Novid Group, Inc.

Selected passages from the FDA letter

Quoted FDA text from the published dataset. These selected excerpts are not the complete letter.

Passage 1

novid NASAL SPRAY is an unapproved new drug introduced or delivered for introduction into interstate commerce in violation of section 505(a) of the Federal Food, Drug, & Cosmetic Act (FD&C Act,) 21 U.S.C. 355(a) and is misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee).

Passage 2

novid NASAL SPRAY is neither formulated, nor labeled in conformance with M012. For example, novid NASAL SPRAY’s labeled active ingredients (i.e., sodium chloride and organic fulvic acids) do not comply with M012. Specifically, sodium chloride and organic fulvic acids are not permitted active ingredients under M012 when used in combination, or as sole ingredients, for any OTC antihistamine or nasal decongestant drug product.

Passage 3

the labeling for novid NASAL SPRAY includes intended use claims that are not permitted under M012. For example, the labeling for your drug product states that novid NASAL SPRAY, “…fights and defends where viruses and bacteria attack,” provides “…individual protection from catching colds or other viral infections when in a large crowd or in close contact with potentially infected individuals,” and that, “If you know that you are going to be in a large crowd, you can use Novid™ nasal spray prior to exposure and afterwards to provide some personal protection.” Such claims that suggest novid NASAL SPRAY protects and/or prevents consumers from getting sick are not permitted under M012.

Passage 4

the labeling for novid NASAL SPRAY also includes additional intended use claims that are not permitted under M012, such as “The only nasal spray that is effective in reducing inflammation,” “Novid™ is formulated with a patented ingredient, Fulvic Gold, which enhances the immune-enhancing activity of the nasal spray,” and your product contains “…a safe and effective ingredient that augments our immune cellular activity.”