Licenses and Approvals That Food and Beverage Brands Often Underestimate in the U.S.

For food and beverage brands entering the U.S. market, demand and distribution are often top of mind. Founders focus on product fit, pricing, and partners, assuming regulatory approvals are a manageable checklist item. In reality, licensing and compliance are among the most underestimated and misunderstood aspects of U.S. expansion.

The U.S. food and beverage regulatory landscape is fragmented, multi-layered, and enforced at federal, state, and local levels. Missing or delaying a single approval can halt operations, delay shipments, void contracts, or expose the brand to fines and recalls. Many of these issues arise not from negligence, but from unfamiliarity with how U.S. approvals actually work.

Below are the key licenses and approvals food and beverage brands often underestimate when entering the U.S., and why early planning is critical.


FDA facility registration is not optional or one-time

Most imported and domestically produced food products fall under the oversight of the U.S. Food and Drug Administration. One of the first requirements is FDA facility registration.

This applies not only to U.S. manufacturing facilities, but also to foreign facilities that manufacture, process, pack, or hold food for U.S. consumption. Many overseas brands assume their local certifications or exporter status is sufficient. It is not.

Commonly overlooked points include:

  • Registration must be renewed every two years
  • Each facility requires its own registration
  • A U.S. agent must be designated for foreign facilities
  • Registration does not equal product approval

Failure to register properly can result in shipments being detained or refused at the port of entry. This often happens at the worst possible moment, when inventory is already in transit and customer deadlines are in place.


Food safety plans and preventive controls

Under the Food Safety Modernization Act, many food and beverage businesses are required to maintain documented food safety plans with preventive controls.

This is not a generic document. It must be tailored to the specific product, process, and facility. Brands often assume that co-packers or manufacturers will handle this entirely. While partners play a role, brand owners are still accountable.

Preventive controls typically cover:

  • Hazard analysis
  • Process controls
  • Sanitation procedures
  • Supply chain controls
  • Recall plans

During inspections or audits, regulators expect documentation to be current and accessible. Brands that lack proper plans risk warning letters, production shutdowns, or forced recalls.


State and local health permits vary widely

Beyond federal oversight, state and local health departments impose their own permitting requirements. These vary significantly depending on location and business model.

Examples include:

  • Food establishment permits
  • Warehouse and storage approvals
  • Sampling and tasting permits
  • Mobile food or temporary event permits

A common mistake is assuming that approval in one city or state automatically applies elsewhere. In the U.S., it does not. Each jurisdiction sets its own rules, timelines, and inspection standards.

Brands expanding distribution across multiple states often discover too late that local permits are required before products can be stored, sampled, or sold in certain locations.


Alcohol licensing is especially complex

For beverage brands involving alcohol, licensing complexity increases dramatically.

Alcohol is regulated at three levels:

  • Federal approval through the Alcohol and Tobacco Tax and Trade Bureau
  • State-level alcohol control boards
  • Local city or county authorities

Each layer has its own application process, fees, and timelines. Licenses are often tied to specific activities such as importing, wholesaling, manufacturing, or direct-to-consumer sales.

Key challenges include:

  • Long approval timelines that can exceed several months
  • Residency or ownership requirements in some states
  • Restrictions on shipping across state lines
  • Separate label approvals for each product variant

Underestimating alcohol licensing often results in delayed launches, unsold inventory, and frustrated distributors.


Labeling approvals and claims compliance

U.S. labeling rules are highly specific, and enforcement is strict. Even small errors can trigger enforcement action or require relabeling.

Common labeling issues include:

  • Incorrect nutrition facts formatting
  • Improper allergen declarations
  • Unsupported health or functional claims
  • Inaccurate ingredient order or naming

For alcohol and certain beverages, label approvals must be obtained before products can be sold. This includes approvals for brand names, alcohol content statements, and origin disclosures.

What may be acceptable labeling in another country is often non-compliant in the U.S. Brands that do not review labels carefully before production risk costly reprints or blocked shipments.


Import and customs related approvals

Food and beverage imports face additional scrutiny at U.S. ports of entry. Customs clearance involves more than paperwork.

Key considerations include:

  • Prior notice filings for imported food
  • Country of origin marking
  • Tariff classifications and duties
  • Random or targeted inspections

If documentation does not match physical goods or FDA records, shipments may be held for examination. Storage fees and spoilage risks add up quickly.

Many brands rely entirely on freight forwarders without understanding their own compliance responsibilities. This can lead to repeated delays and strained distributor relationships.


Zoning and use approvals for facilities

When opening a U.S. production facility, warehouse, or tasting location, zoning and land-use approvals are often overlooked.

Local authorities may restrict:

  • Food production in certain zones
  • Alcohol sales or sampling
  • Hours of operation
  • On-site retail or events

Signing a lease without confirming permitted use can result in expensive build-outs that never receive approval. Zoning due diligence should happen before any property commitments are made.


The cost of underestimating approvals

Underestimating licenses and approvals does not just create delays. It creates cascading risk.

Delayed approvals can cause:

  • Missed retailer launch windows
  • Contractual penalties with distributors
  • Inventory spoilage or write-offs
  • Loss of investor confidence

In some cases, regulators impose fines or require product recalls, which can permanently damage brand reputation.

The most successful food and beverage brands entering the U.S. treat compliance as part of market strategy, not a back-office task.


Final perspective

The U.S. offers enormous opportunity for food and beverage brands, but it is one of the most tightly regulated consumer markets in the world. Licenses and approvals are not hurdles to rush through. They are safeguards that require respect and planning.

Brands that underestimate these requirements often learn through costly mistakes. Those that plan early, understand the regulatory landscape, and secure the right approvals before launch gain a significant advantage.

U.S. expansion in food and beverage is not just about great products. It is about disciplined execution in a complex regulatory environment. When licensing and approvals are handled correctly, brands can focus on growth with confidence rather than firefighting compliance issues.

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