Beverage Quality Controls That Prevent FDA Iced Tea Recalls

When a regional beverage recall hits the news, the instinct is to focus on the company involved. That's the wrong instinct. The more useful question is: what would have caught this before a recall became necessary?

In early April 2026, the FDA announced that Wawa, of Media, PA, was recalling 16-oz. pints of its Wawa Brand Iced Tea Lemon, Iced Tea Diet Lemon, Diet Lemonade, and Fruit Punch beverages produced by the Wawa Beverage Company for sale across Pennsylvania, Delaware, Maryland, New Jersey, and the Virgin Islands. That's a multistate footprint, a regional brand with real consumer trust, and a product line that presumably had some kind of manufacturing process behind it.

And yet here we are.

I'm not interested in piling on Wawa. What I am interested in is the gap between "we have a process" and "our process actually catches problems before they reach customers." That gap is where recalls live. And it's a gap that a well-built quality management system closes.

What FDA Beverage Regulations Actually Require

Beverage manufacturers operating in the U.S. are subject to FDA's Current Good Manufacturing Practice (cGMP) regulations under 21 CFR Part 110 (for conventional foods) and, increasingly, the FSMA Preventive Controls for Human Food rule under 21 CFR Part 117. If your operation has annual sales above $1 million — and most regional beverage operations do — Part 117 applies to you in full, and the expectations are not light.

Under 21 CFR Part 117 Subpart C, a food facility is required to:

• Conduct a hazard analysis that identifies known or reasonably foreseeable biological, chemical, and physical hazards
• Establish preventive controls for each significant hazard identified
• Implement a supply chain program for raw materials and ingredients with identified hazards
• Maintain monitoring, corrective action, and verification procedures for each control point
• Keep records demonstrating the system is actually working — not just that it exists on paper

The regulation's effective dates have already passed for most operations. Large businesses (over $1M in annual sales) became subject to the Preventive Controls rule in September 2016. Smaller operations had staggered compliance dates, but by 2018, virtually all commercial beverage manufacturers were within scope. There is no grace period left. If you are producing beverages for retail sale and you don't have a documented Food Safety Plan under 21 CFR Part 117, you are out of compliance right now.

The FDA also expects manufacturers to have an established recall plan under 21 CFR Part 117.139. But a recall plan is not a prevention strategy — it's a response strategy. The goal is to never need it.

The Three Places Beverage Quality Systems Break Down

In my experience working with food and beverage manufacturers, recalls don't usually happen because a company had no quality system. They happen because the quality system had blind spots. Here are the three places I see those blind spots most often.

1. Incomplete Hazard Analysis

The hazard analysis is the foundation of everything. If you don't correctly identify a hazard at the outset, none of your downstream controls will address it. For ready-to-drink (RTD) beverages like iced tea and fruit punch, the relevant hazard categories include:

• Biological: Pathogens such as E. coli, Salmonella, mold, and yeast — particularly relevant in sugar-containing beverages that can support microbial growth
• Chemical: Sanitizer residues from CIP (clean-in-place) systems, heavy metals from water sources, improper ingredient concentrations
• Physical: Foreign material from ingredient handling, packaging materials, or equipment wear

A hazard analysis that skips chemical hazards because "we're a beverage, not a chemical plant" is incomplete. The FDA expects you to think through every input, every step in the process, and every realistic failure mode. A common blind spot in RTD beverages is the water source and treatment step. Water is typically the primary ingredient, and if the water treatment system isn't validated and monitored, you have an uncontrolled hazard sitting at the beginning of your entire process.

2. Untested or Inadequately Validated Controls

Having a control listed in your Food Safety Plan is not the same as having a control that works. Under 21 CFR Part 117.160, process preventive controls must be validated — meaning you need scientific or technical evidence that the control will actually prevent, eliminate, or reduce the hazard to an acceptable level.

For beverage manufacturers, this usually means:

• Pasteurization validation: Time-temperature records must demonstrate that your thermal process achieves the required lethality for your specific product. A process validated for one formulation may not be valid for a reformulation with different pH, Brix, or viscosity.
• Sanitation validation: CIP cycles must be validated to demonstrate effective cleaning and sanitizer removal. Residual sanitizer at excessive levels is a chemical hazard.
• pH and water activity monitoring: For beverages that rely on pH as a pathogen control (e.g., acidified beverages), continuous or frequent monitoring with calibrated instruments is required.

According to the FDA's own data, validation gaps are among the most cited observations in Form 483 inspections of food facilities. A 2023 FDA analysis of inspection outcomes found that inadequate process controls and failure to validate preventive controls consistently rank in the top five most common observations across food manufacturing sectors.

3. Weak Finished Product Testing Programs

This is the one I find myself returning to most often. Companies invest in hazard analysis and process controls, and then treat finished product testing as a formality. That's a mistake.

Finished product testing is your last line of defense before product leaves your facility. For RTD beverages, a robust finished product testing program should include:

• Microbiological testing: APC (aerobic plate count), coliform/E. coli, yeast and mold, and pathogen-specific testing depending on the hazard profile
• pH and titratable acidity: Especially for acidified or low-pH products
• Sensory evaluation: Trained panel or defined sensory protocol to catch off-notes, unusual appearance, or unexpected turbidity
• Accelerated shelf-life studies: Particularly important for new formulations or when ingredients change

The FDA does not prescribe a specific testing frequency for finished products, but your Food Safety Plan should define a sampling plan that is statistically defensible and risk-appropriate. Testing one bottle per batch and releasing the rest is not a defensible program for a product with a biological hazard profile.

What a Robust Beverage Quality System Looks Like

Let me be specific about what "good" looks like, because "good" is often described in vague terms that don't help anyone build anything real.

The difference between the "minimum" column and the "strong practice" column is often the difference between catching a problem internally and reading about your product on the FDA website.

How FSMA Changed the Compliance Landscape

Before FSMA, the regulatory framework for food manufacturers was largely reactive. FDA inspectors would show up, look around, and cite you if they found problems. Prevention was encouraged but not specifically required in the way it is now.

FSMA flipped that model. Under the Food Safety Modernization Act (signed into law January 4, 2011, with rolling implementation through 2016–2019), food facilities are now required to have a written, implemented, and verified preventive controls program. The law gave FDA new mandatory recall authority under Section 206 of FSMA, which is codified at 21 U.S.C. § 350l. Before FSMA, FDA could only request a voluntary recall. Now they can mandate one.

That matters for beverage manufacturers in a practical way: the regulatory exposure has increased. A problem that might have resulted in a voluntary correction before FSMA can now trigger a mandatory recall, a public enforcement action, and potential suspension of your facility registration under 21 CFR Part 1 Subpart H. The stakes are higher, and the systems have to be proportionate to the stakes.

Supply Chain Controls: The Underestimated Risk

One thing that often gets underweighted in beverage quality programs is the supply chain. Your finished product testing might be excellent, but if a contaminated ingredient gets into your process and your incoming material program doesn't catch it, you're building on a flawed foundation.

Under 21 CFR Part 117 Subpart G, the supply chain program requirements apply when a hazard in a raw material or ingredient has been identified as requiring a supply chain-applied control. For most RTD beverage manufacturers, this means at minimum:

• Tea and botanical ingredients: Subject to pesticide residue, microbial, and heavy metal concerns. A CoA alone is often insufficient — periodic independent testing of incoming lots is a stronger practice.
• Sweeteners and flavor concentrates: Can carry Salmonella (documented in low-moisture ingredients) and chemical adulterants. Your supplier's food safety program matters.
• Packaging materials: Migration of chemicals from packaging into the beverage is a recognized hazard for acidic beverages. Packaging supplier approval should include migration testing data.

According to the FDA's FSMA Supply Chain Program guidance, facilities must evaluate their supplier's food safety performance and conduct supplier verification activities that are appropriate for the hazard and the supplier's history. "We've been using them for years" is not a supplier verification program.

The Role of ISO 22000 and SQF in Beverage Quality

Many regional beverage manufacturers are asking whether certification to a GQSI-recognized standard — ISO 22000:2018, SQF Edition 9, or BRCGS Issue 9 — provides meaningful quality improvement beyond FDA regulatory compliance. In my view, it does, and here's why.

FDA cGMP and FSMA compliance establishes a floor. Third-party certification schemes add structure, audit pressure, and continuous improvement requirements that regulatory compliance alone doesn't demand. Specifically:

• ISO 22000:2018 integrates HACCP principles with an ISO management system framework, requiring documented objectives, management review, and continual improvement cycles under Clause 10
• SQF Edition 9 includes a food safety management system element (Module 2) and, for manufacturing sites, a food quality module (Module 12) that goes beyond food safety into product quality defects
• BRCGS Issue 9 includes prescriptive requirements for site standards, equipment, and production controls that are audited annually by a third-party certification body

None of these schemes replace FDA compliance. But a facility that has gone through the discipline of building to one of these standards typically has a more robust and more documented quality system than one that has only done the minimum to satisfy a regulatory checklist.

If you're a beverage manufacturer wondering where to start, I'd suggest beginning with a gap assessment against 21 CFR Part 117 to establish your compliance baseline, and then evaluating whether a certification scheme aligns with your customer requirements and risk profile. We've helped more than 200 clients through exactly that process at Certify Consulting, and the pattern I see is consistent: the companies that invest in the system before the problem are the ones that don't end up in the news.

Practical Steps for Beverage Manufacturers Right Now

If this recall is prompting you to look more critically at your own systems, here's where I'd focus first:

1. Pull your current Food Safety Plan and check the date. When was it last reviewed? If it hasn't been reviewed in the last 12 months — or if there have been ingredient, formulation, or equipment changes that weren't reflected in a reanalysis — you have a gap.

2. Verify your validation records are current. If you changed a formulation, switched a supplier, or modified your process in any way, your prior validation may not apply. Revalidation isn't bureaucracy — it's how you know your controls still work.

3. Run a mock recall. Pick a lot number from last week's production and trace it forward (where did it go?) and backward (what went into it?). Time it. Document it. If it takes more than two hours to account for 100% of a lot, your traceability system needs work. FDA expects you to be able to do this, and in a real recall, speed matters enormously.

4. Review your finished product release criteria. What has to be true before a batch ships? Is it documented? Is it being followed consistently? Are records being retained for the FDA-required minimum of two years (21 CFR Part 117.305)?

5. Talk to your team. Operators on the floor often know where the soft spots are. They know which step gets skipped when production is behind, which instrument hasn't been calibrated in a while, which supplier has been sending inconsistent material. That knowledge should be flowing into your quality system, not sitting in someone's head.

A Note on Regulatory Timelines

For any beverage manufacturer who has been treating FSMA compliance as an ongoing project rather than a completed one, the timeline to act is now. The FDA has been steadily increasing inspection frequency and enforcement activity since 2022, following a period of reduced inspection activity during the pandemic. The agency's stated priority areas for 2025–2026 include ready-to-drink beverages, acidified foods, and juice products — categories where both biological and chemical hazards are well-documented.

Mandatory recall authority is established. Facility registration suspension is on the table for serious violations. And the public announcement that follows an FDA-initiated recall carries reputational consequences that are difficult to recover from, regardless of the eventual root cause.

In my view, the cost of building a quality system that actually works is significantly lower than the cost of the alternative. A well-run beverage facility doesn't need to fear an FDA inspection — it treats one as a normal part of operating in a regulated industry.

If you're not sure where your program stands, a gap assessment against 21 CFR Part 117 and your applicable GFSI scheme is the right starting point. The gap assessment tells you what you have, what you're missing, and what the priority order should be for getting there.

Last updated: 2026-04-17