Hello! I trust that summer is flying by for those of you in the Northern Hemisphere and I hope that winter is not too harsh for those of you in the Southern Hemisphere. Since dietary supplement companies are now required to comply with FDA’s Good [...]
Hello! Everyone who eats believes they know at least a little bit about food labels; some even think they understand them completely. But folks in the food business know that labels can be surprisingly complicated and sometimes even frustrating. In the past several months [...]
Hello! We have become aware of a new manual from the American Herbal Products Association (AHPA) that provides guidance as well as templates for preparing Standard Operating Procedures (SOPs) for compliance with Dietary Supplement Good Manufacturing Practices (GMPs). Having SOPs is an important part of [...]
Hello! Trade newsletters are reporting that FDA Commissioner, Dr. Margaret Hamburg’s remarks at the Food and Drug Law Institute conference discussed her priority to respond to the increase in adulterated and misbranded imported food products. Many of our clients have noted the increased scrutiny of [...]
I wanted to share with you another interesting post by Kurt Karst at FDALawBlog.com. This one discusses a recent court ruling on patents that has implications for FDA regulated industries. The decision, in part, states “Whoever marks upon, or affixes to, or uses in advertising [...]
The Federal Trade Commission in conjunction with the Food and Drug Administration has announced that they have issued warning letters to several companies who are making claims regarding omega 3 fatty acids and brain and vision function. The agencies are seeking information regarding the substantiation [...]
As 2009 draws to a close FDA continues their ramped up enforcement activities based upon new guidance documents and letters to industry. A draft guidance document published on December 7, 2009 lets us know that FDA is eyeing functional beverages and liquid dietary supplements for [...]
Hello! Many of our dietary supplement clients have struggled with complying with the Good Manufacturing Practice Regulations FDA wrote the industry. The following link takes you to an article in The Natural Products Insider that discusses the agency’s view and includes a video of Vasilios [...]
I will be speaking at the Nutritional Genomics Conference at California State Polytechnic University, Pomona CA, November 12. What is nutritional genomics? It is the study of the impact of diet on health through gene expression. Just as some genetic markers can indicate a person’s [...]
Everyone is aware of today’s trend towards natural foods. Many manufacturers now substitute refined sugar with other cane products including “evaporated cane juice”. Yesterday the FDA issued a new guidance on labeling foods containing this ingredient. The guidance states that in FDA’s view “evaporated cane juice” [...]
Hello! I received the following email from FDA today and wanted to pass it along to you. Please let me know if you have any questions. The U.S. Food and Drug Administration has a new way to head off potential cases of foodborne illness – [...]
Hello! You may find the story from FoodNavigation.com that is pasted below interesting. It involves LaneLabs, a supplement company that is under a consent decree due to making false claims on dietary supplement products. The FTC brought a suit against them due to new claims [...]
In an informal conversation with a current FDA staff member I learned that the agency is expecting to issue many more warning letters and to follow up on those warnings much more quickly. Why is this? First, last fall the agency hired hundreds of new [...]