Freeze-drying, or lyophilization, is a preservation method that removes nearly all moisture from food through sublimation, resulting in a product that is lightweight and shelf-stable. The commercial sale of freeze-dried foods, from candy to prepared meals, is entirely possible and represents a growing market opportunity. Navigating the regulatory landscape for packaged food is the primary challenge for new entrepreneurs, requiring adherence to federal, state, and local laws concerning food safety and labeling.
The Initial Legal Answer
Selling freeze-dried food commercially is permissible, but the specific path to market depends entirely on the product type and the intended sales jurisdiction. A freeze-dried product must be classified as non-potentially hazardous, meaning it does not require time or temperature control to prevent the growth of harmful microorganisms. For freeze-dried items like fruits, vegetables, and confectionery, this classification is generally achievable, provided the final water activity level is below a safe threshold. Conversely, selling freeze-dried meat or poultry requires extensive regulatory oversight due to the inherent risk of pathogens.
Understanding Federal and State Regulatory Authorities
The regulatory authority overseeing a freeze-dried food business is determined by the type of product being processed. The Food and Drug Administration (FDA) holds jurisdiction over most packaged foods, including freeze-dried fruits, vegetables, and confectionery. The FDA establishes the foundational federal standards for safety, manufacturing practices, and labeling for these products under the Federal Food, Drug, and Cosmetic Act. Compliance with the FDA’s Food Safety Modernization Act (FSMA) provides the framework for preventing contamination through Current Good Manufacturing Practices (CGMPs) and risk-based preventive controls.
The United States Department of Agriculture (USDA) governs products containing meat and poultry. USDA-regulated products require continuous inspection and must be processed in facilities that meet distinct, often more stringent, structural and operational standards. State and local health departments then serve as the primary enforcement bodies, implementing and enforcing federal guidelines while often adding their own specific requirements. These local authorities are responsible for facility inspections and permit approvals.
Choosing Your Production Environment
Cottage Food Operations
Many new food businesses begin under cottage food laws, which are state-specific regulations allowing for food production within a home kitchen. These laws are typically restricted to non-potentially hazardous foods, such as shelf-stable freeze-dried fruits and candies, and expressly forbid the processing of meat or poultry.
Cottage operations are subject to strict limitations, including an annual gross sales cap that varies significantly by state, sometimes ranging from $25,000 to over $250,000. Sales are often limited to direct-to-consumer channels, such as farmers’ markets or online sales within the state’s borders, prohibiting wholesale distribution or interstate commerce.
Freeze-dried products sold under cottage law may require specific documentation, such as third-party verification that the final product’s water activity is below 0.60, confirming its shelf stability. While home kitchens are generally exempt from standard health department inspections, the producer is often required to include a statement on the label indicating the food was made in an uninspected home environment.
Commercial or Commissary Kitchens
Transitioning to a commercial kitchen environment becomes necessary for businesses planning to scale, sell wholesale to retailers, or engage in interstate commerce. A commercial kitchen, whether a leased facility or a shared commissary space, must pass inspection by the local health department and maintain compliance with all federal CGMPs.
For any freeze-dried product classified as a Time/Temperature Control for Safety (TCS) food, or for any product containing meat or poultry, a Hazard Analysis Critical Control Point (HACCP) plan is required. HACCP is a systematic, preventive approach that identifies and controls biological, chemical, and physical hazards throughout the food production process.
Freeze-dried meat and poultry must be processed in a USDA-inspected facility, which is a significant distinction from a standard commercial kitchen. The HACCP plan for these products must specifically detail how the freeze-drying process achieves a safe, shelf-stable product, including validation of the drying cycle to ensure all pathogens are controlled. Operating in a fully licensed commercial facility provides the necessary legal structure to pursue large-scale contracts, cross state lines, and expand distribution channels.
Essential Business and Operational Requirements
Establishing a legal business structure is a foundational requirement, regardless of whether production takes place in a home kitchen or a commercial facility. Many entrepreneurs choose to form a Limited Liability Company (LLC) to separate personal assets from business liabilities, though a sole proprietorship is a simpler option for very small operations. Obtaining a general business license from the city or county is necessary to operate legally, along with securing a sales tax permit to collect and remit state and local sales taxes.
An Employer Identification Number (EIN) is mandatory for any business that employs staff, is structured as a multi-member LLC, or elects to be taxed as a corporation. Even a single-member LLC without employees often benefits from obtaining an EIN, as it is required to open a dedicated business bank account and helps protect the owner’s personal Social Security Number from being used for vendor and client transactions.
Securing commercial liability insurance is required, even for cottage food operators. General liability protects against claims of third-party injury, and product liability coverage specifically addresses claims arising from foodborne illness or product contamination.
Mandatory Labeling and Packaging Rules
The final product packaging is regulated primarily by the FDA, with detailed requirements outlined in Title 21 of the Code of Federal Regulations. The label must contain five mandatory elements that provide clear and truthful information to the consumer.
The Principal Display Panel (PDP), the part of the label most visible to the consumer, must prominently display the Statement of Identity, such as “Freeze-Dried Strawberries.” It must also include the Net Quantity of Contents in both U.S. Customary and metric units.
The Information Panel, typically located to the right of the PDP, must include the remaining required elements. This includes the name and place of business of the manufacturer, packer, or distributor. An accurate Ingredient List is required, detailing all components in descending order of predominance by weight.
Furthermore, the label must declare the eight major food allergens as defined by the Food Allergen Labeling and Consumer Protection Act (FALCPA). Finally, a Nutrition Facts Panel is mandatory unless the business qualifies for a small business exemption, which is typically based on the number of employees and annual sales volume.
Marketing and Distribution Strategies
Freeze-dried products are well-suited for a variety of sales channels, including direct-to-consumer methods like farmers’ markets, local craft fairs, and a branded e-commerce storefront. Expanding into wholesale markets, such as local specialty shops, gourmet grocery stores, and co-ops, allows for increased volume and brand visibility. Securing placement in wholesale channels often requires providing a Certificate of Insurance and meeting their specific packaging and labeling standards.
The unique nature of freeze-dried food necessitates specific attention to packaging and shipping logistics to maintain product quality. Packaging must provide a high barrier against oxygen, moisture, and light, which are the primary factors that degrade the product over time. Mylar bags paired with oxygen absorbers are a common commercial solution for long-term preservation, and vacuum-sealing is often used to minimize air space. Shipping requires careful consideration to prevent crushing the delicate, porous food structure, which may involve using sturdy boxes and cushioning materials to ensure the product arrives intact and appealing to the customer.