Categories
News

Supplemented Foods: Food & Drug Regulations Unlocked

 

Supplemented Foods Health Canada

Have you been anticipating the Food and Drug Regulations (FDR) adding supplemented foods as an official category of food?  As a result of the July 20th amendments, these food products can now be sold in Canada as of July 21st, 2022. This has been the result of over 10 years of contributions which began when Health Canada announced their intentions to shift energy drinks from the Natural Health Products (NHP) to the food regulatory framework.

Now that these amendments are in effect there is a clear regulatory framework in place for selling supplemented foods.  Supplemented Foods for those that are not familiar are prepackaged foods that contain at least one supplemental ingredient such as vitamins, minerals, amino acids, and herbal ingredients that were marketed as providing specific physiological or health benefits.  The amendments will fill the gap between the food and drugs space by creating a specific category for the food products.

In our blog, we’ll outline the old regulations, their limitations, the permitted categories/ingredients, the transition timeline, and much more.

Food and Drug Regulations: Amendments Limitations:

Before these regulations, Health Canada let certain supplemented foods be sold through an interim measure known as the Temporary Marketing Authorization (TMA).  These new amendments will seek to address several safety and policy concerns related to food fortification.  Although the TMA process is no longer required certain products will require TMA’s. 

The framework uses limitations that have the intent to prevent claims that could overemphasize the risks of supplemented food or mislead the consumer in any way.  An example of this could be (claims of a nutrient that contributes to growth and development when the supplemented food has a cautionary statement that indicates it’s not recommended for anyone under the age of 18).  Ultimately this could end up impacting the marketing and advertising of supplemented foods in a major way.

Looking for assistance with your Supplemented Foods Regulations?

The Supplemented Food Facts Table (SFFT) Requirement:

Due to the new amendments, all supplemented foods are required to have an SFFT which replaces the Nutrition Facts Table (NFT) although they are still quite similar.  According to the “Directory of SFFT Formats,” the SFFT requires the name and absolute amount of each supplemental ingredient under the mandatory “Supplemented with” heading.  When vitamins, minerals, and nutrients are added to a product, they’ll also be included under this heading.  A statement to interpret this will also be mandatory on supplemented foods to clarify that the amounts of supplemental ingredients declared by your SFFT include both supplemental and naturally occurring quantities. 

Cautionary Statements & Identifier List:

Adding certain ingredients or levels of ingredients to a food product triggers a requirement that the label includes cautionary statements in both English and French. These statements must be separated from other information on the label and must be shown in a way that ensures they can be easily read. When a food product requires cautionary statements, it must also display a “Supplemented Food Caution Identifier” (SFCI) on the principal display panel. The SFCI must be black and white and include an exclamation mark, in addition to the text “Supplemented”.

Permitted Supplemented Food Categories and Ingredients by Health Canada:

List of Permitted Supplemental Ingredients: This list will capture substances that might be added to a specific food as a supplemental ingredients grouped as; mineral nutrients, amino acids, vitamins, etc.  The conditions of use for each supplemental ingredient are also very detailed.  Some examples of this could include the maximum levels of use in a product and ingredients that trigger an SFCI or cautionary statement.

List of Permitted Supplemented Food Categories:  This list captures the various categories of food for which supplemental ingredients can be added.  Various categories of food are exempt from the category like alcohol and fortified foods.

Health Canada can update these lists, and stakeholders can request changes (including additions, removals, or modifications) through a premarket submission process. This submission must be accompanied by supporting information demonstrating that the proposed change would be safe for Canadians.

Amendments Transition Timeline – Jan 1st, 2026

As of July 21, 2022, all TMA approvals for existing supplemented foods on the market will expire. Health Canada will continue to process TMA license applications that have already been submitted, but existing supplemented foods on the market approved under the TMA framework will have until Jan 1, 2026, to become compliant with the new regulations.

This consultation proposes compliance criteria for supplemental ingredients declared in the SFFT. This will affect the manufacturing, testing, and labeling of supplemented foods.

How Quality Smart Solutions can help

If you have questions about the new nutrition symbol and updating or translating your food label reach out to Quality Smart Solutions, email us at info@qualitysmartsolutions.com, or call us at 1-800-396-5144.  We would be happy to serve your compliance needs.

Book Your 30 Minute Free Consultation
Categories
News

Regulations Amending the Natural Health Products Regulations (NHPR) | What you need to know!

NHP Regulations and NHP Amendments 2022

What are the latest Natural Health Product Amendments (NHPR) 

Health Canada will be amending the Natural Health Products Regulations (NHPR) so they can modernize the requirements.  These new requirements for the labelling of NHPs aim to improve consistency and legibility. 

While also making the information clear while being aligned with pre-established rules for comparable non-prescription drugs.

Natural Health Product (NHP) usage amongst Canadians has skyrocketed lately due to several factors, the ageing population, COVID-19, information about NHPs on the Internet, and the increase in the consumer’s increased role in their self-care.

In this blog, we’ll talk about how the original rules were amended and how the new NHP regulation updates will aim to modernize and improve the NHP application process.

NHP Regulations current Issues:

There are a variety of current issues that can stem from NHP labels not being consistent, legible, or clear such as difficulty locating, reading, and comparing safety information on the labels.  This type of poor communication of vital information on NHP labels could lead to poor product selection and potential consumer harm that could be prevented. 

As a result, the safety of Canadians and the impact on our health care system has been the focus of these amendments.  The last thing, Health Canada wants is to place a negative burden on the health of Canadians.

1.     Labelling to improve self-selection and safe use of natural health products (i.e., the product contains a known allergen, is contraindicated, there’s an alternative product or it’s used improperly).

2.     Modernized contact information to reduce preventable harms

3.     Clarification of existing provisions of the Natural Health Products Regulations

4.     Clarification of security packaging requirements in the Natural Health Products Regulations

Pre-Established Regulatory Rules NHP Amendments for Comparable Products:

1) A Product Facts table: Important product data is required to be listed in the configuration of a Standardized Facts Table. Certain exclusions are given to oblige items in small bundles, items that are moderately generally safe, items that are to be utilized somewhere around one day or less (according to the label directions), and items with package(s) that contain, probably, three doses in units.

2) Labeling of food allergens, gluten, added sulphites and aspartame: If an item contains a priority food, gluten or added sulphites, a food allergen source, or gluten source a sulphites statement is mandatory to be on the label. If an item contains aspartame, an assertion about its impact on the product will be expected on the label.

3) Clearly and prominently displayed label text: Regulatory text on the label, including inside the Product Facts table, is likely to further developed legibility requirements, including a minimum type size, font types, and contrast.  

Using a risk-based approach, exceptions from these necessities are accommodated for specific and certain label information (for example the item number and marketing data). 

When you consider items with small packages, items that are to be utilized in no less than one day or less (according to the directions on the label), and items with package(s) that contain three dosage units.

Need help licensing your NHPs for sale in Canada?

            4) Modernized contact Information: A importer, manufacturer and distributor is now expected to show an email address, phone number, or website address inside an NHP’s Product Facts table (or somewhere else on the label if the NHP is excluded from the facts table mandate). Rather than a postal address of the producer and the importer (assuming there is one), as is at present required.

What will these NHP Regulations amendment updates include?

Label (and potentially packaging) updates will be required to meet the newly announced NHP regulations, including:

  • Font requirements (6 point/5.5 point Condensed)
  • Allergen Labelling (Food allergens, sulphites, gluten, aspartame)
  • Product Facts Panel Formatting
  • Plain language/common name usage (eg. INCI)
  • Modernized Contact information
  • Security Packaging

What will be the result of the new NHP Regulation amendments?

These new amendments will hopefully help eliminate the security packaging requirements for certain Natural Health Products (i.e., sunscreens, topical products, and non-prescription drugs for U.S. & Canadian products).

Additionally, Health Canada is using this as a chance to bring up certain amendments to the NHPR without introducing a regulatory burden as the requirements stay the same.

These amendments are very important to make the NHP labels more legible and easier to understand, thus reducing the harm to consumers and facilitating better product selection.  They will also increase the rate of reporting of adverse reactions to manufacturers, leading to Health Canada gaining real-world evidence to monitor NHPs’ safety and effectiveness closer.

Finally, these amendments will enhance Health Canada’s alignment with other countries from a regulatory perspective like Australia, the U.S., and the European Union.  This is because what we consider to be an NHP in Canada could be put into three other categories in other countries: drugs, dietary supplements, and food products. 

In each situation, the facts table and common labelling requirements (i.e., contrast, size, and type) could overlap. On the other hand, certain NHPs could require a Drug Facts Table, Supplement Facts table or Nutrition Facts table as well.

How Quality Smart Solutions can help

At Quality Smart Solutions, we have a team of experts who are skilled in NHP compliance. We offer several solutions to meet your needs like NHPID, Health Claims Substantiation, Clinical Trial Application (CTA), etc. Please contact us today or call us at 1-800-396-5144 to learn about how we can help you.

Want a 30 Minute Free Consultation?
Categories
News

Nutrition Symbol Breaking News: Food Directorate Front-of-Package Label Regulations

Nutrition Symbol

Health Canada recently announced that Front-of-package labelling changes for foods are set to come into effect on July 20, 2022, but the industry will have until January 1, 2026, to comply. A new front-of-package nutrition symbol will be required for prepackaged foods high in sodium, sugars, and saturated fat.

It is likely that those foods that are deemed to be high in saturated fat and sodium will wait as late as possible to implement these symbols.  Many businesses may have excessive labels remaining in stock to be used, prior to implementing this change

Nutrition Facts Table and Food Label Improvements:

In recent months, Health Canada has made several improvements to the Nutrition Facts Table and the list of ingredients on food labels to make them easier to understand.  You can expect the Canadian Food Inspection Agency (CFIA) to verify the compliance requirements and implement enforcement discretion for detailed plans to meet the new requirements by December 14, 2022.

The black and white magnifying symbol displayed above along with the text will need to be seen on the upper right portion of the label with an accurate bilingual translation for English & French.  In this blog, we’ll detail the products that require the label, those that are exempt, and the related exemptions.

Looking for assistance with your Food label Nutrition Symbols!

Why is a front-of-package Health Canada Nutrition Symbol Food Label Change required?

Eating foods on an ongoing basis that are high in saturated fat, sodium, and sugar can increase your risk of getting a variety of health conditions? Some conditions include:

  1. Obesity
  2. Type 2 diabetes
  3. High blood pressure
  4. Type of cancers
  5. Heart disease
  6. Stroke

This label change (addition of the nutrition symbol) will help you make quick and informed choices when shopping for groceries while supporting health professionals in educating their patients.

Foods that will require the Nutrition Symbol Food Label Change include:

  • Prepackaged foods that have a small amount of the average food a person would consume in a single sitting (reference amount). This food product would also exceed 10% of the daily value of sugar, sodium, and/or saturated fats (i.e. salad dressing, cereal, pickles, and cookies).
  • Prepackaged processed meals with a (reference amount) that is over 200 grams that are more or the same as 30% of your daily value of sugars, sodium, or saturated fat such as meat pie, pizza, and lasagna.
  • Other general prepackaged foods that meet or are equal to 15% of the daily value of fat, sugars, sodium, or saturated fat such as soup, frozen dessert, puddings, or deli meats.

Foods that will NOT require the Nutrition Symbol Food Label Change include:

  • If food is formulated to meet the requirements of specific populations like rations for the military’s personal use.
  • Food that has recognized health protection benefits like fresh, frozen, or dried fruits and vegetables, 2% milk, eggs, food with a healthy fat profile, vegetable oils, nuts, and fatty fish. Any combination of these foods can also be exempt assuming they don’t include ingredients that contain sugar, sodium, and saturated fat.
  • Food that is a source of nutrients that are not available in other foods and most Canadians need to get more of like yogurt, and cheese and are made from dairy products that contain calcium.

Health Canada Identified Technical and Practical Exemptions for the Nutrition Symbol Food Label:

  • Foods that are not sold to consumers or foods in small packages like creamers and coffee.
  • Single-ingredient ground meat and raw poultry.
  • Foods where a nutrition symbol would be extremely redundant (i.e. butter, salt, and sugar).
  • If food doesn’t require a Nutrition Facts Table (i.e., raw or single-ingredient whole meats).

Health Canada Food Label Changes for Nutrition Symbol Exemptions Reassessment:

After 10 years, more details will be available with the publishing of the regulations in Canada Gazette, Part 2.  Stay tuned for more regulatory updates.  We were involved early in the consultation of these Nutrition Symbol labelling changes. There were some interesting variations, but at that time this was the most popular version.  

How Quality Smart Solutions can help

If you have questions about the new nutrition symbol and updating your food label reach out to Quality Smart Solutions, email us at info@qualitysmartsolutions.com , or call us at 1-800-396-5144 and we would be happy to serve your compliance needs.

Book Your 30 Minute Free Consultation