Regulatory Status

United States

In the United States, we market ProBiora3® as a food ingredient under self-affirmed Generally Recognized as Safe, or GRAS, status. GRAS is available for food ingredients that are generally recognized as being safe for human use and do not claim to treat, prevent, or cure a disease. Furthermore, food products that make only cosmetic or structure-function claims are typically able to enter the market through what is known as self-affirmed GRAS status. This status means that we performed all necessary research, including the formation of an expert panel to review safety concerns, and are prepared to use these findings to defend ProBiora3®‘s self-affirmed GRAS status.

In 2008, we convened a panel, the members of whom we believe to be qualified as experts by their scientific training and professional experience, to analyze and evaluate the safety data for ProBiora3®. After review, the panel concluded that the safety data of ProBiora3® was sufficient to support our claim to self-affirmed GRAS status for human consumption.

Our marketing for ProBiora3® includes the cosmetic claims of teeth whitening and breath freshening, along with the general structure-function claim that ProBiora3® supports oral health. Regulations vary in markets outside the United States and it may be possible to assert other benefits including health and disease prevention claims associated with probiotics use, especially after independent clinical studies have been completed and appropriate regulatory filings are approved. At present, we are aware of several independent academic studies that have been initiated on a variety of potential health and cosmetic benefits associated with ProBiora3® probiotics use by humans.


International

Regulations vary by country and, as such, we rely on the expertise of local partners to which we sell to assist us in navigating through any applicable regulatory requirements. We are generally aware of the varying regulatory requirements in various geographies, and seek to address these requirements on a case-by-case basis.