Intro
Labels aren’t just about design. They’re also legal documents that carry rules, warnings, and critical product information. When businesses skip the compliance side, it leads to recalls, fines, or worse — a hit to brand reputation that’s hard to recover from.
This guide breaks down the essentials: FDA food labels, pharma and biotech requirements, and California’s Prop 65. If you’re a business owner, this is what you need to know to keep your products on shelves and your business protected.
Why Label Compliance Matters
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Trust & credibility → Consumers rely on labels for safety and accurate information.
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Legal protection → Regulatory agencies can issue fines, recalls, or even bans for noncompliance.
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Real costs → One mislabeled batch can mean wasted inventory, relabeling, or lost contracts.
👉 Bottom line: compliance isn’t just red tape — it’s protecting your investment.
FDA Requirements for Food Packaging Labels
The FDA has strict requirements for food labels, and missing even one element can get your product pulled from shelves.
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Nutrition Facts Panel → Must follow FDA’s standard format.
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Ingredient List → Ingredients listed in descending order by weight.
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Allergens → Top 9 allergens must be clearly declared (e.g., “Contains: Milk”).
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Net Quantity & Product Identity → Must appear on the front (PDP) in the correct font size.
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Placement & Readability → Labels must be legible, not buried on curved surfaces.
✅ At San Diego Label, we double-check layouts before printing to catch issues early.
Pharma & Biotech Labeling Standards
In pharma and biotech, labels aren’t just marketing — they’re about patient safety and global traceability.
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Serialization & Lot Numbers → Every product must have a unique ID for recalls and audits.
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GS1 Barcodes → Standardized barcodes for global supply chains.
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Cryogenic & Durable Labels → Substrates that survive -80°C storage or chemical exposure.
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Tamper-Evident Features → Prevents counterfeiting and protects patients.
✅ San Diego Label works directly with biotech and pharma companies to ensure labels hold up under the toughest conditions.
California Prop 65 Warning Labels
If you sell products in California, Prop 65 compliance is mandatory.
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What it is: A law requiring warnings if your product contains any of 900+ listed chemicals.
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Wording: Must use state-approved “safe harbor” language.
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Placement: Font size must be at least as large as other consumer info.
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Mistakes to avoid: Tiny fonts, burying the warning, or using incorrect wording.
✅ We’ve helped California businesses avoid lawsuits by ensuring Prop 65 warnings are clear and compliant.
Common Compliance Mistakes That Cost Businesses Thousands
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Wrong font size or placement (too small = noncompliant).
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Missing allergen or warning disclosures.
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Using outdated regulatory language.
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Labels failing in real-world conditions (freezer, chemical, or moisture exposure).
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Skipping internal quality checks.
✅ A quick review before production saves time, money, and risk.
Choosing the Right Label Partner
Compliance is about more than design. You need a partner who understands the rules and how to apply them in printing. Look for:
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Experience in regulated industries (food, biotech, cannabis, pharma).
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Quality inspections and compliance checks before production.
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Specialty substrates for harsh conditions.
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Variable data printing for serialization and lot tracking.
👉 San Diego Label has decades of experience helping businesses stay compliant while looking great on the shelf.
Conclusion
Label compliance isn’t optional — it’s protection. Whether you’re in food, cannabis, biotech, or general consumer goods, the rules are there to protect consumers and businesses alike.
If your brand needs FDA, pharma, or Prop 65-ready labels, we’re here to help.
👉 Contact San Diego Label today for a compliance-ready label quote.