The American Herbal Products Association (AHPA; Silver Spring, MD) has revised its guidance policy on residual solvents in herbal extracts, now specifically prohibiting the use of Class 1 solvents. The association also amended its policy concerning the use of acetic acid when it is present in liquid extracts formulated to contain vinegar or acetic acid. [Read more…]
The U.S. Food and Drug Administration today announced that it has completed two tasks required by the new Food Safety Modernization Act (FSMA). FDA has issued an anti-smuggling strategy, and issued draft guidance clarifying agency expectations on new dietary ingredients.
The FDA issued an anti-smuggling strategy developed by the Department of Health and Human Services (HHS) in coordination with the Department of Homeland Security (DHS) that will help to identify and prevent smuggled foods from entering the United States and posing a threat to national security and consumer safety.
“The Food Safety Modernization Act requires the agency to build a new food safety system,” said Deputy Commissioner for Foods Michael R. Taylor. “This new system, overall, will better leverage the resources of federal agencies and it will make industry an important partner in safeguarding the health of U.S. consumers.”
The FDA issued its updated draft guidance on new dietary ingredients (NDIs), which the agency said is intended to assist industry in deciding when a premarket safety notification for a dietary supplement containing a NDI is necessary. The guidance is also designed to help industry prepare NDI notifications.
The draft guidance is laid-out in a Q&A format and explains the definition of an NDI, when an NDI notification is necessary, the procedures for submitting a NDI notification, the types of data and information that FDA recommends manufacturers and distributors consider when they evaluate the safety of a dietary supplement containing a NDI, and what should be included in a NDI notification. In addition, the guidance contains questions and answers about parts of the dietary supplement definition that can affect whether a particular substance may be marketed as a dietary ingredient in a dietary supplement.