Cost-Benefit Analysis Survey for Improved Labelling for Natural Health Products

Background

As you may be aware, from 2016to 2018, Health Canadaconducted consultations on a proposal to modernize the regulation of self-care products(natural health products, non-prescription drugs, and cosmetics) in Canada,to better inform consumers in their selection and use of self-care products, and better align the level of oversight with the level of risk for these products.

As part of these consultations, Health Canada received feedback on a proposal to introduce improved labelling requirements for natural health products (NHPs). Health Canada is proposing to move forward with amendments to the Natural Health Products Regulations to require:

(1)a facts table tostandardize the format for important information and make it easier for consumers to locate this information on the product;

(2)modernized contact information for problem reporting and asking questions (e.g., e-mail address, toll-free phone number); and

(3)the use of comprehensible and readablelanguage (including use ofplain language attributes such as simple sentences, information presented in simple bullets, short lists, contrast, font style and size) on all NHP labels.

Requirements for Cost-Benefit Analysis

As part of a Treasury Board of Canada requirement for all significant regulatory proposals, Health Canadais conducting a Cost-Benefit Analysis (CBA)survey of industries that could be affected should the government proceed with the proposed requirements for improved labelling for NHPs.

Asthe regulator of NHPs, it is important that Health Canada is made aware of any potential costs that you could incur as a result of these potential changes. In order to assist us in preparing the CBA, we would appreciate your input on the questionsprovided herein. You may also provide other costing considerations that are specific to your industry that may not have been specifically identified as part of the survey questions.

Your comments and feedback are greatly appreciated; we understand the challenges surrounding these changes and the short time frames for you to respond.

Health Canada will be responding to questionson the CBA survey from 1:30p.m. to 3p.m. (EST) on April 4, 2018, and 10:30a.m. to 12p.m.(EST) on April 6, 2018, either via teleconference or webinar. Ifyou are interested, please e-mail and indicate your preferred date.

Please feel free to share this survey with other Canadian stakeholders who may have an interest in providing input.

Comments will be accepted untilMay 30, 2018, and should be submittedto:

Office of Legislative and Regulatory Modernization

Policy, Planning and International Affairs Directorate

Health Products and Food Branch

Health Canada

Holland Cross, Tower A, Suite 14

Address Locator: 3105A

11 Holland Avenue

Ottawa, ON K1A 0K9

or by email at:

The Proposal

Under this proposal, the Natural Health Products Regulations would be amended to build on current regulatory labelling requirements. The aim is to ensure that NHP labels are easier to read and understand, and to create a consistent reading experience with other self-care product labels by introducing a Product Facts table. The information required by these proposed regulations would still meet the current regulatory requirement to be presented in a manner that is clear and concise, but will add a requirement to be easily comprehensible to the consumer.

These new requirements would be in addition to the information that is already required to be on the product, which are set out in Part 5 of the Natural Health Products Regulations, such as lot number, expiry date, the NPN or DIN-HM, and the term ‘sterile’ if the product is sterile.

Exemptions

NHPsthat provide a cosmetic purpose would be exempted from the requirements of a Product Facts table entirely. These NHPs are products that meet the definition of an NHP in the Natural Health Products Regulations but that confer a cosmetic purpose, such as cleaning, protecting or altering the appearance of the hair, skin or teeth. These exempted products are toothpastes, mouthwashes, antiseptic skin cleansers, secondary sunscreens, anti-dandruff shampoos, medicated skin-care products, and diaper rash creams (for local use on unbroken skin).

Product Facts Table

The Product Facts table will enable consumers to:

  • more easily compare different products, specifically where there may be similarities in the name, packaging, or ingredients, to help in selection of the product most suitable for their needs or symptoms
  • more easily identify the same medicinal ingredient in multiple products, to avoid the potential for unintentional overdose
  • quickly locate the directions for safe use and associated warnings
  • quickly locate the list of product ingredients, to avoid the potential for allergic reactions
  • quickly locate the sponsor’s Canadian contact information to report problems or ask questions

This table will have a standardized formatwith a prescribed typesize minimum (i.e., 6 point), type style (i.e., sans serif font), and clear contrast requirements (i.e., solid black type on a white background).

It is important to note that this is NOT a proposal to take all of the information present on current product labels and to place it all in aProduct Facts table. Instead, the information required on the label would be streamlined to information that is important for the consumer when selecting a product and allow for this information to be clearer and more comprehensible to the consumer. The proposal includes two components:

1)Simplification of information on the outer label

It is proposed that risk information (such as warning statements) on the label would be simplified to facilitate it being displayedin a Product Facts table. This would include shorter and simplerwarning statements, and avoiding unnecessary generalwarning statements. The recommended use or purpose of the product would be needed in the table if not present on the principal display panel.

2)Point of selection vs. point of use

The approach would include a delineation of information that is required at the point of selection (point of purchase) versus information that is required at point of use of the product, as this can often be different.

For example, only the warning statements needed at point of selection would have to be included in the Product Facts table on the outer label of the NHP.

For reference, point of selection warnings refer to important safety information thatis needed by the consumer when selecting a product for purchase, such as:

  • Warning statements regarding route of administration
  • ‘Do not use’ warnings
  • ‘Ask a doctor or healthcare practitioner before use if you’ warnings
  • Warnings regarding drowsiness or excitability

Warning statements needed at the point of use would only be needed on a label extension (e.g., Health Canada is considering a website linked by URL or QR code, or package insert or leaflet). The label extension would provide the Product Facts table containing both the point of selection information and the point of use information.

In summary, the Product Facts table on the outer label of an NHP would be required to contain only the point of selection information and would essentially look like Figure 1 below. The Product Facts table on the label extension of an NHP would be required to contain both the point of selection and point of use information and would essentially look like Figure 2 below.

In addition to the Product Facts table, additional risk information may also be required on the outer label in certain cases where risk is elevated. This could include the labelling of a new warning statement in the event of an emerging issue or the disclosure of a priority allergen.

This format may be referred to as an abbreviated Product Facts table and is what would be expected on the outer label of an NHP.
Figure 1. Abbreviated Product Facts Table
Note: Must be on outer label of product
Product Facts /
Information sur le produit
For the full table, visit / Pour le tableau complet, visitez :
Medicinal ingredients /
Ingrédientsmédicinaux
Ingredient1/Ingrédient1 (xxx mg), Ingredient2/Ingrédient2 (xxx mg), Ingredient3/Ingrédient3 (xxx mg)
Warnings / Mises engarde
▪Warning_a / MiseEnGarde_a
▪Warning_b / MiseEnGarde_b
Directions / Mode d’emploi
▪First direction / Premier mode d’emploi
Non-medicinalingredients /
Ingrédients non médicinaux
For the list, visit/ Pour la liste, visitez :
Questions? 1-888-123-4567
/ This format may be referred to as a full Product Facts table and is what would be expected on the label extension of an NHP.
Figure 2. Full Product Facts Table
Note: Must be readily accessible by consumer on label extension (e.g., website or insert)
Product Facts/
Information sur le produit
Medicinal ingredients /
Ingrédientsmédicinaux
Ingredient1/Ingrédient1 (xxx mg), Ingredient2/Ingrédient2 (xxx mg), Ingredient3/Ingrédient3 (xxx mg)
Uses / Usages
▪Use1/Usage1/ ▪Use2/Usage2
Warnings / Mises engarde
▪Warning_a / MiseEnGarde_a
▪Warning_b / MiseEnGarde_b
▪Warning_c / MiseEnGarde_c
▪Warning_d / MiseEnGarde_d
Directions / Mode d’emploi
▪First direction / Premier mode d’emploi
▪Second / Deuxième
▪Third / Troisième
Other information / Autres renseignements
Store at room temperature. / Conserver àla temperature ambiante.
Non-medicinalingredients /
Ingrédients non médicinaux
Ingredient1/Ingrédient1, Ingredient2/Ingrédient2,Ingredient3/Ingrédient3
Questions?Call / Composez le
1-888-123-4567

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Flexibilities for the Product Facts Table

All of the flexibilities presented in the table below would be available for use by industry. The flexibilities are not graduated and could be selected “à la carte”.

Coming into Force

Requirements in regulation and/or guidance for industry to support good labelling practices is crucial to providing clear, easy to understand, and complete product labels on which consumers can rely when selecting and using self-care products for themselves and for their families.

Health Canada is proposing that a coming into force period of 1 year be provided to allow sufficient time for new NHP licence applicants to meet the labelling requirements prior to filing an application. NHPs that are marketedin Canada prior to the coming into force could continue to be sold without meeting the new requirements for an additional period of 4 years following the coming into force.

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Cost-Benefit Survey to Industry on the Proposed Improved Labelling for Natural Health Products

Instructions:

  • For those questions that are not applicable to your company or association, please indicate “N/A” in your response.
  • Costing data presented as a cost per stock keeping unit (SKU) would be appreciated, where applicable.
  • Costing data should not be submitted for products that have been identified in the proposal as exempted from the new requirements (i.e., NHPs with a cosmetic purpose).

Scope of the Market:

  1. Please provide the name of your organisation / company:
  1. How many companies and/or manufacturers does your organisation represent?
  1. What industry or industries are you and/or your membership involved in(e.g., food, NHP, non-prescription drug, prescription drug)?
  1. If a member of industry, what areas are you involved in (e.g., product licence holder, labeller/packager, importer, distributor, and/or retailer)?
  1. The Government of Canada defines a Small Business as “Any business, including its affiliates, which has fewer than 100 employees or generates between $30,000 and $5 million in annual gross revenue.”
  1. If an individual company, do you meet this definition? (YES / NO)
  2. If an association, how many of your members are small businesses, and what percentage does this represent of your total membership?
  1. In which province/territoryis your Canadian Head Office?
  1. In which province/territory is the majority of your operations and/or membershiplocated?
  1. How many employees within Canada does your organisation represent?
  1. If an association, what approximate percentage of the total number of product licence holders in your industrydoes your organisation represent?
  1. Where is the majority of yourcompany’s or membership’s product manufactured? What percentage is manufactured within Canada?
  1. Of the number of product licences issued to you or your membership, how many of these products are marketed?
  1. What does this translate to as a percentage of marketed vs. product licences issued by Health Canada?
  1. What does the total number of marketed products translate to, in terms of total SKUs on the market?
  1. On average, how many SKUs are actively being marketed for a single product?
  1. On average, what is the volume per SKU, and/or a range, for your marketed products?

Improved Labelling for Natural Health Products:

  1. Health Canada anticipates that most, if not all, NHP labels will need to be changed to meet the proposed requirements by the coming into force date, as such,
  2. How many of your members would be affected by the proposal, or, how would your company be affected by this proposal?
  1. How many of your company’s marketed products would be affected by this proposal? Both in actual numbers and the percentage of marketed products?
  1. What does this translate to in SKUs? Both in actual numbers and the percentage of marketed product?
  1. Overall, what percent of your products, and SKUs, would be impacted?
  1. What percentage of your company’s or membership’s products have an inner and outer label?
  1. What percentage of your company’s or membership’s products havetwo (2)principal display panels, rather than one (1)?
  1. How often does your company or membership re-design and re-label products?
  1. Please describe the steps involved in changing a product label to meet the proposed requirements (adding a standardized factstable andmodernizedcontact information, and updating text to be clear, concise, and easily comprehensible), and itemize the costs associated with each step.
  1. What is the estimated total cost to your company (or membership) to implement the proposed improved labelling changes for NHPs (with a one (1) year coming into force, and an additional four (4) year transition period)?
  1. What is the average total cost per SKU?
  1. How would these costs change if the four (4) yeartransition period following the one (1) year coming into force was staggered for certain activities (e.g., a five (5) year transition period for labellers and packagers, and a six (6) year period for sellers)? Please quantify.
  1. What is the adjusted average total cost per SKU in this case?
  1. If Health Canada were to have a prolonged coming into force or transition period of this initiative (beyond Question 17), as is proposed, how would costs be mitigated? Please quantify where possible.
  1. Please describe what would be required of your company (or membership) operationally to modernize contact information on NHP labels and receive problem reports. Please itemize detailed costs associated with each step.
  1. How many product packages would require a change in size to accommodate the proposed labelling requirements? What does this translate to in terms of SKUs? Please itemize and quantify the costs related to changes in package sizes.
  1. Are there examples of packages (e.g., small packages) or other instances where the proposed labelling requirements would not be feasible as outlined?
  1. Are there costs specific to the implementation of the proposed standardized facts table and text changes on small packages? Please itemize and quantify.
  1. Please describe and quantify costs associated with extendingthe proposed labellingrequirements to a website through a URL, package insert or leaflet.
  1. Does your company, or what percentage of your membership, already have a website capable of hosting such information?
  2. Does your company, or what percentage of your membership, already use package inserts or leaflets?
  1. Are there differences in steps and costs for small businesses when changing package sizes or creating product labelsversus medium to large size businesses? Please describe and quantify where possible.
  1. Please describe any benefits and/or market opportunities for you or your membership related to the proposed labelling requirements. Please quantify where possible.
  1. How many of your company’s (or your membership’s) products have already adopted product labelling requirements as outlined for NHPs in the Good Label and Package Guide for Non-prescription Drugs and Natural Health Products ()? What percentage of your company’s (or membership’s) total products does this account for? How many SKUs would this represent?
  1. What percentage of your company’s or membership’s products currently have innovative labels (e.g., a peel-back label)?

Additional Considerations:

  1. Do you have any suggestions for further flexibilities not already outlined in the proposal that could minimize costs? Please itemize these proposed flexibilities and quantify projected cost savings/differences from the general proposal.
  1. How could we amend this proposal to achieve our objectives and reduce the burden on industry? Please itemize and quantify any suggestions, if and where possible.
  1. Based on experiences in other jurisdictions where standardized product labelling has been implemented (e.g., in the United States where a Canadian NHPequivalent is regulated as an over-the-counter drug), have there been any lessons learned or methods which may help to mitigate costs?

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