The Ultimate Guide to Labeling Requirements for Contract Manufacturers (Plus Free Checklist)

Contributing Author

September 17, 2021

Explore labeling requirements for contract manufacturers to save time and stay compliant. Plus download your FREE Checklist & get organized!

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Contact manufacturing enables a company to outsource its production to a third-party production facility that will manufacture the product, and if needed, the packaging and labeling too. As a contract manufacturer, the biggest challenges include working with multiple brands simultaneously. Manufacturers need to be constantly in touch with multiple brands, and keep their assets organized. 

Labels are an indispensable part of the product. Labels help establish the brand and product, provides product information, contain handling instructions, warnings, safety hazards, tracking information, and more. 

Product labels are strictly regulated by the government for public safety. Failure to meet regulatory compliance can not only lead to heavy penalties but can also cause harm to the users. Therefore, we have a comprehensive guide for labeling requirements for contract manufacturers. 

7 Basic Labeling Requirements

Here are some of the labeling requirements that should be present across all products, whether it is a medicine, food product, or some chemical.

1. Statement of Identity

The statement of identity refers to the brand and the product identity. This information is present in the primary display panel. For example, when you pick up a bag of Lays Potato chips, right in front, you get the branding, as well as the product identity, the flavoring, and more. This is the statement of identity. 

2. Manufacturer Details

The information panel, which is located on a side, or the back of the packaging has information regarding the manufacturer's office, the address of the office, and contact details. It also contains the address of the manufacturing plant. For products that are imported, there is also an “imported by” section. 

3. Country of Origin

Every product must mention the country where it was manufactured separately. 

4. Product batch number

Every product needs to have some information to add traceability. For most FMCG products, a batch number is used. In some cases, a serial number is also added. These codes make it easier to manage inventory and detect fraudulent products in the market. 

5. Warnings

The product should contain warnings if any part of it can cause harm to the user. For example, liquor packaging comes with a health warning. 

Bag suffocation warning

For products that come in large plastic bags, the contains a logo indicating that the plastic bag may cause suffocation and death. 

Fire Hazard

Flammable chemicals, such as household insecticide sprays, deodorants, or alcohol-based chemicals always contain the fire hazard symbol

6. Regulatory markings

Products need to have a marking showing that they meet the regulatory compliances. For example, the veg/non-veg mark for food products is an example. The "fortified" logo is also added to a food product that comes with fortified nutrients. The packaging label can also bear the mark showing the recyclability of the packaging. 

7. Product Quantity and Contents

Every product label must contain the quantity of the packaging. Depending on the product type, this information may be present on the principal display panel but is always there in the information panel.

Industry-Specific Labeling Requirements

Each industry must meet its own set of regulatory compliances and therefore has its requirements. The product label for medicine is drastically different from the label of a cosmetic product. Here, we go over some of the basic requirements for each industry.

1. Chemicals

These include raw chemicals, paints, insecticides, fertilizers, and other related products.

a. Handling Instructions

All chemical products must have handling instructions to ensure that they are handled safely. For example, volatile chemicals, the label can recommend the use of gas masks, or use in open, well-ventilated spaces. For irritants, the label may inform the user to use gloves and goggles. 

b. Hazard Statements with Pictograms

Hazard statements with pictograms warn the users of potential mishaps if the chemicals are not handled correctly. These are also called chemical warning signs. Examples of pictographic hazard statements include flammable warnings, health warnings, and so on. 

labelling requirements for contract manufacturers
Examples of hazard statements

c. Precautionary Statements

These statements inform the user if a product is a known carcinogen, may cause allergies, may interfere with reproduction, or damage the genome. 

d. Product Grade

The product grade tells the purity or concentration of the product. 

2. Life Sciences

These include media, sera, and reagents for labs. While these products are like chemicals, they are not toxic. Life sciences products can also include consumable products such as nutraceuticals, as well as over-the-counter medication. 

a. Cold Storage and Cryogenic storage requirements

The label should contain information about storage requirements, away from heat and radiation. Labels may contain text such as "Store in a cool dark place." or "Store below -5° C”.

b. Claims and Disclosure

Consumable products should disclose the presence of synthetic additives, artificial sweetening agents, or any other chemicals present. 

c. Nutrition Labeling

All consumable products should have a complete nutrition label present in the information panel. The nutrition label should comply with the regulatory body, such as FDA or FSSAI. 

3. Pharmaceuticals

This category includes all prescription drugs as well as all over-the-counter drugs. Pharmaceuticals are heavily regulated for the sake of public safety and have strict labeling regulations in place.  

a. Active ingredients and Drug Fact Table

All drugs should mention the active ingredient on the label and include a separate table with both the active and inactive ingredients and the amount present in each dosage. 

b. Purpose and Use

Over the counter, drug labels should mention the symptoms that they treat. For example, Acetaminophen is labeled as "pain relief/fever reducer" on the information panel. There is also a separate table mentioning any secondary symptoms that the medicine can treat.

c. Directions

Drug packaging labels should include how the medicine is to be consumed or administered. For example, an injection could be intravenous, intramuscular, Subcutaneous, Intraosseous, or Intradermal. This information should be mentioned on the labels. 

d. Warnings

Warnings on drug labels are mandatory and are also strictly regulated. Misuse of drugs can cause adverse reactions, interaction with other drugs may also lead to side effects. Here are some common warnings on drug labels. 

i. Allergic and Adverse Reactions

Key information is drug labels are allergic and adverse reactions. Adverse reactions include adverse interactions with other drugs where one drug may inhibit the action of another life-saving drug. Drugs may also lead to adverse reactions such as nausea, dizziness, organ damage, and so on. Manufacturers must include all known information about adverse and allergic reactions on the label. 

ii. Do Not Use

This section includes warns users to not use drugs under certain conditions. For instance, when breastfeeding or if pregnant.

iii. Ask a Doctor

This section warns users to consult a doctor if they have a chronic condition that may be aggravated by the medication

iv. May Cause Drowsiness

Drugs that cause nausea, dizziness, drowsiness, or reduce alertness have warning labels telling users not to drive.

v. Keep out of reach of Children

Unintentional overdose is a major problem in the US. All drugs have warning labels requesting users to keep the medication away from children. 

e. FDA compliant layout and typography

All OTC drugs have a specified format provided by the FDA. Manufacturers must use this template when creating labels for drugs. The template provides the fonts and size information that all manufacturers must use. 

fda contract manufacturer requirements
Source: FDA

f. Dosage Instructions

Every OTC drug should have the recommended dosage information mentioned on the label. It also states the maximum allowable dosage for an individual.

4. Cosmetics & Personal Care

Cosmetic and personal care products are slightly less regulated than pharmaceuticals. However, they have specific mandatory requirements beyond the basic labeling requirements. 

a. Directions of use

Every cosmetic and personal care product should include a direction for use. This includes anything from toothpaste to shampoos to creams. 

b. Warnings

The packaging label should include warnings if misuse may cause any harm. For example, perfume bottles have flammability warnings on them.

c. All contents

Personal care products should mention all contents that are used in manufacturing and not just the active ingredients. 

d. Claims

Usually, a part of the principal display panel, telling how effective the product is. For example, a moisturizer can claim to keep the skin moisturized for up to 24 hours. 

e. The period after Opening or PAO

This symbol shows how long the product will last after the packaging has been opened for the first time.

5. Food & Beverages

Government bodies regulate food and beverage labeling. In the US, FDA regulates food and beverage labeling, in India, FSSAI oversees food and beverage packaging. Food packaging requirements and restrictions vary across regions depending on the guidelines of the governing body.

a. Vegetarian/Non-vegetarian logo

In some regions, manufacturers must mention if the product is plant-based, or has animal-based ingredients added to it.

b. Macronutrients per serving

The principal display panel should mention the macronutrients per serving. Depending on the region, it may or may not be present on the principal display panel, but must be there in the information panel

c. Serving size

Every food or beverage packaging must mention the serving size on the information panel. 

d. Presence of flavoring or additives

Besides having a list of ingredients, the packaging should also mention the presence of added flavoring, amount of added sugars, presence of micronutrients, and their amount as the percentage of recommended daily value. 

6. Alcoholic Beverages

Like food and beverages, the labeling requirement for alcohol depends on the region where it is sold. These are some of the requirements that are present in almost all regions. 

a. Origin

Alcoholic labeling must mention the country of origin. Often, the origin is mentioned in the principal display panel itself for the consumers. Country of origin is often a crucial marketing element for alcoholic beverages like Wines. 

b. Alcohol percentage or proof

Nearly all regulatory bodies made it mandatory to mention alcohol percentage on the labels. This can be used to classify if a drink can be considered alcoholic or not. 

c. Presence of Additives

The presence of colorants and flavoring agents should be declared on the label. Alcoholic beverages may contain FD&C Yellow #5 colorant, Cochineal Extract, Carmine, Saccharin, Aspartame, or Sulfites.

d. Health warning declarations

Alcoholic beverages need to declare a warning regarding responsible drinking. It should warn users that consumption of alcohol impairs the ability to drive a car or operate heavy machinery. It should also mention that alcohol consumption during pregnancy may lead to birth defects.

e. Geographically specific requirements

Some regions may have specific requirements. For example, Armenia requires the label to be in both Russian as well as the state language. Similar language regulations apply in other regions as well. In Canada, all mandatory labeling text should be in a font that is at least 1.6mm in height.

7. CBD and Hemp Products

CBD and hemp products have legal restrictions on sales and are strictly regulated in the US and elsewhere. Here are the key labeling requirements for regions where the sale of CBD and hemp products are legalized.

a. Identity and intended use

The manufacturer must declare the exact nature and the intended use of the product. Manufacturers must state if the product is CBD oil, a dietary supplement, or is animal food. 

b. Quantity and CBD concentrations

Each product must mention the concentration of CBD in the percentage of net weight or volume. The net contents should be declared in the principal display panel. 

c. Scannable QR

Each product should have a scannable QR which is a downloadable document with the following contents:

d. Restrictions on Claims

No CDB or hemp product should claim any health benefits or will cure a condition. 

Why Do Contract Manufacturers Need Label Management Software?

Contract manufacturers deal with multiple businesses simultaneously, handling their production and packaging all at once. Managing multiple label development projects can be quite challenging.

However, having a dedicated platform for artwork and label management for contract manufacturers can create organized workflows and simplify communications with collaborators. With artwork management software, you can

Artwork and label management software allows you to organize all your assets in one place. You can track changes in digital assets using version control. With an organized feedback loop and comprehensive feedback tools, it is easier to get precise feedback and make revisions. You can easily onboard external agencies, collaborators, printers, vendors, and any other stakeholder. 

As a contract manufacturer, you need to stay updated on the labeling requirements across various domains. This guideline lists out all the crucial requirements across various industries. Ready to get started on online labeling management?

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