passage 1Based on our review, “Biovanta Dual Action Throat Spray” and “Biovanta Triple Action Lozenges” are unapproved new drugs 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 2Furthermore, these products are misbranded drugs under section 502 of the FD&C Act, 21 U.S.C. § 352.
Passage 3“In conclusion, the scientific studies demonstrate that the active ingredients in Biovanta help reduce the inflammation that causes upper respiratory infections, including COVID-19, while leading brands, which are designed to mask symptoms, do more harm than good.”
Passage 4“Applied Biological Laboratories… launched Biovanta… Biovanta is proven superior to other leading products… in third-party, blind, placebo-controlled laboratory studies. The scientific publication titled ‘Rational drug design for sore throat – An aspirin-based treatment that addresses bradykinin-induced inflammation’ explains the studies in more detail. According to the publication, Biovanta modulates cytokines and strengthens the respiratory lining. Key inflammatory molecules studied include bradykinin, which is implicated in the cytokine storm associated with COVID-19 and other serious upper respiratory diseases… Applied Biological Laboratories Inc. is a New York based biotechnology company committed to the research, development, and manufacturing of drugs and therapies for respiratory diseases such as rhinovirus, influenza, coronavirus (including COVID-19), adenovirus, others.”
Passage 5“Just published the first scientific paper to finally address what works for sore throat, also to prevent a #BradykininStorm, treat #COVID_19 #COVID19 #SARSCoV2 symptoms and prevent #AntibioticResistance.”
Passage 6“Despite my best efforts of trying to avoid getting sick during this pandemic, three days ago I got diagnosed with COVID 19. I had all the symptoms. I had a fever, I had a sore throat. My friend recommended me this product when told them that I was quarantining. It’s called Biovanta. It’s all natural. I got it from my local CVS and it’s a two step spray. I immediately noticed that it just like cleared my airways and I could take a deep breath.”
Passage 7“More evidence that respiratory diseases should be treated in the nose and throat! https://lnkd.in/drSQX38N #biovanta #science #covid”
Passage 8“Study shows use of low-dose aspirin may prevent and shorten the duration of COVID-19 infection. More reasons to love our active ingredient. #science #covidー19 #innovation #health #aspirin #biovanta https://lnkd.in/eu3bm23K”
Passage 9“Hey guys, so despite my best efforts of trying to avoid getting sick during this pandemic… by the time I came home I just started feeling really bad, tired, with a sore throat… noticed a dry cough and a sore throat… fever, I had a sore throat, I had a body aches and chills. I’m so excited that I found this product called Biovanta. It’s all natural which is awesome. I started seeing results immediately. And they deliver a really strong, really fast effective relief. The next day I felt 100%. The recovery was quick. It is phenomenal. Probably gonna get more of these and send them to my family and friends. I hope everyone stays safe out there and if anyone else is sick, I hope you feel better soon.”