NEWS ALERT - USTR’s newly Announced List 3 Exclusion process and List 4 Comment and Hearing Process

USTR published a Federal Notice on May 21, laying out the exclusion process for list 3. USTR anticipates that the exclusion period will open up on or around June 30^th. USTR estimates that over 60,000 US Stakeholders will request an exclusion for a particular product. On May 13, USTR proposed a 4^th list, which slaps a 25% tariff on roughly 300 billion worth of goods. From food products to furniture, the proposed list would include “essentially all products not currently covered” under previously imposed lists including literally thousands of irrelevant goods. If your product appears on any Section 301 tariff list there are three avenues to potentially get it removed. You may submit a comment, attend public hearings, or obtain an exclusion. Below is a big picture of the past and future opportunities get products off tariff lists:

CBP Now Issuing Penalties for Wood Packaging Material Violations

Due to the increase in penalties for wood packaging material (WPM) violations – we thought it important to remind the importing community that CBP is issuing WPM penalties and the background as to why.

On September 25, 2017, CBP issued Cargo Systems Messaging Service (CSMS) #17-000609 informing importers of CBP’s intent to issue penalties for wood packaging material violations. In the message, CBP states all wood packaging material (WPM) imported into the United States must have been treated at the place of origin, and contain the appropriate marking upon importation.  CBP is trying to “prevent the introduction of exotic timber pests,” and is encouraging the importing community to look towards alternatives to WPM and to educate your supply chains about ISPM 15 requirements.

Food Importers – Want to Expedite Your Importations with FDA?

 On January 2, 2018, FDA announced that it expects to begin accepting applications in early 2018 for its Voluntary Qualified Importer Program (VQIP), which we first advised you of back in 2015. VQIP is a voluntary, fee-based program for importers that will allow expedited review and importation of human and animal foods into the United States for approved applicants who achieve and maintain a high level of control over the safety and security of their supply chains. Below are the most important VQIP questions and answers from the FDA.

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

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:

The morning kicked off with a networking breakfast where experienced and novice industry members were able to engage in meaningful dialogue about overlapping issues they experience in their respective workplaces in dealing with the topic of FSMA. We heard comments from small to large business on their current implementation strategies in place to ensure they meet FSMA requirements by FDA’s compliance dates.

The seminar promptly began at 9:00 am with introductory remarks by our own President, Jennifer Diaz. We had all attendees introduce themselves and include why this seminar was important to attend. We were glad to hear from majority of attendees that their reason for participating was to further their education on FSMA. One attendee commented, “Excited to hear from FDA about FSVP requirements and what the broker’s role is in the process.”

Next Representatives of Miami Free Zone explained their role in international business solutions as it provides users and visitors with convenient international business resources including turnkey FTZ solutions for distribution; a wholesale marketplace; an international business center environment; and premium showroom, office, and warehouse spaces. As well as providing FTZ users with flexible control over their domestic and foreign inventory, duty elimination and deferment, and high security standards for their businesses and valuable merchandise.

The first speaker was Elena O. Asturias, is a licensed U.S. Customs Broker, and Certified Customs Specialist providing customs brokerage services for imports. Elena provided top tips for custom brokers as she has been involved in logistics for over fifteen years, and has experience handling a broad range of commodities. Some helpful tips from here presentation include:

• Make sure food facilities that must be registered with the FDA pursuant to the Bioterrorism act are registered to avoid delays upon entry into the U.S.
• A major issue causing FDA to detain food products are product labeling violations
• Ensure you use correct Affirmation of Compliance (AofC) Codes
  • When the entry is filed with FDA, use AofC codes to affirm the products meets specific import requirements.
  • Depending on the product type, many AofC’s are required, and must be submitted upon time of entry.
  • The AofC is a 3 letter indicator, then the qualifier which will vary in format. In some cases no qualifier is required.
    • Examples: PFR is the code used to designate a Manufacturer Food Facility Registration Number and it’s used with a 11 digit qualifier.
      • PFR 12345678901
      • FDA Affirmation of Compliance (AofC) Code Quick Reference
• FSVP – Unique facility identifier (UFI)
  • As of May 30th, you will need to add the UFI (Unique Facility Identifier) when you transmit the entry.
  • The AofC code being added is FSV, which will require the following:
    • DUNS number (as acceptable UFI)
    • Importer name & address
    • Email address
    • If the importer doesn’t have a DUNS number yet, you can transmit UNK “unknown” temporarily.
  • ENTRY DATA TRANSMISSION PROCESS:

• ITACS
  • ITACS – Import Trade Auxiliary Communications System
  • Importers are able to see the current FDA status (as long as they have the entry number), using the ITACS system (you have the ability to monitor your shipments without having to call your broker!).

Lundy Patrick followed Mrs. Asturias’ presentation and echoed the significance of being familiar with the importation process. Mr. Patrick is Lieutenant Commander serves as a U.S. Public Health Officer assigned to the Florida District Office of the FDA as an Imports Compliance Officer.  There were questions and answers during his presentation as the attendees had submitted questions prior to the seminar.  Here are highlights from the discussion:

• Articles are expected to be in compliance AT THE TIME OF ENTRY. Therefore, you need to exercise due diligence to make sure the products you intend to import are in compliance PRIOR to the importation of the goods.
• The following food imports require Prior Notice:
  • Food imported for use, storage, or distribution in the U.S. (including gifts and trade and quality assurance/quality control and market research samples)
  • Food transshipped through the U.S. to another country
  • Food imported for future export, or food for use in a Foreign Trade Zone, unless it is on the list of exemptions
• If you fail to provide Prior Notice, the food shipment is subject to refusal and, if refused, must be held at the port of entry unless directed to another location. The importing or offering for import into the U.S. of an article of food in violation of Prior Notice requirements is a "Prohibited Act" under the laws FDA administers.
• If a food product is assigned for examination/sampling, FDA will examine and will collect samples. Historically between 1-2% get examined/sampled.
• Lieutenant Commander Patrick echoed the importance of product label compliance and stressed FDA does not pre-approve labels for food products.
• He stated that the State of Florida, the third busiest district, has had over 8,000+ detention and 2200+ Refusals and provided the top reasons for food product detentions:
  • Labeling Issues:
    • Incorrect or missing statement of identity/name of the food
    • Failure to List potential allergens
    • Failure to declare ingredients
    • Failure to bear nutrition labeling or the nutrition label is in incorrect format.
  • Most common Import Alerts the FDA sees in Florida:
    • IA 16-81 - "Detention Without Physical Examination of Seafood Products Due to the Presence of Salmonella“
    • IA 99-05 - "Detention Without Physical Examination Of Raw Agricultural Products for Pesticides"
  • If Refused Goods are sold and Cannot be Redelivered for Export / Destruction, you may face:
    • Liquidated Damages and/or 19 USC 1592 Penalties

Thereafter, Giselle Jordan took the floor to discuss the hot topic of FSMA Compliance and Foreign Supplier Verification Program. Giselle is a Consumer Safety Officer at the Division of Import Operations of FDA. In August 2016, she joined the newly established Food Safety Verification Program Team. Here are highlights from her presentation:

• Resources:
  • FDA/FSMA   ß SIGN UP (there is a subscription feature available)
• FSMA Sec. 301 requires importers to have FSVPs and FDA to issue regulations.
  • The goal for FSMA is FOOD SAFETY
• Key Principles of FSVP Rule
  • Establishes explicit responsibility for importers to ensure the safety of imported food
  • Risk-based (according to types of hazards, importers, and suppliers)
  • Alignment with PC supply-chain provisions
  • Flexibility in meeting requirements (assessing activities conducted by others)

• Purpose of an FSVP
  • To provide adequate assurances that:
    • Foreign suppliers produce food using processes and procedures providing same level of public health protection as FSMA preventive controls or produce safety provisions
    • Food is not adulterated or misbranded (as it relates to allergen labeling)
  • Who Must Comply?
    • “Importer” is U.S. owner or consignee of a food at time of U.S. entry.
    • If no U.S. owner or consignee at entry, importer is U.S. agent or representative of the foreign owner or consignee, as confirmed in signed statement of consent to serve as the importer under FSVP (“FSVP Importer”).
    • Note that the responsibility for FSVP compliance lies with the FSVP Importer and the FSVP Importer can be different from the Importer of Record.
  • FSVP Exemptions
    • Firms subject to juice or seafood HACCP regulations
    • Food for research or evaluation
    • Food for personal consumption
    • Alcoholic beverages and alcoholic beverage ingredients (7%)
    • Food transshipped through U.S.
    • Food imported for processing and export
    • “U.S. foods returned”
    • Meat, poultry, and egg products subject to USDA regulation at time of importation
    • Low acid canned food facilities (microbiological hazards only)
  • Appropriate Verification Activities
    • Must document determination, performance, conduct, review and assessment of results
    • Verification activities include:
    • Onsite audits (qualified auditor), sampling and testing of the food, a review of foreign supplier relevant food safety records, other appropriate activities
  • To qualify as a “Very Small Importer”:
    • Must meet definition of a very small importer
    • Less than $1 million/yr. in human food sales
    • Less than $2.5 million/yr. in animal food sales
    • Annually documentation of eligibility
  • Compliance Dates
    • The final FSVP rule was published on November 27, 2015
    • First compliance date: May 30, 2017
    • Last compliance date: July 27, 2020
    • FSMA Food Guidance Regulation

Jennifer Diaz concluded the seminar with best practices for due diligence and best practices for responding to enforcement actions and FDA Notice of Action. Check out DTL’s TOP 10 TIPS for importing food products into the U.S.

For more information on how we can help you through the maze of importing and FSVP email us at info@diaztradelaw.com.

A special thanks to all our prize winner for participating during the seminar. We appreciate your involvement and interest! For pictures of the event LIKE us on Facebook.

Subscribe Today to keep up with the latest Customs and International Trade Law News.

Our next Live Broadcast webinar will be held on Wednesday, May 24, 2017 to discuss Intellectual Property Rights Violations and the U.S. Customs & Border Protections Enforcement. More information is available here.

DTL will also be at the NEI will be hosting the 3rd annual Global Trade Educational Conference held on August 7-8. NEI is bringing customs brokers, freight forwarders, NVOCCs, OTI, service providers, importers, exporters and all global logistics professionals an opportunity to update themselves on industry developments and connect with colleagues old and new. To RSVP - Read more. . .

*****This document is provided for informational purposes only and does not constitute legal advice nor does use of this constitute the formation of an attorney-client relationship.******

FDA Discusses TOP Reasons for Detention of Goods

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.  Contact me with any questions!

HOW TO GET OFF THE FDA BLACK LIST (Import Alert List)

What is the Black List?

The United States Food and Drug Administration (FDA) has authority from Congress to place an importer, manufacturer, shipper, grower, geographic area, or country on a “detention without physical examination” (DWPE) list (aka 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, you can search by country, company, etc. If your company is on this list, any merchandise you import may be detained as soon as it is offered for entry into the United States. You 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. The company/country, etc. will remain on this black list, until information is presented to the FDA that proves the merchandise is no longer violative.

How to Get Off the Black List