The U.S. Food and Drug Administration (FDA) is in full enforcement mode issuing 260 warning letters in 2021 alone! Now is the time to ensure your products are in compliance with the Federal Food, Drug, and Cosmetic Act (the Act) prior to importation. Manufacturers, importers, distributors, and others engaged in the production or sale of over the counter (OTC) drugs or cosmetic products must be aware of FDA’s various enforcement mechanisms, and more importantly, how to avoid and/or mitigate such actions. FDA’s most common enforcement activities include notices of FDA action, warning letters, seizures, voluntary recalls, injunctions, and criminal prosecution.
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.
FDA issued the update below DEFINING the term “Gluten Free”. As a Celiac, this is extremely exciting news! The reason this is a HUGE deal? Us Celiac’s need to know we can trust food products that are labeled “gluten free”. If they are not, the repercussions are severe, ranging from serious health problems, including nutritional deficiencies, osteoporosis, growth retardation, infertility, miscarriages, short stature, and intestinal cancers…
My sincere hope is FDA will now test imported products that make “GLUTEN FREE” claims, and assure these companies are legitimately using the gluten free claim. Meaning, I hope FDA will enforce and penalize those that are importing misbranded product and not correctly utilizing the gluten free claim! The enforcement tools I will look for include FDA detaining imported product making gluten free claims, and sending them to FDA’s own laboratories to check the parts per million of gluten in the product. If the product contains more than 20 parts per million of gluten, FDA should refuse admission of the product – meaning it would need to be exported or destroyed within 90 days of the refusal, otherwise, companies would face a liquidated damages claim. I also hope FDA will take the added step of adding non-compliant companies to the FDA’s Import Alert (black list) so that the products are AUTOMATICALLY stopped before entering the U.S. and the importer is forced to prove compliance prior to getting FDA to release the goods.
The “Compliance Date” for this final rule is August 5, […]
Imagine a world where a manufacturer’s claims that their products are “gluten free” could be trusted by U.S. consumers. Imagine a world where U.S. consumers were promised a definition of “gluten free” by the U.S. Food and Drug Administration (FDA), and the FDA held all manufacturers and importers to the same stringent standard….
Good news, we’re getting close!!
As of August 2, 2011, FDA has re-opened the comment period so that they can hear from YOU. Yes, YOU! FDA wants to hear from Celiacs, gluten sensitive consumers, et al. in the U.S. Why, you ask? Well, the FDA is firming up their definition of “gluten free”; and wants to know that the gluten free community is satisfied with the FDA’s finalized definition. So, let’s make sure we tell the FDA what’s important to us. FDA has proposed a definition of “gluten free” in order for the term to be used on labeling of food products.
FDA’s proposed rule defines “gluten free” as products that do not contain: