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Small brands, big barriers — how new U.S. import and FDA filing rules are reshaping Canada’s indie beauty trade.

Why Your Canadian Serums, Cosmetics, or Skincare Products Aren’t Duty-Free Anymore–and What To Do About It

Small beauty brands are being surprised with customs bills on shipments that used to be duty-free. Here’s what changed with U.S. import thresholds, why it matters for cosmetics, and how to stay compliant.

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The End of “Duty-Free” Imports and What Small Beauty Brands Need to Know

If you’ve recently sent or received a small skincare shipment — a serum, a beauty sample, or a gift set under $800 — and suddenly been hit with a huge customs bill, you’re not alone. Across North America, indie beauty founders and small exporters are being surprised by new FDA fees, warehouse charges, and import duties on packages that used to glide across the border duty-free. For years, Canadian clean-beauty brands could ship to U.S. beauty editors, PR agencies, and customers without worrying about duties or FDA holds. But as of August 2025, those days are over. That’s when U.S. Customs and Border Protection (CBP) suspended the de minimis exemption — the rule that once allowed goods under $800 to enter duty-free. Now, nearly every small beauty shipment headed south of the border falls under full customs review — from complimentary press samples and influencer mailers to direct-to-customer orders. So, what changed? Let’s break it down — and more importantly, talk about what you can do to keep your cross-border business compliant, cost-effective, and thriving.
What Was the “De Minimis” Rule—and Why Did It Matter?

For small brands, it was the silent cost-saver that made cross-border shipping possible

The “de minimis” rule (Section 321 of the Tariff Act of 1930) allowed U.S. imports valued under $800 to bypass duties and taxes (U.S. CBP, 2024).

That simple exemption quietly leveled the playing field for independent brands. It meant small skincare shipments could move quickly and affordably—without the weight of complex customs paperwork or costly brokerage fees. For Canadian clean-beauty founders sending press kits, PR samples, or small customer orders across the border, it was a financial lifeline.

The change doesn’t just add red tape—it reshapes how indie brands operate in a global market already strained by supply chain pressures and rising costs. As Vogue Business recently reported, as “tariffs threaten to disrupt global supply chains, beauty brands must adapt quickly, exploring reshoring and other strategies to stay competitive in a volatile trade landscape…. Smaller, independent beauty brands, lacking the financial flexibility of larger conglomerates, are particularly vulnerable to these shifts, which could reduce competition and diversity in the market.”

What Changed in 2025 and When Did It Take Effect?

US CBP now requires every parcel—no matter the value—to file a full customs entry

Under a White House executive order, the U.S. formally suspended duty-free treatment for all countries on August 29, 2025. (White House, 2025).

A full customs clearance means your shipment no longer moves automatically through the border. Instead, it’s held while a customs broker (like UPS or FedEx Trade Networks) files detailed import data with both U.S. Customs and Border Protection (CBP) and any applicable Partner Government Agencies (PGAs) — such as the FDA for cosmetics and personal-care items.

That process can include:
  • Entry preparation and duty calculation
  • Product classification and tariff verification
  • FDA “disclaim” or document submission (confirming the product is a cosmetic, not a drug or medical device)
  • Optional inspection or document review before release

While a simple entry might clear within 24 to 48 hours, anything flagged for FDA review can extend well beyond that. In most cases, UPS allows a three-day grace period while FDA clearance is pending. After that, warehouse storage fees apply — typically $25 per day for each held package.

For small beauty brands, this adds up quickly. A box containing $100 in product samples can accrue more in storage fees than the shipment’s total value within a week. What used to be a $0-cost, two-day delivery can now stretch into a $150 expense and a 10-day delay.

It’s not just about lost profit — it’s about lost momentum. Editorial mailers arrive too late for publication deadlines, influencer collaborations get postponed, and small businesses are left paying premium storage costs on what were once simple, routine shipments.

Why the Rules Changed—and Who’s Paying the Price?

Officials say the repeal will stop fentanyl shipments. Critics say it’s hurting small businesses instead

One of the main justifications for suspending the de minimis exemption was to close loopholes exploited by illicit shipments — especially those involving fentanyl and synthetic opioids that have devastated communities across North America. But are they catching the right targets?

So far, there’s little evidence that tightening controls on low-value shipments — like the kind sent by small consumer brands — will result in significant fentanyl seizures. CBP data shows that seizures at the U.S.–Canada border account for less than 0.1 percent of total fentanyl recovered nationwide — roughly 59 pounds between 2022 and 2024, compared to 61,900 pounds at the southern border (Government of Canada, 2024).

Critics argue the policy overcorrects: targeting micro-shipments that pose minimal risk while imposing new costs and delays on small exporters. Business Insider reports that “small importers are seeing orders held hostage by customs fees and brokerage surprises,” while Reuters notes that “it’s harder for small businesses to absorb tariffs” and many “plan to increase prices to offset costs.”

Even the National Treasury Employees Union (NTEU) — which supports closing the loophole — warned that CBP lacks the manpower to fully enforce the new requirements, creating “significant operational strain” that may hit compliant small shippers hardest.

In other words, while the policy may improve oversight in theory, its reach lands squarely on honest small businesses, not traffickers. For brands shipping a handful of skincare products or PR samples, a full customs clearance adds hours of processing, days of delay, and — if a parcel is held for FDA or PGA review — $25 per day in warehouse storage fees after the first three days.

How Does This Affect Small Canadian Skincare Brands?

Paperwork meant for smugglers is punishing small beauty brands instead

While cosmetics are regulated by the FDA, prior to July 9, 2025, low-value FDA-regulated products—including cosmetics—were often exempt from Partner Government Agency (PGA) filing requirements under the de minimis provision. As of that date, the exemption has ended. Now, all cosmetic shipments—even those valued under $800—must include full PGA data submission to the FDA during customs entry, following standard import procedures. GHy Trade Update.

This change means every cosmetic parcel crossing into the U.S. is now subject to FDA screening data through the Automated Commercial Environment (ACE) system used by customs brokers. Although most shipments still clear electronically, the process adds time, complexity, and, of course, new costs.

These PGA / FDA filings are not free. Brokers typically charge administrative fees per parcel and/or customs invoice line item to cover the data submission, verification, and agency reviews/clearance. Because every cosmetics shipment now triggers these requirements, the cumulative cost and complexity can disproportionately affect small businesses. For small beauty brands shipping low-value orders or PR samples, these costs add up quickly—and since shipments are held while these clearances are processed, even a few days can trigger warehouse storage fees that exceed the value of the products inside.

While policymakers claim these steps enhance national security and consumer safety, their real-world impact so far has been higher shipping costs, slower deliveries, and increased compliance pressure on legitimate small exporters. As The Washington Post reports, “small businesses have been particularly impacted, as they now face complex customs duties and increased costs.”

In practice, the new PGA and FDA compliance requirements are largely administrative — focused on electronic data submissions, automated targeting systems, and paperwork verification rather than expanded physical inspections or detection tools. CBP’s reforms are designed to improve visibility by giving officers more data up front, allowing high-risk parcels to be prioritized for inspection through automated risk scoring. PwC: CBP Data Enhancement Proposal.

However, these changes are not a broad expansion of on-the-ground enforcement capacity. If a trafficker submits falsified or misleading paperwork, automated systems may still flag the shipment as low-risk until additional intelligence or pattern analysis raises an alert. In other words, the reforms strengthen data transparency but could easily fail to catch illegal shipments. CBP: Frontline Against Fentanyl.

For small businesses, this creates a very different reality. The administrative layers intended to target high-risk goods now impose immediate, measurable burdens on legitimate exporters — from increased brokerage fees to longer processing times and more frequent warehouse holds. For now, these appear to be unintended consequences of a blanket policy change, rather than a proven tool for reducing fentanyl imports. Reuters: Impact on Small Businesses.

What You Can Do Right Now

A simple, up-to-date checklist to help you stay compliant — and minimize customs costs.

  1. Register Under MoCRA (FDA Cosmetics Regulation)

    The Modernization of Cosmetics Regulation Act (MoCRA) now requires facility registration and product listing for most cosmetics sold or distributed in the U.S.

    Doing this reduces the likelihood of FDA holds or clearance delays on import.

  2. Use the Right HTS (Tariff) Codes

    Always list accurate tariff codes on your commercial invoice so customs classifies your goods correctly.

    Incorrect or vague codes can trigger unnecessary FDA flags or extra brokerage lines.

  3. Provide Complete Documentation

    Each shipment should include:

  4. Get a U.S. Importer Number (Form 5106)

    If you regularly ship into the U.S., you can register as an importer so you pay duties directly — eliminating UPS’s disbursement fee.

    You can submit online through the ACE Portal or email it to your broker.

  5. Consolidate Shipments

    Whenever possible, combine several small orders into one parcel instead of sending multiple under-$100 packages.
    Fewer brokerage events = lower cumulative fees.

  6. Work With Experienced Brokers

    Choose a customs broker or courier familiar with FDA-regulated cosmetics. They can:

  7. Keep Records & Track Costs

    Maintain a file for each shipment with:

    This helps if you need to dispute fees or audit your import costs.

TLDR
  • As of August 2025, the U.S. de minimis exemption is suspended — even cosmetic shipments under US$800 must now go through full customs entry and FDA/PGA data filing.
  • The change shifts logistics from simple parcel shipping to data-driven screening, not expanded inspections.
  • While the goal is to intercept illicit goods, the real cost falls on small Canadian skincare brands, which now face delays, brokerage fees, and storage charges that often outweigh product value.
  • You can protect your brand by registering under MoCRA, using accurate HTS codes, consolidating shipments, working with brokers who understand cosmetic imports, and maintaining diligent records.
FAQs
Yes. Since July 9, 2025, the PGA filing exemption for low-value FDA-regulated goods is eliminated. Even parcels under $800 must include full FDA/PGA data at customs entry.
No. The change is primarily administrative — focused on data collection, electronic screening, and automated targeting. Physical inspections may still occur, but not every parcel will be opened.
Yes — if a trafficker submits convincing and plausible documentation, automated models may mark it low-risk. Only when additional signals or intelligence arise will the parcel be flagged for deeper review.
Shipments held for FDA review or brokerage processing can incur warehouse fees (e.g. $25/day after a grace period), extended lead times, and cumulative administrative costs that exceed the product’s value — especially for small-batch or sample shipments.
No — the FDA does not charge fees for cosmetic facility registration or product listing under MoCRA. The burden comes from the time, documentation, and compliance effort.
Small-scale cosmetic businesses with average U.S. sales under USD 1 million (and standard cosmetic products) may qualify for a registration/listing exemption under MoCRA.
No. MoCRA improves transparency and traceability, but it does not give you priority or fast-track status at the border. You still must comply with the same data rules and can be held for review if information is missing or mismatched.
  • Use accurate HTS tariff codes
  • Provide full documentation (INCI, origin, descriptions)
  • Consolidate small shipments where possible
  • Work with brokers experienced in cosmetic imports
  • Keep detailed records for dispute or audit
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