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FDA Specialist News

FDA may detain an imported product if, during an import exam, FDA finds that the product appears to violate the Federal Food, Drug and Cosmetic Act (“FFDCA”). When FDA detains the product, the Agency will mail a Notice of Detention and Hearing (“detention notice”) to the importer and the importer’s Customs broker/filer advising the importer how the product appears to violate the FFDCA and that the importer has a certain amount of time (the “detention period”) to overcome the appearance of a violation by providing testimony such as a private lab report or legal arguments. 

The product may be charged as adulterated e.g. contaminated with Salmonella, illegal pesticide residue, unapproved color additive, etc. Or the product may be charged as misbranded for violations such as labeling violations. The FFDCA provides FDA the authority to detain merely on the appearance of a violation, giving FDA significant power in regulating imported products. Due to this appearance standard, FDA can place a product on the “Red List” of an Import Alert after discovering a violation and then detain future shipments of the red-listed product without having to test or otherwise physically examine it. FDA refers to this as “detention without physical exam” or “DWPE”.

FDA offers an administrative detention and hearing period (“detention period”), which provides the importer the opportunity to overcome a detention by either providing FDA evidence showing that the products comply with the FFDCA or by reconditioning the product as we will discuss in further detail below.

Evidence of Compliance

If the product is detained under an Import Alert, the importer may present evidence such as a private lab report showing the product is free of the violation referenced in the Import Alert. For example, if the product is seafood detained under Import Alert 16-81 “Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella", the Importer may submit a private lab report to FDA indicating the product is free of Salmonella. Or if the importer believes FDA wrongfully charged the products, the detention period provides the importer the opportunity to contest the charges.

Reconditioning

Reconditioning a product involves treating or modifying the product to bring it into compliance with the FFDCA. For example, an importer may sterilize a product via heat treatment to kill Salmonella.  Or a product may be re-labeled to overcome a labeling charge. Sometimes, FDA allows the importer to change the intended use of the product e.g. change the intended use of a product as a food to use as a non-FDA regulated product such as fertilizer. In order to recondition the product, the importer must submit a written reconditioning proposal to FDA.

If FDA accepts the importer’s reconditioning proposal, FDA will usually examine or test the products to verify that they were adequately reconditioned. For example, if the reconditioning involves relabeling the products, FDA will usually have an investigator visually examine the shipment to make sure the products were all relabeled in accordance to the reconditioning proposal.

Responding to a Detention Notice

If the importer fails to respond to the detention notice before the end of the detention period or fails to successfully overcome the violation, FDA may refuse admission of the product into US commerce and issue a Notice of Refusal to the importer. Once FDA refuses the shipment, the importer must redeliver the goods to Customs custody usually within 90 days of the issuance of the Notice of Refusal, and the importer must either have the product exported or destroyed under FDA or Customs supervision.  Read our article on FDA refusals for more information.

The contact information and the respond-by-date are indicated on the detention notice. Note that the respond-by-date on the notice is not necessarily the deadline for submitting all required testimony- it’s the deadline to respond to the notice. So for example, the importer should notify FDA before the respond-by-date if the importer plans to have a private lab test the detained product. However, the lab does not necessarily have to complete the testing before the respond-by-date. The importer should keep FDA apprised of the status of the lab testing and if necessary, request an extension to the detention period.

Once FDA refuses a shipment, it becomes much more difficult to obtain a release for the shipment. That doesn’t mean that refusals are impossible to overcome, but you would need to provide very compelling evidence proving that FDA committed an error in refusing the shipment. So be sure to respond to the detention notice before the respond-by-date listed on the notice!

Other Tips:

  • Telling FDA “I never received the detention notice from FDA, and that’s why I didn’t respond in time” almost never works.
  • Telling FDA “I’ve imported this same product for years, and it was never detained before” also almost never works.
  • FDA rarely considers hardship as a basis for release e.g. “I’ll go out of business if this shipment is refused!”
  • If a shipment is detained because FDA’s lab finds an adulterant, FDA rarely accepts private lab testing as testimony for overcoming the detention.
  • Read the charges listed on the detention notice very carefully so you know what specific testimony is needed to overcome the detention.
  • Always remember that FDA sometimes makes mistakes! FDA reviewers must review thousands of entries each year and are subject to human error like anyone else! That is why the detention period provides the importer the opportunity to challenge the detention if the importer feels the FDA detained the shipment in error.

We at FDA Specialist have had significant success in overcoming FDA detentions and refusals. We can advise you on whether or not FDA made a mistake in detaining or refusing your shipment and then represent you before FDA to have the shipment released. Or we can inform you if any charges can be overcome via reconditioning and prepare and submit a reconditioning proposal to FDA on your behalf. So contact us right away if you receive a detention or refusal notice to see how we can assist you in getting the shipment released as quickly as possible!

FDA Import Alerts – What They Are and How to Get off Them

The Federal Food Drug and Cosmetic Act (“FFDCA”) provides FDA the authority to automatically detain imported products including foods, pharmaceutical drugs, medical devices, cosmetics, tobacco products, biologics, and radiation-emitting devices due to any previous violations. Such products may be placed on a “Red List” of an Import Alert. FDA may detain red-listed products without physical exam at the port of entry.  For example, if FDA tests an imported food product and finds Salmonella, FDA may detain all future shipments of that product without needing to test the product.

Read more about FDA detentions and refusals here.

Most Import Alerts list products made by specific manufacturers, but Import Alerts may also be “country-wide”, meaning that they list certain types of product made in specific countries. For example, all foods produced in China containing vegetable protein are subject to detention without physical exam (“DWPE”) under Import Alert 99-29 for melamine contamination. A country-wide Import Alert may also contain a “Green List” which includes products exempt from DWPE under that Import Alert. Of course, FDA may still perform routine, surveillance exams and testing on green-listed products and may remove a product from the Green List if any violations are found.

How to Get Off the Red List

For a company to have its products removed from the Red List of an Import Alert, the company must submit a petition to FDA, detailing how the company has identified the source of the problem and is implementing specific, corrective actions that will prevent future violations.  As evidence that the problem(s) has been overcome, the company usually must present to FDA at least five consecutive shipments that are free of any violations of the FFDCA (“clean shipments”). Supporting evidence may also include monitoring records, revised Standard Operating Procedures (SOPs), third party audit reports, etc.

Common mistakes and problems that may result in the failure of an Import Alert petition:

  • Corrective action plan is inadequate – In the past, simply presenting five clean shipments to FDA was often sufficient for removing a company from a Red List. However in more recent times, FDA has shifted it regulatory focus to preventative measures and thus now typically requires an Import Alert petition to detail the measures taken to resolve the conditions that led to the violation(s).
  • Shipments are not of commercial-size – A company may not simply ship a small sample or split one commercial shipment into several smaller, non-commercial size shipments to meet the five clean shipment criteria. FDA has not formally established a “minimum size” for the shipments but as a rule of thumb, FDA considers a shipment to be of commercial-size if it has a value of 2,500.00 USD or more (the value at which Customs requires a shipment to be covered by an entry bond as a “formal entry”).
  • Shipments are not consecutively free of violations – For example, if three shipments are found to be free of FDA violations but FDA refuses admission of the fourth shipment for any violation, then the company must start over with 5 new, clean shipments. A shipment (delivered to any importer) found to contain any violation of the FFDCA may break the chain of consecutive shipments.
  • Shipments are not adequately spaced apart – FDA requires the shipments to be “routine, commercial” shipments, and thus the shipments should be adequately spaced apart. FDA has not established any specific timeframes required to separate the shipments, but requires that the shipments occur at a “reasonable” frequency to sufficiently demonstrate that the conditions that led to the violations have been resolved.
  • FDA does not detain a shipment – FDA must detain a shipment for it to count as evidence supporting an Import Alert petition. However, sometimes, FDA will inadvertently release a shipment subject to an Import Alert without first detaining it, resulting in the company losing the opportunity to use that shipment as evidence to support an Import Alert petition.  Therefore, the company should ensure that its importers are checking to make sure that FDA is detaining the shipments before releasing them.

Petitioning to be placed on a Green List

Product(s) included on a Green List of a country-wide Import Alert are exempt from DWPE under that Import Alert. As with Red List petitions, a Green List petition must provide assurances to FDA that measures have been taken to prevent violations from occurring.  FDA generally reviews Green List petitions much more exhaustively than Red List petitions, and the company should be prepared to address any compliance concerns, even those related to problems not covered by that particular Import Alert.  For example, if the company is petitioning to be added to the Green List of Import Alert 99-08 for melamine contamination, the company may be required to show that it has adequate measures to prevent microbial contamination as well.

Consequences of Being on an Import Alert

  • Importers bear the cost of any private lab testing required for the release of each shipment detained under the Import Alert.
  • The importer may incur significant costs related to the storage and transport of the goods needed for private lab sampling, staging of the products for FDA exam, etc.
  • Importers are disqualified from participating in FDA’s Voluntary Qualified Importer Program (VQIP) if they import foods from any company listed on an Import Alert Red List.
  • FDA’s Foreign Supplier Verification Programs (‘FSVP”) rule now requires food importers to approve their suppliers. When approving their suppliers, the importers must take into consideration whether or not the suppliers are subject to any Import Alerts. That doesn’t mean that importers are not allowed to import from those suppliers, but the importers must have written justification for importing from a supplier listed on an Import Alert.
  • It may take several weeks or longer for a shipment to be released after detention including the time required for private lab testing, FDA review of the evidence, etc.

Don’t hesitate to contact us to assist your company in being removed from any Import Alert Red List or added to a Green List!

FDA Now Accepting Applications for the Voluntary Qualified Importer Program (VQIP)

VQIP is a voluntary program in which food importers may participate to expedite release of their human or animal food shipments. FDA will not examine or sample shipments that are imported under VQIP unless warranted by public health reasons or for auditing purposes. FDA began accepting VQIP applications on October 1, 2018 and indicates they will review about 200 applications for the Fiscal Year 2020.

To participate in VQIP, an importer must submit an application to FDA and must:

  • Have at least a 3-year history of importing food into the United States.
  • Have a Data Universal Numbering System (DUNS) number. DUNS numbers are issued by Dun & Bradstreet (D&B) and can be obtained at: https://www.dnb.com/duns-number/get-a-duns.html.
  • Use a filer/broker that passed its most recent FDA filer evaluation.
  • Not import any foods listed on the Red List of any FDA Import Alert at the time of the VQIP application.
  • Not import any foods subject to a class 1 recall in effect at the time of the VQIP application.
  • Have a compliant history related to food safety and ensure that all applicable entities associated with the VQIP foods e.g. supplier, filer/broker etc. also have compliant histories related to food safety.
  • Have each foreign supplier of their VQIP foods certified in accordance to FDA’s Accredited Third-Party Certification program.
  • Submit to FDA a written Quality Assurance Program (QAP) for their VQIP.
  • Not have been subject to Customs regulatory action i.e. penalties, forfeitures, or sanctions related to food safety within the past 3 years.
  • Pay an annual user fee to FDA which FDA currently estimates to be about 16,400.00 USD/year.

According to FDA, once an importer is enrolled in the VQIP, FDA’s electronic entry screening system will release most shipments of the importer’s VQIP foods immediately after receiving the entry data from the Customs broker/filer.

Contact FDA Specialist today to find out how we can assist you in successfully applying for the VQIP!

Update 12/12/18! Congress has passed the 2019 Farm Bill which, if signed into law by the President, will lift federal restrictions on hemp production. As CBD is derived from hemp, this could lead to changes in the legal status of CBD oil products which, as noted in the article below, are actually not legal to market as dietary supplements under current federal law. FDA has previously stated that CBD products are “excluded from the definition of dietary supplements”. (Furthermore, FDA still considers any product marketed with claims or implied claims to treat, cure, mitigate, or diagnose and disease to be a drug product which may not be legally marketed as a dietary supplement.) We will continue to provide additional updates to the regulatory status of CBD oil, so check back here soon!


Law enforcement officials have taken regulatory action against cannabidiol (CBD) oil, a popular dietary supplement marketed for it for relaxation, anti-inflammatory, pain relief, and other benefits. For example, the Drug Enforcement Agency (DEA) has seized CBD oil products held for sale in retail stores, and FDA has issued warning letters to companies marketing CBD oil as dietary supplements. Yet, the product remains widely available in stores across the United States. Hence, the legal status of CBD oil remains a confusing issue even to federal and local regulatory agencies at this time.

In spite of CBD oil being a popular product in the United States, FDA has stated in warning letters that CBD products are “excluded from the dietary supplement definition” and thus are subject to drug regulation under the Federal Food, Drug, and Cosmetic Act. In addition, CBD is a controlled substance under the Controlled Substances Act.

FDA appears to focus its attention on products that are marketed using claims of treating, curing, diagnosing, or preventing any disease. The Agency has issued warning letters to firms for marketing CBD products as dietary supplements with claims of treating cancer, diabetes, high blood pressure, arthritis, mental disorders, and other conditions. FDA charged these products as unapproved new drugs.

In order to legally market a drug in the United States, a new drug application must be approved by the FDA for the product. FDA recently approved a CBD drug used for treating epilepsy, and this drug has been placed in the schedule 5 list of controlled substances, which clears the way for the product to be sold as a drug in the US. However, CBD products not approved by FDA for drug use remain as schedule 1 controlled substances which are not permitted for medical use under federal law.

In summary, CBD oil remains a popular product sold in stores across America though federal officials have taken enforcement action against the product. FDA currently maintains its position that in order to sell a CBD product in the United States, it must be covered by a new drug application. The issue remains the subject of much debate, so stay tuned to www.fdaspecialist.com for further developments!

FDA has begun to enforce the FSVP rule which requires food importers to maintain documentation and records verifying that certain steps have been taken to ensure that the foods they import meet US food-safety standards. Most food importers have been required to comply since May 30, 2017, and FDA is already inspecting food importers ranging from small to large companies!

For the purpose of the FSVP, FDA defines the importer (“FSVP importer”) as the US owner or consignee of the food shipment. If no US owner or consignee exists for the shipment, then the FSVP importer may be an agent or other authorized representative of the foreign supplier or owner. Each food from each supplier must have its own, separate FSVP! For example, if you import bean paste from two different suppliers, then each bean paste must have its own FSVP. If you import bean paste and also import dried noodles from the same supplier then again, each food must have its own FSVP. Certain foods such as foods that comply with the seafood or juice HACCP regulation are exempt from the rule.

The FSVP includes activities that must be performed, reviewed, and documented by one or more “qualified individuals”. FDA considers a qualified individual to be a person with the education and or experience that qualifies that person to accomplish the specific activity for the specific food. The activities include:

Hazard Analysis and Risk Evaluation – For each imported food, a qualified individual must identify and document all known or reasonably foreseeable food safety-related hazards including physical, chemical, and biological hazards. The qualified individual must then evaluate the risk of each hazard based on the severity of the hazard and the probability of the hazard occurring if not controlled.

Supplier Evaluation – A qualified individual must evaluate the food safety performance of the supplier taking into consideration, factors such as any FDA inspection results, third-party audit results, any FDA regulatory actions (e.g. warning letters, listing on import alerts, detentions, refusals, etc.), and effectiveness of any recalls. Note that FDA does not approve the suppliers. The importer must evaluate and approve the suppliers from which they import their food products and document the evaluation.

Verification Activity – The importer must periodically have a qualified individual(s) perform an activity that verifies that the supplier (or other entity responsible for controlling the food safety hazards) is effectively controlling the hazards. These activities may include on-site audits, private lab testing, or review of the supplier’s food safety records.
For example, if the importer’s qualified individual determines that Salmonella contamination is a reasonably foreseeable hazard for a food, then the company may choose to have the product periodically tested by a private lab for Salmonella. A qualified individual must determine the frequency and method of the activity. If the hazard could result in serious adverse health consequences or death, the importer should have an on-site audit of the supplier’s facility performed by a qualified individual at least once a year.

Corrective Actions – A qualified individual must review and document any corrective actions taken by the supplier in response to any problems related to the safety of the food.

Re-evaluation of FSVP – The importer must have a qualified individual re-evaluate the FSVP at least every 3 years to ensure it is sufficiently meeting the requirements of the FSVP rule. If the importer becomes aware of any changes or other new information that could affect the safety of the food, then the FSVP must be evaluated at that time as well.

Remember that a person FDA recognizes as a “qualified individual” must perform and document the above activities! Contact FDA Specialist to assist you as the qualified individual for your FSVPs!

In 2016, FDA published new requirements for food nutrition labeling that significantly change the appearance of the Nutrition Facts panels and the information required to be declared on the label. FDA provided time for companies to implement the changes and recently announced the dates by which food products marketed in the US must comply with the new requirements.

The new requirements include changes to the format of the Nutrition Facts panel, rounding rules for the nutrient values, and the Reference Daily Intakes (RDIs) used to calculate the %Daily Values (%DVs). For example, the old RDI for Total Carbohydrate was 300g and the new RDI is 275g. So if a food contains 10g of Total Carbohydrate per serving, the original %DV was 10/300 = 3%. But under the new RDI, the %DV is now 10/275 which rounds to 4%.

Also, you must now declare Added Sugars in addition to Total Sugars. For example, if the product is a fruit juice that contains 30g of Total Sugar per serving, but only 20g of sugar per serving naturally occurs in the juice (the remaining 10g is added to the product), then you would need to declare 30g of Total Sugar and 10g of Added Sugar in the Nutrition Facts panel.

The new rule also requires that the amounts of the vitamins and minerals be declared in the Nutrition Facts panel in addition to their %DVs. For example, a product containing 10mg of iron should now declare 10mg as the amount in addition to the %DV which would be 60%. Furthermore, Potassium and Vitamin D must now be declared in addition to Calcium and Iron. Vitamin A and C are no longer mandatory nutrients (unless the label includes a claim about the nutrient e.g. “good source of Vitamin C”).

In addition, several new formatting requirements for the Nutrition Facts panel are now in place. These include new minimum font sizes, positioning of bars and text, etc. The required footnote has also been changed to “The % Daily Value tells you how much a nutrient in a serving of food contributes to a daily diet. 2,000 calories a day is used for general nutrition advice.”

For manufacturers with $10 million or more in annual food sales, the compliance date is January 1, 2020. For manufacturers with less than $10 million in annual food sales, the compliance date is January 1, 2021. Remember, FDA may not be enforcing these new requirements until the above dates, but the requirements are now in effect. That means you should now be adjusting your nutrition labeling to follow the new requirements!

Always remember that labels are usually the first thing FDA officials see when they examine your product. Contact FDA Specialist today to ensure your food labels comply with the new requirements and prevent FDA charges for labeling violations that can be easily avoided!

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Richard Chiang worked for the FDA for 13 years beginning as a field investigator and entry reviewer and later worked at the FDA’s headquarters Center for Food Safety and Applied Nutrition (CFSAN)

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