Regulations Amending the Food and Drug Regulations (Flavoured Purified Alcohol): SOR/2019-147

Canada Gazette, Part II, Volume 153, Number 11 Registration
SOR/2019-147 May 22, 2019 FOOD AND DRUGS ACT P.C. 2019-573 May 21, 2019 Her Excellency the Governor General in Council, on the recommendation of the Minister of Health, pursuant to subsection 30(1) footnote a of the Food and Drugs Act footnote b , makes the annexed Regulations Amending the Food and Drug Regulations (Flavoured Purified Alcohol) .

Regulations Amending the Food and Drug Regulations (Flavoured Purified Alcohol)

Amendment

Coming into Force

2 These Regulations come into force on the day on which they are registered.

REGULATORY IMPACT ANALYSIS STATEMENT

( This statement is not part of the Regulations .)

Issues

There is a new and growing class of flavoured alcoholic beverages in Canada that are characterized as high in alcohol and sold in large, single-serve containers. footnote 2 However, they do not taste like alcohol, as the alcohol base is purified, flavoured, footnote 3 and often highly sweetened, which masks the alcohol taste. These flavoured purified alcoholic beverages footnote 4 are formulated, packaged, and marketed in a manner that can appeal to a younger segment of the drinking population. The sweetened taste profile combined with the large format and high alcohol content can result in unintentional overconsumption or excessive drinking due to the multiple standard alcoholic drinks footnote 5 in what appears to be a single-serve container. Some of these products contain as much alcohol as 4 standard alcoholic drinks.

Available data, research studies, and reports related to these products point to an alarming trend and growing public health risk. Regulatory measures are necessary to reduce the risks associated with these products and protect Canadians — especially youth footnote 6 — from unintended over consumption, which can lead to alcohol-related harms, including acute alcohol poisoning.

Background

In October 2017, emergency physicians in Quebec expressed concerns after observing an increase in the number of young people admitted to hospital emergency rooms with alcohol intoxication after drinking these types of beverages. On October 26, 2017, the National Assembly of Quebec passed a motion that instructed the national public health director to examine cases of alcohol poisoning following the consumption of beverages with high sugar and alcohol content, especially among young people, and directed the provincial Minister of Public Health to report back to the Assembly with findings and recommendations. The ministère de la Santé et des Services sociaux asked the Institut national de santé publique du Québec (INSPQ) to produce a scientific study on this public health issue. The INSPQ published its report footnote 7 on March 13, 2018.

The researchers found that from January 1 to November 26, 2017, an average of 21 individuals aged 12 years and older were admitted to emergency rooms each day in Quebec for acute alcohol poisoning, with the rate for the 18–24-year-old age group at least two and a half times higher than other age groups. Although the researchers could not attribute emergency room visits to flavoured purified high alcohol content beverages specifically, they reported a 319% increase in the sales of high alcohol content (at least 11% alcohol by volume [alc/vol]), flavoured malt-based beverages in Quebec between 2016 and 2017 (flavoured malt-based beverages are a type of flavoured purified alcohol). The report also showed that emergency room visits for the 12–17 and 18–24 age groups fell from 2014 to 2015 and then increased annually thereafter. This timing coincides with these large format, single-serve, high alcohol content flavoured malt-based beverages first appearing in Quebec in late 2014 and increasing in sales in subsequent years. footnote 8

A separate study conducted in Sherbrooke, Quebec, also found that in 2017, 17% of individuals aged 12–24 presenting at an emergency department had consumed a type of flavoured purified alcoholic beverage, whereas no medical records referred to these types of products between 2012 and 2016. footnote 9 There were four other cases of alcohol overdoses (e.g. poisoning) related to these products documented in the Canadian Hospitals Injury Reporting and Prevention Program in 2017. footnote 10

In December 2017, one of these products was implicated in the death of a 30-year-old male in Quebec, and another was implicated in the death of a 14-year-old female in Quebec in late February 2018. The coroner’s investigative report on the death of the 14-year-old female (released March 27, 2019) determined the cause of death to be drowning and possibly hypothermia after drinking approximately three 568 mL cans of a sugary alcoholic beverage in a short period of time (i.e. approximately thirty minutes). At 11.9% alcohol and 568 mL, each can contained four standard drinks of alcohol, meaning that the 110 lb, 14-year-old female could have consumed up to the equivalent of approximately 12 glasses of wine in less than thirty minutes. The incident resulted in public concern and calls from the Province of Quebec, health stakeholders, and Canadians for federal action.

On March 19, 2018, the House of Commons Standing Committee on Health (HESA or the Committee) adopted a motion to study the health and safety risks of pre-mixed drinks that are highly sweetened, high in alcohol and contain caffeine. The Committee’s report footnote 11 was tabled in the House of Commons on June 19, 2018, and it highlighted the need to take action to reduce the health and safety risks of these types of beverages. Specifically, one of the report’s recommendations was for Health Canada (the Department) to take regulatory action to restrict the alcohol content of these types of products.

Alcohol regulation in Canada

Alcohol regulation in Canada is a shared responsibility between federal, provincial and territorial governments.

At the federal level, Health Canada regulates alcohol under the regulatory framework for food. The Food and Drug Regulations (FDR) set out compositional standards for different categories of alcoholic beverages, including beer, cider, gin, vodka and wine, among others. A compositional standard sets out permitted ingredients and manufacturing requirements. Compositional standards are primarily for interprovincial trade purposes and provide consumers with predictability on what is contained in certain foods. Outside of these Regulations, there are no federal regulations that prescribe or otherwise limit the alcohol content of alcoholic beverages for health and safety purposes. There is also no pre-market approval required for alcoholic beverages. Like most foods, manufacturers must ensure that alcoholic beverages meet general food safety requirements.

Many of the regulatory controls on alcohol are set by provincial and territorial (PT) governments. Provinces and territories have exclusive control of alcohol sales within their jurisdiction, notably the responsibility for enacting laws and regulations regarding the sale, legal drinking age, and distribution of alcohol. Each province and territory has a liquor board or commission to oversee these activities. Some jurisdictions allow sales from private liquor stores while others operate government retail monopolies. Most jurisdictions have a mix of private and public retailers. footnote 12, footnote 13

In response to the death in late February 2018 of a 14-year-old female in Quebec, the Government of Quebec enacted legislative changes to restrict the sale of beer blends with more than 7% alc/vol to the Société des alcools du Québec (SAQ). As a result, the sale of beer blends with more than 7% alc/vol is no longer permitted in corner stores and grocery stores. The Government of Quebec also committed to establishing an expert group to review the advertising and promotion of alcohol in the province.

Why flavoured purified alcoholic beverages appeal to youth

A. Taste

Unlike traditional alcoholic products such as beer, wine, and spirits, flavoured alcoholic beverages lack a perceptible taste and aroma of alcohol since they take on the taste of added flavours. This difference is the result of the practices used in the manufacturing of these products.

All alcoholic beverages first undergo fermentation, where yeast converts sugars in the source material to ethanol (alcohol) and carbon dioxide. This process of fermentation imparts a distinct taste and aroma to the alcohol based on the source of sugars used (e.g. malt for beer, grapes for wine, apples for cider). Spirits are also manufactured through the fermentation process and undergo distillation as an additional processing step to increase the strength of the alcohol in the finished product.

Beverages in this new class of flavoured purified alcohol are manufactured using innovative purification methods (e.g. reverse osmosis, carbon filtration) that further process the fermented liquid, stripping it of its source taste and aroma — essentially leaving only alcohol and water. This step creates a neutral-tasting high-alcohol liquid to which flavouring and/or sweetening ingredients are added to enhance palatability. As a result, the final product is high in alcohol, subject to lower excise duties (see section “C. Price and Availability”), and takes on the taste of the added flavours and sweeteners, effectively masking the taste of alcohol.

A major reason why flavoured purified alcoholic beverages appeal to youth is that their sweet and fruity flavours make these alcoholic beverages taste more like soft drinks than alcohol. Studies show a link between age and a preference for sweetness, with children and adolescents showing a much stronger preference for sweetness than adults. footnote 14, footnote 15 The results of an experiment footnote 16 exploring the acceptability of a range of alcoholic and non-alcoholic beverages among youth and young adults (aged 12–30) revealed that the acceptability of traditional alcoholic beverages (e.g. beer, wine, spirits) increased with age whereas the acceptability of sweeter beverages, including mixed alcoholic drinks, decreased. Focus groups footnote 17 conducted with 12–17-year-olds corroborate the importance of taste as a key driver in the choice to consume a flavoured alcoholic beverage. Alcohol strength (% alc/vol), convenience and product packaging were also identified as important factors to youth.

Not only is the flavouring and sweetening more palatable for youth, many youth may not be aware they are consuming alcoholic beverages if the characteristic taste of alcohol is masked, which is what happens when flavours and sweeteners are added to a neutral-tasting alcohol base. In one study that compared beer, wine, and flavoured and sweetened spirits-based beverages, footnote 18 100% of teenagers aged 18 and 19 detected the taste of alcohol in beer and wine, whereas 24% did not detect the taste of alcohol in the flavoured and sweetened beverages. Furthermore, flavoured and sweetened beverages had the most taste appeal — 60% of participants reported liking their taste compared to 38% and 25% liking the taste of beer and wine, respectively.

B. High alcohol content and container format

A number of flavoured purified alcoholic beverages are also high in alcohol and many are sold in large single-serve containers, a combination which facilitates excessive drinking and increases the risk of unintended intoxication. The size of these containers combined with most of them being non-resealable suggests that the entire contents should be consumed in a single sitting. The consumer may not be aware that a large single-serve container can contain multiple standard drinks of alcohol. Many single-serve containers of flavoured purified alcoholic beverages contain as much alcohol as 4 standard drinks.

At 4 standard drinks per container, consuming the contents of one container in under one hour would put most adults weighing 180 lbs or less over the legal limit for impaired driving (as set out in the Criminal Code of Canada), which is a blood alcohol concentration (BAC) of 0.08%. As the body can only metabolize a certain amount of alcohol per hour, increasing the length of time over which these products are consumed is not an effective mitigation measure. Consuming two such containers over the course of two hours more than doubles an individual’s BAC (twice the legal limit) and would result in significant intoxication for adults weighing 180 lbs or less. Consuming three containers would likely result in a BAC that has been associated with hospitalization (e.g. alcohol poisoning). footnote 19, footnote 20

The impact would be even greater for teenagers who, on average, weigh less than adults. For example, consuming a single flavoured purified alcoholic beverage containing 4 standard drinks would result in severe intoxication for a youth weighing 100 lbs (BAC greater than 0.15%); consuming two of these would result in hospitalization with a possibility of death (BAC greater than 0.3%).

According to Canada’s Low-Risk Alcohol Drinking Guidelines (“Guidelines”), individuals between 25 and 64 years of age can reduce long-term alcohol-related health risks (e.g. liver disease, some cancers) by drinking no more than 10 standard drinks a week for women (with no more than 2 drinks a day most days) and 15 standard drinks a week for men (with no more than 3 drinks a day most days). To help reduce the short-term risk of injury and harm, women should drink no more than 3 drinks and men no more than 4 on any single occasion. The alcohol content in a single container of many flavoured purified alcoholic beverages exceeds the recommended daily maximum set out in the Guidelines for men and women.

C. Price and availability

In general, alcohol is like many other products in that consumer demand is inversely related to price: when the price decreases, demand (sales) increase, if other factors such as income (consumer purchasing power) are kept constant. footnote 21 Cost and convenience are key factors in youth’s choice of which alcoholic beverage to consume (after taste and alcohol strength), footnote 22 as they generally have lower incomes compared to the rest of the population.

There are no federal laws regarding the minimum retail price of alcohol. However, federal excise duties are charged on alcoholic beverages under the Excise Act and the Excise Act, 2001 . Flavoured purified alcoholic beverages between 7.1 and 11.9% alc/vol currently have one of the lowest excise duty rates for that alcohol strength. footnote 23 Spirits and spirits-based beverages with more than 7% alc/vol have the highest excise duty rates. This results in a market incentive for manufacturers to produce spirits-based coolers with lower alcohol (i.e. 7% or less alc/vol) and flavoured purified alcohol with higher alcohol (i.e. between 7.1 and 11.9% alc/vol).

Lower excise rates also allow for lower retail prices, making high alcohol flavoured purified products cheaper and therefore more accessible to youth compared to spirits or spirits-based alcoholic beverages, which are generally priced higher. Spirits and spirits-based products are subject to higher minimum retail prices footnote 24 than malt-based products in many jurisdictions (Alberta and Quebec are the exceptions).

Moreover, flavoured purified alcoholic beverages are more widely accessible compared to spirits-based products. Many jurisdictions allow the sale of non-spirits alcoholic beverages (e.g. malt-based or wine-based) by grocery and/or corner stores (i.e. British Columbia, Ontario, Quebec, and Newfoundland). No jurisdiction allows widespread sale of spirits-based beverages by grocery or corner stores. footnote 25, footnote 26

Parliamentary study

In spring 2018, HESA conducted a study titled “Pre-mixed Drinks Combining High Alcohol, Caffeine, and Sugar Content.” The Committee held two meetings in April and May 2018 and heard testimony from 15 witnesses and received 7 written briefs. Government of Canada officials representing Health Canada appeared as witnesses, along with public health experts, physicians, toxicology experts and industry representatives.

The Committee’s “Report on Highly Sweetened Pre-mixed Alcoholic Beverages” was tabled on June 19, 2018. It contains 15 recommendations for the Government of Canada, mostly pertaining to the broader alcohol industry (e.g. labelling, marketing, pricing, monitoring and surveillance, and the National Alcohol Strategy). Recommendations specific to flavoured purified alcoholic beverages were

The recommendations above, as well as feedback received during Health Canada’s consultations, were taken into consideration in the development of the Regulations Amending the Food and Drug Regulations (Flavoured Purified Alcohol) [the Regulations].

Caffeine

There have been media reports stating that flavoured purified alcoholic beverages contain caffeine, a combination that can increase the risk of unintentional overconsumption (caffeine masks the depressant effects of alcohol). It is important to clarify that it is illegal in Canada to sell alcoholic beverages that contain caffeine as an additive. Caffeine directly added to food and food ingredients is strictly controlled as a food additive under the FDR. Currently, caffeine is only authorized for use as a food additive in non-alcoholic carbonated soft drinks.

Caffeine may be present in some alcoholic beverages due to the use of flavouring ingredients that naturally contain caffeine (e.g. guarana seed extract, coffee, chocolate). Some alcohol products may be advertising the use of such flavourings. However, the amount of caffeine contributed to beverages by such flavourings is very low and as a result there is little to no caffeine in these types of products. For example, the amount of caffeine in the product that triggered the HESA study was less than 1 mg per 568 mL can (as confirmed through testing by the Canadian Food Inspection Agency [CFIA]). Regular coffee contains between 70 and 180 mg per 237 mL and an average cola-type carbonated soft drink can contain up to 50 mg of caffeine in a 355 mL can.

Objective

The objective of these Regulations is to reduce the health and safety risks associated with unintentional overconsumption and acute alcohol poisoning as a result of consuming flavoured purified alcoholic beverages by limiting the alcohol content in single-serve containers of these types of beverages.

Description

Division 2 (Alcoholic Beverages) of the FDR has been amended to