Labeling Regulations for FDA-Compliant Packaging in the U.S.

Everything manufacturers need to know about compliant labeling for food, supplements, and cosmetics.

If your product is consumed, applied to the body, or comes into contact with food, your packaging and labeling must meet strict guidelines set by the U.S. Food and Drug Administration (FDA).

But what does “FDA-compliant labeling” really mean?

This guide explains the essential FDA regulations related to label materials, adhesives, design, and layout — so you can stay compliant, avoid recalls, and maintain consumer trust.

Why FDA-Compliant Labels Matter

FDA-compliant labeling is not just about what's printed on the label — it also involves the materials, adhesives, and applications used in your packaging process.

At Tekna Impact, we help U.S. and Mexico-based manufacturers produce industrial labels that meet FDA standards for:

• Food & beverage products

• Nutritional supplements

• Cosmetics & personal care

• Pharmaceutical and medical packaging

FDA Labeling Requirements Overview

The FDA regulates two major aspects of labeling:

1. Label Content & Layout

(Regulated under FDA 21 CFR Part 101 for food; Part 701 for cosmetics)

• Principal Display Panel (PDP): must show product identity, net quantity, and branding

• Information Panel: must show ingredients, directions, warnings, manufacturer/distributor details

• Font size & contrast: must be legible and proportional to packaging

• Nutrition facts or drug facts: required depending on category

• Allergen declaration: mandatory for food products

• Label placement: must not be misleading or hidden

Tekna Impact can pre-print these fields or leave blank space for in-house printing.

2.  Label Material Safety

(Regulated under FDA 21 CFR Part 175.105 and 21 CFR Part 177.1520)

• Indirect food contact: Label materials and adhesives must not migrate into food when applied to the outside of food packaging

• Direct food contact: Very limited — specialized materials only

• Temperature and humidity resistance: Labels must remain intact under processing, transport, and storage conditions

At Tekna Impact, we offer certified FDA-compliant label stocks and adhesives for indirect food contact, freezer environments, and high-humidity operations.

Industry	Common Label Types	FDA Compliance Area
Food & Beverage	Nutrition labels, product ID, expiry	21 CFR 101 & 175.105
Nutritional Supplements	Bottle wraps, ingredient panels	21 CFR 101.36
Cosmetics	Primary product label, warnings	21 CFR 701
Frozen or Refrigerated Goods	Freezer-grade labels	Adhesive & durability
Export Packaging	Traceability codes	International & FDA

Key Tips for Staying Compliant

• Use face stocks and adhesives certified for indirect food contact

• Ensure your design and layout match FDA formatting rules

• Work with a label provider that knows regulatory labeling inside and out

• Keep documentation of material safety data sheets (MSDS)

• Review changes in labeling rules regularly

Why Tekna Impact Is Your Compliance Partner

With over 20 years of experience, we help clients in regulated industries avoid labeling errors that can result in costly recalls or non-compliance issues.

We offer:

• FDA-compliant label materials and adhesives

• Flexographic and thermal printing

• Freezer-grade & moisture-resistant solutions

• Support for maquiladoras, food manufacturers, logistics, and cosmetics

• Full traceability and quality standards (ISO 9001:2015, PPAP)

Based in McAllen, Texas, serving the U.S. and industrial need FDA-compliant labels? Let’s talk.

Tekna Impact offers custom solutions that align with your industry, your environment, and your regulatory needs.

 Call us or write us