Tag: labels

FDA Steps Up Enforcement of Label Violations for Food Imports

Posted on by Patrick Morin

I previously posted an article discussing the importance of accurate labeling, especially for food importers. Labeling errors are one of the most common reasons products shipped to the United States are refused entry. If a product is found to contain a labeling violation, the FDA may deem the product “misbranded,” making it a prohibited act to distribute the product in the U.S. Once the FDA identifies one mistake on a businesses’ labels, the agency is more likely to stop this businesses’ products at the border in the future.

In March 2018, the FDA refused entry to over 150 food products attempting to enter the U.S. These food products from various countries throughout the world now cannot be sold in the U.S. in their current form due to labeling violations, so now importers are faced with a difficult business decision.

There are three things importers can do with the refused products. First, they may re-label each item with FDA compliant labels. This would require the importer to design, print and affix new labels to each item refused entry within 15 days’ of receiving the refusal notice. The tight time-frame to accomplish these tasks is very difficult for smaller single-item shipments and almost impossible for larger multi-item shipments due to the manpower it would take to complete the labeling, in addition to the cost a labeling specialist will charge to expedite revised labels.

Another option is to export the products back to their port of origin or another suitable country (e.g., Canada, Mexico). While the importer would retain ownership of the products, the additional shipping cost may exceed the value of the underlying products. The last option, and usually the option of last resort, is to destroy the products while under FDA supervision. This usually occurs when the cost to re-label or export exceeds the value of the products refused entry.

FDA previously announced their intention to focus on import violations, as demonstrated by the March refusal list and their commitment to enforcing labeling laws. In order to avoid the high costs and delays resulting from a labeling violation, it is best to have food labels reviewed for FDA compliance prior to shipping the products to the U.S. The cost of such reviews are minimal in comparison to the cost of fighting to get your seized products released or exported due to a labeling violation.

If your business is unsure whether a product label is in compliance with, or need assistance in adapting your label to meet, FDA regulations Morsel Law can help. Order your flat-free label review to make sure your food label is in compliance.

Label Reviews Are Critical For Food Importers

Posted on by Patrick Morin

I previously posted a similar article discussing the importance of label reviews for domestic produced products here. But a recent event reminded me to reiterate the importance of accurate labeling, especially for food importers. Non-compliant labels can cost you time, money and even your relationship with customers.

A few weeks ago, JFC International Inc. issued a voluntary recall for rice seasoning products shipped to the United States. Apparently, the recall was initiated after the company discovered the product was not labeled in English, which is required under U.S. law. Also, because the label was not in English, it is deemed to have failed to disclose allergens contained in the ingredients. Important to point out is that this isn’t JFC International Inc.’s first time being involved with a recall event; they issued a similar recall in 2016 for failing to label in English and undeclared allergens.

This event is an important illustration of how important it is to review your labels prior to shipping your products to the United States. First, one of the most common misbranding mistakes for imports is failure to label in English. This seems like a simple fix, but you would be surprised how often this occurs. Importers should require the shipper to forward a copy of the label prior to shipping to confirm compliance with U.S. law. Now this won’t stop mistakes by workers at the warehouse who load the EU labeled products onto a pallet instead of the U.S. bound product, but if you include language in your contract that makes the shipper responsible for all costs to correct the misbranding in the event the wrong product labels are attached, they will quickly change their quality control practices. This is especially true for shippers who have had to foot the bill after a container is stopped by U.S. Customs.

Second, does a voluntary recall trigger coverage under your product recall insurance policy? Generally, coverage isn’t triggered unless there is an “actual” contamination, which is usually proved by product testing or other evidence. For JCF International, if the recall was initiated for misbranding due to failure to label their products in English, the coverage would be denied. However, because the product contained “actual” allergens, then coverage would probably be triggered. But if the product didn’t contain allergens, then coverage would be denied. Even if the product didn’t contain allergens the company would still need to recall the product because it is still considered misbranded and in violation of the FDC Act, but the recall would potentially result is significant non-reimbursable expenses.

Most food label misbranding violations can be prevented through quality control measures. Importers should, if they have not already, institute best practices to minimize the risk of a potential violation that result in having to respond to FDA Notice of Action letter. These practices should also address who bears the cost and burden to deal with a misbranding violation. Prior planning can help ensure your business identifies and minimizes potential risks commonly associated with the food import industry.

If you have questions about labeling, contact our attorneys at Morsel Law.

How Beverage Companies Can Avoid Unnecessary Lawsuits

Posted on by Patrick Morin

In a recent suit filed in California, Millennium Products, Inc., the maker of GT’s Kombucha and Synergy drinks, was challenged on claims that its drinks contain “powerful antioxidants”, which plaintiffs claim is in violation of the Food, Drug and Cosmetics Act because the antioxidant statements it makes are misleading and unauthorized nutrient content claims as proscribed by the FDA.

Pursuant to federal regulations, a nutrient content claim is a claim on a food product that directly or by implication characterizes the level of a nutrient in the food (e.g., “low fat,” “high in oat bran,” or “contains 100 calories”). Only those claims that are specifically defined in the regulations may be used, all other claims are prohibited. Previously approved nutrient content claims characterize the level of a particular nutrient (e.g., ‘low sodium’), whereas a term such as ‘high in antioxidants’ ties a claim (i.e., ‘high’) to a class of nutrients that share a specific characteristic (i.e., they are antioxidants).

GT’s label use lists “EGCG 100mg” (a polyphenol found in tea with recognized antioxidant properties) in order to substantiate their antioxidant claim. However, for claims characterizing the level of antioxidant nutrients in a food, a reference daily intake (RDI) must be established for each of the nutrients that are the subject of the claim, but in this case there is no established RDI for EGCG. Moreover, since GT’s product is a type of tea, and the FDA considers tea a food with no nutritional significance, the plaintiffs claim the drinks do not contain “even a single antioxidant nutrient with an established RDI.”

It is important to note that Millennium Products, Inc. isn’t the only company to face legal action in recent years from consumers making false labeling claims. Recently, Twinings North America, Inc. was sued for allegedly deceiving consumers by mislabeling its teas as a “natural source of antioxidants”, however, in this case the judge dismissed the lawsuit stating that a “natural source of antioxidants” is not a nutrient content claim because it did not state or imply the level of antioxidants. However, in warning letter sent in 2012 the FDA noted that the statement “very powerful antioxidant” is an unauthorized nutrient content claim because “very powerful” characterize the level of antioxidants in the product. Other tea producers were also sent warning letters by the FDA over their green teas because they were improperly labeled with the term “antioxidant” (see Unilever, Inc. maker of Lipton Tea and Dr Pepper Snapple Group).

As lawsuits are increasingly targeting food and beverage makers challenging their labeling claims, it is more important than ever to make sure your labels are thoroughly reviewed prior to introducing the products into the marketplace. If your business is unsure whether a product label is in compliance with, or need assistance in adapting your label to meet, FDA regulations please contact our attorneys at Morsel Law.