FDA WARNING_LETTER - Spirochaete Research Labs, LLC aka Scitus Laboratory Products - March 08, 2024

The FDA issued a Warning Letter to Mr. Ritter concerning the distribution of "ATOMIC RHINO -(SMELLING SALTS)-," "RED LINE ATOMIC RHINO -(SMELLING SALTS)-," "MEGATON ATOMIC RHINO -(SMELLING SALTS)-," and "MEGATON RED LINE ATOMIC RHINO -(SMELLING SALTS)-" drug products.

These products are deemed unapproved new drugs under section 505(a) of the FD&C Act, 21 U.S.C. 355(a), and misbranded under section 502(ee) of the FD&C Act, 21 U.S.C. 352(ee). The FDA cited claims from the company's website and social media, indicating the products are intended as stimulant drug products for uses such as providing "explosive energy and focus" and "waking up when tired."

The products, containing ammonium chloride, ammonium hydroxide, sodium polyacrylate, and/or sodium carbonate, are considered reflex stimulants. A 2008 FDA proposed rule (73 FR 34895) determined that ammonia and other ammonia ingredients used as reflex stimulants are not Generally Recognized as Safe and Effective (GRASE) or are misbranded. Therefore, these products are deemed new drugs requiring an approved application under section 505 of the FD&C Act since