Enforcement – Page 2 – FDA Compliance Made Easy

US Marshals Seize Topical Products Deemed Drugs by FDA

Disease Claims, Drugs, Enforcement, FDAFDA

On April 16, 2015, U.S. Marshals seized what the U.S. Food & Drug Administration (“FDA”) classified as unapproved prescription drugs from Stratus Pharmaceuticals, Inc. of Miami, Florida. Stratus purchased these unapproved prescription drugs, worth over $1.5 million, from Sonar Products, …

Food & Drug (FDA) Attorney Katherine Giannamore Interviewed on Complexities of Marketing Cosmetics

Cosmetics, Disease Claims, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning LettersFDA

On March 31, 2015, Attorney Katherine Giannamore, of The Law Office of Katherine Giannamore, P.A., was interviewed by Ryan Nelson of “The Rose Sheet” about the challenges that companies face when marketing cosmetic products. “The Rose Sheet” is one of …

FDA Warns of Marketing Cosmetics with Drug Claims

Cosmetics, Disease Claims, Drug, Drugs, Enforcement, FDA, Labeling, Structure-Function Claims, Warning LettersFDA

The difference between a product being marketed as a cosmetic and marketed as a drug can be a very thin line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) …

FDA Stops Company from Marketing Unapproved New Drugs

Disease Claims, Drugs, Enforcement, FDA, Injunction, Labeling, NDA, Warning LettersFDA

On January 30, 2015, and at the request of the U.S. Food and Drug Administration (FDA), a federal judge granted a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. …

Court Issues Injunction after FDA Warning Letter Issues Persist

CGMP, Dietary Supplements, Enforcement, FDA, Injunction, Recalls, Warning LettersFDA

On January 16th 2015, a California dietary supplement manufacturer, Health One Pharmaceuticals, Inc., was ordered to stop sales of its products until the company meets certain U.S. Food & Drug Administration (“FDA”) regulations and mandated standards (Current Good Manufacturing Practices …

FDA Approval Required for Company Enjoined from Marketing Products

Disease Claims, Drug, Drugs, Enforcement, FDA, FDA Approval, Injunction, Labeling, Marshalls, NDA, SeizureFDA

On October 10, 2014, a federal judge from the U.S. District Court for the Southern District of Ohio sided with the U.S. Food & Drug Administration (“FDA”) and entered a consent decree for permanent injunction against Ascend Laboratories, LLC. As …

Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

CGMP, dietary supplement marketing, Dietary Supplements, Disease Claims, Drugs, Enforcement, FDA, Labeling, manufacturing practices, permanent injunction, Structure-Function Claims, Warning LettersFDA

On August 8, 2014, the U.S. Food and Drug Administration (“FDA”) obtained a court order from the United States District Court for the Middle District of Georgia against a dietary supplement manufacturer. The Order prohibits the manufacturer from selling dietary …

Tag: Enforcement