Is Safety the New Gremlin for CBD Regulation? – firebird-cbdoil
By Rob Verkerk PhD, Scientific and Executive Director, ANH-Intl
Finding your way around can be difficult: the vast majority of products in the fastest growing sector that the natural health market has experienced in over two decades – namely, hemp products that contain cannabidiol (CBD) – are both illegal in Europe and the United States.
Regulators and industry on both sides of the pond are still trying to find a solution, knowing full well that any attempt to pull products off the shelves will be hit by a popular uprising, as is the popularity of the products. No wonder, because so many of us have found that regular use of CBD supplements causes pain relief, anxiety and countless other disorders without the side effects associated with NSAIDs and . opioids.
It is also not surprising that Big Pharma did not want to sit back and do nothing when it began to question its market share through foods and supplements that did not have drug approval systems, and those with teardrops associated costs avoided.
This piece is in fact an update of our special report published in November last year about CBD, which in particular contains new information and perspectives on the regulatory position of CBD supplements, especially in the USA , were treated in Great Britain, EU and USA.
No easing of the legal interpretation in Europe
First things first: In Europe, following the decision of the German district court last November it hardened rather than softened the positions of the national authorities with regard to CBD in foods and supplements. The Brexit is only a few days away, and just as Britain is trying to free itself from the Brussels chains, the British Food Authority, the Food Standards Agency (FSA), has consolidated its position as a CBD hardliner at Westminster at Forum in London last week.
In order to escape the catch of new types of food and to avoid a complex and expensive pre-marketing authorization process, which generally took more than three years in the EU, CBD would have to be considered as traditional food. At least in the UK, this case seems to be pretty much lost.
Nutraingredients already reported on the fate of CBD foods and nutritional supplements in February last year. commercial sale while application for permission to use it is completed. "
At the Westminster Forum last week, the FSA suggested that enforcement action could be initiated shortly after Brexit Day on January 31, 2020. zealous EU regulation.
Reality is not always so convenient. Britain has long been a key architect for strict EU legislation. Even worse, it had a historical tendency towards "Gold-Plate" EU laws. Regarding CBD, the United Kingdom, together with Germany, France, Italy and the Netherlands, petitioned the European Commission's Novel Food Working Group and persuaded the 17 other EU Member States to adopt a plan to treat CBD isolates or – Support concentrates as novel foods. The European Commission continues to use the FSA classification of CBD as a novel food as a key example and argues that for CBD isolates, no consumption history prior to May 1997 and the chemical composition of the CBD in CBD supplements was proven differed (surprise, surprise) from the hemp and seed oil starting material from which it was obtained.
Most CBD supplements are illegal in the United States.
Despite the generally more liberal approach to dietary supplement regulation in the United States, based on the current interpretation of the Dietary Supplement Health and Education Act of 1994 (DSHEA) and the subsequent Legal victory of leading US constitutional lawyer Jonathan Emord in Pearson v Shalala (1999), the US situation has many similarities to that of Europe. The problem that CBD faces is that it was considered a drug before it was a dietary supplement. Honestly, we would all benefit from a successful legal challenge to take a back seat to this perspective as CBD is nothing new. It was always present in hemp oils and seed products, albeit in low concentrations.
The US Food and Drug Administration (FDA) makes it clear on its website that it has only approved one product and that it is a prescription drug for the treatment of two rare forms of epilepsy.
While the many thousands of dietary supplements sold on the US market are not subject to FHEA rating under DSHEA, the ingredients they contain are considered GRAS (generally classified as safe). However, CBD is considered a new food ingredient (NDI) and is not approved under GRAS.
This gives the FDA enough foundation to gain a foothold in the CBD industry. The agency is likely to be forced to do this to keep its big pharma paymaster happy. An example of this is that it is reporting its decision to send letters to 15 companies for “illegally selling products containing cannabidiol (CBD) in a manner that is against Federal Food , Drug and Cosmetic violates Act (FD & C Act). “Even more worrying is the inclusion of information about CBD products on the FDA healthcare fraud website. Finally, "heather fraud" has become the new collective term used by regulators, international organizations such as the World Health Organization and Internet service providers such as Google and Facebook to disparage products that compete with approved drugs.
Recognizing that all CBD products labeled as containing CBD are currently illegal, the FDA appears to be interested in finding a legitimate way to enable the continued sale of CBD products. The supplement industry botanical associations such as the American Herbal Products’s Association and elected representatives of the Congress are driving the FDA hard.
There are two ways, none of which find a consensus, not even among those who do not want to interrupt the sale of CBD products. One of them is creating a completely new regulatory path for CBD products that can take several years. The other is the "Petersen Bill" (HR 5587) which was introduced to the House of Representatives on January 13, 2020. It tries to create the "exclusion clause" of DSHEA, a one-time exception for CBD, which is otherwise considered an NDI and is not GRAS approved. Both approaches have their supporters and critics, and both approaches may be required, one providing a long-term solution and the other a short-term continuity.
A new problem: security
For two years, companies responsible for the explosion of CBD products have been struggling with uncertainty about the legal status. But what if a view develops that suggests that all of these CBDs cause health problems and not just solve them? In Europe, probably more than any other part of the world, safety is taken incredibly seriously – and has been used time and time again to ban non-medicinal products and supplements from the market, regardless of the benefits they could have for citizens. Healthcare risk-benefit ratio, we are told, is primarily the domain of pharmaceutical companies – and they pay a lot of money to play this game. When we recall how outdated the system is, foods and food ingredients that have been shown to pose a measurable or theoretical health risk, especially if they are considered non-essential nutrients, are routinely banned from public access in Europe with novel food or drug laws as a legal instrument ,
This is inevitably an area that we are watching very closely. We have identified three alarm bells that give us cause for concern and are all the more worrying as they can be seen on both sides of the pond. Two are in Europe and one in the United States. All three are generated by heavyweight players in the field of risk assessment, all of whom are closely linked to some of the largest companies (in the food and pharmaceutical industries) in the world.
Alarm 1: BfR, Germany (2018)
On November 8, 2018, the Federal Institute for Risk Assessment in Germany (BfR) published a statement (No. 034/2018) on THC in hemp-containing foods. In essence, the opinion was that German consumers could be exposed to excessive levels of ∆9-tetrahydrocannabinol (THC), the psychoactive component of hemp that is found in very low levels (below 0.3%) in most hemp crops source of its non-psychoactive cannabinoid relative CBD. The report even went so far as to say that if German consumers only consumed hemp products and dietary supplements, they could find themselves in the therapeutic range for THC, which is more than 2.5 mg per person per day, which is also from CONTAM EFSA takes into account panel the lowest observable side effect (LOAEL). According to the report, these doses could produce "psychomotor effects such as decreased responsiveness or fatigue in this dose range, restrictions on the ability to drive and use dangerous machines" on cannabis "stoned". The BfR also reminded us that the effects of alcohol and certain other drugs can be increased – but I have to say that it never worked for me. For many of us, this BfR report was a classic case of BfR alarmism, similar to the concern of the German risk assessor about cinnamon in Christmas cookies. However, the actual headline was not about the risk of stoning CBD products, but about the acute reference dose (ARfD) of miserably 1 μg / kg body weight (corresponding to 36 μg Δ9-THC / kg body weight) per day (i.e. the 30th times the lowest dose that could cause psychomotor effects in the most sensitive people) could be exceeded. This is not surprising since EFSA's AfRD is set too low, which is justified by data uncertainty in the usual way (hence 30 times, not for example 3 times, the uncertainty factor).
Alarm 2: EFSA, EU
On January 7 this year, EFSA published a new exposure study about THC in products made from hemp. It appeared to be comprehensive and based mainly on data from the food authorities, but also from industry. However, when you look at risk assessment, data in some key areas is poor and not always as reliable. It included 13 food categories, including hemp seeds and oil, herbal teas, breakfast cereals, pasta, bread and rolls, pastries, beer and beer-like drinks – and of course CBD supplements. An attempt was made to rely on data using the most precise analysis techniques such as LC-LC / MS and HPLC-DAD, but it was a shame if they were not available. The exposure to these foods was then estimated using 12 different scenarios, with the worst-case scenario / highest possible consumption being very important for the various population groups examined (infants, other children, adolescents, adults, the elderly and adolescents) older). While concentration is important, the final exposure to the psychoactive THC component depends heavily on how much you consume and how sensitive the person is. Therefore, exposure assessment is critical for different groups. So far, everything has been relatively good.
Things are shaking in the key area of food supplements. In total there were only 26 samples that were intended for very different types of products. 9 were classified as "dietary supplements" (possibly from the USA), two as vitamin supplements, 8 as "protein and amino acid supplements" and 7 as "food supplements". Plant extract formula ”. Since different extraction and analysis methods were also a challenge, the uncertainty about the limited data was a big problem.
It was long and short that, when considering the highest occurrence rates and the highest consumption rate (ie "worst case" exposure), high exposure levels were found, especially for teas (infusions) (40 to 208) μg THC / kg body weight in adults ), Hemp oil (3 to 21 μg THC / kg body weight in adults), hemp seeds (2.3 to 9 μg THC / kg body weight in adults) and food supplements (1.5 and 9.9 μg) THC / kg body weight in adults) , Interestingly enough, many hemp-containing teas, the only category with a highest exposure scenario that exceeded EFSA's ultra-conservative AfRD (equivalent to 36 μg THC / kg body weight in adults), were well on the market before the CBD supplement outbreak the market in 2017. Not only the data on the basis of which this exposure assessment on site was very poor, there is also no guarantee that these figures reflect THC values from well-known manufacturers. There is also no evidence that anyone has ever experienced psychomotor effects from these very low THC teas.
While EFSA establishes the limits of its own assessment and clarifies that much work is still needed to refine it, this opinion is used as an alarm by the parties it finds in its interest. Just don't tell anyone that only the presence of some unidentified hemp teas and not the supplements triggered the EFSA alarm.
Alarm 3: FDA, USA
The FDA is actively updating its website on cannabis and CBD. At the time of writing, it was last updated on January 15, 2020. The amount of information about security concerns is striking here. Yes, the United States is a very controversial company, the FDA is the regulatory authority, and FDA officials are aware that there is a wild west in CBD products. The most important page to read at the beginning of your journey through the FDA's electronic assets related to CBD is the "What you need to know (and what we're working to find out …") page. This is not just about THC contamination. There are a plethora of risks, including the CBD warning that causes liver damage, side effects you may not notice, drowsiness, gastrointestinal upset, mood swings such as irritability and restlessness, and – one for the boys – male reproductive toxicity males ( after animal experiments – in what dose?).
The FDA information continues to claim that some CBD products are marketed with unproven medical claims (yes, agreed, but many are more than justified) and "could be manufactured using unsafe manufacturing practices" that expose to contaminants such as z metals and pesticides.
There is more to entertain if you read everything .
In my humble opinion, it would be a big mistake to ignore this increasing dialogue between security agencies.
Where to now?
Now is the time for anyone interested in this incredibly important sector and freedom of choice to seriously consider rolling up their sleeves and taking action.
From a regulatory perspective, the world of CBD supplements now seems to be fluctuating, from the place where no regulator has existed in the past two years to what we consider to be much more treacherous place to be: "We think your products could be dangerous. "
If you don't challenge regulators now and only accept what they throw at the sector, you can expect very challenging regulatory obstacles that will be placed in front of the CBD industry. You can also expect extensive safety studies that are no less complex than those for the approval of medicinal products.
Depending on whether you are a consumer or a producer, you can do the following.
If you are a citizen : Buy CBD products from reliable sources who know how much CBD the product contains and confirm that they source CBD from low THC cannabis strains and are free of impurities. Follow the dosage on the bottle or the advice of a qualified and experienced health professional – enjoy and write down your experience. Then let your elected representative know about your concerns about disproportionate regulation that may deny you access to your favorite CBD products. Tell your stories about your positive experiences with CBD as much as possible on social media and other channels. In general, avoid providing company names unless a company has agreed that this is okay to reduce the likelihood that regulators will target the company.
If you are a company : Work with other companies, trade associations and us at ANH-Intl to meet the security challenges measured by BfR, EFSA and the FDA. This includes knowing exactly how much THC is in your products using accurate analytical methods such as LC-MS / MS, as well as laboratory reports showing that contaminants are below the set thresholds. It will also be necessary to question the belief that low-dose CBD is responsible for significant harm, that EFSA's AfRD is unnecessarily low, and that normal usage patterns pose no significant risk compared to other common foods or herbal ingredients. This information must be submitted to your national food agency and your customers will thank you for letting them know that you are up to the task, however you feel it is appropriate.
Further information: –
If you would like to learn more, please take part in the CBD Global Summit which I will attend a panelist in March.