Import Alert

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Don’t be a Target, Learn Best Practices to Mitigate FDA Enforcement

posted by Jennifer Diaz May 27, 2021 0 comments

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.

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FDA Import Alert on Mexican Hand Sanitizer

posted by Jennifer Diaz February 4, 2021 0 comments

For the first time in history, the United States Food and Drug Administration (FDA) has issued a countrywide import alert for any category of drug product. Specifically, on January 26, 2021, the FDA announced that it will Take Action to Place All Alcohol-Based Hand Sanitizers from Mexico on Import Alert to Help Prevent Entry of Violative and Potentially Dangerous Products into U.S., Protect U.S. Consumers. FDA singled out importations of hand sanitizers from Mexico due to the frequent use of methanol.

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posted by Jennifer Diaz September 4, 2019 0 comments

FDA Warning LetterThe Food Safety Modernization Act (“FSMA”) is in full force and the U.S. Food and Drug Association (FDA) is now enforcing its Foreign Supplier Verification Program (FSVP) regulation. This blog discusses FDA’s first FSVP Warning Letter and illustrates what NOT to do when FDA starts asking questions about your products. The FSVP regulation requires that importers perform certain risk-based activities to verify that human and/or animal food imported into the United States has been produced in a manner that meets applicable U.S. food safety standards.

In the case of the U.S. importer who received the FSVP Warning Letter, their FDA issues started in the beginning of 2019 when a salmonella outbreak ravished multiple states and was traced back to the importer’s tahini product.

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Here’s a Recap of Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals on FDA FSMA and FSVP

posted by Jennifer Diaz May 19, 2017 0 comments

Yesterday, we at DTL, had the pleasure of hosting Part II of our #WorldTradeMonth Seminar Series for Compliance Professionals. The second seminar focused on FDA FSMA (Food Safety Modernization Act) Compliance for Importers with expert speakers from the U.S. Food and Drug Administration (FDA) and industry. We had a packed house with an array of attendees such as importers of food, beverages, and medical devices, along with customs brokers, freight forwarders / NVOCCs, lawyers, consultants, and others. We received requests for a re-cap from those who attended and industry members who were not able to attend. You asked and we deliver. Here is our recap:

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FDA Discusses TOP Reasons for Detention of Goods

posted by Jennifer Diaz March 20, 2013 0 comments

At today’s Import Operations Training, sponsored by the U.S. Food and Drug Administration (FDA) and the Florida Customs Brokers and Forwarders Association (FCBF), top officials from FDA traveled to Miami to educate importers and brokers.  Topics ranged from a general overview of FDA compliance, TOP rationales for FDA detentions, Food Safety and Modernization Act (FSMA) updates, an overview of the newly re-organized (now DIO) Division of Import Operations (formerly DIOP – policy has now been removed), an overview of CBP & FDA’s Joint Team 488 – which handles liquidated damages claims for underlying FDA violations and much more. Highlights of the TOP rationale for detentions follows, as I feel this is of most value to you to know and is arranged by commodity.

Food Products Top Rationales for Detention

  • Manufacturer (processor, packer or person holding food product) is not registered with the FDA pursuant to the Bioterrorism Act.  (You can Register with the FDA here: www.FDA-USA.com)
  • Low Acid Canned Foods (LACF) are imported without establishment registration (FCE #) or scheduled process (SID #)
  • The products are subject to an Import Alert
  • Product labeling is not compliant (FDA does not pre-approve food labeling, it is up to importers to assure it is compliant before importing)
  • Common labeling violations include:
  1. Label is not in English
  2. Incorrect or missing statement of identity
  3. Failure to list allergens
  4. Failure to declare ingredients
  5. Failure to include a proper “Nutrition Facts” label (incorrect formats for Nutrition Facts labeling is also common) required by 21 C.F.R. 101.9
  6. Color additives are not declared correctly (or at all) on the label or not certified
  7. Food  additives are unsafe or not declared on the label

Dietary Supplements Top Rationales for Detention

  • The products are subject to an Import Alert
  • Product labeling is not compliant (FDA does not pre-approve dietary supplement labeling, it is up to importers to assure it is compliant before importing)
  • Common labeling violations include:
  1.  Label is not in English
  2. Unauthorized health claims
  3. Undeclared active ingredients
  4. Lacks a “Supplement Facts” panel required by 21 C.F.R. 101.36
  5. Failure to list the name of product and “Dietary Supplement” or “Herbal Supplement” on the label
  6. Failure  to list the appropriate disclaimer necessary when claims are made

Cosmetics Top Rationales for Detention

  • The cosmetics are subject to an Import Alert (for example IA 66-38 for cosmetics labeled with drug claims)
  • The cosmetics are contaminated and unsafe to use
  • The cosmetics are manufactured under unsanitary conditions
  • The cosmetics contain a non-permitted color additive
  • Product labeling is not compliant (FDA does not pre-approve cosmetic labeling, it is up to importers to assure it is compliant before importing)
  • Common labeling violations include:
  1.  Label is not in English
  2. Labeling is missing ingredients
  3. Label lacks warnings and adequate directions for use
  4. Missing the net quantity of contents
  5. Cosmetic  contains a “drug” claim

Drugs Top Rationales for Detention

  • The cosmetics are subject to an Import Alert (for example IA 66-41 – Unapproved new drugs)
  • Drugs are not registered or listed with the FDA
  • Product labeling is not compliant (FDA does not pre-approve drug labeling, it is up to importers to assure it is compliant before importing)
  • Common labeling violations include:
  1. Label is not in English
  2. Label does not contain adequate directions for use
  3. Active Pharmaceutical Ingredients (API) is not properly labeled or listed
  4. Drug contains a “new” chemical or a different dosage making the product a “new drug”

Medical Devices Top Rationales for Detention

  • The manufacturers is not registered with the FDA
  • The initial importer is not registered with the FDA
  • The device is not listed with the FDA
  • The product does not contain a 510k or PMA
  • Product labeling is not compliant (FDA does not pre-approve medical device labeling, it is up to importers to assure it is compliant before importing)
  • Common labeling violations include:
  1. Label is not in English
  2. Label is false or misleading 

Bottom line, as you can see, it is up to you, the importer to perform pre-compliance and assure you get compliance right before you import.  FDA expects you to know the requirements and has little mercy if you don’t.  Assure you stay compliant and avoid the top rationale for FDA to detain your goods by hiring someone that is extremely knowledgeable with FDA’s laws and regulations and continually stays up to date with the constant changes. 

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International Boston Seafood Show – LIVE!

posted by Jennifer Diaz March 22, 2011 0 comments

I am at the final day of the annual International Boston Seafood Show held at the Boston Convention Center. With record attendance and a record number of exhibitors filling the convention center floor with extravagant booths overflowing with shrimp, fish, crab, lobster, and other seafood delectables from all over the world, the Show is a success.   After all, this is the largest seafood show in North and South America.  Perennial exhibitors Pescanova, Inc. and Preferred Freezer Services had the largest and most memorable displays.  In addition to my speaking on the topic of "Food Safety", my law firm exhibited at the Show for the first time, and shared a booth with food testing laboratory, ABC Research Corp.

Serious topics for the educational seminars included "Rebuilding Consumer Confidence in Gulf Seafood," and "Food Safety".   There was significant discussion of aquaculture.  For pure fun, the Show included a new Game Lounge, the 5th Annual Oyster Shucking Competition, the 2nd Annual Tweet & Meet Tweetup, and a keynote address from Wayne Rogers, the actor from the hit series M*A*S*H.

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FDA Import Alerts for Seafood

posted by Jennifer Diaz August 23, 2010 0 comments

Americans are constantly bombarded with warnings that the seafood we eat is contaminated with salmonella, listeria, or some other antibiotic, fungicide, or microorganism that will make us sick.  The U.S. Food and Drug Administration (FDA) is taking more samples of imported seafood, holding more seafood for laboratory analysis, and rejecting more seafood than in past years. That is true of basa from Vietnam, crabmeat from Indonesia, and a variety of seafood from countries as far away as China, or as close to the United States as the Bahamas.

The FDA issues ‘Import Alerts’ to attempt to prevent  contaminated seafood (or specific products) from certain overseas suppliers from entering the food supply chain in the United States.  Seafood importers should be very familiar with Import Alert 16-81 – "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella". 

The Obama Administration’s Import Safety Working Group Food Protection Plan encourages the FDA to issue more Import Alerts.  An Import Alert is an order to all FDA district officials to detain and examine imported seafood that is identified on an Import Alert, or to detain and examine any seafood shipped by an overseas company  that is listed on the Import Alert (i.e. the "Red List"). 

Import Alerts are issued on an almost daily basis by the FDA.  For Import Alert 16-81, the "Charge" reads as follows:

The article is subject to refusal of admission pursuant to Section 801(a)(3) in that the product appears to contain salmonella, a poisonous and deleterious substance, which may render it injurious to heath. [Adulteration, Section 402(a)(1).]

The explanation for such a food safety procedure was explained in a 2004 report to Congress by the U.S. General Accountability Office in Report 04-426 with a scathing criticism of the FDA’s "Food Safety" program.

More than 80% of the seafood that Americans consume is imported from an estimated 13,000 foreign suppliers in about 160 nations. If contaminated, imported and domestic seafood can cause foodborne illnesses with problems ranging from mild gastrointestinal discomfort to neurological damage.

Next year, when Congress passes, and the President signs, a new food safety law, suppliers, importers, warehouses, and transportation companies should all expect a lot more changes from the FDA.  The U.S. House of Representatives already approved H.R. 2749 entitled "Food Safety Enhancement Act of 2009," and the Senate is now debating S.B. 510 entitled "Food Safety Modernization Act of 2010." With reports that now 90% of our seafood is from overseas, the increased use of aquaculture, and the continuing threat of contaminated seafood, companies which are manufacturing, shipping, warehousing, and transporting seafood will have to face the reality of more government regulation.

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How To Get Off The FDA ‘Black List’

posted by Jennifer Diaz August 3, 2009 6 Comments

What is the FDA ‘Black List’ (Also Referred to as the Red List/Green List)?

The United States Food and Drug Administration (FDA) has authority to put an importer, manufacturer, shipper, grower, geographic area of a country, or an entire country on a “detention without physical examination” (DWPE) list  (a/k/a the FDA’s ‘Black List’).  To check if a company you are doing business with is on such a list, check FDA’s Import Alert page  or FDA’s Data Dashboard. You can search the Import Alert page by country, company, etc.  If your company is on this list, any merchandise you attempt to import into the United States may be detained by the FDA as soon as it is offered for entry into the United States.  An importer will have to prove to the FDA that the merchandise should be allowed to enter the U.S., otherwise, it will be refused entry and must be exported or destroyed within 90 days under very specific guidelines (each port follows their own process).  The company/country, etc. will remain on this ‘Black List’ until sufficient information is presented to the FDA that proves the merchandise complies with the FDA requirement.

How to Get Off the Black List

FDA’s Regulatory Procedures Manual provides guidance to those who wish to get off the ‘Black List’.  The specific method to use to get off the ‘Black List’ is directly related to why you were placed on the ‘Black List’ in the first place.  For example, if a food product was placed on the ‘Black List’ because it was deemed “adulterated” or “misbranded” by the FDA, a minimum of five consecutive non-violative commercial shipments must thereafter enter the U.S., and at least one of the five non-violative entries should be audited by the FDA to ensure compliance.  The five shipments must be over a reasonable time period, not one day.  Separately, a Petition must be filed with the FDA requesting that the importer be removed from the ‘Black List’.  The Petition must include the specific products being automatically detained, the Entry Numbers, and any other relevant documentation to detail steps taken to prevent entry into the U.S. of merchandise that violates the FDA’s many requirements. 

It is wise to know whether you or your company are on the FDA ‘Black List’, to know the FDA requirements to get off the list as soon as possible, and to take action, so that you too, can get off the FDA ‘Black List’.