Conventional Foods vs. Supplemented Foods
The easiest way to know the difference between these categories are that Conventional foods are older-common foods and Supplemented foods are newer-unique foods.
The category of supplemented foods(canada.ca) originated from the struggle of classifying and regulating the first handful of novel Energy Drinks in Canada. Companies originally held NPNs (Natural Product Numbers) for their Energy Drink products, but the dosage format (ready-to-drink beverage) does not lend itself to dosing as is required for NHPs (Natural Health Product). Thus, a new category was born.
Originally intended to be a short-term bridge for safety and market data collection, Temporary Market Authorization Letters (TMAL) were granted to supplemented foods. Years later, this is still the practice for obtaining regulatory approval for a Novel/Supplemented food. Since NHPs are closely related to these products, it is necessary to consider this as a third option when classifying foods and supplemented foods.
Regulators want to ensure consumers are well educated and prepared to make decisions regarding nutrition and food selection. With safety in mind, ensuring all products are regulated, formulated, labelled, and classified properly can help protect the population from unwanted side effects. Additional regulatory requirements aim to ensure this added protection.
How These Categories Are Defined:
Food: It includes any article manufactured, sold, or represented for use as food or drink for human beings, chewing gum, and any ingredient that may be mixed with food for any purpose.
Supplemented Food: A supplemented food is broadly defined as a pre-packaged product that is manufactured, sold, or represented as a food, which contains added vitamins, minerals, amino acids, herbal or bioactive ingredients. These ingredients may perform a physiological role beyond the provision of nutritive requirements.
Other novel foods are: Products and ingredients that do not have a history of safe use as a food, Foods resulting from a process not previously used for food, causing the food to undergo a major change, or Foods that have been modified by genetic manipulation, also known as genetically modified foods, genetically engineered foods, or biotechnology-derived foods. Foods meeting this classification are submitted for premarket assessment and assigned a Temporary Market Authorization Letter (TMAL).
Natural Health Product (NHP): It is a substance or combination of substances in which all the medicinal ingredients are manufactured, sold, or represented for use in:
(a). the diagnosis, treatment, mitigation or prevention of a disease, disorder or abnormal physical state or its symptoms in humans;
(b). restoring or correcting organic functions in humans; or
©. modifying organic functions in humans, such as modifying those functions in a manner that maintains or promotes health.
Products meeting this classification are submitted for premarket assessment and are assigned a Natural Product Number (NPN).
In summary, and in most cases, a supplemented food usually sits between the classification of Traditional food and Natural Health Product. Usually, these are a traditional food that has added ‘active’ ingredient(s) or attribute(s). This alteration/fortification would be considered novel.
Product Composition: Any fortification of ingredients or novel preparation as per the definition (of a supplemented food when a vitamin, mineral, amino acid, herbal or bioactive ingredient is added to a food), would shift the classification into territory of Supplemented Food.
Product Representation: Any marketing verbiage, label claims, images, etc. suggested on traditional foods are very regulated and regimented. Wording for foods is intended to speak more to flavour, texture and satiety. Health claims by way of nutrient function can be available for use, so long that your ingredient/food meets any specific criteria. How you represent or speak about your product may shift the classification.
Product Format: is a key indicator for classifications on the Food vs. NHP interface. Ready to drink beverage and snack bar formats are commonly thought of and classified as foods. Foods are generally linked to the concept of ad libitum consumption. Tablet and capsule formats are thought of as NHPs. NHPs are thought to be delivered more by dose.
Public Perception: of food plays a big role in classification. Questions you may ask yourself are: Have I eaten this before? Am I able to purchase this at the local grocer? Is there any historic or traditional use? Has another country been eating this food for centuries? Etc.
Since there are many overlapping-complicated concepts involved in classification of foods, supplemented foods and NHPs, we highly suggest a formula feasibility review for all supplemented foods. And, in some cases, we suggest reaching out and receiving written confirmation from the regulator.
The Experts at Quality Smart Solutions can review your formulation to determine product classification.
Supplemented Foods Formulation:
It should be noted there are ingredients that are not permitted in supplemented foods. There are also specific ingredient limits set out for these types of products. Health Canada has posted several guidance documents that refer to specific types of supplemented foods (such as: caffeinated energy drinks).
Risk statements, directions of use and other labelling items are often required on the label for supplemented foods, depending on the amount of ingredients within the formula. This is explained in the applicable guidance document to which your product best fits or can be assigned by Health Canada during their review of the application. Similarly, both products will require a Nutrition Facts Panel and will follow general food labelling regulations.
The Experts at Quality Smart Solutions can conduct a review of labels or marketing materials for your food products.
Simplification of Pathway to Market:
Conventional Food – Compliant/bilingual label, adhering to food specific requirements/standards, arranging importation and distribution, meeting SFCR requirements.
Supplemented Food – All of the above plus licensing requirement which entails: a TMAL Application (may include: a label, label text, application form and other administrative documents). During the review of your application, Health Canada will likely issue several rounds of Request Notices. Health Canada reserves the right to suggest/make changes to your formula, application form and label content to ensure your product is compliant.
Natural Health Product – NPN (review timeline 60-210 days, depending on product class), Compliant/bilingual label, Manufacturing site annexed to a Canadian Site License.
Post Licensing Requirements for TMALs:
To help Health Canada draft appropriate regulations for supplemented foods, there are additional requirements throughout the lifecycle of your product. This data/research protocol will be agreed upon with Health Canada during their review. Adverse events are also required to be recorded and submitted to the regulator annually. These pieces of data will help Health Canada understand consumer trends and provide support for any ingredients being used.
Safe Foods for Canadians Regulations Note:
All foods in Canada are regulated by the Safe Foods for Canadians Regulations (SFCR). Conventional and Supplemented foods now have additional requirements such as licensing, traceability and preventative controls.
Reach out to our team for assistance complying and importing within this new framework.
How Quality Smart Solutions can help:
At Quality Smart Solutions, we provide you with the guidance to plan your food business, navigate the legal requirements, and acquire the appropriate license for your operations.
Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including Hazard Analysis, SOPs, Preventative Control Plans (PCPs) and more.
How We Can Help
At Quality Smart Solutions, we provide you with the guidance to plan your Veterinary Health Products business, navigate the legal requirements, and acquire the appropriate license for your operations.
Quality Smart Solutions has a team of professionals to offer support from day one of starting your business, including formulation and label reviews, Veterinary Health Product notifications and more.