Introduction of Two New NHP Monographs: Sports Electrolyte Supplements and Oral Rehydration Solutions

By: Joanna Chudyk, SENIOR REGULATORY AFFAIRS SPECIALIST, email

The Natural and Non-prescription Health Products Directorate (NNHPD) has announced updates in their Batch 4a consultation: new monographs for Sports Electrolyte Supplements and Oral Rehydration Solutions. These revisions will affect Class I products, which cannot be combined with Class II submissions. This blog post highlights the key aspects of these monographs and the opportunities they offer to the natural health product (NHP) sector. The publication date for these monographs will be set once the consultation period concludes.

Oral Rehydration Solutions Monograph for NHPs

The Oral Rehydration Solutions monograph introduces a streamlined framework for products designed to address rehydration and electrolyte replacement, particularly in conditions such as diarrhea and vomiting that lead to dehydration. The monograph specifies the following approved ingredients:

• Sodium
• Potassium
• Chloride
• Citrate
• D-Glucose

These ingredients are scientifically validated to support effective rehydration, making them suitable for a broad demographic, including children, adolescents, and adults.

From a regulatory standpoint, adhering to this pre-approved list and associated health claims simplifies the approval process under the Class I framework. This could potentially reduce the time required for companies to bring new Oral Rehydration Solution products to market, presenting a valuable opportunity for brands aiming to expand their offerings in this category.

Sports Electrolyte Supplements Monograph for NHPs

For those focusing on fitness and sports nutrition, the new Sports Electrolyte Supplements monograph provides a clear path for developing products that aid hydration and electrolyte balance during physical exercise. The monograph outlines the following key ingredients:

• Sodium
• Potassium
• Calcium
• Magnesium
• Chloride
• Sucrose
• D-Glucose

Health claims associated with this monograph center around hydration and electrolyte replacement during exercise. Unlike the Oral Rehydration Solutions monograph, the Sports Electrolyte monograph is intended for adolescents and adults, catering specifically to individuals engaged in physical activity.

This monograph is ideal for companies looking to create sports drinks or electrolyte powders that support exercise recovery. By following the monograph’s guidelines, companies can make compliant claims related to performance and hydration, directly appealing to athletes and active consumers.

Opportunities for NHP Companies

Both the Oral Rehydration Solutions and Sports Electrolyte monographs offer expanded pre-approved health claims, providing greater flexibility in product development while ensuring regulatory compliance. These updates present an excellent opportunity for companies to innovate and enhance their product portfolios with clear, compliant claims.

Did you know some electrolyte products may be classified as supplemented foods? Discover more about Supplemented Foods and the approved supplemental ingredients.

Thinking about developing or reformulating electrolyte-based products? Now’s the perfect time to take advantage of the new monographs! Reach out to Dell Tech today to streamline your product’s regulatory journey and achieve market success. Our expert team will assist with product classification, application preparation, and labeling, ensuring a smooth path to market.

New to NHP regulations in Canada? Learn how to register your products with out guide – How to Register Natural Health Products in Canada.

FAQs

What are the new Sports Electrolyte Supplements and Oral Rehydration Solutions monographs?
The NNHPD’s new monographs for Sports Electrolyte Supplements and Oral Rehydration Solutions are updated guidelines that outline the approved ingredients and health claims for these products. The Sports Electrolyte Supplements monograph focuses on products for hydration and electrolyte balance during physical activity, while the Oral Rehydration Solutions monograph addresses products for rehydration and electrolyte replacement due to dehydration from conditions like diarrhea and vomiting.

Can the ingredients in Sports Electrolyte Supplements be used in Oral Rehydration Solutions?
Some ingredients are listed in both monographs, allowing them to be used in both types of products. However, it’s crucial to remember that each monograph may have specific requirements for these ingredients and the products overall. Ensure that the ingredient dosages in your product align with the specifications of the applicable monograph and meet all technical requirements.

Who can use products formulated under the Sports Electrolyte Supplements monograph?
Products formulated under the Sports Electrolyte Supplements monograph are intended for adolescents and adults who are engaged in physical activity. These products are designed to support hydration and electrolyte balance during and after exercise. Additional information on the acceptable subpopulation will be available upon the release of the monographs.

How can companies benefit from these new monographs?
The new monographs present several significant advantages. By adhering to the pre-approved ingredient lists and health claims, companies can streamline the regulatory approval process, which helps reduce time to market. Additionally, the expanded health claims allow businesses to make specific, compliant statements about hydration and electrolyte balance, effectively targeting their desired consumer groups. Furthermore, these monographs offer clear guidelines for developing products within the expanding sports nutrition and rehydration markets, opening opportunities for innovation and growth.