Category: Import

Dietary Supplement Importers Must Verify Foreign Suppliers

Posted on by Patrick Morin
dietary supplement imports

Dietary supplement importers must engage an agent physically located in the U.S. to verify their foreign suppliers compliance with U.S food safety laws. In fact, in 2019 the FDA cited the lack of developing a foreign supplier verification program (FSVP) as one of the most cited violations for FDA registered facilities. For most businesses the FSVP deadlines for compliance have passed, so making sure you have your FSVP plan in place before you ship is critical. FDA requires importers to present their FSVP’s upon request.

The FSVP rule was issued by FDA after passage of the Food Safety Modernization Act signed into law in 2011. The FSVP rule requires importers to perform “risk-based activities” to verify that the food they bring into the United States has been produced in a manner that meets U.S. food safety standards.

One of the key elements of the FSVP rule for foreign dietary supplement importers or exporters with no employees located in the U.S. is the requirement to designate an “agent” to carry out FSVP responsibilities on behalf of the importer. The agreement with the agent must be in writing and the agent must be identified in U.S. customs paperwork submitted with each shipment.

The FDA cited numerous registered facilities for FSVP-related violations, including:

  • Failing to follow or maintain a FSVP plan
  • Failing to translate the FSVP plan into English
  • Failing to sign and date modification to the FSVP
  • Failing to make adequate assurances of a supplier’s food safety

There was a 17% increase in the number of FSVP violations in 2019 from 2018. This demonstrates FDA’s continued focus on ensuring the safety of dietary supplements and food products entering the U.S. supply chain.

So if you are exporting dietary supplements to the U.S. or a U.S.-based importer, I’m sure you are wondering how the FSVP rule applies to you. For starters you need to pay attention because compliance with FSVP is mandatory. Businesses found in violation of the FSVP rule can face a variety of penalties, from seizure of the imported products to criminal prosecution. The FDA is currently conducting regulatory audits of importers and has made this new initiative their priority. Fortunately, there is still time to put a FSVP plan in place.

If you have questions about FSVP, need to develop a FSVP plan or need to engage a U.S. FSVP Agent, please feel free to schedule a call with our attorneys at Morsel Law.

U.S. importers are you verifying your suppliers?

Posted on by Patrick Morin
foreign supplier verification program

The FDA took action against a U.S. importer who failed to establish procedures to verify food safety standards of their foreign suppliers. While investigating a salmonella outbreak that was traced back to a particular brand of tahini, FDA investigators visited the offices of the U.S.-based importer Brodt Zenatti Holdings LLC. To their surprise they discovered the importer had neglected to meet the FDA’s food safety requirements. As a result FDA issued the importer a Warning Letter and an Import Alert ordering detention of all associated tahini products.

The Foreign Supplier Verification Program (FSVP) rule was issued by FDA after passage of the Food Safety Modernization Act signed into law in 2011. The FSVP rule requires importers to perform “risk-based activities” to verify that the food they bring into the United States has been produced in a manner that meets U.S. food safety standards. Most importers were required to put in place FSVP programs by 2019, while some qualified small business have until 2020 to comply.

So if you are a U.S. food importer, I’m sure you are wondering how the FSVP rule applies to you. For starters you need to pay attention because compliance with FSVP is mandatory. Importers found in violation of the FSVP rule can face a variety of penalties, from seizure of the imported products to criminal prosecution. The FDA is currently conducting regulatory audits of importers and has made this new initiative their priority. Fortunately, there is still time to put a FSVP plan in place.

If you have questions about FSVP or need to develop a FSVP plan, please feel free to schedule a call with our attorneys at Morsel Law.

Importing Dietary Supplements? What You Need to Know

Posted on by Patrick Morin

Dietary supplement products that are destined for importation into the United States and for marketing to U.S. consumers are governed by a complex body of federal laws and regulations. These laws and regulations establish requirements that pertain to product manufacturing practices, product and ingredient safety, product labeling, marketing claims and product importation procedures, among other matters.

If you plan to import supplements into the U.S. and don’t know where to start, below is a checklist of items to consider.

Ingredients

  • Check the ingredient list for non-permitted ingredients and/or colors, or colors that require certification
  • Check ingredient name for the proper declaration

Label Format

All labels should include, at a minimum the following items:

  • Statement of Identity
  • Net Quantity
  • Supplement Facts
  • Ingredient List
  • Manufacturer, Packer, Distributor name and address
  • Country of Origin

Ingredient Permits

Do any of the ingredients of animal-origin requiring a permit (APHIS/USDA)?

Low-acid or acidified canned food

Is the product a low-acid or acidified canned food (pH/water activity) requiring additional process filings with FDA?

Claims

Claims are a common red flag for FDA/Customs inspectors. Make sure to review any disease or health claims for compliance with applicable regulations.

Facility Registration

Make sure the facility that manufactures the product is registered with FDA prior to importation to avoid delays.

Prior Notice

Each shipment requires a prior notification to be filed with FDA before the product arrives at its port of entry. Failure to file the prior notice in a timely manner can result in customs refusing entry of your shipment.

If you are unsure if the dietary supplements you plan to import comply with FDA regulations, contact our import specialists at Morsel Law for a FREE consultation.

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.

Worldwide Olive Oil Shortage

Posted on by Patrick Morin

Buyers beware: this could mean an increase in food fraud as criminals attempt to cash in on record high prices. Olive Oil accounts for more than 10% of all incidents of food fraud worldwide. Fraudsters in the past have been caught passing off cheaper oils from Turkey and Tunisia as higher priced Italian oil.

Other schemes have been identified where importers were blending cheaper oils, such as hazelnut, soy, corn, walnut or palm oil, and passing the products off as 100% pure olive oil. This is especially concerning when nut-oils are substituted which can lead to major problems for those with food allergies.

For more, you can view the article.

If you have questions about food fraud, please contact our attorneys at Morsel Law.

Food Importers Required to Verify Foreign Suppliers

Posted on by Patrick Morin

As I’m sure those of you in the food import business are aware, FDA finalized its rule on Foreign Supplier Verification Programs (“FSVP”) for Importers of Food for Humans and Animals. The rule requires that importers implement a FSVP to verify that their foreign suppliers are producing food in a manner that provides the same level of public health protection as the preventive controls or produce safety regulations, and to ensure that the supplier’s food is not adulterated and not misbranded with respect to allergen labeling.

If you import food into the U.S. you must comply with the requirements under the rule or face regulatory action. The following is an overview of rule and what your business can do to comply its requirements.

What Importers Are Affected:  The rule applies to all importers of food into the U.S. An “importer” is the U.S. owner or consignee of food that is being offered for import or, if there is no such owner or consignee, the U.S. representative or agent of the foreign owner or consignee at the time of entry.

What Food Is Covered: The FSVP Rule applies to all food that is imported or offered for import into the United States. Certain foods are not covered by FSVP, including (1) juice and fish that complies with FDA’s Hazard Analysis and Critical Control Point (“HACCP”) regulations; (2) food for research or evaluation; (3) food for personal consumption; (4) alcoholic beverages; (5) food that is imported for processes and future export; (6) low-acid canned foods; and (7) certain meat, poultry, and egg products that are regulated by the U.S. Department of Agriculture at the time of import. The rule also sets forth modified requirements for importers of dietary supplements and dietary supplement components, very small importers, and importers of food from certain small foreign suppliers.

Importer Requirements Under Rule: Each importer must develop an FSVP that ensures “foreign suppliers” are producing food in a way that provides the same level of protection as what is required under the Preventive Controls Rules and the Produce Safety Rule (if applicable) and ensure that the supplier’s food is not adulterated and is not misbranded with respect to allergen labeling. A “foreign supplier” is an entity that manufactures, processes or grows food, or raises animals that are exported to the U.S. without further manufacturing or processing.

What Must Be Included:  An FSVP must be developed by a “qualified individual” who must perform the various activities and be able to read and understand the language of any records that must be reviewed. In developing an FSVP, an importer is required to conduct and document the following activities:

  • Hazard Analysis: An importer must complete a written hazard analysis that identifies potential hazards for each food and each supplier, including biological, chemical (including radiological) and physical hazards.
  • Risk Evaluation: An importer must evaluate the risk posed by a food, based on the hazard analysis, and the foreign supplier’s performance. Factors that importer’s must consider in the evaluation can include the foreign supplier’s procedures, processes and practices related to food safety, and any information that FDA may have regarding the foreign supplier’s compliance. The importer can also rely on another entity to perform the risk evaluation under certain circumstances.
  • Verification Activities: Based upon the evaluation of risk conducted, the importer must establish and follow written procedures to ensure that it only imports from approved foreign suppliers. Appropriate supplier verification activities may include annual on-site audits of the supplier’s facility, sampling and testing, or a review of the supplier’s relevant food safety records. The importer can also rely on another entity to determine and perform appropriate supplier verification activities under certain circumstances.
  • Supply Chains: The final rule also adds flexibility and recognizes the reality of modern distribution chains by not requiring an importer to conduct supplier verification (or evaluate the risk posed by a food and the foreign supplier’s performance) when the hazard requiring a control in a food will be controlled by a subsequent entity in the distribution chain in the United States. For example, if an importer’s customer will control the hazard, the importer can rely on its customer to provide written assurance that the food will be processed for food safety and must disclose that the food has not been processed to control the identified hazard. If the hazard will be controlled by a subsequent entity in the distribution chain, the rule requires disclosure that the food has not been processed to control the identified hazard as well as a series of written assurances starting with assurances from the customer to the importer and continuing the obligation to provide written assurance of processing for food safety throughout the distribution chain. The rule provides flexibility for an importer to establish, document and implement an alternative system that ensures adequate control, at a later distribution step, of the hazards in a food product distributed by a manufacturing/processing facility.
  • Conduct Corrective Actions: If something goes wrong and an importer determines that its foreign supplier has not used safe processes and procedures, the importer must take immediate corrective action. The appropriate action will depend on the circumstances, but can include discontinuing use of the foreign supplier until the cause of noncompliance, adulteration or misbranding has been adequately addressed.

The risks evaluated as part of an FSVP must be promptly reevaluated upon the discovery of new information. Additionally, an FSVP must be reassessed for each food and each foreign supplier at least once every three years. Based on the results of any such FSVP reassessment, an importer must promptly adjust its supplier verification activities if necessary.

What is the Deadline to Comply:  Importers must comply with the rule by the latest of the following dates:

  • 18 months after publication of the final rule;
  • For the importation of food from a supplier that is subject to the preventive controls or produce safety rules, six months after the foreign supplier is required to meet the relevant regulations;
  • For an importer that is itself a manufacturer or processor subject to the supply-chain program provisions in the preventive controls regulations, the date by which it has to comply with those provisions.

It is important for companies to determine whether they are subject to FSVP requirements, and, if so, to begin taking steps to ensure compliance. If you are unsure of whether your company is subject to, or if you need assistance complying with, the FSVP rule please contact our attorneys at Morsel Law.