Closer to Zero” Contaminant Limits
The FDA’s “Closer to Zero” initiative has expanded in 2026 with updated action levels for:
- Cadmium
- Inorganic arsenic
- Lead
These limits affect all processed foods, particularly:
- Infant and children’s products
- Cereal-based foods
- Fruit and vegetable blends
- Snack products
Manufacturers must implement contaminant monitoring programs and supplier verification systems to demonstrate compliance.
Microplastics Research & Emerging Enforcement
The FDA launched expanded research programs to detect microplastics in the human food supply. This initiative focuses on:
- Packaging degradation
- Processing equipment wear
- Storage material contamination
While regulatory limits are still developing, FDA expects manufacturers to demonstrate awareness and mitigation planning. We assist clients in documenting packaging safety assessments and contamination prevention strategies.
FSMA Food Safety Plan Development
Under the Food Safety Modernization Act (FSMA), most processed food facilities must maintain a written Food Safety Plan prepared by a Preventive Controls Qualified Individual (PCQI).
Required elements include:
- Hazard analysis
- Process controls
- Allergen controls
- Sanitation controls
- Supply chain controls
- Recall procedures
We develop customized Food Safety Plans aligned with operational realities and FDA inspection expectations.
FCE-SID Filing for Canned & Shelf-Stable Products
Manufacturers of Acidified Foods (AF) and Low-Acid Canned Foods (LACF) must comply with specialized regulations under 21 CFR Parts 108, 113, and 114.
Requirements include:
- Food Canning Establishment (FCE) registration
- Scheduled Process filing
- Submission Identifier (SID) numbers
- Thermal process validation
- Process authority certification
Incomplete or inaccurate filings frequently lead to shipment detention.
CFR 101 Labeling Reviews
Food labeling remains one of the most common sources of FDA enforcement.
Our audits cover:
- Nutrition Facts accuracy
- Ingredient declarations
- Allergen labeling
- Net quantity statements
- “Healthy” claim eligibility
- Added sugar disclosures
- Updated nutrient reference values
We align your labels with new federal standards and emerging enforcement interpretations.
U.S. Agent & FSVP Support
Foreign manufacturers must designate a U.S. Agent and cooperate with U.S. importers under the Foreign Supplier Verification Program (FSVP).
Our services include:
- Maryland-based U.S. Agent representation
- FDA communication management
- Importer compliance support
- FSVP documentation coordination
- Inspection response assistance
This integrated approach reduces regulatory risk across borders.
