Tag: import

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.

FDA Label Review to Prevent Food Import Refusal

Posted on by Patrick Morin

Labeling violations are one of the leading causes of food import refusals to the United States. In fact, more than 7,000 labeling violations for food products were cited by the U.S. Food and Drug Administration (FDA) in 2017 alone.

If an imported food product is stopped by the FDA for a labeling violation they have three choices: detention, seizure or refusal of admission. None of these are good options for food importers. Know what to avoid to make sure this doesn’t happen to your business.

Below is a list of the top five labeling violations for food imports.

Nutrition information

 

More than 1,000 import refusals in 2017 were due to missing nutritional information. The FDA requires that most food and beverages are labeled with a specifically formatted nutrition facts panel. However, often import food labels include a nutrition facts panel from a foreign country. Unfortunately for the importer these panels don’t meet the FDA requirements and are therefore deemed misbranded under the law.

This will be even more important now that FDA has changed the Nutrition Facts panel to a new format. It is important to make sure you utilize the new format going forward to avoid potential labeling errors.

Ingredients

FDA requires that every ingredient included in a food or beverage be disclosed on the label in descending order of the prominence by weight. The FDA will not only review labels, but will sample products to ensure the labels are what they say they are, which is why it’s important to follow the rules when listing ingredients.

FDA regulations also require ingredients to be listed by specific  names. Imported food products, which often contain ingredients know by different names in their home country, frequently fail to list certain ingredients by the required name under FDA regulations.

Labeling in English

FDA requires that all information on labels appear in English. Labels may include other languages as well, but if a foreign language is used all of the information on the label must appear in that language as well.

Net Quantity

FDA requires a statement that provides the amount of food in a container or package. This statement must include both the U.S. and metric measurement and must be listed in the front of the package.

 

Manufacturer Name

The name and address of the manufacturer, packer or distributor must be listed on a food label. If the importer is not the manufacturer, or if the product is made for the importer, the name and address of the importer may be preceded by “Manufactured for” or “Imported by” if applicable.

 

If the FDA discovers that your food product has one of these labeling violations, the FDA will refuse entry or detain your product. This will end up costing you a lot of money and could potentially damage your relationships with buyers.

FDA is now also required to increase the number of routine inspections overseas at foreign food facilities. If a non-compliant label is found during an inspection, FDA can charge you to reinspect the facility to ensure the labels have been brought into compliance at a rate of $305 USD per hour.

Morsel Law can help assure your labels are FDA compliant through our label review service. Our experts will review and markup your labels to make sure they meet FDA regulations. Order your FDA import label review today and keep your import business running smoothly!

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.

Streamlining Your Food Imports Into the U.S.

Posted on by Patrick Morin

If you import food into the United States then you are familiar with the headaches and hassles that go along with this burdensome regulatory process. But that may change with the release of the draft guidance that outlines FDA’s plan to implement the Voluntary Qualified Importer Program (VQIP) mandated under the Food Safety Modernization Act. The VQIP is a voluntary, fee-based program for the expedited review and importation of foods from importers who achieve and maintain a high level of control over the safety and security of their supply chains.

The new draft guidance lays out the various benefits in addition to expedited entry that an importer can expect to receive from participating in VQIP, including limiting examination and/or sampling of VQIP food entries to “for cause” situations. Additionally, participants in the VQIP will have access to the VQIP Importers Help Desk, which will be dedicated to responding to questions and concerns of VQIP importers.

The draft guidance lays out the eligibility for participating in the program, which includes: (a) 3-year history of importing food into the U.S.; (b) do not import food subject to an import alert or Class 1 recall; (c) have a current facility certification for each foreign supplier of food intended to be imported under VQIP; and (d) be in compliance with Foreign Supplier Verification Program requirements and applicable seafood and juice HACCP regulations.

Participation in the VQIP is for the U.S. fiscal year, which begins on October 1st each year. Applications to participate in VQIP will need to be submitted electronically through the FDA’s industry portal between January 1st and May 31st before the fiscal year in which the importer seeks to join the program. FDA has indicated that due to resource constraints, it will limit the number of participants in the first year to 200 at the most. Participation must be renewed annually, and participants will be subject to FDA inspection.

If your company is considering participating in the VQIP program, carefully review the draft guidance as the FDA will only accept comments on until August 4, 2015.

U.S. On Verge Of “COOL” War

Posted on by Patrick Morin

Those of us born before 1980 probably remember growing up the midst of the Cold War between the United States and Soviet Union. The Cold War ended in 1991, however, the U.S. could find itself facing a trade war, this time with its North American neighbors.

On Monday, the World Trade Organization (WTO) ruled the U.S. country-of-origin labeling (COOL) required on certain meat packaging discriminates against livestock from Canada and Mexico. The ruling could lead to retaliatory measures in the form of tariffs on U.S. imports.  Canada and Mexico have both indicated they intend to impose sanctions on U.S. exports as early as late summer.

The labeling law was originally introduced by Congress as part of the 2002 farm bill. The current rules require labels to state, for example, that the animal that produced the meat was “born in Mexico, raised and slaughtered in the United States” or “born, raised and slaughtered in the United States.”  Canada and Mexico argued that these labeling requirements caused the prices of their meats to drop because meatpackers don’t want to go through the hassle and expense of segregating imported animals. The WTO report supports this argument, claiming that U.S. regulations, which require meat producers to indicate on retail packaging where each animal was born, raised and slaughtered, give less favorable treatment to imported meat than domestic products.

As a result of the WTO ruling, Congress is now faced with a tough choice: amend or repeal the law, or suffer punitive tariffs on a range of goods. Any amendment needs to be narrowly tailored so that U.S. meat producers are not favored over imports. In 2013 while the dispute was working its way through the WTO, Congress amend the labeling rules, but the WTO stated in their report the amendment did not go far enough. Repealing the law could appease Canada and Mexico and prevent a trade war; however, what message would this send to U.S. consumers? As consumer demand has

been increasing over the past several years for transparency in the food supply, by repealing COOL Congress would in effect be telling consumers that U.S. trade interests are more important. How well this would sit with consumers is unknown, but with the 2016 election on the horizon I’m willing to bet legislators are polling their constituents on this issue. If Congress does nothing U.S. exporters will certainly suffer, most likely passing the additional cost onto consumers. But it isn’t just additional cost, it’s lost jobs. Jobs in the industries affected by the tariffs and jobs that supply those industries. In the stagnant economy in which we live, any action that results in job losses needs to be thoroughly reviewed.

The U.S. Congress is on the clock and the world is watching.  Whatever side you may be on, this is going to be a fight of historic proportions as money continues to pour in from all sides. Stayed tuned for updates as we closely follow this matter and post updates to our blog.