Browse By Tags

On Thursday, May 7, Amarin Pharma took the unprecedented step of proactively suing the U.S. Food and Drug Administration (FDA) over the agency’s alleged infringement of the company’s First Amendment Rights. The case arises from Amarin’s...

The U.S. Food and Drug Administration, acting through the U.S. Department of Justice appears to have relied on the Park Doctrine, [ enhanced version available to lexis.com subscribers ], to hold a corporate officer of a compounding pharmacy criminally...

by Cori Goldberg and Saul Perloff Kim Kardashian’s recent Instagram post yielded 466,000 “likes” and one FDA Warning Letter . In her social media post, also posted on Facebook, Kardashian discussed the drug DICLEGIS and the positive...

The FDA's final rule on gluten-free labeling was published in the Federal Register on August 5, 2013, with a mandatory date for compliance of one year thereafter, or August 5, 2014. But the FDA makes clear that this is an outside date. "However...

By Julie Glazer Last week the FTC sued Gerber Products Co., alleging that it has no basis for asserting that its Good Start Gentle baby formula reduces the risk of infant allergy development and that these health claims were falsely advertised as “FDA...

On October 27, 2015, the U.S. Food and Drug Administration (FDA) published notice of two draft guidance documents in the Federal Register [1] : “Interim Policy on Compounding Using Bulk Drug Substances Under Section 503A of the Federal Food, Drug...

Kim Kardashian is promoting Diclegis® on social media once again. But this time, she is posting about the drug to correct her prior actions. On August 12, we discussed Kim Kardashian’s Instagram and Facebook post in which she discussed the...

Kim Kardashian is promoting Diclegis® on social media once again. But this time, she is posting about the drug to correct her prior actions. On August 12, we discussed Kim Kardashian’s Instagram and Facebook post in which she discussed the...

On November 27, 2013, the Drug Supply Chain Security Act (DSCSA) was enacted “to build an electronic, interoperable system by November 27, 2023, which will identify and trace certain prescription drugs as they are distributed in the United States...

The U.S. Food and Drug Administration (FDA) recently finalized two rules requiring that calorie information be listed on menus and menu boards in chain restaurants and similar retail food establishments, as well as on certain vending machines. In announcing...

On February 27th, the Food and Drug Administration (FDA) announced the availability of three proposed rules that would revise the Nutrition Facts label requirements. These proposals were published in the Federal Register on Monday, March 3. Food Labeling...

FDA Publishes Operational Strategy for Implementing FSMA The FDA has published its “Operational Strategy for Implementing the FDA Food Safety Modernization Act (FSMA),” which will be considered the Agency’s launching pad for all food...

Last month the Food and Drug Administration (FDA) released draft guidance for industry with instructions on how to obtain a food allergen labeling exemption through submission of a petition or notification to FDA.[1] The Food Allergen Labeling and Consumer...

On April 1, 2014, the U.S. Food and Drug Administration (FDA) published notice of its Draft Guidance for Industry on Fees for Human Drug Compounding Outsourcing Facilities Under the Federal Food, Drug, and Cosmetic Act ("Draft Guidance"), which...

On June 12, 2013, the U.S. District Court for the District of New Jersey denied Tropicana’s motion to dismiss a false advertising suit. In Lynch v. Tropicana Products, Inc. , the plaintiffs alleged that the juice’s label falsely claimed that...