Jun 28, 2021 | Did You Know, Foods
On June 11, 2021, FDA published in the Federal Register a final rule amending the standard of identity for yogurt, 21 CFR 131.200. The final rule, more than a decade in coming, (proposed rule was published in 2009) has been a priority under FDA’s Nutrition Innovation...
Jun 1, 2021 | Did You Know, Tobacco
FDA recently announced a plan to propose product standards banning menthol as a flavor in cigarettes and banning all characterizing flavors (including menthol) in cigars within the next year. If implemented, this ban will apply to all manufacturers, distributors,...
Feb 25, 2021 | Did You Know, Foods
A medical food per FDA is a specific category “formulated to be consumed… under the supervision of a physician and which is intended for the specific dietary management of a disease or condition” which need “distinctive nutritional requirements.” This means that...
Feb 18, 2021 | Did You Know, Dietary Supplements, Drugs, Foods, Medical Devices, Veterinary
In addition to Good Manufacturing Practices, supply chain oversight, labeling, registrations, listings, adverse event tracking and all the other regulatory requirements required by FDA, use of electronic records and submissions adds an additional compliance...
Feb 1, 2021 | Did You Know, Foods
Derived from natural materials, biopesticides, are inherently less toxic than conventional pesticides and when used as a component of Integrated Pest Management (IPM) programs, can greatly reduce conventional pesticide use and improve crop yields. EPA has regulatory...
Jan 1, 2021 | Did You Know
In the competitive FDA space, mergers and acquisitions of brands and formulations are a common occurrence and help gain a competitive edge. These critical decisions have far reaching implications, including exposure to regulatory risks which can have devastating...