Wellness devices are big business, creating an accountability partner for the user and providing real-time data to their medical provider. But where does a wellness device cross the line to a medical device and what does that mean for the manufacturer? From design, to claims to special
Ingredient suppliers have an alphabet soup of compliance requirements, beyond those of FDA. From EPA to OSHA to even DOT, all product ingredients are regulated depending on the hazards
The industry’s interest in Medical Foods is growing with many new products as well as the repositioning and relabeling of existing products that places them into the medical foods space. FDA’s oversight and enforcement effort focused on Medical Foods has been limited partly …
The Canadian Food Inspection Agency (CFIA) is responsible for the safety of food products sold in Canada by enforcing the recently implemented Safe Foods for Canadians Regulation (SFCR). It is a compilation of 14 sets of regulations governing safety of human …
FDA’s proposed rule “Requirements for Additional Traceability Records for Certain Foods” mandates traceability recordkeeping requirements for certain foods such as cheeses, shell eggs, some types of fish and produce. When finalized, the Traceability Regulation will be …
Presented by Tara Lin Couch, Ph.D., EAS Senior Director for Dietary Supplement and Tobacco Services The Family Smoking Prevention and Tobacco Control Act referred to as the Tobacco Control Act (TCA), signed into law on June 22 …