Month: October 2020

On October 5, 2020, the Natural and Non-Prescription Health Products Directorate (NNHPD) sent a notice to all Canadian product licence holders to announce a new policy being introduced to help reduce unintentional ingestion of alcohol-based sanitizers packaged in beverage containers.

Due to the COVID-19 pandemic and global supply shortages, the high demand for alcohol-based hand sanitizer has led to significant shortages in raw materials, products and standard packaging material. The Government of Canada issued guidance to industry on acceptable packaging materials and sizes for hand sanitizer products to ensure their availability during the COVID-19 pandemic. Manufacturers were encouraged to consider the appearance of their containers to avoid potential confusion by consumers. However, such packaging shortages have resulted in the use of unconventional types of containers such as beverage or food containers. These containers include water bottles, sports drink bottles, soda bottles, wine and liquor bottles, and children’s food pouches.

The additional flexibilities that were provided to industry on acceptable packaging materials and sizes are outlined below:

• Any food or pharmaceutical grade packaging can be used to package hand sanitizers (for instance, bottles, bags, pouches), provided that it is chemically resistant to the hand sanitizer.
• Although hand sanitizers are generally packed in clear (see-through) containers, appropriately graded packaging that is opaque (for example, white, coloured) can also be used.
• Health Canada does not regulate the size of hand sanitizer packaging:
  – As long as the formulation is identical to what has been authorized by us, any size of packaging that ensures appropriate shelf-life will suffice.
  – The same Natural Product Number (NPN) can be used for different container sizes.
• Keep the size of the opening on the container small to prevent evaporation (for instance, no wide-mouth containers
  – large openings increase the surface area where alcohol and other ingredients can evaporate, lessening the effectiveness of the product.
• Label large-format containers used for bulk packaging as refill containers
• Use only lids designed for use with the container to prevent contamination and evaporation
• Use packaging that is not re-sealable only once, as this may be prone to contamination and evaporation once opened
• Make refill formats compatible with existing pump or lid components

Furthermore, suppliers were encouraged to facilitate or advise users to continue to recycle used containers in accordance with the recommended practices and waste management systems available locally.

Unfortunately, the use of beverage containers for alcohol-based hand sanitizers may increase the risk of unintentional ingestion, as consumers are led to believe that these products are consumable products at first glance. These product packaging materials/labels and branding may be similar to the labels and branding of known alcoholic beverages or bottled water resulting in confusion of hand sanitizer for water or other beverages. Accidental ingestion of alcohol-based hand sanitizers could cause serious harm or even be fatal, particularly in children, because of the high alcohol content. Data from the Canadian Poison Control Centres (PCCs) show that the number of reported incidents related to hand sanitizer has increased in 2020 compared to 2019, up to 4.5 fold higher on a month-to-month basis.

Currently, alcohol-based hand sanitizers must comply with:

• the packaging and labelling requirements of the Natural Health Products Regulations (NHPR)
• Health Canada’s safety and efficacy standards as outlined in the Antiseptic Skin Cleansers monograph

All hand sanitizer products authorized for sale by Health Canada have an eight-digit Drug Identification Number (DIN) or Natural Product Number (NPN) on the label, and are listed on the List of Hand Sanitizers Authorized by Health Canada.

Currently, under the Antiseptic Skin Cleansers monograph, hand sanitizer labelling must include the following caution/warning statements:

• For external use only
• When using this product avoid contact with eyes. If contact occurs, rinse thoroughly with water.
• Stop use and ask/ consult a doctor/ physician/ health care practitioner/ health care provider/ health care professional if irritation develops.
• Keep out of reach of children. If swallowed, call a poison control centre or get medical help right away.
• Flammability warning Keep away from open flame and sources of heat. (if the product contains ethanol or isopropanol)

In addition to these requirements, products cannot be marketed in a manner that misleads the consumer about its composition or safety. Otherwise, they may be viewed as contravening section 9 of the Food and Drugs Act and enforcement action may be taken by Health Canada. Under the Antiseptic Skin Cleansers monograph, hand sanitizers are permitted to make the following claims on product labelling:

• Antiseptic (skin) cleanser
• Medicated (skin) cleanser
• Antibacterial (skin) cleanser
• Kills harmful bacteria/germs
• Effective in destroying (harmful) bacteria to provide antiseptic cleansing
• For personal hand hygiene to help prevent the spread of bacteria

To reduce the likelihood of any further incidents of hand sanitizer ingestion, the Natural and Non-Prescription Health Products Directorate (NNHPD) is implementing a new policy requiring an alternative closure as well as an additional warning statement and symbol, to alcohol-based hand sanitizers packaged in a beverage containers.

To develop this policy document, Health Canada reviewed existing labelling requirements for other health products and consulted with experts in labelling of food and health products, industry stakeholders, consumer and patient groups, provincial and territorial governments as well as other government departments.

These measures must be put in place no later than 8 weeks after this policy comes into effect, allowing existing stock to be used up. Therefore, hand sanitizers packaged in beverage containers and distributed after November 27, 2020, must have an appropriate closure along with the warning statement and graphic. Distribution in Canada of alcohol-based hand sanitizers packaged in beverage containers without these measures must stop after this date.

Beverage or food containers that are unable to accommodate the required closures and, as such, should not be used for hand sanitizers include beer and soda cans, food and beverage pouches, tetra packs and vaping cartridges.

The intent of this new policy is to ensure hand sanitizer products packaged in beverage containers:

• are presented to the public in a manner consistent with their market authorization
• use a simple and symbol-based warning and
• include the use of a closure to help prevent unintentional ingestion and injury to health

These measures are especially important for hand sanitizers that are produced by companies that:

• are associated with beverages or other ingestible products
• use the same containers and visual branding elements as beverages or other ingestible products

Specific details on the packaging and labelling requirements under this new policy (use of both an alternative closure and an additional warning statement and symbol) for alcohol-based hand sanitizers packaged in a beverage container are outlined below:

• Closures such as a pump or dispensing cap are conspicuous and are not generally used on beverage containers. Such closures will help to differentiate hand sanitizer packages from beverages or other ingestible products. By having to open or use the container in this way, the consumer will understand the product is not to be consumed. These types of closures will be required for alcohol-based hand sanitizers packaged in beverage, drinking or food containers.
• Section 95 of the Natural Health Product Regulations requires safety seals or security packaging for all natural health products, including alcohol-based hand sanitizers. These measures will continue to be required. They assure consumers that the product has not been opened or tampered with before purchase. However, they are not sufficient to reduce unintentional ingestion and do not meet the requirements outlined in this policy.
• Acceptable closures include:
  – Pumps
  – Dispensing caps (maximum width/diameter of opening should be no more than 20% of the width of the cap):
         – flip top lids
  – disc top caps (like those on cream-type cosmetic products)
  – any cap or dispensing lid that forces interaction with the product and
  is not listed below as an unacceptable closure
  – other closures that clearly differentiate the hand sanitizer container from a beverage container and force consumer interaction
• Unacceptable caps or closures include:
  – drinking spouts
  – beer bottle caps
  – conventional twist-off caps or lids
  – corks
• A warning statement on the front label is considered an effective way to inform consumers that the product is not a beverage. Symbols or pictures used along with a warning statement also help to communicate potential health risks.
• Additional labelling requirements include a front-of-pack warning featuring a red octagon with the text “Do not drink / Ne pas boire” and “Health Canada / Santé Canada.” Attributing the warning to Health Canada will lend credibility, as the public recognizes Health Canada’s role to protect the health and safety of Canadians.
• This warning must include the text “Do not drink / Ne pas boire”
  – bolded black text on a white background
  – English and French text on separate lines in either official language order
  – font size is proportional to the size of the container, label and branding of the hand sanitizer:
  – equal to or greater than the product’s brand name or a minimum of 22-point font
  – acceptable font types include non-decorative sans serif fonts, such as Arial and Helvetica
  – letters cannot touch
• the text “Health Canada / Santé Canada”
  – black text on a white background
  – font size can be 50% smaller than warning text (minimum font size is 11 point, Helvetica font, letters cannot touch)
• a symmetrical octagon graphic symbol that:
  – precedes the warning statement
  – is red in colour and framed or enclosed with a black border of a minimum of 1 point weight on the white background
  – is in the same height as the stacked warning statement
• The graphic symbol, warning statement and Health Canada attribution must appear together within a black border, of at least 1 point, with a white background to ensure visibility. The warning should appear on the top 50% of the main display panel label.
• An example of the warning:

As mentioned above, these measures must be put in place no later than 8 weeks after this policy comes into effect, allowing existing stock to be used up. Distribution in Canada of alcohol-based hand sanitizers packaged in beverage containers without these measures must stop after this date.

Over-stickers with the graphic symbol and warning statement will be permitted for 6 months from implementation and up to April 2, 2021, or by the next labelling run, whichever comes sooner. By this date, the warning statements must be incorporated into the packaging and permanent label design. The over-sticker cannot cover other labelling text or information.

The addition of the warning over-sticker should be placed on products before distribution and as soon as possible within the 8-week implementation period. Additionally, product sponsors are expected to make every effort to shift to using traditional hand sanitizer containers.

Health Canada strongly recommends against marketing hand sanitizers to children given the additional heightened risk to this vulnerable subpopulation. For additional information, please see Health Canada’s public advisory on hand sanitizers and children’s safety and the consumer advertising guidelines for marketed health products.

Compliance and Enforcement

Enforcement efforts will focus on compliance monitoring and promotion. Health Canada will consider escalated enforcement if risks to health and safety are identified.

When Health Canada identifies or is notified of potential non-compliance with the Food and Drugs Act and/or its Regulations, the information is assessed. A case may be opened to verify if non-compliance has occurred. Each case is assessed and prioritized, and the appropriate compliance action is taken in proportion to the risk posed to the public. The main goal of Health Canada’s compliance and enforcement approach is to manage the risks to Canadians by using the most appropriate level of intervention.

For more information on Health Canada’s national compliance and enforcement approach for health products regulated under the Act and its regulations, please refer to the compliance and enforcement policy (POL-0001).

As demand for hand sanitizers, disinfectants and medical devices continues to increase to keep the public safe, our team continues to work tirelessly to deliver the compliance and import solutions that are needed. Our Experts at Quality Smart Solutions continue to support your needs for natural health products, 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!