Navigating the Maze: Cannabinoid Labelling and Health Claims Explained

If you're in the business of producing or selling cannabinoid products, you're probably no stranger to the complex web of laws and regulations that govern product labelling. It's a tricky landscape to navigate, with different rules applying to other product groups and varying from one European country to another. Whether it's EU Regulation 1169/2011, the cosmetic Directive, or CLP regulation, staying compliant is essential. But don't worry; we're here to help you understand everything.

Cosmetic, Medicinal, and Food Supplement Products: What's the Difference?  ¹

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Cosmetic Directive defines “cosmetic product” as  

“Any substance or preparation intended to be placed in contact with the  various external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucous membranes of the oral cavity.  With a view exclusively or mainly to cleaning them, perfuming them, changing their appearance and/or correcting body odours and/or protecting them or keeping them in good condition.” ²

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Medicinal Products Directive defines “medicinal product” as follows:  

“(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or  

(b) Any substance or combination of substances which may be used in or administered to human beings either to restore, correct or modify physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis."

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Food supplements literature defines “supplement” as follows:

A food supplement is a concentrated source of nutrients and other beneficial substances that are marketed in dose forms, such as capsules, tablets, or liquids.

They are intended to supplement the regular diet and provide additional nutrients or other beneficial substances that may not be obtained in sufficient quantities from the normal diet.

Unlike medicinal products, food supplements are not intended to prevent, treat, or cure a disease or medical condition.

They are not used to restore, correct, or modify physiological functions by exerting a pharmacological, immunological, or metabolic action.

The primary purpose of food supplements is to supplement the daily diet and support overall health and well-being. ³

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So, What Health Claims Can I Make for My Wellness Product?

Product claims on packaging can be tricky to navigate, especially regarding health claims. Health claims link a particular food, ingredient, or product to specific health benefits. General health claims refer to the overall benefit of a nutrient or food for good health or well-being. If you want to make a general health claim, you can only use specifically authorised health claims from the EU. This means that if a product does not meet the criteria for a specific health claim, it cannot be used to make a general health claim.

Cosmetic Claims and Their Limitations

Despite this, you can make cosmetic claims if you have framed it with a study that you have performed. For example, "improved skin elasticity in 80% of people surveyed." You can also use cosmetic terms such as soothing, botanical/plant-based, hypoallergenic, nourishing, and reducing the appearance of skin elasticity or skin hydration. You can make claims around vitamins in foods or supplements, but if the product is topical, for instance, it must be shown to be effective in the specific route of administration.

There are also some things you cannot do. You cannot make any medical claims on packaging, such as those relating to bruising, inflammation, blood circulation, pain relief, or pharmacological, immunological, or metabolic action. You cannot use peer-reviewed literature as a basis for a claim. You would need a clinical trial and a registered medicine.

Clinical testing of cosmetics and personal care products is crucial in substantiating your product claims for packaging and advertising. It also ensures that your products are safe and effective for consumer use. Generally, a particular product cannot be regulated by the Cosmetics Directive and the Medicinal Products Directive simultaneously.

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“A product may have a principal cosmetic purpose and secondary purpose to maintain health. A secondary preventive purpose does not exclude the classification of a product as a cosmetic product. As well as this, the marketing of this type of product will dictate if the product is medical or cosmetic. For example, a bath foam that bears a claim such as "relaxing" or which mainly refers to "well-being" will normally be considered by the consumer as a typical cosmetic product.”  ⁴

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The example above illustrates how language is used to make implicit claims. Even these implicit claims must be compliant, including any made regarding linked publications. The legislation that applies to the words used on labels also applies to the imagery used on packaging. The context in which the claims are made and the overall presentation, including labelling, packaging/package inserts, graphics, promotional literature, advertisements, marketing and sales channels, and any particular target of the marketing information/advertising material, should also be taken into consideration.

What about cannabinoid claims?

CBD, short for cannabidiol, is a natural component of cannabis. With increased media and social media attention, there has been a rise in consumer interest in CBD products due to their perceived health or medicinal benefits. These products are typically taken orally as drops, capsules, or tablets and may contain other ingredients besides CBD.

Determining the regulatory definition of CBD products can be complex and may depend on various factors. As such, no single description applies to all CBD products. However, it is the responsibility of marketers to identify the applicable regulatory regime for their product to ensure compliance with relevant regulations.

Regulations Governing Cannabinoids in Food and Supplements

In Europe and the UK, the use of cannabinoids in food and supplements is heavily regulated. Generally, only limited health claims can be made about cannabinoids due to a lack of sufficient scientific evidence to support their efficacy and safety. The European Food Safety Authority (EFSA) has evaluated a few health claims related to cannabinoids and found them unsubstantiated.

However, in Europe, a few authorised health claims can be made under specific conditions. For example, a claim related to the contribution of omega-3 fatty acids (which are found in some hemp seed products) to the maintenance of normal blood cholesterol levels may be made if the product contains a specific amount of these fatty acids; the same applies to vitamins so adding vitamins to the mix allows the brands to use health claims related to those vitamins.

It is important to note that each European Union (EU) member state has its own regulations regarding the use of cannabinoids, and it is essential to comply with the relevant rules in the country where the product is marketed. In general, it is recommended to seek legal and regulatory advice before making any claims related to cannabinoids in food or supplements.

Currently, there are no approved health claims for CBD on the EU Register. Therefore, it is recommended that marketers refer to the EU Register before making any health claims for food products.

The Golden Rules for Labelling CBD Products

Navigating the world of CBD product labelling can feel like walking through a minefield. But don't worry; we've got some golden rules to help you stay on the right side of the law:

Overall, the criteria that marketers must consider are extensive, and any claims made for the product, either implicitly or explicitly, must be scrutinised.

To reiterate, 'claims' must be legitimate on all elements of the marketing of the product and must be compliant with the regulations relevant to the product categorisation:

• Be careful with product naming – don't make implicit claims using an ambiguous or manipulative name.

• Graphics must not be misleading.

• Be mindful of promotional literature and advertisements, including “advertorials” and any (social) media presence.

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Let TNL Guide You Through the Regulatory Landscape

We know how challenging bringing a CBD product to market can be. With ever-changing guidelines and regulations, it's a tough market to navigate. But don't worry; we're here to help. Contact a member of the team, and let's make your journey a little easier.

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Some additional Notes:

1 Guidance document on the demarcation between the cosmetic products Directive 76/768 and the medicinal products Directive 2001/83 as agreed between the commission services and the competent authorities of Member States https://ec.europa.eu/docsroom/documents/13032/attachments/1/translations

2 https://www.cosmeticsinfo.org/regulation-and-oversight/how-cosmetics-and-personal-care-products-are-regulated-in-other-countries/cosmetic-regulation-in-the-european-union/

3 https://www.efsa.europa.eu/en/topics/topic/food-supplements

4 https://ec.europa.eu/docsroom/documents/13032/attachments/1/translations

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