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Imminent Changes to the Current Canada Natural Health Product (NPN) Licensing timelines

In October 2014, the Natural and Non-prescription Health Products released a policy to manage the overall application review process.  It brought a streamlined and predictable timeline when NPNs would be issued (prior to this, there was a massive backlog of applications, NPNs sometimes took several years go be issued and many companies were selling natural health products before an NPN Health Canada was issued, utilizing the submission number as an equivalence to authorization where Health Canada was not enforcing the regulations of NPN Health Canada requirements to sell an NHP).

It was anticipated that the number of NHP applications would decrease since this policy came into effect.   Though class 2 and 3 application volume has been steady, the number of class 1 applications has been significantly increasing.  Given the size of the Canadian retail market and the number of Natural Health Products available on the market, in theory, a saturation point should have been met.  There are several reasons for this volume increase, particularly for class 1.  One reason is our trade partner to the south.  The US economy is hot, unemployment levels are at record lows and recent corporate tax cuts have fueled business growth and expansion.  Naturally, the next destination for many US companies in Canada given its similar culture, buying power, and a higher per capita consumption of health and wellness products than in the United States.  Another reason is the exportation.  Here at Quality Smart Solutions, we’ve had a number of clients in the past few years who are obtaining NPNs (mostly class 1) for the sole purpose of exportation.  Certain countries take the NPN as an equivalency to their regulations which helps expedite approval and distribution in the respective jurisdiction.

Since fall 2017 we have noticed performance targets, particularly for some class 3 applications being missed.  This missed timeline has been a few weeks to 2 months past the performance target deadline!  These were the first signs that NNHPD’s resources were stretched and they couldn’t keep up with the inflow of applications.   The goal was to ensure the quality of applications reviewed remained consistent and performance targets were met.

The proposed NHP Management of Applications Policy Update includes the following:

 CurrentProposed
Performance Service Standard

Class 1:

10 business days

Class 2:

30 calendar days

Class 3:

30 calendar days for screening + 180 calendar days to review

Class 1:

60 calendar days (target of 30)

Class 2:

90 calendar days (target of 45)

Class 3:

210 calendar days

IRNAs little as 2 days to respondAs little as 5 days to respond
Post License AmendmentNot required for Class 1 if changes are within monograph scopeChanges required for all products aligning with NHPR Sections 11 & 12
Submission optionsPaper by mail, ePost or DVD/CD by mailePost or DVD/CD by mail

A proposed Electronic Product License Amendment and Notification Form (PLAN) will be created to ensure data captured is in a consistent format.

It is anticipated this new policy update of NPN Health Canada will be published in fall 2018 and fully implemented by the end of the year.

Now is the time to submit your class 1 and 2 Natural Health Products under the current service standard timelines!  Quality Smart Solutions can conduct a comprehensive review of your Natural Health Product and determine what classification your product will fall under.  Licensing, Labelling, and Importer of Record.  We are your end-to-end solution provider.  Contact us today!

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
Categories
Blog

Collagen & Gelatin: Not Your Average Protein Sources

Hydrolyzed collagen and gelatin are animal-based proteins that have recently gained popularity within the food and supplement industry. Gelatin and collagen possess similar amino acid profiles, including essential amino acids which the body uses for internal protein and collagen synthesis.

These wonderful benefits have made collagen and gelatin hot ingredients in Canadian food products. However, it is important to note that while providing the consumer with essential amino acids, gelatin and collagen are not considered complete proteins. For those who might be wondering “What is a complete protein?” a complete protein is defined by the Canadian Food Inspection Agency (CFIA) as a protein source which provides all essential amino acids. Additionally, food products which provide a complete protein source and have a Protein Rating of 20 or more are considered by the CFIA to be sources of protein and can be labelled in this manner. When it comes to gelatin and collagen, the CFIA has given them a Protein Efficiency Rating of ‘0’ meaning they are low quality proteins and thus would not contribute to a ‘source of protein’ claim.

Wanting to use innovative protein-based ingredients as sources of protein and label products in this manner is not a novel idea for the industry. A few years back we saw companies using cheaper alternatives to whey protein, such as free amino acids and creatine monohydrate, and declaring them as protein sources. While amino acids and creatine are known to be involved in protein synthesis within the body, they would not contribute to a ‘source of protein” claim on the food product’s label.

As for our new hot protein sources, collagen and gelatin, they can be included as ingredients in a food product, however you must be cautious of how you are marketing the product. As discussed above, positioning the ingredients as contributing to a source of protein claim would not be considered compliant. You also cannot market your food product as a source of amino acids or call out any of the amino acids provided by collagen or gelatin. Having said this, there are ways to market your gelatin and/or collagen containing-products if calling out amino acids is important to you. The Natural and Non-Prescription Health Products Directorate (NNHPD) has published a monograph for hydrolyzed collagen which allows for the following protein-focused claims to be used on the product label:
• Source of the essential amino acids histidine, isoleucine, leucine, lysine, methionine, phenylalanine, threonine, valine which are used for the maintenance of good health and involved in protein synthesis
• Source of the non-essential amino acids alanine, arginine, aspartic acid, glutamic acid, glycine, proline, serine, tyrosine which are involved in protein synthesis
• Source of the essential amino acid lysine to help in collagen formation.

Our team of labelling and licensing specialists at Quality Smart Solutions are available and ready to discuss any regulatory challenges or marketing questions you may have. Contact us today to discuss how we can be your solution!

Quality Smart Solutions is an end-to-end compliance solutions expert which has been assisting clients for 10 years in the areas of Dietary Supplements/NHPs, Foods, Cosmetics, Medical Devices, OTC drugs and Medical Marijuana. Ask us for details by calling 1-800-396-5144 or visit our website at www.qualitysmartsolutions.com

[1] Protein Rating = Protein in a Reasonable Daily Intake x Protein Efficiency Ratio (CFIA, 2016)

How We Can Help

Our Experts at Quality Smart Solutions also offer to support your needs for foods, cosmetics, OTC drugs and medical devices for North America.

Contact us today to learn more about how we can support your compliance needs during and after licensing!

30 Minutes Free Consultation
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