Name: Health Canada and FDA Regulatory Compliance Solutions
Brand: Quality Smart Solutions
Rating: 4.8 (44 reviews)

Health Canada and the Canadian Food Inspection Agency have joined forces to evaluate the incorporation of Veterinary Health Products (VHPs) into Livestock Feeds (Food).

This Project originated from an expressed interest by the industry to allow active VHP ingredients into Livestock feeds. Since the successful roll-out of the more recent VHP Notification Program, many Health Products have been approved for use. But more work is still needed to ensure these beneficial ingredients can be safely and legally added to foods for our animals. The marriage of these two product classifications may be on the horizon and your company can be part of the regulatory decision-making process!

Please note you can amend your SFC license at any time utilizing the My CFIA Portal without incurring an additional fee.

Obtaining a Safe Food for Canadians License:

The first step involved in obtaining a Safe Food for Canadians license is to create a My CFIA Account. It is through the use of the My CFIA account that you can request license and export certifications as well as set up electronic payment methods. While enrolling, you can create one or more profiles for your business. This way if your company involves multiple site locations, you can have a profile for each site.

Within the current framework, VHPs and Livestock Feeds are sorted into distinct categories requiring a separate regulatory pathway to market. Livestock feeds are currently regulated based on two published ingredient lists, requiring notification when for example, ingredients are listed in Part II of the regulations, when ingredients are considered novel or when other languages (besides English and French) are used on the label. VHP Notifications must be submitted for all products, a Notification Number is assigned upon approval.

Under this new investigative project, several common and low risk Organic Acids and Essential Oils are being explored. Industry will be able to make label claims for these ingredients relating to maintaining general health for approved products. Only these types of general health claims are allowed currently allowed for VHPs. [Veterinary Health Products: used to maintain or promote the health and wellness of companion and food-producing animals. VHPs are not for use to treat, prevent, or cure a disease or condition.] Products with more specific: therapeutic, antiparasitic or antimicrobial claims would better meet the classification of a Veterinary Drug and not be allowed within the scope of this Project.

This Project will help regulators gather important data for use in law/decision making and the future of both Veterinary Health Products and Livestock feeds. Ultimately, leading to improved access to Health Products and a wider range of ‘active’ ingredients for livestock. Thus, easing the path to market for VHPs, enabling broader aspects to these types of products and reducing the use of drugs and other antimicrobials for animals. A compendium of ingredients will be published at the conclusion of this program to allow newly approved ingredients to be used in Livestock Feeds.

For this specific project, industry has been provided with a List of Ingredients that will be permitted. This will allow Health Canada to control the project and gather specific evidence on ingredients they have deemed as potentially acceptable. Under the current proposal allowable ingredients may include:

Organic Acid, such as Acetic acid and Malic acid.
Essential Oils, such as Peppermint and Rosemary.
Common Non-medicinal ingredients such as Coconut oil and Silicon dioxide.

Each ingredient may have specific inclusion limits as explained within the Notice or the currently published Permitted Substances List. Please reach out to our team to determine the admissibility of your ingredients.

The following formula criteria must also be met to be eligible for the program:

Contain at least 1 approved active/medicinal ingredient.
Contain only approved inactive/non-medicinal ingredients.
Make only approved general health (VHP style) claims.

The company representative will need to attest that the product is safe and supported by convincing evidence and that the product is effective when used properly per the directions. Under this project, please ensure that all manufacturing processes are evaluated to ensure the final availability or stability is not impacted when any new ingredients are added to your food.

The recommended use of the product is to be marked specifically on the application and you will need to confirm the formula has been sufficiently tested. Products currently marketed as either Food or VHPs will need to be re-submitted to be eligible for this new project. When a VHP product or ingredient is being added to livestock feed, the new label will also be required to carry the VHP Notification number.

The sequence of steps for this proposal, as laid out in the notice are:

Pre-screening Process (begins March 2021)
Notification Process (begins May 2021)
Publication of Compendium (July 2021)

To register, prescreening templates with product information must be submitted to Health Canada between March 15^th and April 2^nd, 2021. Once approved for eligibility by Health Canada a subsequent Notification will need to be sent.

Please contact our team for more information on Veterinary Health Products, Livestock Feeds or to have one of our specialists determine if your formulas are eligible and to enroll in this exciting project!

References:

Health Canada and the Canadian Food Inspection Agency to launch a pilot project to allow veterinary health products in livestock feed, Inspection Canada

Veterinary Health Products – Notification Program, Government of Canada

Rules for VHPs, Government of Canada

Update on the pilot project to allow veterinary health products in livestock feed, Inspection Canada

Introduction – Regulation of Livestock Feed in Canada, Inspection Canada

Introduction:

Identifying the correct application type has become increasingly crucial for Natural Health Product (NHP) applications. Incorrect classification can result in detrimental outcomes such as the issuance of rejection notices (RN) and further delays to go-to-market plans.

A basic understanding of the different NHP application classes (Class I, Class II, Class III) can help to better plan for this. Our Experts at Quality Smart Solutions can help you navigate this decision process and understand some of the limitations and benefits each application type offers.

Health Canada currently defines NHP applications as three types of application classes, which are then further subdivided into two application streams: compendial and non-traditional. The compendial application stream is exclusive to Class I applications, while the non-traditional application stream includes Class II and Class III applications.

First, let’s begin by discussing one of the primary points of deciphering application classes: the compendium of monographs. The compendium of monographs is an online repository created by Health Canada for a variety of NHP ingredients. The monograph outlines pre-cleared information (PCI) by Health Canada which is defined as:

Any form of information supporting the safety, efficacy, or quality of a medicinal ingredient or natural health product that the Natural and Non-prescription Health Products Directorate (NNHPD) has reviewed and determined to be acceptable. PCI can be used to speed up the evaluation of the NHP and serves as a reliable source of product information for consumers.

With the NNHPD monographs as a reference point, the application streams can now be better defined as follows :

Class I: must comply with all of the parameters of an individual NNHPD monograph with no modifications. Only one NNHPD monograph per application in Class I can be referenced.
Class II: supported entirely by a combination of 2 or more NNHPD monographs or 1 NNHPD monograph, where slight deviations to claims are permissible.
Class III: a full assessment is required as in the following cases: novel preparations, ingredient master files, ingredient combinations, and going beyond NNHPD monograph parameters

One may ask, what are the main differences between the three? While Class I applications are referencing pre-approved information from Health Canada, it is also the most restrictive of the three but with the shortest application processing time.

Class II applications, by contrast, have greater flexibility than Class I. However, there are still limitations on the extent to which claims can be made. Class II applications have a median application processing time of the three.

Lastly, Class III applications offer the greatest flexibility; however, this also is at the cost of application processing time. Of the three application types, Class III is the longest.

As always, there are exceptions to these general guidelines. In some cases, there may be some exemptions or further restrictions.

The Natural and Non-Prescription Health Products Directorate (NNHPD) has created monographs to ensure the safety, efficacy, and quality of natural health products. These monographs provide important guidelines for product claims and labeling, as well as manufacturing standards for these products.

What is the NNHPD Monograph?

The Natural and Non-Prescription Health Products Directorate (NNHPD) Monograph is a set of rules and regulations for the manufacture, composition, claims labeling, safety, and efficacy of natural health products. It outlines the procedures for evaluating ingredients and manufacturing standards, as well as product claims and labeling. It also helps to ensure that these products are safe, effective, and of high quality.

How to Read and Interpret the NNHPD Monograph Regulations?

The NNHPD Monograph contains specific regulations for natural health products. It is important that you understand how to read and interpret these regulations before using the monograph for guidance. Knowledge of the meaning and purpose of each section, such as ingredients, composition, claims, labeling, and safety, can help you better identify what type of product is compliant with the Monograph requirements. Additionally, understanding how to evaluate whether a product meets these requirements will help ensure that your natural health products are safe to use.

What are Non-medicinal Ingredients?

Non-medicinal ingredients are substances that originate from plant or mineral sources. These substances may be added to a health product to improve its appearance, taste, stability, or ability to absorb other ingredients. For example, vitamin E (tocopherol) and certain carotenoid pigments may be used as non-medicinal ingredients. The NNHPD monograph will provide specific information regarding which non-medicinal ingredients are acceptable for use in a given formulation.

What are Quality Control Requirements for NNHPD Monographs?

Quality control requirements for NNHPD Monographs help to ensure the quality of the ingredients and the product manufactured from them. The monographs generally include a description of acceptable manufacturing methods, tests to be performed on each batch, and analytical requirements to ensure that the active ingredients are present in sufficient quantities and meet specific purity levels. It is important to adhere closely to these requirements to ensure the safety and efficacy of the finished product.

Why are NNHPD monographs important?

NNHPD monographs are important because they provide a standardized set of guidelines for the safety, efficacy, and quality of natural health products. They help ensure that products on the market are safe for consumers to use and that they meet certain quality standards. Monographs also provide valuable information for healthcare professionals, who can use them to make informed decisions about which products to recommend to their patients. Overall, NNHPD monographs play a crucial role in protecting public health and ensuring the safety and effectiveness of natural health products in Canada.

What are the regulatory requirements for NNHPD monographs?

NNHPD monographs are subject to strict regulatory requirements in Canada. They must be based on scientific evidence and meet certain quality standards. Monographs must also be updated regularly to reflect new research and changes in the natural health product industry. In addition, manufacturers of natural health products must comply with the regulations set forth by Health Canada, which include requirements for product labeling, packaging, and advertising. Failure to comply with these regulations can result in fines, product recalls, and other penalties.

How to use NNHPD monographs in product development and marketing?

NNHPD monographs can be a valuable resource for manufacturers of natural health products. They provide guidance on the safety, efficacy, and quality of ingredients commonly used in these products. By using monographs as a reference, manufacturers can ensure that their products meet regulatory requirements and are backed by scientific evidence. Monographs can also be used in marketing efforts to educate consumers about the benefits of natural health products and the scientific evidence supporting their use. However, it’s important to note that monographs are not a substitute for clinical trials or other forms of scientific research.

References:

Natural Health Products Management of Applications Policy

Listing of Monographs