How to choose an FDA approved dry ice pack for shipping breast milk?
Introduction: When you need to ship frozen breast milk, using an FDA approved dry ice pack ensures your baby’s food stays safe and compliant. Dry ice — solid carbon dioxide at −109 °F (−78.5 °C) — keeps milk deeply frozen, but the pack’s materials must be safe for food contact. FDA approved packs undergo the Food Contact Notification (FCN) process, so you can ship confidently while following regulations. This guide explains why FDA approval matters, how to pack milk properly, alternatives to consider and emerging trends shaping cold chain logistics.
Why choose an FDA approved dry ice pack when shipping breast milk?
How do you pack frozen breast milk with dry ice safely and effectively?
How much dry ice is needed and how do rules like the 2.5 kg limit affect shipping?
What alternatives or complementary cooling methods are available?
What regulations and 2025 trends should you know about before shipping?
Why choose an FDA approved dry ice pack for shipping breast milk?
Direct answer: Using an FDA approved dry ice pack protects your breast milk from contamination and ensures regulatory compliance. The U.S. Food and Drug Administration regulates food contact substances under 21 CFR Parts 170–199. Manufacturers must submit data on composition, migration and toxicology; only after approval can they market the pack for direct food contact. This prevents chemicals from leaching into milk and avoids legal issues when shipping across states.
Background and practical context: An FDA approved pack goes through the FCN process, which scrutinizes both the gel and wrapper for safety. Non approved packs may use industrial polymers or dyes that can migrate into food, including ethylene glycol or propylene glycol. Because breast milk is consumed by infants, ensuring the pack’s materials meet federal safety standards reduces health risks and simplifies interstate shipments. HMBANA accredited milk banks, such as the Northwest Mothers Milk Bank, follow CDC, FDA and WHO guidelines and rely on dry ice to keep milk deeply frozen during transport. Choosing approved equipment aligns home shippers with the same standards.
What qualifies as a food grade dry ice pack?
An FDA approved dry ice pack must meet several criteria:
Food contact safety – Both the gel and wrapper must be food safe. Approved desiccants include amorphous silica gel and synthetic zeolites; natural clays and food grade calcium oxide are also listed under GRAS notices.
Proper labeling – The pack should display a “Do Not Eat” warning, lot codes and references to CFR sections, allowing traceability and recall if needed.
Direct vs indirect contact – For direct contact, all materials touching food must be compliant. For indirect contact (gel sealed within a compartment), the outer barrier must prevent migration.
Ventilation design – The pack should allow carbon dioxide gas to escape as dry ice sublimates to avoid pressure buildup.
Understanding these factors helps you pick a pack that protects milk and meets legal requirements.
| Cooling method | Typical temperature range | Typical duration | Implication for your shipment |
| FDA approved dry ice pack | −109 °F (−78.5 °C) sublimating to vapour | Up to 24 hours in a lunch cooler; up to 72 hours in insulated shipping kits when combined with proper insulation and quantity | Keeps milk completely frozen; requires gloves and venting; both gel and wrapper must meet FDA requirements |
| Reusable gel pack | 32 °F to −12 °C depending on formulation | 4–12 hours | Non toxic polymer or cellulose gels are GRAS; ideal for chilled (not frozen) shipments such as postpartum travel or daytime transport |
| Water pack | Around 32 °F (0 °C) | ~2 hours in an insulated box | Simple, natural option with no regulatory burden; suitable for short car trips where milk should remain chilled rather than frozen |
Practical tips and advice
Verify the food contact statement – Always check packaging for clear FDA statements or GRAS references.
Check wrapper and ink quality – Labels should be legible; faded warnings signal possible counterfeit or expired packs.
Right size matters – A 10 L insulated cooler typically needs about 0.5–1 lb of dry ice for 8–12 hours of freezing. Overfilling reduces airflow and efficiency.
Use within recommended time – Even the best pack warms over time; plan to refreeze or use within the expected duration.
Add insulation – Reflective liners, vacuum insulated containers or extra newspaper layers extend cooling.
Real case: A Washington milk donor transporting frozen milk to a HMBANA accredited bank used FDA approved gel ice packs and insulated coolers. By verifying food contact safety and adding insulation, she kept milk below 40 °F and avoided leaks; the bank praised the high quality and avoided liability issues.
How do you pack frozen breast milk with a dry ice pack safely?
Direct instructions: Freeze the milk bags flat, double bag them for leakage protection and place them in an insulated cooler. Layer cushioning material like newspaper at the bottom, then add a wrapped dry ice pack. Keep the dry ice above or beside the milk but separated by cardboard or paper. Leave vent holes in the cooler lid so carbon dioxide can escape. Seal the cardboard shipping box lightly; do not create an airtight seal. Mark the package “Dry ice – Carbon dioxide solid” and specify the net weight to comply with 49 CFR § 173.217.
In depth explanation: Milk should be frozen at −18 °C (0 °F) before shipping; partial thawing reduces quality. Use heavy duty ziplock bags and place them in a secondary sealed bag to catch leaks. For long distance shipping, line a thick Styrofoam or EPS foam cooler with crumpled newspaper, place the milk inside and add dry ice on top; additional newspaper fills gaps and prevents shifting. Always wear insulated gloves and protective eyewear when handling dry ice to avoid frostbite and burns. The Children’s Hospital of Philadelphia warns to store dry ice in the trunk when driving and ensure good ventilation to prevent CO₂ build up. For air travel, the Federal Aviation Administration (FAA) and DOT limit dry ice to 2.5 kg (5.5 lb) per package and require vented packaging with appropriate marking. Milk banks like NWMMB pack milk in insulated containers with dry ice, include temperature indicators and verify cold chain compliance during overnight shipping. Following these steps keeps milk safe for your baby and protects you from regulatory penalties.
How much dry ice do you need?
The amount depends on trip length, container insulation and payload weight. Use this guide:
| Shipping duration | Recommended dry ice weight | Real world benefit |
| Overnight (12–24 h) | About 0.5 × payload weight; 5–10 lb for standard cooler | Keeps milk completely frozen for one day without excess weight; cost effective for short trips |
| Two day (24–48 h) | Approximately equal to payload weight | Ensures continuous freezing even if delivery is delayed by a day |
| Three day (48–72 h) | 1.5 × payload weight | Suitable for cross country or international shipments; still within 2.5 kg per package limit for each box if weight is distributed |
Tips for determining quantity: Dry ice sublimates at roughly 5–10 lb per 24 hours depending on container density. Factor in additional ice for anticipated delays, as recommended by UPS Healthcare packaging experts who add an extra 24 hours of dry ice for risk mitigation. When shipping multiple days, divide milk into several packages to stay below the 2.5 kg limit per package.
Packing scenarios and solutions
Weekend relocation: For a 48 hour cross country move, freeze milk, layer it in an EPS cooler with 8 lb of FDA approved dry ice and ship early in the week. Use temperature loggers to monitor the shipment, and choose overnight courier services; label properly to meet DOT and IATA rules.
Air travel: When flying with milk, many airlines permit up to 5.5 lb of dry ice per passenger. Pack dry ice in a vented cooler, declare it at check in and leave the lid slightly ajar. Do not seal the cooler with duct tape. Check with the airline for specific rules.
Local donation: For local milk bank drop offs, gel packs may suffice if the trip is under two hours. However, if you’re delivering to a bank that requires milk to arrive frozen, use a small FDA approved dry ice pack and inform the staff on arrival.
Real case: A military family shipped 400 oz of milk to a donor bank across country. They froze milk flat, placed it in a foam cooler, added 1.5× the weight in dry ice and left vent holes. Despite transit delays, temperature indicators showed the milk remained below −20 °C. The shipment complied with 49 CFR 173.217 marking rules and was accepted by the milk bank without issues.
Alternatives and complements to FDA approved dry ice packs
Direct answer: Dry ice packs keep breast milk frozen, but they’re not always necessary. Reusable gel packs, water packs, phase change materials (PCMs) and vacuum insulated shippers can maintain chilled temperatures for shorter trips or sensitive products that shouldn’t freeze. Combining dry ice with gel packs can extend cooling while avoiding over freezing.
Expanded discussion: Dry ice has an extremely cold temperature of −109.3 °F (−78.5 °C), making it ideal for products that must stay frozen. Yet some biologics and thawed milk degrade if exposed to deep cold. UPS notes that combining dry ice with other coolants can be prudent when transit times exceed two days. Reusable gel packs maintain around 2 °C–8 °C and are non toxic; they’re suitable for short term transport and postpartum travel. Water packs are inexpensive and natural but offer only ~2 hours of cooling. Phase change materials, engineered to melt at specific temperatures, offer longer duration without extreme cold. FedEx’s cold shipping kits, for example, hold 2 °C–8 °C for up to 96 hours and require no dry icelocalhost. Hybrid kits combining dry ice with PCMs provide an initial deep freeze followed by stable refrigeration once the dry ice sublimates; such systems reduce dry ice quantity and weight.
Gel packs vs dry ice for breast milk shipments
When choosing between gel packs and dry ice:
Temperature needs: If milk must remain frozen, dry ice is mandatory. For chilled (but not frozen) transport — for example, carrying pumped milk home from work — gel packs suffice.
Safety and handling: Gel packs are easier to handle; dry ice requires gloves, eye protection and ventilation. For novice shippers, gel packs reduce risk.
Cost and logistics: Gel packs are reusable and cheaper but may require returning packaging to remain cost effective. Dry ice packs provide more cooling per weight but involve hazmat paperwork and can be more expensive to source.
Environmental impact: Dry ice sublimates to CO₂ gas and leaves no residue, but production can contribute to carbon emissions. Many gel packs now use plant based, non toxic gels and recyclable liners. Sustainable dry ice production and biodegradable wrappers are emerging trends.
| Method | Temperature range & duration | Pros | Cons | When it’s best |
| Dry ice pack | −109 °F; 24–72 h depending on quantity | Keeps milk fully frozen; no liquid residue; extremely high cooling capacity | Requires handling precautions; limited to 2.5 kg per package; regulated labeling | Long distance shipments and milk bank donations |
| Gel pack | 2 °C–8 °C for 4–12 h | Safe, reusable, non toxic; no special regulations | Cannot keep milk frozen; may leak when thawed | Commuting or short trips where milk need only stay cool |
| PCM pack | Custom melt points, typically 5 °C or −20 °C; 24–96 h | Stable temperature; reusable; less extreme than dry ice | Higher cost; requires preconditioning | When precise temperatures are needed without deep freezing |
| Vacuum insulated shipper | 2 °C–8 °C up to 96 hlocalhost | Eliminates dry ice; simple activation; fewer regulations | Not suitable for keeping milk frozen; higher upfront cost | International shipments of fresh or thawed milk |
Choosing the right method
For postpartum travel within a city, gel packs are often sufficient. For shipping frozen donor milk cross country, FDA approved dry ice packs remain the gold standard. Combining dry ice with gel packs can balance freezing and cooling, ensuring the milk doesn’t thaw or suffer freezer burn.
Real case: A corporate traveler pumped milk during a weeklong trip. She stored milk in hotel freezers, then used a PCM cooler to keep it at 2 °C–8 °C during flights home. Because the milk wasn’t fully frozen, she avoided dry ice regulations yet maintained quality. The cooler’s integrated temperature indicator gave her peace of mind.
Regulatory compliance and safe handling of dry ice shipments
Direct answer: Shipping breast milk with dry ice is regulated by DOT, FAA and IATA. The key rule is that each package may contain no more than 2.5 kg (5.5 lb) of dry ice and must be labeled “Carbon dioxide, solid” or “Dry ice” with the net weight. Packages must be vented to release CO₂ gas and marked with the contents being cooled. For diagnostic or treatment purposes, shipping papers can be waived if proper marking is present.
Detailed discussion: Dry ice is classified as a hazardous material (Class 9), so training is required for anyone preparing shipments exceeding 5.5 lb. Airlines limit passengers to 5.5 lb and require approval and labeling. UPS recommends using EPS containers and adding enough dry ice for transit plus a 24 hour buffer. Do not seal containers airtight; use vent holes to prevent explosions. The CHOP travel guide advises wearing gloves, keeping dry ice in the trunk when driving and disposing of unused dry ice outdoors. Milk banks use temperature indicators and cold chain verification for every shipment and follow HMBANA guidelines, which align with CDC and FDA standards. Finally, carriers like UPS or FedEx have their own requirements; for international shipments you must follow IATA Packing Instruction 954. Familiarize yourself with these rules to avoid fines or shipment delays.
Checklist for compliant packaging
Prepare documentation: Include a note stating “Dry Ice” along with UN 1845 and the net weight. For diagnostic/treatment milk (e.g., donor milk), shipping papers may be exempt but marking is still required.
Vent the package: Use a foam cooler with a loose lid or vent holes; never seal dry ice in an airtight container.
Use correct weight: Keep each package under 2.5 kg (5.5 lb) of dry ice; if more is needed, divide the shipment into multiple boxes.
Label clearly: Print or write “Contains Dry Ice (Carbon dioxide, solid)” and the net weight; mark the contents as breast milk or human milk.
Protect yourself: Wear insulated gloves and avoid inhaling CO₂ gas; handle dry ice outdoors or in a well ventilated area.
Check carrier policies: Contact your airline or courier beforehand. Some carriers require you to sign a special commodities contract.
Real case: A researcher shipping human milk samples for nutritional analysis followed DOT and IATA rules by using three separate boxes with 2 lb of dry ice each. She labeled each box with “UN 1845 Carbon dioxide, solid” and included the net weight. Because she observed the 2.5 kg limit and used vented coolers, the samples passed customs quickly and arrived frozen.
2025 innovations and trends in FDA approved dry ice packaging
Trend overview: The cold chain industry is rapidly evolving. In 2025, sustainable materials and smart monitoring dominate conversations. Researchers are developing carbon negative dry ice by capturing CO₂ from industrial emissions and repurposing it. Plant based aerogels and biodegradable wrappers offer the same insulation performance but reduce environmental impact. Smart packaging with integrated sensors provides real time temperature data, allowing shippers to intervene before milk thaws. Hybrid kits combine dry ice with phase change materials to reduce overall dry ice consumption and weight. Reusable containers with data loggers are becoming standard for milk banks and high value shipments.
Latest developments at a glance
Carbon negative dry ice: Manufacturers are starting to capture CO₂ and convert it into dry ice, reducing greenhouse gas emissions. This makes shipping more sustainable.
Smart sensors and IoT tracking: Packaging companies are embedding sensors that monitor temperature and location, sending alerts to parents or milk banks if temperatures drift. Some sensors integrate with smartphone apps for real time visibility.
Plant based aerogels: Innovative insulation materials derived from cellulose or rice husks offer high R values while being compostable. These replace petroleum based foams.
Hybrid cooling kits: Combining dry ice with PCMs extends cooling and reduces weight. This approach is especially useful when shipping internationally, where re icing may not be possible.
Reusable containers and subscription services: Milk banks and parents increasingly subscribe to reusable shipper programs. After each use, the container is returned, sanitized and recharged with dry ice or PCM for the next shipment. This reduces single use waste and total cost.
Market insights: The dry ice market is growing due to increased demand from pharmaceuticals, food delivery and personal shipments. Industry observers note a shift toward localized production hubs to reduce transport losses and shortages. Reusable cold chain packaging is projected to grow significantly by 2034 as companies prioritize sustainability. Consumers and donors increasingly prefer suppliers that offer eco friendly and ethically sourced materials, pressuring the industry to adopt greener solutions.
Frequently asked questions
Q1: Can I use a homemade dry ice pack or regular ice when shipping breast milk?
DIY packs made from frozen water bottles or homemade gels are not recommended for frozen milk because they lack FDA approved materials and don’t stay cold enough. Use FDA approved dry ice packs for frozen shipments and gel packs for chilled transport.
Q2: How long will my breast milk stay frozen with a dry ice pack?
With proper insulation and enough dry ice, milk can remain frozen for 48–72 hours. Factor in 5–10 lb of dry ice per day and add a 24 hour buffer to account for delays.
Q3: Is dry ice allowed in carry on luggage for air travel?
Yes, but airlines limit you to 5.5 lb (2.5 kg) and require you to declare it. The cooler must be vented and labeled “Dry ice.” Check with your airline and abide by FAA and IATA rules.
Q4: How do I dispose of unused dry ice after my milk arrives?
Let unused dry ice sublimate in a well ventilated area away from children and pets. Do not throw it in a sink or trash bin, as the rapid gas release can damage plumbing or cause pressure build up.
Q5: Can I ship thawed or partially thawed milk with dry ice?
Avoid refreezing partially thawed milk because it can degrade quality; if milk has started to thaw, keep it chilled with gel packs and use within 24 hours. Dry ice can refreeze thawed milk, but quality may suffer.
Summary and recommendations
Using an FDA approved dry ice pack ensures your breast milk remains safe and compliant during transport. These packs undergo rigorous testing under 21 CFR to prevent chemical migration. When packing, freeze milk completely, insulate your cooler and place dry ice above or around the milk with vents for gas release. Follow the 2.5 kg dry ice limit per package and clearly mark shipments. Consider gel packs or PCMs for shorter or chilled transport and explore hybrid kits for longer trips. Keep abreast of emerging trends like carbon negative dry ice and smart sensors that will make future shipments easier and greener.
Actionable next steps
Assess your needs: Determine whether you need to keep milk frozen or just chilled. This dictates whether to use dry ice or gel packs.
Select FDA approved products: Verify that both the dry ice pack and the cooler are approved for food contact and display proper labeling.
Plan the quantity: Use the duration table to estimate how much dry ice you need; add an extra 24 hours of ice to cover delays.
Prepare your shipment: Freeze milk, double bag, layer insulation, add the dry ice, vent the cooler and label it clearly.
Consult professionals: Contact your carrier or a cold chain packaging expert for assistance with international or long distance shipments. Consider subscription services that provide reusable containers with built in sensors and return logistics.
About Tempk
Tempk is an innovative cold chain packaging provider specializing in FDA approved dry ice packs, gel packs and insulated solutions. Our products are developed in our R&D Center, certified under ISO and Sedex standards, and compliant with 21 CFR food contact regulations. We offer eco friendly options, including biodegradable liners and carbon negative dry ice, to help you ship safely and sustainably. Whether you’re a breastfeeding parent, a milk bank or a biomedical lab, we deliver precision cooling technology tailored to your needs.
Call to action: Need help choosing the right pack? Contact Tempk’s cold chain specialists for a personalized recommendation. We’ll guide you through compliance, quantity estimates and sustainable options to ensure your milk arrives safely.
