Information Classification: General

FOOD PRODUCTS DERIVED

FROM CANNABIS SATIVA L.

WHAT’S THE CURRENT

STATE OF PLAY?

Vitafoods ConferenceGeneva, 8 May 2019

Karin Verzijdenwww.axonlawyers.com

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Introduction Axon Lawyers

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• Who are we? Amsterdam based life sciences law firm with international focus

• What do we do? Assisting high tech, science-based companies marketing innovative

food products, medicinal products and medical devices

• What’s the offer? Offering unique life sciences expertise on an EU-wide level through

Alliance of European Life Sciences Lawyers and other close collaboration with peers

• What more? Reporting current life sciences developments at three different blogs:

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Agenda

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Current state of play of Cannabis sativa L. derived food products

• Current state of play regarding cannabis derived products and what's new?

• Implications of change in legal framework on current practice

• Enforcement regarding CBD food products in the EU

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Cannabis derived products - currentstate of play and what’s new?

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Current state of play – what’s new?

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So all CBD food products are Novel Foods… or what?

• Cannabis derived food products are not Novel Foods when history of safe use can be

established.

• What factors should be taken into account to establish “consumption to a significant degree”?

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Current state of play – what’s new?

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Consumption to a significant degree (1)

• Geographical aspects: widely and commonly used in EU country or just at local / regional scale?

• Quantity of use: may vary per product category > should be linked to typical levels of consumption

for specific product categories.

• Intended purpose: only food uses are taken into account, not use as a medicinal / cosmetic

product.

• Intended audience: does the food target only specific groups or the general population?

• Timeframe: single availability during trade show or single availability long ago may not be

significant use.

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Current state of play – what’s new?

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Consumption to a significant degree (2)

• For plants: which parts are used? Do not consider plant in its entirety but differentiate amongst

parts for which history of food use can be established.

• Processing method applied: new processing method may alter composition of the food or its level

of undesired substances.

• Availability: limited availability in pharmacies or health stores does not carry the same weight as

general availability in supermarkets or common food stores.

• Type of offering: food should be legally placed on the market and be offered for sale in a

commercial context.

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Current state of play – what’s new?

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Novel Food Catalogue

• is not legally binding but constitutes a reference for FBO’s and regulatory authorities;

• is a living document that has changed and will change over time;

• does not contain restrictive list of cannabis parts with history of safe use.

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Current state of play – what’s new?

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Current state of play – what’s new?

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So what do we know about food uses of parts of Cannabis sativa L?

• EIHA compiled documentation demonstrating food use

for hemp flowers going back to 1996.

“….hemp flowers used for the production of beer-like

beverages are considered to be food ingredients and

not additives since they are used in the same manner

as hop flowers”

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Current state of play – what’s new?

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Application of parameters for significant use applied to hemp flowers

• Geographical aspects

• Quantity of use

• Intended purpose & audience

• Timeframe

• Processing methods

• Availability

• Type of offering > When all these parameters are positively assessed:

▶️ Similar exercise can be done for other parts of the Cannabis sativa L.

▶️ Do check however for national restrictions for marketing Cannabis sativa L. derived products.

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Implications of change in legalframework on current practice

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Implications of change in legal framework

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Nowadays, there are 5 options for marketing CBD food products

1. No Novel Food

2. Make application for NF authorization

3. Take advantage of transition regime

4. Rely on third party NF authorization

5. Consultation procedure at Member State level

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Implications of change in legal framework

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Application for NF authorization

• Contrary to former NF-Regulation, generic authorizations under current NF-Regulation.

• Apart from protection of confidential information or data protection, no commercial monopoly.

• In order to share the investment, joint applications can be made for instance by industry

organizations.

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Implications of change in legal framework

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Take advantage of transition regime

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Implications of change in legal framework

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Take advantage of transition regime

• Contrary to prior NF-application, CBD product can be continued to be marketed while making

application.

2 conditions precedent:

(1) CBD product should have be legally marketed before 1 January 2018;

(2) NF-application must be made prior to 2 January 2020.

▶️ To establish if a product was legally marketed, guidance on “consumption to a significant degree

degree”

”

is of relevance.

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Implications of change in legal framework

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Rely on third party NF authorization

• Currently the entire CBD scene is watching the one and single pending application for CBD food

supplements applied for by the Czech company Cannabis Pharma.

• If EFSA grants a positive opinion and a NF-authorization is granted, any third party can market a

CBD food supplement with the same specs and for the same targeted audience.

• The same goes for any other potential third party authorization for a CBD food product, so watch

that Union list of authorized Novel Foods!

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Implications of change in legal framework

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Implications of change in legal framework

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Consultation procedure at Member State level

• Based on Implementing Regulation 2018/456 a request for determining the NF status of a food

can be filed at MS level.

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Implications of change in legal framework

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Consultation procedure at Member State level

• Relatively quick procedure: national authorities should decide within 4 months after receipt

request (in principle including potential requests for additional information).

• Protection of confidential information possible to certain extent.

• If request for confidentiality is not granted: consultation request can be withdrawn.

• Outcome published at Commission website (currently 11 publications, 2 not novel).

• For the entries not considered novel, a history of food use in the EU < 1997 was established.

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• Big pro national consultation process: European Commission is bound by MS decision on non-

novelty of food product.

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Enforcement regarding CBD food products

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Enforcement re. CBD food products

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What types of enforcement can FBOs meet when marketing CBD foods?

(1) Marketing CBD foods without required Novel Food authorization

(2) Marketing CBD foods in violation of applicable labeling and advertising rules

▶️ Each type of exposure comes down to violation of a EU legal norm.

▶️ Enforcement however takes place on a national MS level > for proper risk assessment, consult

local expert.

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Enforcement re. CBD food products

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Marketing CBD foods without required Novel Food authorization

• In the NL, food safety is assessed by the Dutch Food Safety Authority (NVWA), having authority

to order withdrawal of food products from the market and imposing fines.

• Sanctions on marketing NFs without market authorization depend on assessment of risk.

• High risk assessment for health or safety of the consumer: immediate market withdrawal / fine of

€ 525 or € 1.050 / re-inspection in due course.

• No high risk assessment: 6 month term is granted to terminate offence, however no further retail

deliveries allowed / re-inspection in due course > fine if offence has not been remedied.

• NB Also consider reputational damage!

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Enforcement re. CBD food products

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Recent example of enforcement in Spain directed

against CBD food products

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Enforcement re. CBD food products

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Marketing CBD foods in violation of applicable labeling and advertising rules

• Various uses of Cannabis sativa L. derived products occur: use of CBD foods should not be

confused with potential medicinal applications.

• Despite potential therapeutic effects, CBD foods are food products, not medicinal products > stick

to the rules of food law!

• In essence: use of nutrition and health claims is allowed, use of medical claims for CBD food

products is strictly prohibited.

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Enforcement re. CBD food products

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Distinction nutrition and health claims from medical claims

• Nutrition claim informs what’s in the product: e.g. “high in protein”.

• Health claim informs on the effect of a product: e.g. “Plant sterol esters have been shown to

lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary

heart disease”.

• Medical claim states or implies that a certain product reduces a health problem: “Spirulina

contributes to the improvements of the brain function” or “Aloë Vera contributes to calming down

digestion”.

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Enforcement re. CBD food products

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Claims applied to CBD

• To date, no specific health or nutrition claims for CDB have been authorized.

• Yet CBD products used to be promoted using various health and/or medical claims.

And some still are.

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Enforcement re. CBD food products

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Exposure for sanctions when using medical claims

• When marketing food products that by function or presentation qualify as a medicinal product, you

are at risk of important fines.

• Rationale: medicinal products legislation > any other legislation (art. 2.2 Directive 2001/83),

prohibiting offering for sale and marketing medicinal products without market authorization.

• € 10K fine by Dutch NVWA in September 2018 against two online CBD store using medical

claims for hemp oil.

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Enforcement re. CBD food products

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Don’t forget proper labelling, especially via online sales

• According to the Food Information to Consumers Regulation (1169/2011), certain mandatory

information should be provided for each type of food product, also for CBD products.

• When the product is marketed as a food supplement (and most CBD products are), certain

mandatory information is derived from the Food Supplements Directive (2002/46). Examples:

• name of the product > CBD should be mentioned as characteristic for the product

• warning not to exceed recommended daily dose

• statement that supplement should not be used as substitute for varied diet.

• Consumers should be able to access all mandatory info prior to purchase. Sanctions include fines

or prohibition to further market product at stake.

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Conclusion

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• Despite changes in regulatory framework, CBD market is not dead.

• There are various ways to market CBD products in addition to making your own application for a

NF-authorization.

• Serious players however play it by the rules: consider not only NF-aspect but also proper labelling

and advertising.