Navigating FDA Compliance: A Practical Guide for Emerging CPG Brands

For emerging food, beverage, and dietary supplement brands, FDA compliance can feel like navigating a maze without a map. The regulatory landscape is complex, the consequences of non-compliance are severe, and the rules vary significantly depending on your product category. This guide provides a practical overview of the key compliance requirements every CPG brand needs to understand.

Understanding Product Categories

The first—and often most critical—compliance decision is determining how FDA will classify your product. Different categories have fundamentally different regulatory requirements, and misclassification can lead to serious consequences.

Conventional Foods and Beverages

Traditional food and beverage products are regulated under the Federal Food, Drug, and Cosmetic Act and the Food Safety Modernization Act (FSMA). Key requirements include facility registration, adherence to Current Good Manufacturing Practices (cGMP), Hazard Analysis and Risk-Based Preventive Controls, and proper labeling.

Dietary Supplements

Dietary supplements are regulated under the Dietary Supplement Health and Education Act (DSHEA) of 1994. While they don't require pre-market approval, manufacturers must comply with supplement-specific cGMP requirements, follow strict labeling rules, and ensure product safety. Claims are limited to structure/function statements that cannot diagnose, treat, cure, or prevent disease.

Functional Foods and Beverages

Products that blur the line between conventional foods and supplements—like beverages with added vitamins or functional ingredients—require careful regulatory strategy. The classification often depends on intended use, marketing claims, and the form of the product.

Facility Registration Requirements

Any facility that manufactures, processes, packs, or holds food (including dietary supplements) for human consumption in the US must register with FDA. This applies to both domestic and foreign facilities.

Key Registration Requirements:

• Initial Registration: Required before beginning operations. No fee for registration itself.
• Biennial Renewal: Must renew every two years during the October-December renewal period.
• Updates: Registration information must be updated within 60 days of any changes.
• US Agent: Foreign facilities must designate a US agent for FDA communications.

If you're working with a contract manufacturer, they should already have their facility registered. However, brands should verify registration status and ensure their manufacturing partners maintain compliance.

Good Manufacturing Practices (GMP)

GMP requirements ensure that products are consistently produced and controlled according to quality standards. The specific requirements differ between food and supplement manufacturing.

Supplement cGMP (21 CFR Part 111)

Dietary supplement cGMP regulations are more prescriptive than food GMPs. Key areas include:

• Personnel: Qualifications, training, and hygiene requirements
• Physical Plant: Facility design, cleaning, and maintenance
• Equipment and Utensils: Calibration, cleaning, and maintenance
• Production and Process Controls: Master manufacturing records, batch records, and in-process testing
• Laboratory Operations: Testing requirements for identity, purity, strength, and composition
• Holding and Distribution: Storage conditions and distribution controls
• Records and Recordkeeping: Documentation requirements and retention periods

Food CGMP and Preventive Controls

Conventional food facilities must comply with 21 CFR Part 117, which combines traditional GMPs with FSMA's risk-based preventive controls. This includes hazard analysis, preventive controls for identified hazards, and supply chain programs.

Labeling Requirements

Labeling violations are among the most common FDA enforcement actions. Getting labels right the first time saves costly recalls and relabeling.

Principal Display Panel (PDP)

The PDP—usually the front of your package—must include:

• Statement of identity (product name)
• Net quantity of contents
• For supplements: "Dietary Supplement" statement

Information Panel

The information panel must include:

• Nutrition Facts or Supplement Facts panel
• Ingredient list in descending order of predominance
• Allergen declarations (Big 9 allergens)
• Name and address of manufacturer, packer, or distributor

Claims Compliance

Claims are heavily regulated and vary by product category:

• Health Claims: Require FDA authorization or qualification
• Nutrient Content Claims: Must meet specific criteria (e.g., "low sodium," "high fiber")
• Structure/Function Claims: For supplements, must be truthful, not misleading, and include required disclaimer

New Dietary Ingredient (NDI) Notifications

If your supplement contains an ingredient that wasn't marketed in the US before October 15, 1994, you may need to submit an NDI notification to FDA at least 75 days before marketing the product.

When NDI Notification is Required:

• The ingredient is a "new dietary ingredient" (not marketed pre-DSHEA)
• The ingredient is not a vitamin, mineral, amino acid, or botanical
• There's insufficient history of use to establish safety

NDI notifications require substantial safety documentation. The notification process can take significant time and resources, so plan accordingly during product development.

FSMA Compliance for Food Brands

The Food Safety Modernization Act transformed FDA's approach from reactive to preventive. Key FSMA rules affecting CPG brands include:

Preventive Controls for Human Food

Facilities must implement a food safety plan that includes hazard analysis, preventive controls, monitoring procedures, corrective actions, and verification activities. A Preventive Controls Qualified Individual (PCQI) must oversee the program.

Foreign Supplier Verification Program (FSVP)

Importers must verify that foreign suppliers are producing food that meets US safety standards. This includes hazard analysis, supplier approval, and ongoing verification activities.

Building a Compliance Program

Working with Contract Manufacturers

Most emerging brands rely on contract manufacturers (co-packers) for production. While this transfers some compliance responsibilities, brand owners retain ultimate responsibility for their products.

Due Diligence Questions:

• Is the facility FDA registered and in good standing?
• Can they provide evidence of GMP compliance (audit reports, certifications)?
• What testing do they perform on ingredients and finished products?
• How do they handle lot traceability and recall procedures?
• What's their history with FDA inspections?

"Your contract manufacturer's compliance is your compliance. Thorough vendor qualification isn't just best practice—it's essential risk management."

Preparing for FDA Inspections

FDA can inspect any registered facility without advance notice. Being inspection-ready means maintaining compliance every day, not just when auditors arrive.

Key preparation steps include maintaining organized and accessible records, ensuring all SOPs are current and being followed, training staff on inspection protocols, and having a designated person to manage inspector interactions.

CalNutri

CalNutri's manufacturing partners maintain rigorous FDA compliance programs. We help emerging brands navigate regulatory requirements while developing high-quality products.