“For FDA to issue an EUA (Emergency Use Authorization), there must be no adequate, approved, and available alternative to the candidate product for diagnosing, preventing, or treating the disease or condition. A potential alternative product may be considered “unavailable” if there are insufficient supplies of the approved alternative to fully meet the emergency need. A potential alternative product may be considered “inadequate” if, for example, there are contraindicating data for special circumstances or populations (e.g., children, immunocompromised individuals, or individuals with a drug allergy), if a dosage form of an approved product is inappropriate for use in a special population (e.g., a tablet for individuals who cannot swallow pills), or if the agent is or may be resistant to approved and available alternative products.”
Emergency Use Authorization of Medical Products and Related Authorities
And here we go again… another effective remedy to bite the dust…
Amazon is removing NAC-containing dietary supplements from its website following an FDA ban. NAC (N-acetyl-L-cysteine) a precursor of the antioxidant glutathione was originally approved as inhaled drug in 1963. It is used as treatment in poisoning cases to prevent severe liver damage to this day. NAC is widely used in dietary supplements for years, with 1,468 products containing NAC according to the Dietary Supplement Label Database from the NIH’s Office of Dietary Supplements.
According to data provided by SPINS to NutraIngredients-USA, sales of NAC-containing products grow year-on-year, totalling $5.68 million in 2020, a 32% increase from $4.31 million in 2019.
FDA was surely aware of the ingredient being on the market in supplement form for decades, so why now? In the warning letter to Wilmington, NC-based Happy Hour Vitamins, the Agency stated:
“FDA has concluded that NAC products are excluded from the dietary supplement definition under section 201(ff)(3)(B)(i) of the Act [21 U.S.C. § 321(ff)(3)(B)(i)]. Under this provision, if an article (such as NAC) has been approved as a new drug under section 505 of the Act [21 U.S.C. § 355], then products containing that article are outside the definition of a dietary supplement, unless before such approval that article was marketed as a dietary supplement or as a food. NAC was approved as a new drug under section 505 of the Act [21 U.S.C. § 355] on September 14, 1963. FDA is not aware of any evidence that NAC was marketed as a dietary supplement or as a food prior to that date.”
How NAC can help with COVID19 Short version
Dear Racoon Medicine,
When YouTube was sold to the Facebook mob, I immediately stopped using YouTube.
DO you have any other sites that Your Videos are shown on?
Thank you,
Deirdre