Hemp seed oil sold as medical cannabis confuses consumers

The recent advertising of some hemp seed oil-based food supplements as “cannabis oil” is causing confusion among consumers and users of cannabis for medicinal purposes in Portugal, warned the OPCM — Portuguese Observatory of Medicinal Cannabis, which already asked for clarification from Infarmed — National Authority for Medicines and Health Products IP 

Cannareporter contacted Infarmed, which confirmed that it had received several complaints about these products and guaranteed to be, since yesterday, “monitoring and investigating the situations of the products described that may fall within the scope of the competences it holds in terms of medicines, preparations and substances”. based on the cannabis plant for medicinal purposes, other than food supplements”.

In a reply sent by email, Hugo Grilo, Infarmed’s press advisor, also clarified that “food supplements, whose regulation is the responsibility of the Directorate-General for Food and Veterinary and supervision of the Food and Economic Security Authority, may contain hemp seed oil”.

For its part, the The Ministry of Agriculture, responsible for approving food supplements through the Directorate General for Food and Veterinary Medicine (DGAV), said that this could be a situation of “deceptive advertising”, referring to the Directorate General for Consumers (DGC) and the Authority of Food and Economic Security (ASAE).

In this follow-up, Cannareporter contacted the DGC, which replied that it had not received “so far any complaint on this subject, being a matter whose inspection is an attribution of the Food and Economic Security Authority” (ASAE).

The legalization mess

After the approval of the legislation that regulates the use of cannabis for medicinal purposes, in January 2019, several food supplements appeared in Portugal with the name “CANNABIS”, which are being advertised in the media and sold freely in pharmacies, herbalists or cannabis specialty stores.

It turns out that these food supplements, despite being rich in essential fatty acids, omega 3 and 6 and GLA (gamma-linolenic acid), do not have the therapeutic properties attributed to cannabis. Thus, many consumers believe they are buying CBD oil (cannabidiol), when in fact they are buying a cooking oil, extracted from hemp seeds, and with little therapeutic properties, since the cannabinoid content is residual or non-existent.

The advertisement of these products in the context of the legalization of cannabis for medicinal purposes may, therefore, be misleading and create false expectations in, above all, patients, who are looking for the therapeutic properties associated with cannabinoids and this plant.

At the same time, all CBD oils (cannabidiol) disappeared from the market, which were previously considered food supplements and which now lack a marketing authorization (ACM) by Infarmed and which can only be used according to prescription. medical and in therapeutic indications approved by Infarmed.

Patients who already used cannabis for medicinal purposes were left with no alternatives, and they are currently turning to the illegal market to buy CBD oils, which they use in cases of epilepsy, multiple sclerosis, spasticity or chronic pain, among other pathologies.

In view of the benefits announced by brands such as Lister More, phytogold ou Cabis, the president of the OPCM, Carla Dias, questioned the effectiveness of these food supplements and expressed concern about the clarity of the information disclosed in the respective product descriptions. After receiving reports from patients who were advised in pharmacies to use these food supplements in conditions such as multiple sclerosis, chronic pain or anxiety, Carla Dias says that the OPCM considers this situation “a public health issue”.

CBD Oil and Hemp Seed Oil: What's the Difference?

The lack of knowledge about the range of products that can be extracted from cannabis, along with the recent legalization and absence of CBD products in pharmacies, leads consumers to end up confusing the two things, not least because the species is the same, Cannabis sativa L. However, theThe medicinal properties of cannabis come, essentially but not only, from the components that the plant accumulates in the flowers and leaves, mainly CBD (Cannabidiol) and THC (Tetrahydrocannabinol), the two cannabinoids with medicinal effects already proven in clinical trials and scientific studies. However, these cannabinoids (CBD and THC) are not found in hemp seeds or, if found, will only be residual values.

Although both oils (seeds and flowers) are rich in vitamins and nutrients, only those with cannabinoids in their composition contain sufficient levels to trigger the therapeutic effects on the endocannabinoid system, common to all human beings.

On the other hand, hemp seed oil, extracted from the plant's seeds through a cold process, despite preserving the plant's nutritious ingredients, has a consistency similar to that of olive oil, and is freely sold in herbalists and pharmacies. It is used as a cooking oil, in food products or in cosmetics such as lotions, lipsticks, creams or moisturizers.

That is, despite the benefits of its components, seed oil contains a very low level of CBD, making it impossible to use it as a therapeutic source of cannabinoids. The problem is that the vast majority of consumers, and even healthcare professionals, do not have this information, easily confusing the two products. And theCompanies are selling cooking oil at a clearly inflated price — around €40 per 50 ml — instead of the normal price for this type of hemp seed oil, which costs an average of 13 euros for a 250ml bottle .

Information on cannabis is scarce and is often incorrect or misleading

Recently, an article from the online magazine NIT (New in Town) — reported that “Cannabis capsules for weight loss have arrived — and the government approves”. In fact, hemp seed oil has long been approved in Portugal as a food supplement, but without the therapeutic properties of cannabinoids, especially CBD, which is what most users look for in a cannabis oil. The products being promoted as “CANNABIS” end up misleading potential consumers, who purchase them in the hope of obtaining the benefits of CBD, the non-psychotropic component of cannabis with relaxing effects. But, virtually undetectable in seeds.

A Lister More has been advertising on several prime-time television channels a cannabis-based product with beneficial effects on diseases such as cancer, pain, sleep, lack of appetite, or as an aid in psychosis, epilepsy, Parkinson's, anxiety, depression, etc., as appears on the product label “Premium CANABIS”, on the company's website.

To Cannareporter, Lister Silva, director of Lister Mais Saúde, said only that “our product is not analytically quantified for CBD but only for THC according to European and national regulations on food supplements, as is the case with the product we produce and market” .

However, on his Facebook page, Lister Silva writes, along with the television ad, that “cannabidiol, better known as CBD, is one of more than 100 cannabinoids documented in the cannabis plant. CBD has no psychoactive effects, does not cause euphoric states, is not addictive and can be taken by the overwhelming majority of people, including children.” Asked if he does not think he may be misleading consumers, Lister Silva did not respond.

Phytogold, on the other hand, has at least two products that it advertises as “CANNABIS” seed oil in magazines such as Maria or in drug store windows, as a food supplement. Carla Ribeiro, Manager at Phytogold, told Cannareporter that DGAV certifies its products and refers it to legislation applicable to food supplements and their labelling.

Asked why she calls a hemp seed oil “cannabis”, the executive says that “the name of the plant is cannabis sativa, just like any other, like Garcinia, Fucus, Ginkgo etc. Name?"

Phytogold's slimming product, reported by NIT, is on sale at Portuguese Pharmacies for about 39 euros a box of 30 capsules. CANNABIS FORMULA + FUCUS, a food supplement based on “CANNABIS” seed oil, is also sold on the website Sunflower as an “ally in weight loss” with the following “Therapeutic Indications”, “Helps to control weight, Increases satiety and Contributes to laxative action”.

Carla Ribeiro emphasizes that “a supplement is not a medicine”, so Phytogold's products are not intended for “any pathology”. “We cannot put any indication on the product, either in this supplement or in 95% of other supplements”. In a telephone conversation, the Phytogold executive also said that she does not sell online and that she trusts a close relationship with pharmacists, who will be able to better explain to consumers the true benefits of their products. However, the OPCM has reported situations in which patients are being misinformed precisely in pharmacies, where some professionals, certainly without any training in this area, have already indicated these oils for diseases such as multiple sclerosis, chronic pain or anxiety — clearly confusing the benefits of CBD with hemp seed oils.

The golden package of Phytogold's "CANNABIS" food supplement with 30 capsules of "Cannabis sativa Seeds Oil", appears in the Portuguese Pharmacies website and is sold on the Celeiro website for €49,99, with one capsule per day recommended. According to the label, a capsule contains 1000mg of “Cannabis sativa (seed oil)”, and the capsule is made up of Gelatin and Stabilizers, including Glycerin, Sorbitol Syrup and also Colorants, such as Titanium Dioxide and Sodium Cupric Chlorophyllin. .

Regarding the effectiveness / price ratio of this product, Carla Ribeiro says that “it cannot be compared with CBD, because the price charged by Phytogold is 4 to 5 times lower” than that of CBD.
A virtually identical product, CABIS, is also listed in the Portuguese Pharmacies website.

Infarmed is monitoring the situation

In response to the questions sent by email, Hugo Grilo, Infarmed's press officer, assured that “Infarmed is monitoring and investigating the situations of the products described that may fall within the scope of its competences in terms of medicines, preparations and substances based on the cannabis plant for medicinal purposes, other than food supplements”.

Hugo Grilo also clarified that “food supplements, whose regulation is the responsibility of the Directorate-General for Food and Veterinary Medicine (DGAV) and supervision of the Food and Economic Security Authority (ASAE), may contain hemp seed oil”.

DGAV refers to Ministry of Agriculture that refers to DGC and ASAE

Contacted by Cannareporter, the General Directorate of Food and Veterinary Medicine (DGAV), responsible for authorizing food supplements, sent any clarifications to the press office of the Ministry of Agriculture.

La Salete Marques, advisor to the Minister of Agriculture, Luís Capoulas Santos, mentioned, in a telephone conversation, that this could possibly be “a situation of misleading advertising”, referring to the Directorate General for Consumers (DGC) or, in the case of inspection may be necessary for the ASAE (Food and Economic Security Authority). Asked about the fact that the DGAV is certifying food supplements based on hemp seed oil and, on the other hand, if it has refused to certify the seeds of national hemp producers, intended for cultivation, La Salete Marques stated that this is two totally different things: “cultivation is one matter, food supplements are another. The Ministry may not authorize the production of a variety of a particular plant and may authorize the marketing of a food compound that has extracts from that plant.”

CBD: Supplement or Medicine?

Due to the clear differences in the composition of the products (with and without cannabinoids), there are higher prices for those with CBD or THC, as they also have higher production costs. For the consumer to be able to understand the difference, while a liter of hemp seed oil costs around 50 or 60 euros, a liter of CBD oil can easily reach the thousand euros barrier.

The status of CBD is yet to be defined in many countries that have already legalized cannabis for medicinal purposes. Anca Paduraru, spokesperson for European Union (EU) projects on Health, Food Safety and Energy, referred to Cannareporter, in November 2018, that “CBD can be classified in many ways — as a medical product (medicinal products), food or supplement

I'm feeding. The classification of a product as a medicinal product, as a food or a food supplement is a national competence. As such, each Member State must decide whether CBD can be sold as a medicine or food supplement in its territory, taking into account all the characteristics of the product. If it is classified as a medicinal product, EU legislation requires that a marketing authorization (MA) be issued by the competent authority before it is placed on the market”.

This means that the different EU countries, if they so wish, can regulate CBD as a “food”, as cannabidiol, cannabinoids and Cannabis sativa L. have already been included in the European Commission “novel foods” catalog.

In Portugal, and after the approval of cannabis for medicinal purposes, all cannabis-derived products came under the purview of Infarmed, including varieties intended for industrial purposes. THE Infarmed regulations published on January 15, 2019, also established, in its Aarticle

6-A, that “the instruction of requests and procedures related to the granting of authorizations for the exercise of activities related to the cultivation, manufacture, wholesale trade, transit, import and export of medicines, preparations and substances based on the plant of cannabis for medicinal, medical-veterinary or scientific research purposes, as well as authorizations for the exercise of the activity of growing the cannabis plant for other purposes, namely industrial, as well as the security measures to be adopted, are defined by order of the members of the Government responsible for the areas of finance, internal administration, justice, health, economy and agriculture".

However, this Ordinance, signed by six ministries, is not yet known nor is there a date set for its publication. Asked about this lack of legislation, Hugo Grilo, from Infarmed, explained that “as this is a joint Ordinance, which requires the intervention of several Ministries, Infarmed does not have information on the expected date for its publication”.

Cannabis Store Amsterdam sells CBD that is not for human consumption

However, confusion sets in, taking advantage of the “voids in the law”. Last April, it opened in Lisbon the Amsterdam Cannabis Store, a store specializing in “cannabis” products, which is selling, among chocolates, candies or drinks, a CBD oil extracted from hemp flowers, with a concentration of 5% and 2,5mg of CBD, including terpenes such as myrcene and limonene, among others.

The OPCM received a report from a consumer who bought this CBD oil for his 80-year-old grandmother, but when he got home and read the label, he was concerned about what he read: “it is not a smoking product but is intended only as an object decoration, collection or souvenir. Do not ingest or inhale”. When in doubt, the caregiver chose not to give it to the patient, but the money was already lost.

Bulgaria is the first European country to approve the free sale of CBD

After years of studies and evidence gathering on the benefits of the therapeutic use of cannabis, the World Health Organization (WHO) recognized the medicinal potential of cannabidiol (CBD) and considered that its consumption is safe, presenting no danger of dependence or health risks.

In a letter sent to the UN Secretary-General, António Guterres, on 24 January 2018, the WHO recommended removing cannabis from Category IV, the most restrictive of the table of the Single Convention on Narcotic Drugs of 1961, signed by countries around the world, noting that the CBD should not be subject to strict international controls, including for production and sale.

In Europe, the first country to move forward with the decision to regulate CBD as a food supplement was Bulgaria, as recently reported. to Forbes. “Bulgaria has issued its first authorization for a company to freely sell hemp-derived cannabidiol, or CBD, products on open markets.”

CBD chocolates for sale at Cannabis Store Amsterdam in Lisbon. They are made with hemp seed oil and theoretically contain no CBD.

According to official documents acquired exclusively by Forbes, the Ministry of Agriculture, Food and Forestry and the Bulgarian Food Safety Agency have issued a Free Sale Certificate for a number of CBD-containing products. The products, produced by Kannaway, a subsidiary of medical cannabis company Medical Marijuana Inc. (OTC: MJNA), are now certified to “fully comply with the relevant requirements of the Food Products Act of the Republic of Bulgaria and Regulation (EC) no. 852/2004 of the European Parliament and of the Council on the hygiene of foodstuffs.” The permission also allows exports.

In Portugal, DGAV has already said that, after the EU has included cannabinoids in the catalog of new foods, risk assessment tests should be carried out, if Portugal decides to regulate them as “food”, which at the moment seems a distant reality. and unlikely. Paula Carvalho, from DGAV, said that “cannabidiol is considered a novel food, so it cannot be included in food supplements without having undergone a risk assessment, in accordance with the provisions of Regulation (EU) 2015/2283 of the European Parliament and of the Council of 25 November 2015 on novel foods, so that this substance can be marketed as a food supplement”.