加拿大卫生部新规：尼古丁袋等产品需药剂师监督销售

New Regulations from Health Canada: Products such as nicotine pouches require pharmacist oversight for sales.

8月22日，据加拿大政府官网消息，加拿大卫生部部长马克·霍兰（Mark Holland）宣布，对 NRT（尼古丁替代疗法）产品采取新措施，以应对这些产品对年轻人的伤害，并确保这些产品仅限于帮助戒烟的成年人使用。

新措施包括：

禁止广告或促销，包括可能吸引青少年的标签和包装；
要求新的和新兴形式的尼古丁替代疗法（NRTs），如尼古丁袋，只能由药剂师或在药剂师监督下的个人销售，并且必须放在药房柜台后方；
禁止新兴形式的尼古丁替代疗法，如尼古丁袋，销售除薄荷或薄荷醇以外的其他口味；
要求在包装正面标示尼古丁成瘾警告，并清楚标明其作为戒烟辅助用品的用途，适用于试图戒烟的成年人；
要求制造商提交所有新或修订的尼古丁替代疗法许可证的标签和包装样本，以确保不吸引青少年。

根据加拿大《食品和药品法》， NRT 属于药品监管范围。所有 NRT 必须获得加拿大卫生部的批准，并附有经批准的健康声明，才能在加拿大合法销售。

该部长表示，"我们的首要任务是保护加拿大人，尤其是年轻加拿大人的健康和安全。我们知道戒烟产品在帮助成年人戒烟方面发挥着重要作用，但我们需要确保这些产品能够发挥其预期作用。我们今天采取行动就是为了做到这一点，同时保护青少年和非吸烟者免受尼古丁的有害影响。"

Health Canada introduces new measures to help prevent harms to youth from nicotine replacement therapies

There are growing concerns that the popularity of new and emerging Nicotine Replacement Therapies (NRTs) is leading to recreational use by people who do not smoke, and, in particular, youth under 18 years of age.

Today, the Honourable Mark Holland, Minister of Health, is announcing that Health Canada is introducing new measures for NRTs through a Ministerial Order to reduce the appeal of, access to, and use of these products by young people for recreational purposes, ensuring access is restricted to adults who use these products to help them quit smoking.

The Order introduces new measures that will:

Prohibit advertising or promotion, including labelling and packaging, that could be appealing to youth.
Require NRTs in new and emerging formats, such as nicotine pouches, to be sold only by a pharmacist or an individual working under the supervision of a pharmacist, and to be kept behind the pharmacy counter.
Prohibit NRTs in new and emerging formats, such as nicotine pouches, from being sold with flavours other than mint or menthol.
Require a front of package nicotine addiction warning, as well as a clear indication of the intended use as a smoking cessation aid for adults trying to quit smoking.
Require manufacturers to submit mock-ups of labels and packages for all new or amended NRT licenses to ensure no youth appeal.

For adults who smoke and are trying to quit, smoking cessation aids, such as nicotine gums, lozenges, sprays and inhalers, which have an established history of appropriate use, will continue to be available in a wide range of retail locations, with a variety of flavours.

Nicotine is a powerfully addictive substance, and youth are especially vulnerable to its negative effects, which include harming the part of the brain that controls mood, learning, and attention. Even using small amounts of nicotine may increase the risk of developing a dependence in the future, since youth can become dependent at lower levels of exposure than adults.

NRTs are regulated as drugs under the Food and Drugs Act. All NRTs must be approved by Health Canada and carry an approved health claim to be legally sold in Canada.

Quotes

"Stronger measures are needed to protect youth from the harmful effects of nicotine and stop dependency before it starts. The action our government is taking will keep these products available for adults who need them to quit smoking while making sure they don't get into the hands of youth for recreational use."

The Honourable Mark Holland Minister of Health

"Our priority is protecting the health and safety of Canadians, especially younger Canadians. We know that smoking cessation products play an important role in helping adults quit smoking, but we need to make sure these products are doing as they are intended. We're taking action today to do just that, while protecting youth and non-smokers from the harmful effects of nicotine."

The Honourable Ya'ara Saks

Minister of Mental Health and Addictions and Associate Minister of Health

Quick facts

Tobacco use is responsible for over 45,000 preventable deaths in Canada each year.
Excessive amounts of nicotine can cause overdose or acute poisoning, which can lead to respiratory failure and death.
In the U.S., the 2023 National Youth Tobacco Survey found that nicotine pouches were a popular nicotine product among middle school and high school students, and such products were the most used behind e-cigarettes, cigarettes, and cigars.
The growing popularity of nicotine pouches within the U.S. may also have a significant impact on the awareness of and interest in using these products among youth in Canada, for example through exposure via social media platforms and other forms of media.

https://www.canada.ca/en/health-canada/news/2024/08/health-canada-introduces-new-measures-to-help-prevent-harms-to-youth-from-nicotine-replacement-therapies.html

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