Infrared Safety Regulation: What the 2025 Recall Means for Hotworx Franchisees

Your Hotworx investment depends on infrared saunas operating in a mostly unregulated space. That space is getting smaller.

In October 2025, the Consumer Product Safety Commission issued its first major recall of infrared fitness equipment — 78,000 sauna blankets pulled from the market for burn injuries. That same year, the FDA continued enforcing against companies making unsubstantiated health claims about infrared devices. Neither action targeted Hotworx directly. But both signal that the regulatory environment around infrared fitness is shifting from passive to active.

If you’re evaluating a Hotworx franchise, the question isn’t whether regulation will come. It’s who pays when it does.

There is no single federal agency responsible for regulating commercial infrared fitness studios. Instead, oversight is fragmented across multiple bodies, each covering a piece of the picture.

FDA jurisdiction. The FDA classifies certain portable far-infrared saunas as Class II medical devices, requiring 510(k) premarket notification and compliance with performance standards. This classification currently applies to devices marketed with therapeutic or medical claims — not to fitness equipment marketed for workout enhancement.

The distinction matters. Hotworx positions its infrared saunas as fitness equipment, not medical devices. But that positioning is a marketing decision, not a regulatory safe harbor. The FDA has demonstrated willingness to reclassify products when their actual use or marketing crosses the line.

FDA enforcement on health claims. In July 2022, the FDA issued a warning letter to Living Foods LLC (Therasage) for marketing infrared devices with unsubstantiated health claims including pain relief, detoxification, and immune system enhancement. This wasn’t a one-off. The FDA monitors health claims for infrared products and has the authority to act when companies overpromise.

CPSC jurisdiction. The Consumer Product Safety Commission oversees consumer product safety and has the power to mandate recalls, impose civil penalties, and set mandatory safety standards. Until 2025, the CPSC had not taken significant action on infrared fitness equipment.

State regulation. State health departments regulate gyms and fitness facilities, but infrared-specific rules are rare. Most state fitness facility codes were written before infrared studios existed. They cover basics — ventilation, sanitation, emergency exits — but don’t address infrared-specific risks like temperature regulation, burn prevention, or contraindication screening.

The regulatory gap. Commercial infrared fitness exists in a gray area between “fitness equipment” and “medical device.” Studios like Hotworx don’t market their saunas as medical devices, so FDA medical device regulations don’t apply. But the equipment produces physiological effects — elevated core temperature, cardiovascular stress, potential for burns — that go beyond a treadmill or weight rack. That gap won’t last indefinitely.

In October 2025, the CPSC announced the recall of 78,000 Lifepro Fitness Bioremedy Infrared Sauna Blankets due to the inability to regulate internal temperatures that could exceed safe limits. Dozens of burn injuries had been reported.

Three things make this recall significant for Hotworx franchisees:

• It’s the first major CPSC action on infrared fitness equipment. Prior to this, the infrared fitness category had no notable regulatory enforcement history. That’s no longer true.
• The failure mode is directly relevant. The recall wasn’t about a manufacturing defect in one batch. It was about a fundamental design issue — the inability to regulate temperatures. Temperature regulation is central to the safety of any infrared sauna, including the units in Hotworx studios.
• Regulatory expansion follows a pattern. Product category regulation typically accelerates after the first major recall. The CPSC now has infrared fitness equipment on its radar. Expect increased scrutiny, reporting requirements, and potentially mandatory safety standards.

This recall didn’t involve Hotworx equipment. But it established infrared fitness as a product category that regulators are actively monitoring. That changes the risk calculus for anyone investing in the space.

Regulation doesn’t arrive as a single event. It builds incrementally. Here are the plausible scenarios, ranked roughly by likelihood:

Mandatory safety certifications. The most probable near-term change. Commercial infrared equipment could be required to carry UL, ETL, or CSA safety certifications — third-party verification that the equipment meets established safety standards for temperature control, electrical safety, and burn prevention. Some commercial sauna manufacturers already pursue these certifications voluntarily. Making them mandatory would force any non-certified equipment out of commercial use.

Temperature monitoring and automatic shutoff requirements. New standards could require real-time temperature monitoring with automatic shutoff if internal temperatures exceed safe thresholds. This is essentially what the Lifepro recall flagged as missing. Expect this to become a baseline requirement for commercial infrared equipment.

Restriction on health claims. Already partially enforced at the FDA level, this could expand to state consumer protection enforcement. If your local marketing materials promise “detoxification,” “1.5x calorie burn,” or therapeutic benefits, you could face state-level action. Review the infrared trend risk assessment for a detailed breakdown of which claims the science supports.

Required medical disclaimers and contraindication screening. Infrared saunas are contraindicated for people with certain cardiovascular conditions, pregnant women, those on photosensitizing medications, and individuals with heat sensitivity disorders. Regulators could require studios to screen members and post medical disclaimers — similar to tanning bed regulations in many states.

State health department inspections. As infrared fitness grows, state health departments may develop inspection protocols specific to infrared facilities — temperature calibration verification, equipment maintenance records, incident reporting requirements.

FDA reclassification. The most disruptive scenario. If the FDA expands Class II medical device classification to include commercial infrared saunas used in fitness settings, the compliance burden jumps dramatically — premarket notification, quality system regulation, adverse event reporting, and manufacturing controls. This is unlikely in the near term but not impossible over a 10-year franchise agreement.

Regulation costs money. The question is how much, and who pays.

Equipment retrofits or replacement. A Hotworx location carries roughly $60K–$300K in infrared sauna equipment depending on configuration and studio size. If new safety standards require temperature monitoring upgrades, automatic shutoff systems, or entirely new equipment models, the replacement cost is substantial. Review the full equipment lifecycle and replacement costs analysis for baseline capital expenditure projections.

Compliance systems. Temperature monitoring hardware, documentation systems, incident reporting protocols, and emergency shutoff mechanisms. Estimate $5K–$15K per location for basic compliance infrastructure, plus ongoing monitoring costs.

Staff training and certification. If states require infrared-specific training for fitness facility staff, franchisees bear the cost — both the direct training expense and the labor cost of pulling staff for certification. For a concept that markets semi-absentee ownership, this adds operational complexity. Factor this into your hidden operating costs projections.

Insurance premium increases. As regulatory scrutiny raises the perceived risk profile of infrared fitness, insurers adjust. Expect premium increases in the 15–30% range if the category sees additional recalls or enforcement actions. The insurance and liability analysis covers the current liability landscape in detail.

Marketing material overhaul. If health claim restrictions tighten, every piece of marketing — local ads, social media, in-studio signage, website copy — needs review and revision. This isn’t just a cost; it potentially weakens the value proposition that drives member acquisition.

Total estimated compliance exposure per location: $20K–$80K for moderate regulatory tightening (new safety certifications, temperature monitoring, marketing changes). $100K–$350K+ if FDA reclassification or full equipment replacement is required.

This is where the franchise agreement matters more than the marketing brochure.

What the franchisor typically controls:

• Equipment sourcing and approved vendor relationships
• Brand-level marketing standards and materials
• Technology and system specifications
• Franchise-wide operational standards

What the franchisee typically bears:

• Local regulatory compliance
• Equipment purchase, maintenance, and replacement at your location
• Local marketing execution and compliance
• Insurance procurement and cost
• Staff hiring, training, and certification

The critical gray area: When the franchisor mandates a new equipment standard — say, upgraded saunas with integrated temperature monitoring — who pays for the swap? In most franchise agreements, technology and equipment upgrade obligations fall on the franchisee.

Review your franchise agreement carefully, specifically:

• FDD Item 6 (Other Fees): Look for technology fees, equipment upgrade fees, or compliance-related assessments the franchisor can impose.
• FDD Item 11 (Franchisor’s Obligations): What is the franchisor actually required to provide versus what they currently choose to provide?

Hotworx’s proprietary equipment relationships may limit your options. If regulation requires specific safety features, you can’t shop the open market for a cheaper compliant solution — you buy what the franchisor approves, at the price they negotiate. Check FranchiseGrade’s Hotworx review and FranchisePayback’s cost data for additional perspective on the financial structure.

Regulatory risk is real but manageable if you price it into your model and ask the right questions upfront. Here’s a due diligence framework:

Before Discovery Day:

1. Review your state’s current fitness facility regulations. Search for any pending legislation related to infrared equipment, sauna safety, or fitness device classification.
2. Check the CPSC recall database for any actions involving equipment used in Hotworx studios.
3. Review the FDD Items 6 and 11 for equipment upgrade obligations and fee structures.

During Discovery Day:

4. Ask directly: “If federal or state regulations require equipment modifications, who bears the cost?” Get the answer in writing if possible. Use the Discovery Day playbook for the full question framework.
5. Ask: “Has any equipment modification or safety upgrade been required at existing locations since opening? What did it cost franchisees?”
6. Ask: “What is the franchisor’s process for responding to new regulatory requirements?”

In your financial model:

7. Add a 5–10% annual compliance contingency to your operating budget. This accounts for incremental regulatory costs without assuming a worst-case scenario.
8. Model a one-time $50K compliance event in years 3–5 of your projections. If it doesn’t happen, that’s upside. If it does, you’re prepared.
9. Verify your insurance policy covers infrared-specific incidents and check whether your insurer has exclusions related to regulatory non-compliance.

Are Hotworx infrared saunas classified as medical devices?

No. As of 2026, Hotworx infrared saunas are marketed and classified as fitness equipment, not medical devices. The FDA’s Class II medical device classification for infrared saunas applies to devices marketed with therapeutic or medical claims. However, this classification boundary is determined by the FDA and could shift if the agency decides that commercial infrared fitness equipment warrants medical device oversight.

Could a CPSC recall affect Hotworx equipment specifically?

The October 2025 recall involved Lifepro Fitness sauna blankets, not Hotworx studio equipment. However, the recall established regulatory precedent for CPSC oversight of infrared fitness products. If safety concerns emerge with any commercial infrared sauna equipment — including the type used in Hotworx studios — the CPSC has the authority to investigate and mandate recalls.

What happens to my franchise if regulations require expensive equipment upgrades?

This depends on your franchise agreement. In most franchise structures, equipment replacement and upgrade costs fall on the franchisee. The franchisor sets the standard; you pay to meet it. Before signing, identify exactly which FDD provisions address equipment upgrades, technology mandates, and compliance-related costs. A $50K–$100K unplanned equipment upgrade in year 3 changes your return timeline significantly.

Should regulatory risk stop me from investing in Hotworx?

Not necessarily — but it should change how you model the investment. Every franchise carries regulatory risk of some kind. The issue specific to Hotworx is that infrared fitness sits in an unregulated space that’s attracting new regulatory attention. Price that uncertainty into your financial projections with a compliance contingency, verify your franchise agreement doesn’t leave you fully exposed, and make sure the unit economics work even if compliance costs add $15K–$25K annually to your operating expenses.