Tag Archive: Drugs

Jan 21

District Court sides with Industry on Dietary Supplement Substantiation

A U.S. District judge New Jersey has ruled in United States v. Bayer Corporation that Bayer will not be held in contempt for alleged violations of a 2007 consent decree regarding the marketing of its Phillip’s Colon Health (PCH) product. The 2007 Consent Decree prohibited Bayer from “making any claim about the performance or efficacy …

Continue reading »

Apr 30

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 the regulation thereof. These two-day long hearings come after the FDA received over 1,500 public comments about the possibility of regulating homeopathic drugs in a manner consistent with over-the-counter (OTC) drugs. A primer for the …

Continue reading »

Apr 23

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 from Stratus Pharmaceuticals, Inc. of Miami, Florida. Stratus purchased these unapproved prescription drugs, worth over $1.5 million, from Sonar Products, Inc. of New Jersey and marketed the topical products, deemed drugs by the FDA to …

Continue reading »

Apr 07

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

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 the industry’s premier sources for specialized, in-depth coverage and analysis of regulatory and market developments …

Continue reading »

Mar 27

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 line. However, the differences in regulation between the two are stark. The Federal Food Drug and Cosmetic Act (The Act) governs the regulation of drugs and cosmetic products. The Act defines a cosmetic, in part, …

Continue reading »

Feb 12

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 a consent decree of permanent injunction against Laclede, a U.S.-based manufacturer in connection with the marketing of unapproved new drugs. The permanent injunction prohibits Laclede from selling and distributing unapproved new drugs or misbranded drugs …

Continue reading »

Oct 22

FDA Approval Required for Company Enjoined from Marketing Products

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 we previously reported, Ascend had been targeted in connection with the marketing and sale of …

Continue reading »

Oct 05

FTC-FDA Warning Letter Issued to Company Marketing Ebola Cure

On September 23, 2014, the U.S. Food & Drug Administration (“FDA”), in conjunction with the Federal Trade Commission (“FTC”), issued a Warning Letter to Natural Solutions Foundation in Newton, New Jersey. FDA representatives allege the FDA warning letter was prompted by the certain marketing. In particular, the Company violated the Federal Food, Drug, and Cosmetic …

Continue reading »

Sep 02

Dietary Supplement Company Prohibited from Operations After Ignoring FDA Warning Letter

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 supplements until they comply with FDA good manufacturing regulations and other applicable, federal requirements. In …

Continue reading »

Jul 12

FDA Seeks Injunction against Company for Misbranding Drug Products

On June 25, 2014, the U.S. Department of Justice (“DOJ”), in response to a request made by the U.S. Food and Drug Administration (“FDA”), filed a complaint seeking a permanent injunction against Laclede, Inc. of Rancho Domingo California and the Company’s president, Michael A. Pellico. The injunctive relief, which was sought in the U.S. District …

Continue reading »

Older posts «

Switch to our mobile site