According to the FDA, approximately 3 million people (or 1 in 133 people) in the United States have celiac disease (CD), including me. While there is currently no cure for CD, unfortunately, individuals who have the disease are advised to follow a strict gluten-free diet. Over time, the continued ingestion of gluten by Celiacs triggers the production of antibodies that attack and damage the lining of the small intestine. Such damage hinders the absorption of nutrients, which leads to an array of severe health issues. This makes truthful gluten-free labeling essential for a Celiac’s survival, and celiac’s like me ecstatic that the “gluten-free” claim will be enforced, come August 5, 2014. If you manufacturer a food product, and are not ready to comply, read on.
For those of you keeping up with the FDA Food Safety Modernization Act (FSMA), big changes are coming for those in the food industry. We have been keeping you up to date with blogs on updates to FSMA. We have even created an updated website on FDA to help you understand the vast requirements under the FSMA, as well as complying with FDA generally. If you are a foreign manufacturer, processor, packer, storer or holder of food products, you need a U.S. agent, and must register with the FDA – for more information, review www.FDA-USA.com.
The latest news is that the FDA has released the third Edition of the U.S. Food & Drug Administration (FDA) draft guidance titled “Guidance for Industry: Prior Notice of Imported Food Questions and Answers”. Prior notice is just what it sounds like, “notification to the FDA that an article of food, including food for animals, is being imported or offered for import into the United States in advance of the arrival of the article of food at the U.S. border.”
FDA is seeking comments on the draft guidance and addresses questions received since the publication of the second edition of the guidance in May 2004. The guidance also includes information related to the FSMA, which requires additional information to be provided in a prior notice of imported food submitted to the FDA. The FSMA included a new Prior Notice element, now the FDA requires a person submitting prior notice of imported food, including food for animals, to report the name of any country to which the article has been refused entry.
Although pursuant to 21 CFR 10.115(g)(5), comments can be made on the guidance at any time, in order to ensure that the FDA considers your comments on this draft guidance before it begins to work on the final version of the guidance, your comments must be submitted either electronically or in writing within sixty (60) days from the date in which the notice announcing the availability of the draft guidance is published in the Federal Register, or March 31, 2014. If you have questions on FDA’s FSMA or on submitting a comment, please feel free to contact me at (305) 260-1053 or via email at JDiaz@bplegal.com.