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Legal / illegal

The term “psychoactive substances” comprises both legal and illegal substances

Product labelling is the main component of a comprehensive public health strategy to reduce psychoactive substances-related harm

 

Alcohol

Alcohol is a psychoactive substance with dependence-producing properties that has been widely used in many cultures for centuries. The harmful use of alcohol causes a large disease, social and economic burden in societies. Alcohol-related harm is determined by the volume of alcohol consumed, the pattern of drinking, and, on rare occasions, the quality of alcohol consumed. In 2012, about 3.3 million net deaths, or 5.9% of all global deaths, were attributable to alcohol consumption. In 2012 139 million net DALYs (disability-adjusted life years), or 5.1% of the global burden of disease and injury, were attributable to alcohol consumption. There is also wide geographical variation in the proportion of alcohol-attributable deaths and DALYs, with the highest alcohol-attributable fractions reported in the WHO European Region. In general, the greater the economic wealth of a country, the more alcohol is consumed and the smaller the number of abstainers.

Alcohol product labelling could be considered as a component of a comprehensive public health strategy to reduce alcohol-related harm. Adding health labels to alcohol containers is an important first step in raising awareness and has a longer-term utility in helping to establish a social understanding of the harmful use of alcohol. Labelling requirements worldwide for alcoholic beverages are currently quite diverse and somewhat limited compared to labelling on food products and tobacco. Alcohol labeling regulation is applied, nationally and internationally, through one or a combination of means including food standards laws and codes and voluntary agreements reached between industry and government. Some countries have introduced mandatory health labels on alcoholic beverages.

 

International conventions and agreements

Labelling provides a unique opportunity for governments to disseminate health promotion messages at the points of sale and consumption. Health information labels are an inexpensive tool that provides direct information on the risks associated with alcohol consumption. Health information labels can deliver clear messages about the harm to the individual and others of consuming alcoholic drinks. Such harm includes damage to physical health (cirrhosis of the liver, cancers, etc.), mental health issues, physical injuries, violence and the risk of dependence. In addition, specific messages could warn of the dangers of consuming alcohol during pregnancy and when driving a vehicle, underage, operating machinery or taking certain medications. As on tobacco products, warning labels could have a standard format and design, irrespective of the particular brand of the alcoholic beverage, thereby ensuring better visibility. Health information messages could be accompanied by a recommendation for action; for example: “If you are concerned about your alcohol consumption, call [appropriate help line and phone number] or visit [appropriate website].” This message could be in a smaller font than the health information message.

World Health Assembly, 2010, the Sixty-third endorsed the Global strategy to reduce the harmful use of alcohol, supported by all 194 Member States. Within the 10 recommended target areas, labelling of alcoholic beverages as a tool to increase awareness and reduce alcohol-related harm was included in Area 8: “Reducing the negative consequences of drinking and alcohol intoxication” (1). Following the endorsement of the global strategy, the European action plan to reduce the harmful use of alcohol 2012–2020, outlining a portfolio of policy options specifically aimed at the Member States of the WHO European Region, was endorsed at the 61st of the WHO Regional Committee for Europe. Within the action plan, the need ingredients listing, including the calorie content, is outlined. Specifically, labels serve to provide this information, as they do for foodstuffs, in such a way as to ensure that consumers have access to complete information on the content and composition of the product, for the protection of their health and other interests.

The Codex Alimentarius (Rome, the Codex) is supervised by the Codex Commission, which is responsible to WHO and the Food and Agriculture Organization (FAO). The Codex Commission’s primary purposes are to protect the health of consumers, ensure fair trading practices in the food trade and promote the coordination of international food standards. The Codex has become a highly significant influence on global food law and is also important in settlement of World Trade Organization (WTO) disputes (domestic standards which comply with the Codex are more likely to comply with WTO expectations). Any new regulatory provisions under WTO and EU rules have to be justifiable and proportionate to the compliance burden they impose.

Regulation (EU) No. 1169/2011, Article 16, on the provision of food information to consumers exempts alcoholic beverages containing more than 1.2% ABV from mandatory listing of ingredients and the nutrition declaration. Although there is no requirement for alcoholic beverages to list their ingredients, food business operators may voluntarily provide this information to consumers. In accordance with Article 36 of the Regulation, such information must comply with the provisions governing the mandatory listing of ingredients.

Regulation (EC) No. 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods, alcoholic beverages are prohibited from bearing health claims; the only nutritional claims that are permitted are ones referring to low alcohol levels and reduction of alcohol or energy content.

World Health Organization, the 2016 WHO global survey on alcohol and health (not yet published) included several questions on the provision of consumer information about, and labelling of, alcoholic beverages to indicate the harm related to alcohol. Thirteen of the 53 Member States of the WHO European Region reported that health warning labels are legally required on the containers/bottles of alcoholic beverages at the national level (one Member State did not respond). Ten Member States reported that there is a national legal requirement stipulating the size of the health warning labels on the containers/bottles of alcoholic beverages or on alcohol advertisements (one Member State did not respond). In countries with such warning labels, examples of the wording used include: “Drinking can harm your unborn baby”; “Drinking alcohol damages the young developing brain”; “Alcohol abuse can cause over 60 diseases and health conditions”; “Warning: contains alcohol – it is recommended to avoid excess consumption”; and “Warning: excess consumption of alcohol endangers life and is harmful to health”. Health warning labels regarding pregnancy are mandatory in 13 Member States; underage drinking in 12; and drink–driving in 11. It is mandatory to display consumer information about calories, additives, vitamins and microelements on the labels of beer containers in 15 Member States; on wine containers in 15 Member States; and on spirits containers in 13 Member States (two Member States did not respond). There is a national legal requirement to display the number of standard alcoholic drinks on the labels of alcohol containers in three Member States, and there is a requirement to display alcohol content on the labels of alcohol containers in 48 Member States (two Member States did not respond).

World Health Organization, Regional Office for Europe, 2017. Alcohol labeling A discussion document on policy options. Conclusions: ”At present, alcoholic beverages are exempted from international conventions that govern all other psychoactive substances and from key food legislation that requires labelling of ingredients and nutritional information. Among the various tools and policy options that could be implemented to raise awareness of the risks of alcohol misuse, several consumer organizations (such as the European Consumer Organization) and public health organizations (such as WHO) have long been calling for consideration of mandatory content and nutritional labeling and health messages. As a general principle of good governance, citizens should feel confident that the food regulatory system, which is designed to protect their health and safety, operates effectively”.

 

Caffeine 

Caffeine (1, 3, 7-trimethylxanthine) is a naturally-occurring member of the methylxanthine class of compounds. Even though it is not an essential nutrient, caffeine is one of the most commonly consumed stimulants world-wide due to its abundant presence in food products, as well as over-the-counter and prescription drugs. While caffeine content varies in different products, a typical eight-ounce cup of ground coffee contains approximately 95 milligrams (mg) of caffeine. When an individual consumes a high dose of caffeine, he or she will experience the effects quickly and for a longer period of time. Toxic effects (including tachycardia, ventricular arrhythmia, and seizures) are observed at approximately 1200 mg, or 1.2 grams. A lifethreatening dose of caffeine is typically estimated at between 10,000 and 14,000 mg, or 10 and 14 grams (g), although smaller doses can be life-threatening in certain individuals (such as children or other sensitive populations). One product type that has appeared on the market in recent years is powdered caffeine containing products labeled as dietary supplements. We have also begun to see liquid products containing highly concentrated caffeine that are labeled as dietary supplements. 

Caffeine occurs naturally in foods, such as coffee, tea and cocoa and has a long history of safe use as a mild stimulant. Products are also available with added caffeine, including cola-type soft drinks, formulated caffeinated beverages (energy drinks) and energy shots. There is no recognised health-based guidance value, such as an Acceptable Daily Intake, for caffeine. However, the available literature concluded that there was evidence of increased anxiety levels in children at doses of about 3 mg of caffeine per kilogram of bodyweight per day. The anxiety level for children aged 5-12 equates to a caffeine dose of 95 mg per day (approximately two cans of cola) and about 210 mg per day (approximately three cups of instant coffee) for adults. Foods containing added caffeine must have a statement on the label that the product contains caffeine. Foods containing guarana, a South American plant with high levels of natural caffeine, must also be labelled as containing caffeine. In cola-type drinks, the total caffeine content must not exceed 145 mg/kg in the drink as consumed. Energy drinks must not exceed 320 mg per litre. Some Standards includes additional labelling requirements advising the products are not suitable for young children, pregnant or lactating women and individuals sensitive to caffeine. The FDA (2018) suggested “When formulated and marketed appropriately, caffeine can be an ingredient in a dietary supplement that does not present a significant or unreasonable risk of illness or injury”.

Caffeine content of some food and drinks:

 

Food Caffeine content
Espresso 145 mg/50 mL cup
Formulated caffeinated beverages or ' Energy' Drinks 80 mg/250 mL can
Instant coffee (1 teaspoon/cup) 80 mg/250 mL cup
Black tea 50 mg/250 mL cup
Coca Cola 48.75 mg/375 mL can
Milk chocolate 10 mg/50g bar

 

Food and Drug Administration (FDA, Center for Food Safety and Applied Nutrition, April 2018) Highly Concentrated Caffeine in Dietary Supplements: Guidance for Industry: “we consider products containing potentially lethal amounts of highly concentrated, liquid caffeine, sold in bulk such that the consumer is required to separate out a safe serving from a potentially lethal amount, to meet the standard for adulteration under section 402(f)(1)(A) of the FD&C Act. Even if the product label specifies a serving size that could be considered safe for many healthy adult consumers, a measuring device is provided that can approximate that serving size, and a warning statement urges the consumer not to exceed that serving size, this type of product can still present a significant or unreasonable risk of illness or injury under the conditions of use recommended or suggested in the labeling. An inherent feature of the conditions of use for such products is that the consumer must separate out a small, precise serving from a potentially lethal amount of product – a task that poses a significant or unreasonable risk of illness or injury”. 

The Council for Responsible Nutrition, 2018. CRN Recommended Guidelines for Caffeine‐Containing Dietary Supplements: “Disclosure of A. Total Caffeine Content: The purpose of this guideline is to provide consumers with information on the total caffeine content per serving in dietary supplements, whether from added or naturally occurring caffeine. 1. Caffeine content from both added caffeine and naturally occurring caffeine combined should be declared in milligrams per serving either in the Supplement Facts Box or in a separate statement elsewhere on the label.   2. This section does not apply to dietary supplements that contain no added caffeine and less than 25 mg per serving of naturally occurring caffeine.  B. Label Advisories for Conditions of Use : The purpose of this guideline is to provide consumers with additional information about the use of dietary supplements containing caffeine.  As with all dietary supplements, consumers taking medication should consult a healthcare professional about the supplements they are taking. 1. Any supplement with total caffeine content of more than 100 mg per serving should provide the following statements or equivalent language on the product label: a. This product is not intended/recommended for children and those sensitive to caffeine.   b. Pregnant or nursing women, those with a medical condition, and those taking medication should consult a healthcare professional before use. C. Serving Size and Daily Intake Recommendations: The purpose of this guideline is to encourage dietary supplement manufacturers and marketers to establish caffeine levels per serving and total servings per day that are consistent with current science and in compliance with applicable laws. 1. Labeling should provide serving size and daily intake recommendations that are consistent with safety information about caffeine established by competent and reliable scientific evidence.     2. Serving size and daily intake recommendations should comply with Section 402(f)(1)(A) of the Federal Food, Drug, and Cosmetic Act, which requires product ingredients to be safe under the conditions of use recommended in labeling, or if no conditions of use are recommended in the labeling, under ordinary conditions of use. D. Restraints Against Marketing In Combination with Alcohol The purpose of this guideline is to discourage marketing of caffeine‐containing dietary supplements in a manner that encourages combination with alcohol.   CRN members should not advertise, market, or otherwise promote the use of caffeine‐ containing dietary supplements in combination with alcohol, or to counter the acute or immediate effects of alcohol. E. Restraints Against the Sale and Marketing of Bulk Amounts of Pure or Highly Concentrated Caffeine in Powder or Liquid Form: The purpose of this guideline is to discourage the sale and marketing of bulk amounts of pure or highly concentrated caffeine in powder or liquid form directly to consumers. 1. CRN members should not sell or market bulk amounts of pure or highly concentrated caffeine in powder or liquid form directly to consumers.2 This section is not intended to limit CRN members from marketing or selling bulk amounts of pure or highly concentrated caffeine in powder or liquid form to a business entity as part of a business transaction. F. Implementation: Effective immediately, CRN recommends that dietary supplement companies comply with these guidelines”.

 

Nicotine

Nicotine is highly addictive. There are more than one billion tobacco smokers worldwide. Nicotine is a potent parasympathomimetic stimulant and an alkaloid.  Nicotine acts as an agonist at most nicotinic acetylcholine receptors (nAChRs). Nicotine is found in the leaves of Nicotiana rustica, in concentrations of 2–14%; in the tobacco plant, Nicotiana tabacum; in Duboisia hopwoodii; and in Asclepias syriaca. An average cigarette yields about 2 mg of absorbed nicotine. When a cigarette is smoked, nicotine-rich blood passes from the lungs to the brain within seven seconds and immediately stimulates nicotinic acetylcholine receptors; this indirectly promotes the release of many chemical messengers. Nicotine is unusual in comparison to most drugs, as its profile changes from stimulant to sedative with increasing dosages. While acute/initial nicotine intake causes activation of nicotine receptors, chronic low doses of nicotine use leads to desensitisation of nicotine receptors (due to the development of tolerance) and results possibly in an antidepressant effect. 

Tobacco use is the single largest preventable cause of disease and death in the United States. Since 2009, FDA has regulated cigarettes, smokeless, and roll-your-own tobacco. FDA finalized a rule, effective August 8, 2016, to regulate all tobacco products. FDA's comprehensive plan places nicotine, and the issue of addiction, at the center of the agency's tobacco regulation efforts. The FDA's key features of the comprehensive plan for tobacco and nicotine regulation are: A. Regulatory policies on addiction, appeal and cessation, like educating the public and correcting misperceptions about nicotine, B. Science-based review of tobacco products, like implementing product standards for safety, and C. Preventing youth use of, and access to, tobacco products. 

In 2018, the U.S. Food and Drug Administration (FDA) is putting its stamp on tobacco products, warning consumers of nicotine addictiveness. The new cautionary statement reads: “WARNING: This product contains nicotine. Nicotine is an addictive chemical.” Niches affected by the FDA warning labels ruling include advertising and packaging of vapor products, cigarette tobacco, cigars, hookah tobacco, roll-your-own tobacco, electronic cigarettes and pipe tobacco. Print advertisers also have new guidelines. Among the most prominent alterations, warning statements must cover at least 20 percent of the ad and the lettering must be black on a white background, with a font size of at least 12 points and be in Helvetica bold or Arial bold type. The print ad also must be flanked by a rectangular border. The multi-media warning must be present on a series of promotional materials, including brochures, catalogs, direct mail, cellphones, display racks, emails, leaflets, magazines, newspapers, internet web pages, posters, placards, social media applications, television, and websites will be affected.

 

Legal or illegal, psychoactive drugs demand caution.

The World Health Organisation (WHO) has defined psychoactive substances as substances that, when taken in, or administered into one’s system, affect mental processes such as cognition. The term “psychoactive substances” comprises both legal and illegal substances. 

Today, we acknowledge the continuously growing threat of the emergence of new psychoactive substances, also known as “legal highs”, “designer drugs” or “herbal highs”, which are mainly developed for recreational use (Negrey C et al, Daru. 2017; 25: 14). 

By December 2015, the UNODC (The United Nations Office on Drugs and Crime) had reported the presence of over 643 “new” psychoactive substances in 101 countries. More substances have been reported in Europe than any other region. According to a study conducted in China, Japan, Korea and Taiwan, between 2007 and 2015, among a total of 940 “new” psychoactive substances reported, only 25 were at the time controlled in four countries, with Japan and Korea being the most proactive in regulation. 

kava may be classified as a food, a dietary supplement, a herbal remedy, or a psychoactive substance, depending on how it is presented (including advertising and labelling). There are considerable differences in penalties and regulatory requirements between the different legislative regimes and these may result in unnecessary prosecutions or 'gaming' of the system.

Janik P et al, Categorization of psychoactive substances into “hard drugs” and “soft drugs”: a critical review of terminology used in current scientific literature, the American Journal of Drug and Alcohol Abuse 63(6):636-646 : Conclusions: Although it initially appeared that there is substantial agreement as to which psychoactive substances should be regarded as “hard” and “soft,” closer inspection shows that the dividing line is blurred without clear criteria for categorization. At this time, it remains uncertain whether these terms should persist in the scientific literature. We therefore recommend these terms should be avoided or, if used, be clearly and precisely defined. 

 

References  

Alcohol labeling A discussion document on policy options, World Health Organization, Regional Office for Europe, (Kaczmarek A ), 2017.

Global strategy to reduce the harmful use of alcohol. Geneva: World Health Organization; 2010. 

European action plan to reduce the harmful use of alcohol 2012–2020. Copenhagen: WHO Regional Office for Europe; 2012. 

Martin-Moreno et al. Enhanced labelling on alcoholic drinks: reviewing the evidence to guide alcohol policy. Eur J Public Health. 2013;23(6):1082–7. 

Annunziata A et al. Nutritional information and health warnings on wine labels: exploring consumer interest and preferences. Appetite. 2016;106:58–69.

Hersey JC et al. Effects of front-of-package and shelf nutrition labeling systems on consumers. Nutr Rev. 2013;71:1–14.

Grunert KG, Wills JM. A review of European research on consumer response to nutrition information on food labels. J Public Health 2007;15:385–99. 

Guillemont J, Lιon C. Alcool et grossesse: connaissances du grand public en 2007 et ιvolutions en trois ans [Alcohol and pregnancy: knowledge of the general public in 2007 and developments over three years]. Paris: National Institute of Prevention and Education for Health; 2008.

Fredholm BB, Battig K, Holmen J, Nehlig A, Zvartau EE. 1999. Actions of caffeine in the brain with special reference to factors that contribute to its widespread use. Pharmacol Rev 51: 83-133.

 

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