NEWS, WEBINARS, & MORE

Historically, approximately 70% of dietary supplement notifications to FDA were rejected. This high rejection rate has had a chilling effect on submission of notifications for new dietary supplement ingredients.  These rejections were usually not based on a specific violation of the Act (i.e., Dietary Supplement Health and Education Act), but one of many administrative state tools used by FDA to thwart implementation of a statute with which FDA did not agree including, but no

“Why should I invest in a GRAS when everyone is already selling my ingredient?” Well, to be frank – it’s the law. “Any substance that is intentionally added to food is a food additive, that is subject to premarket review and approval by FDA, unless the substance is generally recognized, among qualified experts, as having been adequately shown to be safe under the conditions of its intended use, or unless the use of the substance is otherwise excepted from the definition of a

The above dialogue is a common one in consulting and usually refers to an opinion on the safe use of an ingredient, or a GRAS determination. The manufacturer has a new ingredient that he intends to add to food or use as a dietary supplement, but doesn’t have the depth of bench on his staff to generate a supportable opinion on safety. He needs the documentation in case the unthinkable happens — the FDA, FSIS or a third-party auditor asks for his supporting documentation on the