California Slack Fill Requirements Regulatory Review

Compliance Program Implementation Based on 21 CFR § 100.100 and California BPC § 12606, § 12606.2, HSC § 110375

To establish and maintain packaging compliance with U.S. Federal and California State Slack Fill regulations, ensuring the client’s product containers are not deemed misleading due to nonfunctional empty space. This program minimizes regulatory risk, protects brand integrity, and supports accurate product representation in the marketplace.

Scope of Work

Product & Packaging Information Review

Gather essential product and packaging data, including:

• Product formulation and ingredient list
• Packaging condition, structure, and dimensions
• Net weight and actual fill content
• Packaging material and label design
• Headspace measurements and technical justifications
• Manufacturing and filling process overview
• Current labels (front, back, side panels)
• State/s where product is marketed
• Any pre-existing certifications or exemption claims

Slack Fill Compliance Assessment

Conduct a compliance evaluation in line with:

• 21 CFR § 100.100 – Misleading containers
• California BPC § 12606 and § 12606.2
• California HSC § 110375

Review packaging size and shape relative to product content to determine whether any empty space qualifies as nonfunctional slack fill. Evaluate if slack fill is justifiable for purposes such as:

• Protection of contents during shipping
• Mechanical requirements during processing
• Standard industry practice

Provide regulatory analysis and guidance on how to mitigate or justify slack fill to meet FDA and California standards.

Deliverables

Customization Guide

Slack Fill Regulatory Compliance Report with findings and references

Federal and California-specific compliance evaluation

Label and packaging recommendations (if applicable)

Slack fill justifications or alternatives for compliance

Fees and Subscriptions

Standard Slack Fill Regulatory Review – $650 USD per product

Includes:

• Full packaging and process evaluation
• Slack fill justification and regulatory assessment
• FDA and California-specific compliance report
• Suggested label or package redesign guidance (if required)

Ideal For:

Brand owners, co-packers, or exporters looking to:

• Enter the California or U.S. market with pre-packaged goods
• Avoid misleading packaging violations
• Document slack fill justifications for compliance
• Prepare for retailer and regulatory audits