FDA News Update
Gluten Free Label Rule Now In Effect
Last year the US Food and Drug Administration (FDA) annouced a new rule for gluten free labeling. The rule gave manufacturers until yesterday (August 5,…
Three Steps to Selling FDA Approved Products on Amazon
“Is it FDA approved?” This is the most frequent question received by phone and e-mail. It’s also the most commonly asked question by Amazon. The…
Press Release: Springer Taps Marc Sanchez for Food Law Textbook
For Immediate Release: June 23, 2014 Marc C. Sanchez, Esq. Senior Counsel, Contract In-House Counsel and Consulting, LLC Adjunct Professor of Law, Northeastern…
FDA Finalizes Rule Prohibiting Certain Nutrient Content Claims for DHA, EPA, and ALA Omega-3 Fatty Acids
The FDA annouced a new rule in late April limiting the claims that can be made about food and dietary supplement products containing Omega 3…
Tips for Appeals and FDA Meetings: Reflections from Recent Visit to FDA HQ
An enforcement meeting with the US FDA, whether in person or over the phone, can become an intimidating task. There are number of variables to…
Watermelon Water – New Fad, but FDA Approved?
ABC news and other media outlets are reporting on a new beverage fad – watermelon water. Before jumping on the bandwagon, it is important to…
Data Integrity and Form 483 or Warning Letters
Data integrity is an essential component of both clinical and nonclinical research conducted under the supervision of the Food and Drug Administration.
New FDA E-Cigarette Rules – What Does It Mean
Yesterday (April 24, 2014) the US Food and Drug Administration (FDA) announced new regulation of e-cigarettes. The rule changes the FDA’s prior position of only…
Nearly 25% of 2014 Warning Letters Issued to Seafood Industry
A warning letter issued by the US FDA is the most common and widely used enforcement tool. It is also among the most public. Every…
FDA Proposes New Nutrition Label
The US Food and Drug Administration announced today dramatic new changes to the food nutrition label. The proposed label is open for comment over the…
FY 2013 483 Data Released; Top Ten Observations Unchanged
The US FDA released enforcement data from fiscal year 2013. The data provides the total number of Form 483 Inspectional Observations, the most common pre-enforcement…