FDA has warned consumers not to use two products containing ammonia chloride, “Nose Slap and Soul Slap products, which are unapproved drugs marketed to promote alertness and boost energy.” The Agency says, “Inhaling ammonia can quickly lead to eye, nose, and throat irritation; coughing; and airway constriction” and it “has received reports of adverse events such as shortness of breath, seizures, migraines, vomiting, diarrhea, and fainting from consumers after using the Nose Slap or Soul Slap products.” (see FDA notice here).
The FDA also issued a warning letter to the internet marketer of these products (here) informing them that they are marketing an unapproved new drug for the treatment of alertness and energy. The letter outlines FDA’s view that the two products are “drugs as defined by section 201(g)(1)(B) of the FD&C Act, 21 U.S.C. 321(g)(1)(B), because they are intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease and/or under section 201(g)(1)(C) of the FD&C Act, 21 U.S.C. 321(g)(1)(C), because they are intended to affect the structure or any function of the body. Specifically, these products are intended for use as stimulant drug products.”
The warning letter further explains how ammonia was not generally recognized as safe and effective (GRASE) saying:
“The term “smelling salt” typically is used to refer to an ammonia aromatic preparation used as a reflex stimulant. On June 19, 2008, FDA issued a proposed rule (73 FR 34895) setting forth a determination that ammonia and any other ammonia ingredient in a drug product that is labeled with claims or directions for use as a reflex stimulant are not GRASE or are misbranded.”
The Agency discusses the OTC monograph M011 for stimulant drugs and notes: “In particular, stimulant drug products are deemed to be GRASE and not a “new drug” if, among other things, they conform to the conditions of use set forth in the Over-the-Counter Monograph, M011: Stimulant Drug Products for Over-the-Counter Human Use (hereinafter M011). However, your “NOSE SLAP” and “SOUL SLAP” stimulant drug products do not conform to the conditions of use specified in Monograph M011 because your products are formulated with the active ingredient ammonium chloride and labeled with directions for intranasal administration, neither of which are covered under the deemed final order.”
The FDA appears to be further ramping up their efforts to tackle the marketing of unapproved new drugs as well as illegal dietary supplement and dietary supplement that contain undeclared drug substances. We expect the Agency’s effort to continue, and we may even expect some action by Congress to aid the FDA battle against the marketing of unapproved new drug products.
