1. Review Import Data for Accuracy

Begin with a thorough audit of your import data. Confirm that HTS classifications are correct and current, declared values accurately reflect your transactions, and country-of-origin determinations are well documented. Small mistakes can lead to large penalties.

2. Reassess Tariffs and Duty Exposure

Year-end is the ideal time to evaluate whether you are paying unnecessary duties and explore your options for tariff mitigation strategies. Consider what exclusions have changed, whether tariff engineering may reduce costs, or whether sourcing strategies should be updated. Many importers discover duty-saving opportunities simply by reassessing their tariff positions annually.

3. Strengthen Forced Labor Compliance

With UFLPA enforcement intensifying, importers must confirm that supplier information, ownership structures, and supply chain documentation are up to date. Now is the time to verify traceability records, refresh internal training, and assess whether high-risk suppliers require additional review.

4. Update Written Compliance Procedures

If your compliance manual or SOPs haven’t been updated this year, they’re likely outdated. Written processes should reflect current regulations, product updates, tariff changes, and internal workflow adjustments. CBP expects importers to document their compliance efforts clearly and accurately.

5. Conduct a Recordkeeping Audit

Recordkeeping is a key part of an importer’s duty to use reasonable care. Ensure you can quickly retrieve all required import documents from invoices and packing lists to HTS support, bills of lading, and supplier certifications. Recordkeeping failures are one of the most common issues CBP flags during audits, and year-end is the perfect time to clean up files.

6. Update Internal Training

Import compliance is only as strong as the people involved. Year-end is an excellent opportunity to refresh your team’s understanding of classification, valuation, country-of-origin rules, reasonable care, and forced labor compliance. Well-trained teams help prevent mistakes and reduce future risk.

7. Assess Audit Readiness

Consider how prepared your company is to respond to a CBP Form 28 or 29, a Focused Assessment, or a forced labor detention. If gaps or uncertainties exist, year-end provides the chance to correct them, strengthen documentation, or make a plan to improve your readiness approach over the coming weeks. 

8. Set Compliance Goals for the Upcoming Year

Finally, look forward. Establish measurable goals for the new year, whether it’s improving classification accuracy, reducing filing errors, tightening supplier oversight, implementing new technology, or enhancing training. Strategic goals help transform compliance from a reactive function into a competitive advantage.

Contact Diaz Trade Law for Compliance Help

A year-end compliance review is one of the most valuable things an importer can do to reduce risk, control costs, and prepare for the evolving trade environment. Diaz Trade Law has decades of experience helping importers with pre-compliance. With an increased focus on enforcement expected in 2026, NOW is the time to get your compliance strategy in order. Contact us today for assistance. 305-456-3830 or info@diaztradelaw.com.

Learn more:

• Bloomberg Law: CBP Recordkeeping Requirements
• Bloomberg Law: Responding to a CBP Form 28 or 29
• Bloomberg Law: What is an Importer’s Reasonable Care Standard?
• Band-Aid or Stitches? What’s Your Compliance Approach?
• UFLPA DHS Forced Labor Guidance – What Importers Need to Know
• Know Your Supply Chain: Forced Labor
• Webinar: Tariff Mitigation Strategies
• Webinar: Importing 101 – Introduction to U.S. Customs
• Webinar: ACE: Auditing Your Import History
• Webinar: CBP 201 – Building & Maintaining an Effective Import Compliance Plan

Pre-planning and investing in regulatory compliance measures are key to success

The US is the most lucrative wellness market in the world – and for some small and medium-sized enterprises (SMEs) that produce supplements, the potential for growth and a bigger bottom line is difficult to ignore. 

And who would blame them? The US wellness sector is valued at US$2tn and is poised to continue growing, recording an average annual growth rate of 8.3% between 2019 and 2023, according to research by the Global Wellness Institute. 

In contrast, China’s market, ranked the second-largest in the world, trails at a more modest US$870bn, followed by Germany at $310bn.

However, rushing in without being fully compliant could result in products being blacklisted or seized at the border, says Jennifer Diaz, an attorney and founding partner at Miami-based Diaz Trade Law, which specializes in customs and US Food and Drug Administration (FDA) laws and compliance.

Here, Diaz offers her top five tips for new brands to stay compliant and off the FDA’s blacklist.

1. Know the regulators

One of the first steps for SMEs planning to import supplements into the US is to register with the FDA, as they are considered a food product, Diaz says.

Companies also need to designate a US agent to act on their behalf before shipments begin.

“Most entities also don’t realize that the US has 47 regulatory agencies that can regulate imports and exports, so you may be dealing with multiple federal regulatory agencies that regulate your product,” she adds.

For example, the FDA, Federal Trade Commission (FTC) and US Customs regulate the imported supplements market, she says.

2. Beware of being blacklisted

One underestimated risk for SMEs launching their supplements in the US is the FDA’s import alert system, which Diaz describes as a blacklist for companies that have failed to comply with regulations.

This could be anything from mislabeling products to not using English on labels, making false medical claims, or failing to register with the FDA, Diaz explains, adding that it is time-consuming and costly to be removed from the list.

“Many SMEs don’t have the ability to survive the enforcement because the full weight of the government on you when you’re non-compliant is big,” she says.

“The government does not have the resources to hold your hand and help you when it comes to compliance – the expectation is that the product is already compliant and you’re smart enough to pick the right business partners and agents before you launch.”

3. Be wary of influencers

Marketing claims, even those from third parties such as influencers, also fall under FDA and FTC regulations, according to Diaz.

“What many don’t realize is that the FDA can legally make your life miserable over your marketing claims, in addition to what’s on your product,” Diaz says.

For example, suppose a business sends a supplement to an influencer to promote it on social media and they claim that it cured their cancer. In this case, the company is deemed liable if they don’t “de-escalate” the claim, Diaz explains.

“The FDA has the legal ability to issue a company a warning letter for the claims that they make on their website or for the claims that influencers make on their behalf on social media.”

4. Set a budget for compliance

Not spending the time or money on pre-compliance preparation can also lead to costly errors, says Diaz.

“It could be hundreds of thousands of dollars if your goods are seized or you receive an FDA audit or warning letter,” she says.

Diaz recommends that SMEs conduct independent testing in a laboratory to verify ingredient claims, as well as taking out product liability insurance to protect against litigation and organizing a legal review of all labels, ingredients and marketing content.

5. Protect your brand

Diaz also recommends that SMEs protect their brands by registering them with the US Patent and Trademark Office.

“Once you register your trademark, you should also record it with US Customs and then teach them how to spot copies of your brand, such as unique packaging,” Diaz says. 

“Customs then logs it in its secret database and it goes to all customs officers – there are 60,000 customs officers in the country at 328 ports of entry – and they will fine the offender and alert you if they spot a fake.”

With trade policy in flux, now is the time to ensure you are on solid footing by auditing your compliance strategies, reassessing tariff exposure, and ensuring your business is prepared for what’s ahead.

Audit Your Business Before CBP Does

Conducting an audit of your business to check for import compliance is an essential step to avoid costly penalties, thwart supply chain disruptions, and to minimize legal risk. An audit helps identify potential compliance gaps, ensuring that your existing business practices are in compliance with all applicable regulations. It also allows businesses to proactively address issues before they escalate.

Import Report Card

Diaz Trade Law can provide a customized ACE report card to give you an overview of your import compliance. The report contains a summary of your import transactions and identifies potential issues in your business’ processes as well as substantive recommendations to ensure compliance. The report provides information like:

• Your last 5 years of import history
• List of HTS’s you use
• Total amounts paid in AD/CVD
• Manufacturer ID’s reported to Customs
• Inconsistencies in reporting
• Total value of imports and duties paid by year
• Review of countries of origin of your imported merchandise
• Use of Free Trade Agreements
• Your surety, bond coverage, and bond type
• And more!

Lastly, the Report Card service includes a one hour debrief with a Customs and Trade Law expert on the findings and recommendations.

Pre-Compliance – Plan Now or Pay Later

Many mistake the ease of importing to mean there is no liability or obligation on the part of the importer. Whether your company is new to importing, or has been in the business for years, CBP expects importers to use “reasonable care” to ensure compliance with relevant rules and regulations.

Reasonable care requires importers to conduct themselves as a reasonable importer would under the circumstances with respect to importing goods into the United States.

Reasonable care requires importers to:

• Meet the standard to enter, classify and determine the value of imported goods
• Provide other information necessary to aid CBP in properly assessing duties and collecting accurate statistics
• Determine whether other applicable legal standards and requirements have been met

Diaz Trade Law has significant experience in a broad range of trade compliance matters, including helping companies customize their own import compliance program. The program can entail developing import compliance documents, ongoing training for various departments in your business, regular internal audits, record keeping, and more. Such a program can help you not only avoid penalties and potential criminal liability but can also help in the mitigation process should a violation be discovered. Remember, just because your goods have been allowed to enter the U.S. in the past, doesn’t mean those importations were compliant or that Customs will never pursue additional duties for those entries. 

Tariff Minimization

Tariff increases have a significant impact on businesses involved in importing goods into the U.S. However, importers are not without options. There are several legal ways to minimize tariff costs, including:

• Temporary Importation under Bond (TIB)
• Incoterms
• Duty drawback
• Tariff engineering
• Country of origin change
• First sale
• Duty deferral
• Free trade agreements
• Moving some manufacturing to the U.S.

Importers exploring options to minimize tariff liability should always work with an expert to ensure they comply with all U.S. Customs regulations before making any changes. Duty evasion, even if unintentional, is a serious matter and can result in hefty monetary penalties or even prison time in the case of fraud.

A Customs Attorney Can Help You Prepare and Adapt

Diaz Trade Law has significant experience in a broad range of trade compliance matters and can help your business navigate constantly changing trade policy. From evaluating your existing practices to building a compliance program from scratch, we can help. Contact us at info@diaztradelaw.com or call us at 305-456-3830.

Learn more:

• Webinar: Navigating Tariff Challenges: Mitigation Tools and Tactics
• Webinar: Navigating CBP Regulations: Essential Practices for Import Success
• Webinar: Building and Maintaining an Effective Import Compliance Plan
• Webinar: CBP: ACE – Auditing Your Import History
• Webinar: Introduction to Importing
• Bloomberg Law: What is an Importer’s ‘Reasonable Care’ Standard?
• Bloomberg Law: Customs Administrative Enforcement Process: Fines, Penalties, Forfeitures and Liquidated Damages
• Bloomberg Law: Tariff Classification Basics

We’d love to hear your feedback!

U.S. Customs and Border Protection (CBP)

• On February 2, U.S. Customs and Border Protection (CBP) successfully deployed the following functionality in the modernized ACE Portal:
  • Individual Licensed Broker (ILB) Indicator for Broker Employees
    • When viewing and editing a “Trade Employee,” users can now indicate that an employee is also a licensed broker
  • Improved Functionality for Uploading Employees
    • The bulk upload process now allows up to 200 employees to be uploaded
    • A new “Pending” status is displayed to show that a bulk upload is in progress
      • Important: When viewing the “View Uploads” list after completing an upload action, users should click the “Refresh” button periodically to view the updated “# of Successes,” “# of Errors,” and “Status” for the upload
    • Duplicate employees are no longer created
  • New Column on Broker Employees List
    • The “Employee End Date” field is now displayed as a column on the “Employees” list for “Broker Permit”
  • Check for Duplicate Social Security Numbers (SSN) when Creating an Employee Record
    • When creating a new employee, the system now prevents the creation of records with duplicate SSNs
• On March 18, 2023, CBP will deploy the Uyghur Forced Labor Prevention Act (UFLPA) Region Alert enhancement to the Automated Commercial Environment (ACE). This enhancement will provide an early notification to importers and their representative of goods that may have been produced in the Xinjiang Uyghur Autonomous Region (Xinjiang or XUAR) and may be excluded from importation into the United States. This enhancement includes electronic data interchange (EDI) impacts.

United States Attorney for the Southern District of New York 

• U.S. Attorney announces $22.8 Million settlement of civil fraud lawsuit against vitamin importer for underpaying customs duties owed on products imported into the United States. Under the settlement agreement approved by U.S. District Judge Mary Kay Vyskocil, IVC will pay $22,865,055 to the United States. As part of the settlement agreement, IVC also made admissions regarding its conduct. IVC admitted that, between 2015 and 2019, it utilized HTS classifications for 32 products it imported from China that carried duty-free rates, even though those products, if accurately classified, would have been subject to the payment of duties.

U.S. Government Accountability Office

• The U.S. Government Accountability Office has released their investigative report to the Ranking Member of the Subcommittee on Competition Policy, Antitrust, and Consumer Rights Committee on the Judiciary U.S. Senate. The report delves into Antidumping and Countervailing Duties.

If you have questions about these updates, contact our Diaz Trade Law attorneys at info@diaztradelaw.com or call us at 305-456-3830.

To receive an email notification whenever a new post is published, please subscribe to our weekly blog here.

U.S. Customs and Border Protection (CBP)

• In December 2022 alone, U.S. Customs and Border Protection (CBP) processed more than 2.5 million entry summaries valued at more than $260 billion, identifying estimated duties of nearly $6.8 billion to be collected by the U.S. government. In December, trade via the ocean environment accounted for more than 40 percent of the total import value, followed by air, truck, and rail.
• In December 2022, CBP identified 310 entries valued at more than $59 million for further examination based on the suspected use of forced labor, and which may be subject to a Withhold Release Order, Forced Labor Finding, or the Uyghur Forced Labor Prevention Act’s rebuttable presumption, and prohibited importation into the United States under 19 U.S.C. § 1307.
• CBP announced intellectual property rights violations continue to put America’s innovation economy at risk. Trade in counterfeit and pirated goods threaten the competitiveness of U.S. businesses, the livelihoods of American workers, and the health and safety of consumers.
• In December 2022, CBP seized 1,501 shipments that contained counterfeit goods valued at more than $178 million.
• CBP completed 26 audits that identified $86.9 million in duties and fees owed to the U.S. government, stemming from goods that had been improperly declared in accordance with U.S. trade laws and customs regulations. CBP collected over $25 million of this identified revenue and from previous fiscal years’ assignments.
• CBP announced new #quota updates on #brooms and #chocolate! For those similarly curious about the chocolate quota – check out more information here: https://www.cbp.gov/trade/quota/bulletins/qb-23-216“

U.S. Department of Agriculture (USDA)

• This rulemaking amends the United States Department of Agriculture (USDA) organic regulations to strengthen oversight and enforcement of the production, handling, and sale of organic agricultural products. The amendments protect integrity in the organic supply chain and build consumer and industry trust in the USDA organic label by strengthening organic control systems, improving farm to market traceability, and providing robust enforcement of the USDA organic regulations.
  • Topics addressed in this rulemaking include: applicability of the regulations and exemptions from organic certification; National Organic Program Import Certificates; recordkeeping and product traceability; certifying agent personnel qualifications and training; standardized certificates of organic operation; unannounced on-site inspections of certified operations; oversight of certification activities; foreign conformity assessment systems; certification of producer group operations; labeling of nonretail containers; annual update requirements for certified operations; compliance and appeals processes; and calculating organic content of multi-ingredient products.

Department of Homeland Security (DHS)

• In this final rule, the Department of Homeland Security (DHS) makes the 2023 annual inflation adjustment to its civil monetary penalties. On November 2, 2015, the President signed into law The Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015 (the 2015 Act).

Food and Drug Administration (FDA)

• The Food and Drug Administration (FDA) is essentially rejecting CBD in dietary supplements and conventional foods. The basic take-away is “Given the available evidence, it is not apparent how CBD products could meet safety standards for dietary supplements or food additives. For example, we have not found adequate evidence to determine how much CBD can be consumed, and for how long, before causing harm. Therefore, we do not intend to pursue rulemaking allowing the use of CBD in dietary supplements or conventional foods.”

If you have questions about these updates, contact our Diaz Trade Law attorneys at info@diaztradelaw.com or call us at 305-456-3830.

To receive an email notification whenever a new post is published, please subscribe to our weekly blog here.

We’d love to hear your feedback!

U.S. Customs and Border Protection (CBP)

• U.S. Customs and Border Protection is reminding the traveling public to be mindful that certain agricultural items such as raw eggs and poultry from Mexico are prohibited from entry into the United States, and failure to declare these items may result in monetary penalties.
• CBP released operational statistics today for December 2022, which can be viewed online here.

The Department of the Treasury’s Office of Foreign Assets Control (OFAC) 

• The Department of the Treasury’s Office of Foreign Assets Control (OFAC) is publishing two general licenses (GLs) issued pursuant to the Global Magnitsky Sanctions Regulations: GLs 3 and 4, each of which was previously made available on OFAC’s website.

Department of Commerce (DOC)

• Based on affirmative final determinations by the U.S. Department of Commerce (DOC) and the U.S. International Trade Commission (ITC), Commerce is issuing an antidumping duty order on certain preserved mushrooms from France.

Food and Drug Administration (FDA)

• The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled “Dosage and Administration Section of Labeling for Human Prescription Drug and Biological Products—Content and

Federal Trade Commission (FTC)

• The Federal Trade Commission has taken action against Instant Brands, manufacturer of Pyrex-brand kitchen and home products, for falsely claiming that all its popular glass measuring cups were made in the United States during a time some measuring cups were imported from China.

If you have questions about these updates, contact our Diaz Trade Law attorneys at info@diaztradelaw.com or call us at 305-456-3830.

To receive an email notification whenever a new post is published, please subscribe to our weekly blog here.

Department of Commerce 

• The United States Department of Commerce, International Trade Administration (ITA), is announcing one upcoming trade mission that will be recruited, organized, and implemented by ITA. This mission is: Executive-led Business Development Trade Mission to Kenya with optional (Gold Key) stop in Tanzania, March 28-30, 2023.
  • For further information contact, Jeffrey Odum, Events Management Task Force, International Trade Administration, U.S. Department of Commerce, 1401 Constitution Avenue NW, Washington, DC 20230; telephone (202) 482-6397 or email Jeffrey.Odum@trade.gov.
• The Secretary of Commerce, through the Office of Trade and Economic Analysis (OTEA) of the International Trade Administration, received an application for an amended Export Trade Certificate of Review. This notice summarizes the proposed application and requests comments relevant to whether the amended Certificate should be issued.
• DOC determines that countervailable subsidies are being provided to producers and exporters of barium chloride from India.
• On November 23, 2022, DOC published the notice of initiation and preliminary results of a changed circumstances review of the antidumping duty order on certain corrosion inhibitors from the People’s Republic of China. For these final results, Commerce continues to find that Kanghua Chemical Co., Ltd. (Chuzhou Kanghua) is the successor-in-interest to the Nantong Kanghua Chemical Co., Ltd (Nantong Kanghua).

International Trade Commission

• The U.S. International Trade Commission (USITC) has determined not to review an initial determination of the presiding administrative law judge, amending the complaint and notice of investigation to correct a respondent’s name.

U.S. Department of the Treasury, Office of Foreign Assets Control 

• The U.S. Department of the Treasury’s Office of Foreign Assets Control (OFAC) is publishing the names of one or more persons that have been placed on OFAC’s Specially Designated Nationals and Blocked Persons List (SDN List) based on OFAC’s determination that one or more applicable legal criteria were satisfied. All property and interests in property subject to U.S. jurisdiction of these persons are blocked, and U.S. persons are generally prohibited from engaging in transactions with them.

• OFAC is publishing two general licenses (GLs) issued pursuant to the Venezuela Sanctions Regulations: GLs 8K and 41, each of which was previously made available on OFAC’s website.

• OFAC is issuing this final rule to adjust certain civil monetary penalties for inflation pursuant to the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended by the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015.

U.S. Customs and Border Protection 

• U.S. Customs and Border Protection (CBP) officers working at the Brownsville and Matamoros International Bridge Port of Entry seized $931,739 in bulk, unreported U.S. currency.
• CBP officers at the Otay Mesa port of entry thwarted a significant smuggling attempt after discovering two live toucans wrapped in stockings hidden inside a traveler’s purse. The incident occurred at about 4 p.m., on December 26, when a CBP officer encountered two travelers, a 35-year-old male and a 37-year-old female, in a 2015 Toyota Camry, applying for entry into the U.S. at the Otay Mesa vehicle lanes.
• CBP officers in Louisville are seeing nightly counterfeit jewelry shipments arriving from locations known to produce fakes. On January 2, Louisville CBP seized a shipment of jewelry deemed to be counterfeit by CBP’s Centers of Excellence and Expertise, the agency’s trade experts.

If you have questions about these updates, contact our Diaz Trade Law attorneys at info@diaztradelaw.com or call us at 305-456-3830.

To receive an email notification whenever a new post is published, please subscribe to our weekly blog here.

With the passage of the Omnibus bill recently, the Food Drug and Cosmetic Act is also amended to include significant changes to cosmetics regulation, including: 

• Cosmetic Registration & Ingredient Listing (becomes mandatory, it is currently voluntary) 
  • Required in 1-year from enactment (this will be signed very soon). 
  • For products developed after enactment, 120 days of first marketing. 

• Serious Adverse Events 
  • Cosmetics will have a Serious Adverse Events requirement (same as OTC drugs and dietary supplements). Thus, the labels will need a U.S. phone number or mailing address to receive reports and the company identified on the label will report to FDA, as needed. “Serious Adverse Events” are events where your customer ends up harmed or having to go to the doctor. We can develop a system for this reporting requirement. 
  • Required 2 years from enactment. 

• Fragrance Allergen Declarations 
  • Labels must declare fragrance allergens (a change from merely declaring “fragrance”). 
  • Required 18 months from enactment. 

• Substantiation of Safety 
  • The legal standard is “adequate substantiation of safety,” which means data (tests, studies, research, analysis) considered sufficient by qualified experts to support “a reasonable certainty that a cosmetic is safe.”  “Safe” does not require the cosmetic or ingredient to cause no minor or transient irritation. The new law codifies FDA’s approach. 
  • We do not expect this requirement to be enforced often, absent serious safety concerns, or as a stand-alone charge. Much like the dietary supplement New Dietary Ingredient Notification requirements that mostly get enforced with there is a public safety concern. FDA will likely produce guidance on this, but we don’t think we should expect much enforcement without a significant resource allocation to enforcement. 
  • Effective 1 year after enactment. 

• Good Manufacturing Practice (GMP)s for Cosmetics 
  • FDA will establish GMPs for cosmetics. 
  • Will take more 3 years to establish regulations. 
• Perfluoroalkyl and Polyfluoroalkyl Substances (PFAS) Recommendations 
  • FDA will assess PFAS substances within 3 years. 
  • Various states have enacted laws regarding food and cosmetics packaging with intentionally-added PFAS. 
  • Expect PFAS to be banned widely. 
• FDA gains mandatory recall authority 
• Record keeping and records inspection rules 

Diaz Trade Law attorneys have vast experience in assisting companies in complying with FDA regulations. Contact us at info@diaztradelaw.com today to assist in assessing the impacts of the Omnibus bill and the Food Drug and Cosmetic Act amendments on the regulation of your cosmetic products.