FDA
Potential Changes to FDA Regulation of Homeopathic Drugs
On April 20, 2015 the Food and Drug Administration (FDA) heard testimony regarding homeopathic drugs and the Agency’s role in…
US Marshals Seize Topical Products Deemed Drugs by FDA
On April 16, 2015, U.S. Marshals seized what the U.S. Food & Drug Administration (“FDA”) classified as unapproved prescription drugs…
Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics
On March 31, 2015, Attorney Katherine Giannamore, of Shehadeh Giannamore, PLLC, was interviewed by Ryan Nelson of “The Rose Sheet”…
FDA Warns of Marketing Cosmetics with Drug Claims
The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin…
FDA Regulation of OTC Sunscreen Products
Have you ever wondered who ensures the safety of your sunscreen? With many people, including pregnant women and children, choosing…
FDA Stops Company from Marketing Unapproved New Drugs
On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted…
FDA Guides on General Wellness and Low Risk Devices
On January 20, 2015, the U.S. Food and Drug Administration (FDA) published a proposed guidance document regarding the FDA’s current…
Court Issues Injunction after FDA Warning Letter Issues Persist
On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its…
Overview of FDA’s Final Menu and Vending Labeling Rules
Menu and Vending Labeling Rules On November 25, 2014, the U.S. Food and Drug Administration (FDA) finalized two rules requiring…
FDA HACCP Enforcement Sandwiches Food Company between a Rock and a Hard Place
On November 21, 2014, the U.S. Food & Drug Administration (“FDA”) filed for a permanent injunction in the Eastern District…