Cannabis Control Act, Product Safety and Vaping Crisis in the USA

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Another aspect that determines the current discussion about the legalization of Cannabis, besides the already discussed aspect of social responsibility, is the often poor quality of the products available on the black market in Germany. Here, too, the Cannabis Control Act offers detailed regulations, which we would like to look at in detail today.

But first a word about the current vaping crisis in the USA. The market figures from the legalized US states and Canada show that 50 % of the market will be divided into smokables and extracts. Smokables are dried and unprocessed flowers as well as prefabricated joints for immediate consumption. Whereas the extracts „thc-infused“ are Vape Pens, Edibles and Beverages.
Now there were several 100 diseases and 7 deaths in the USA, which are said to have been related to E-Liquids containing THC. The products are said to have been available both on the black market and on the regulated market. The authorities are still trying with all urgency to clarify the causes. The first suspicions are that manufacturers have used additives that have caused the problems in the entire interaction and under heating.

For the just developing legal cannabis market in the USA, but also worldwide, this „vaping crisis“ is not a good signal. A panic is also not indicated, as it seems to be a very limited regional problem for the time being. However, the American legal system is designed to regulate and „tame“ the industry more through legal actions than through legal regulations. We can therefore expect a wave of lawsuits soon, which could bring the whole industry to a standstill. California was the first US state to introduce strict test methods for THC cartridges at the beginning of the year.

If we look at the Cannabis Control Act, product safety is another central component of this draft law. Thus, according to § 9 the

– the name of the placing on the market and the address of the manufacturer,
– the land of cultivation,
– the weight of the charge in grams,
– the date of harvest of the variety,
– the date of maximum durability,
– the list of other ingredients and
– the percentages of THC and at least one other cannabinoid, usually CBD,

must be specified.

Traceability is thus ensured. The consumer should also be able to assess the potential of the product he has purchased.
Furthermore, detailed warnings on the packaging and a package leaflet are prescribed, which must list contraindications and explain appropriate precautions, especially in the case of interactions. For proper application, the necessary instructions on dosage, type of application and duration of action, and instructions in the event of overdosage must be provided, among other things.

In § 10, which is expressly titled consumer protection, it is regulated that cannabis may not be placed on the market,
– if it has not been manufactured and tested in accordance with the state of the art in science and technology;
– mixing with tobacco products or alcohol is not permitted;
– Plant protection products, fertilizers, stock pesticides or pesticides may only be present in fixed maximum quantities.

Furthermore, the cannabis may
– not be contaminated with substances likely to endanger health, and
– not contain additives which are not clearly identified.

The problems with the partly poor quality of the cannabis flowers available on the black market in Germany, to which dangerous and even poisonous substances are partly added in order to increase the weight and thus the profit, have been well known for decades.

With these two paragraphs, the Cannabis Control Act aims to ensure the product safety of the future regulated market. This ensures that the consumer is protected from inferior and bad products from the black market or from dubious manufacturers.
This, of course, presupposes that these regulations are also strictly enforced and regularly reviewed. It must not be the case that, as in the Wild West, specialist shops are opened that are not licensed and the authorities do not follow suit in enforcing the licensing requirement. One might imagine one or the other corner in Berlin or another German city where something like this can happen.

Another challenge is the extensive control of the quality of the new cannabis products. In detail, it is still completely unclear and not regulated how it can always be ensured that only products with the required quality are put on the market.
For the new cannabis products, the extracts, there are already many legal provisions which must also be observed. Since THC and CBD have so-called CAS numbers (Chemical Abstract Numbers), they are subject to the European CLP and REACH regulations, with the corresponding additional requirements for product labelling. The Product Safety Act continues to apply to e-liquids, and the Tobacco Product Act will soon also apply to nicotine free liquids in Germany.

In the case of food products containing THC, there are also extensive food regulations.

As a rule, the legal system is structured in such a way that the entrepreneur must determine on his own responsibility which regulations apply to the products he wishes to bring onto the market. In addition, the law stipulates that a product must not endanger the safety and health of persons when used as intended or in a foreseeable manner. This must also be determined by the entrepreneur on his own responsibility. The entrepreneur must pay the greatest possible attention to product safety at every stage of economic activity, as considerable liability risks may arise.

However, there is usually no prior authorization requirement, such as for medicines, which brings us back to the vaping crisis in the USA. It is still being investigated whether the cases that have occurred are related to vitamin E acetate, which is reported to have been used in some THC concentrates. Thus, if traders, whether for greed or other reprehensible reasons, are too reckless in putting products on the market whose composition, when used as intended, cannot guarantee consumer safety, such a „crisis“ can be expected at any time.

It remains to be discussed whether the previous model, i.e. leaving it to the entrepreneur to decide first and foremost on his own responsibility whether to bring a safe product onto the market and only later to decide through controls or competition lawsuits whether this is really the case, is also suitable for the new, pharmacologically active cannabis products to come.

At least in the initial phase, as we now see in the hype surrounding CBD products, there will be many black sheep who promise the blue of the sky and whose products do not even begin to have the promised content of cannabinoids, or even worse, contain dangerous substances.

This will be the right balancing act between sufficient regulation and industry’s voluntary commitment. Strict requirements on the „compliance“ of the products pose a hurdle for market entry on the one hand, and generally already prefer larger and professional companies that can map these requirements, but on the other hand also guarantee the protection of the consumer.

In Canada, for example, where the new regulations on Edibles and Beverages will be introduced at the end of October this year, Aurora has been conducting an awareness campaign for several months now. In this campaign, the public is made aware of the new products, in particular about the effects of oral intake of THC, the dangers involved and how it can best be dosed.

After the last paragraph, the author himself sets off for a trip to the USA to get an overview of the legal markets in Colorado and California. A report will follow…

RA Kai-Friedrich Niermann