What are the regulatory requirement for dental prophylaxis products to be able to make therapeutic claims?

While the addition of anti-caries agents makes logical sense in dental prophylaxis, large scale, multi-center clinical studies are required to determine the safety and efficacy of prophylaxis paste containing these therapeutic additives. Clinical studies are expensive and in small professional markets, the payback from such studies would be cost prohibitive. Additionally, the wide spread use of fluoride in drinking water, OTC and Rx oral care products greatly reduces the likelihood of a semi-annual application of prophylaxis paste providing any incremental caries prevention benefit for patients. As a result prophylaxis paste manufacturers have not conducted anti-caries studies to support any therapeutic claims platform.