"FDA is concerned with the marketing of this over-the-counter drug for use by school children and others," said Steven K. Galson, M.D., M.P.H., director of FDAâs Center for Drug Evaluation and Research. "Over-the-counter (OTC) drugs are often widely used without supervision by a doctor or other health care professional, so it is essential that manufacturers obtain FDA approval or fully comply with OTC monographs and agency policies."
Under its OTC drug monograph system, FDA allows OTC drugs to be marketed without first obtaining agency approval in certain circumstances. These drugs must comply with applicable standards regarding monographs that specify conditions for the drugsâ labeling and formulation. OTC drugs that do not have FDA approval and do not meet these requirements are considered unapproved drugs that are unlawfully marketed.
There is a proposed OTC monograph that covers triclosan, the active ingredient in Early Defense. FDA allows companies to market their products (which would otherwise be unapproved new drugs) under proposed monographs, as long as the companies comply with the conditions in the proposed monograph. In this case, the product's claims that it prevents colds and provides up to three hours of antimicrobial activity are not allowed under the proposed monograph. Under the proposed monograph, when antimicrobial products use triclosan as their active ingredient, their labeling must direct consumers to rinse with water after use and Early Defense does not. Early Defense falls outside the proposed monograph and is considered an unapproved new drug because it lacks these directions and makes these impermissible claims.
FDA regards compliance with its approval and monograph requirements to be integral to drug safety. Without the foundation of compliance, it is not possible to ensure that consumers and the health care community are provided with established and emerging drug safety information so that they can make the best possible medical decisions about the safe and effective use of drugs.
Companies that do not resolve violations in FDA warning letters risk enforcement actions, such as injunctions against continuing violations and seizure of illegal products.For a copy of the warning letter, visit: http://www.fda.gov/foi/warning_letters/s6508c.htm.
For more information on FDA's Drug Safety Initiative, visit: