Month: October 2024

Natural health products (NHPs) are widely used in Canada, ranging from vitamins, minerals, and herbal remedies to probiotics and homeopathic medicines. As these products play a vital role in promoting health and wellness, clear and accurate labeling is essential to ensure consumers can make informed decisions about the products they use.

To strengthen consumer safety and product transparency, Health Canada has introduced new labeling regulations for NHPs that align closely with non-prescription drug labeling standards. These changes are aimed at improving readability, consistency, and access to important product information. Below is a comprehensive breakdown of the most significant changes to NHP labeling and what they mean for manufacturers, retailers, and consumers.

Why Health Canada Updated NHP Labeling Requirements

The updated regulations reflect a growing concern for consumer safety, particularly as the market for natural health products continues to expand. With so many products available, it is essential that consumers have access to clear and concise information regarding ingredients, usage, risks, and allergens. The goal of these updates is to provide standardized and user-friendly labels that enhance transparency and facilitate better decision-making.

In addition, these changes address challenges identified through consumer feedback, industry consultations, and research on product labeling practices. By ensuring that NHP labels follow stringent standards, Health Canada is also working to increase confidence in the products available on the market.

Key NHP Labeling Changes: An Overview

The new NHP labeling rules include several critical changes designed to improve clarity, transparency, and accessibility. Below are the most important elements of these changes:

1. Product Facts Table

One of the most significant changes to NHP labeling is the introduction of a standardized Product Facts Table. This table is similar to the Drug Facts Table found on non- prescription drugs and serves as a quick reference for consumers to find essential product information.

•  Required Information: The Product Facts Table must include key details such as active ingredients, dosage instructions, uses, warnings, and potential allergens.
• Format: The table must follow a consistent format, making it easier for consumers to compare products and access relevant information quickly.
• Importance: This change ensures that important safety information is highlighted and easily accessible, especially for consumers with specific health concerns or allergies.

2. Minimum Font Size

The updated regulations set strict requirements for minimum font sizes to improve the legibility of NHP labels.

• Why It Matters: Previously, some NHP labels were difficult to read due to small fonts, especially for older consumers or those with vision impairments.
• New Standards: The new rules specify that key information, such as the product name, dosage, and warnings, must be printed in a minimum font size to enhance readability. This requirement applies to both the Product Facts Table and other parts of the label.

3. Use of Plain Language

Another critical update is the requirement for labels to use plain language. This change is aimed at ensuring that the health claims, warnings, and instructions provided on NHP labels are written in simple, easy-to-understand terms.

• Health Claims: Label must list at least one recommended purpose and must use the exact wording on your terms of market authorization.
• Warnings and Risk Information: Warnings about potential risks, side effects, or interactions with other products must be communicated as they are on your terms of market authorization and must be in specific order under the new regulations.

4. Allergen Disclosure

Allergen labeling is a critical aspect of food and natural health product regulations, and the new NHP rules enhance allergen disclosure to align with food labeling requirements.

• Required Information: NHP labels must clearly identify potential allergens such as

peanuts, tree nuts, gluten, and other common allergens that may be present in the product.

• Why It’s Important: This change helps protect consumers with allergies and ensures they can make safe choices when selecting products. Clear allergen disclosure also prevents accidental exposure, which could lead to serious health consequences.

5. Expiry Date and Lot Number

Consumers rely on product labels to determine the shelf life and safety of natural health products. The updated regulations require that expiry dates and lot numbers be displayed more prominently on NHP labels.

• Visibility: Expiry dates must be easy to locate and read, ensuring consumers are aware of when the product may lose its efficacy or safety by expressing in a specific format.
• Lot Numbers: Lot numbers are essential for tracking purposes, especially in the case of product recalls. This ensures that manufacturers, retailers, and consumers can identify specific batches of products quickly and efficiently.

6. Standardized Risk Information

In addition to clear instructions on product use, labels must now include standardized risk information that outlines any potential side effects, interactions, or precautions associated with the NHP.

• Risk Information: Cautionary statements must be clearly stated as they are written on the terms of market authorization. Subsections such as Allergens, Flammability warning, Choking Warning, and Keep out of reach of children may be included on the Product Facts Table.

7. Contact Information

The updated labeling regulations also require NHP labels to include contact information for the license holder.

• Why This Matters: Including a phone number or email address or website ensures that consumers can quickly reach out to the company if they have questions about the product or wish to report any adverse reactions. This promotes greater accountability and transparency in the NHP industry.

8. Transitional Period for Compliance

License holders are given a transitional period of up to 3 years from the effective date of the new label regulations to comply with the new labeling requirements, allowing time to adjust packaging and update label designs.

• Products with NPNs issued before June 21, 2025: They will have until June 21, 2028 to comply with the new label regulations.
• Products licensed on or after June 21, 2025: Labels must comply with the new label regulations immediately. No grace period

What the Changes Mean for Consumers

These new labeling requirements have been implemented with the consumer in mind. By standardizing how information is presented on NHP labels, Health Canada aims to

improve the consumer experience and ensure that all individuals have access to accurate, easy-to-understand product information.

1. Enhanced Clarity and Transparency

Consumers will benefit from clearer labels that provide straightforward, easy-to-find information about product usage, risk information and ingredients. The new Product Facts Table makes it simpler to compare products and understand essential details about their use and safety.

2. Improved Safety for Vulnerable Populations

With better allergen disclosures, clearer warnings, and standardized expiry date formats, consumers can make safer, more informed choices when selecting natural health products. This is particularly important for individuals with allergies, chronic health conditions, or those taking other medications.

3. Easier Access to Product Information

The inclusion of plain language, readable fonts, and contact information ensures that all consumers, regardless of literacy level or health knowledge, can access the information they need to use NHPs safely and effectively.

Implications for Manufacturers and Retailers

The updated labeling regulations present both challenges and opportunities for manufacturers and retailers in the NHP industry. While the changes require adjustments to packaging and label design, they also offer several long-term benefits.

1. Increased Consumer Trust

By adhering to the new labeling standards, manufacturers can enhance the trust consumers place in their products. Clear, transparent labeling signals that the company is committed to safety and regulatory compliance, boosting brand reputation.

2. Streamlined Compliance

While the new regulations may require an initial investment in redesigning labels, they provide a standardized framework for compliance, reducing ambiguity and ensuring that all manufacturers are held to the same standards.

3. Competitive Advantage

Companies that implement these labeling changes promptly and effectively may gain a competitive advantage by being seen as early adopters of best practices in the NHP industry. Consumers are more likely to trust and purchase products that prioritize safety and transparency.

4. Need for Regulatory Guidance

To ensure compliance, manufacturers and license holders may need to seek guidance from regulatory experts who are familiar with the updated labeling requirements. This can help streamline the process and avoid costly mistakes that could lead to product recalls or regulatory penalties.

Why NHP License Holders should start Updating Labels Now

Though current NHP license holders have until 2028 to update their labels to meet the new label requirements the reason to start the changes now is consumer clarity. Having two types of label formats under the same brand will inevitably create confusion in the short term. Major retailers will likely require current NPN holder brands to comply with the new label regulations much sooner than the 2028 deadline. Managing packaging inventory and product turns will be key to developing a roll out strategy for new NHP label implementation.

Also, NHPs with product license/s issued on or after June 21 2025, must meet the new labeling requirements.

A Positive Step for Consumer Safety and Transparency

The new NHP labeling requirements represent a significant step forward in improving consumer safety, transparency, and product consistency in Canada. By introducing standardized labeling practices, Health Canada is ensuring that natural health products are labeled in a way that is clear, concise, and accessible to all consumers.

For manufacturers and retailers, these changes may require an investment of time and resources to ensure compliance, but the long-term benefits—both in terms of consumer trust and regulatory alignment—are substantial. As the natural health product market continues to grow, the importance of clear and transparent labeling will only increase, making these updates a vital component of public health and consumer protection.

How Quality Smart Solutions Can Help

With thousands of natural health product registrations and NHP label reviews we can ensure your packaging complies with the new NHP label regulations. We can help strategize the optimal time to begin this process if your products are licensed before the effective date so you minimize packaging liability. Reach out to us today by completing the form below.

Reference: https://www.canada.ca/en/health-canada/services/drugs-health- products/natural-non-prescription/legislation-guidelines/guidance- documents/labelling.html