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Vitamin D Limits for NHPs are now Higher

The “Sunshine” vitamin, Vitamin D, Vitamin D3 or Vitamin D2 as it is more commonly known. The term “sunshine” was coined by the sunlight’s ability to provide levels of Vitamin D based on the level of exposure a person has. The most widely used form of Vitamin D is Cholecalciferol, which is predominately sourced from sheep’s wool otherwise known as lanolin making most Vitamin D sources non-vegan or vegetarian. 

Vitamin D is important in a large number of biological functions and processes such as helping with immune function and the development of bones and teeth as well as the absorption of calcium and phosphorus. Vitamin D is most commonly associated with international unit or IU value, however, the correct unit for the sunshine vitamin is micrograms (mcg).  Both the microgram and the IU value are listed on the product license for the Natural Product Number (NPN).  

Formerly, the highest dosage acceptable for natural health products (NHPs) was 1000 IU or 25 mcg daily. Daily doses above 25 mcg are considered prescription drugs and are on the prescription drug list.  Health Canada has since changed their decision on this. As of February 2021, the prescription drug list was amended to allow doses below 2500 IU or 62.5 mcg daily are permissible to be licensed as natural health products, values above this remain as prescription drugs. 

Fortunately, Health Canada has published a product monograph specifically for this high dose Vitamin D category.  The high dose monograph is exclusive to single ingredient products and restricts the use of such a high dose to six months without the advice of a health care practitioner or physician. Furthermore, only two claims can be made at such a high dose: 

  • Helps to prevent vitamin D deficiency
  • Vitamin D intake, when combined with sufficient calcium, a healthy diet and regular exercise may reduce the risk of developing osteoporosis in people with vitamin D deficiency

As there are many product monographs it may be difficult for one to easily identify which monographs are specific to Vitamin D. One of the easiest ways is to search Vitamin D within the natural health product ingredient database (NHPID). The entry is linked to the monographs and only displays the applicable ones. Additionally, the entry details the restrictions around the non- NHP eligibility such as below: 

  • A non-NHP because listed in the Prescription Drug List as follows: Vitamin D, in oral dosage form containing more than 62.5 µg or 2,500 International Units of Vitamin D per dosage form, or where the largest recommended daily dosage shown on the label would result in the daily intake by that person of more than 62.5 µg or 2,500 International Units of Vitamin D.

As this change in regulation is recent, there is a large opportunity to tap into this untouched market. Our Experts at Quality Smart Solutions can offer support to your needs for foods, cosmetics, OTC drugs and medical devices for North America.

How We Can Help

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

30 Minutes Free Consultation

Source:

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=multi_vitmin_suppl&lang=eng

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/atReq.do?atid=vitamin.d.hd&lang=eng

http://webprod.hc-sc.gc.ca/nhpid-bdipsn/ingredReq.do?id=2935&lang=eng

https://www.canada.ca/en/health-canada/services/drugs-health-products/drug-products/prescription-drug-list.html

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Blog

Summary of Guidelines for Advertising Health Products

Advertising is something almost all people experience and view daily. Yet, it can be challenging to navigate this space as it can be unclear to identify the truthful claims from the misleading claims. Fortunately, in Canada, Health Canada is the regulatory authority for consumer advertising, more specifically, health products.

How does Health Canada regulate marketing?

Health Canada is committed to ensuring that information in a health product advertisement is not false, misleading, or deceptive. Advertising for Non-prescription drugs and Natural Health Products stems from the terms of market authorization (TMA).  In the case of non-prescription drugs, it is the labelling standard, product monograph, authorized labelling and category IV monograph. While for Natural Health Products, it is the product license.  We will discuss each of the components of a label and ad and the standards around them. 

What statements can be made when advertising a health product?

The recommended use, the direction of use, duration of use, side effects and product performance must be consistent with the TMA. At least one claim should be listed on a label. Additionally, the ad and claims should be a consistent representation of the TMA.  As there are many types of products, health products must be accurately represented as per it’s TMA, such as a non-prescription drug or a natural health product. For products making claims on organic or natural, the following must be satisfied:

Organic:

  • Advertisers should possess evidence of certification, i.e. a copy of the Organic Certificate, issued by a recognized certification body.
  • Products that are certified organic, i.e. where the organic content is greater than or equal to 95%, may be advertised as “organic.” The trademark of the recognized certification body may be included in advertising.

Natural:

  • A synthetically derived ingredient should not be represented as “natural” or “natural source(d).”
  • Claims that a product is “natural” or “natural source(d)” are permissible only if the claim is true for all ingredients (both medicinal and non-medicinal).
  • Claims that one or several ingredients in a multi-ingredient product are “natural” or “natural source(d)” are permissible, as long as it is clear to which ingredient(s) the claim applies.

On the topic of product guarantees, it is inherently clear that this is not permitted as it suggests that a product is suitable for all individuals. While much of this information is a helpful tool in making the right decisions for claims and advertising, the question remains: 

Who preclears ads and ad campaigns? 

Well, advertising material for non-prescription drugs and natural health products directed to consumers is reviewed and precleared by independent agencies that have publicly self-attested to meeting Health Canada’s recommended attestation criteria.

With anything, there are always some outliers who chose to heed some of the regulatory guidelines around advertising. Should individuals find instances of suspected misleading practices, there is an online tool to submit complaints for Health Canada to review. The complaints are prioritized and acted on based on the risk that they pose.

As you take steps to understand this complex marketing space, there may be many things that remain unclear. Advertising practices are plenty and frequently changing, and having the quality level expertise can help ensure you are up to date on the most current regulatory information.

Our Experts at Quality Smart Solutions can offer support to 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!

Sources:

www.canada.ca

www.adstandards.ca

Categories
News

Performance Standards for NHP Applications

The coronavirus-19 (COVID-19) pandemic has had a long-lasting effect on many of the processes done in business and everyday life. One of the resulting main effects is delays in application processing times. From simple applications such as passports to larger-scale applications such as NHP licensing.

Prior to the pandemic, Natural and Non-Prescription Health Products Directorate (NNHPD) had a well-established service standard for Class I, II and III applications, which is outlined in the Management of Application Policy (MAP) guidance as shown below:

As the focus had started to shift to prioritize COVID-related product applications, a resultant de-prioritization of the non-COVID-related applications occurred. Not surprisingly, the volume of priority applications began to create a backlog on the non-priority product, site, and post-license submissions, thereby increasing the service standards. Within the past year, NNHPD has managed to achieve the following:

  • NNHPD licensed 4,290 new alcohol-based hand sanitizers and issued 2,054 interim Covid site licenses.
  • NNHPD issued 10,826 Non-COVID related product licence and 1,126 site licence decisions

To manage stakeholder expectations, NNHPD provided discretionary dates in which they hoped to see 90% of applications fulfill their original committed service standard. These dates were further broken down into application type and class. In addition, regular updates were provided by NNHPD via the Performance standards for NHP applications Stakeholder Meetings, with the most recent one being March 24, 2021.

As of this fiscal year, NNHPD has already completed 5,046 Class I submissions, which is up 343 submissions from the previous year. The standard processing time for Class I submissions is 60 calendar days from the date of submission. NNHPD was able to meet the 90% target in months of January (93.8%), February (97.4 %), and March (91.4%).

For Class II, 2,221 submissions were completed in this fiscal year, which is up 301 submissions from the previous year. The standard processing time for Class II submissions is 90 calendar days from the date of submission. NNHPD was able to meet the 90% target in January (93.7%), February (93 %); however, they fell slightly below in March (89%).

Lastly, 3,298 Class III submissions were completed within the current fiscal year, which is up by 585 submissions from the previous year. Therefore, as a result, NNHPD is on track to meeting their 80% goal for the original 210 calendar day service standard, with over 88% of the backlog completed.

While much has been achieved, NNHPD has warned about the impacts of further volume increases will have on the current system. For example, a 40% increase in Class II and Class III applications was observed in March; thus, NNHPD has asked to limit submissions to critical applications.

Post-licensing submissions are subdivided into two categories: amendments and notifications.

Amendments are defined changes to an NHP that may have an impact on the safety, efficacy and/or quality of the product. In contrast, notifications are defined as changes to an NHP that do not significantly impact the product’s safety, efficacy, and/or quality. Similar to new product submissions, amendments follow the 3 Class application system and service standard. On the other hand, notifications have no established service standard and do not follow the 3-class system.

Only 63.9% of the received amendments have been issued a decision. There are approximately 147 submissions received in 2020, which remain to be processed. Similarly, 62% of received notifications have been completed to date.

The target has been successfully met for both Stream I (94%) and Stream II (96%) site license applications. Approximately 201 Stream I submissions, 389 Stream II submissions, and 318 renewals have been completed this year. In addition, extensions were granted for renewals to accommodate further processing.

Although it may seem that little can be done as a stakeholder to speed up the licensing process, there is one way, using the most up-to-date licensing forms. Within the last year, NNHPD has launched online webforms to be used in application submission. The web-based Product Licence Application (web PLA) and the amendment and notification form (ANF). The forms have a validation component built-in, which thereby lessens the burden for NNPHD.  A lower burden allows for greater processing times and avoids unwarranted application refusals.

The ever-present changes resulting from COVID make it increasingly challenging to keep up with the most up-to regulatory information. As planning is a large part of the product launch, it is crucial to be in the know on impacts to your product plan. Our Experts at Quality Smart Solutions can offer support to 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!

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.

30 Minutes Free Consultation
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The Difference between a Class I, II and III NHP Application

nhp, nnhpdIdentifying the correct application type has become increasingly more 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 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 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 is the most restrictive of 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.

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