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.
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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.
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.
