Are recent interventions by regulators in Europe and the US over the safety of CBD products grounded in genuine concern, or are they the product of stealth tactics by Big Pharma to stymie a booming natural health category?
That’s a question raised in new analysis of the CBD sector by UK-headquartered campaign group Alliance for Natural Health International.
Until recently, says ANH, the most obvious threat to the explosive growth of the CBD food and supplement market has been about how such products – the majority of which remain illegal in both Europe and the US – will be regulated
This uncertainty continues, and there have been some indications from European regulators and Member States of a hardening of attitudes towards CBD’s treatment as a ‘Novel Food’ in the EU. Meanwhile, signals from the US Food & Drug Administration in early 2019 that it would adopt an approach of ‘enforcement discretion’ evaporated when senior FDA officials quickly rowed back on such assurances and began issuing warning notices to companies it accused of selling CBD products illegally.
Alarm bells
More recently, says ANH, warnings about the safety of CBD-containing products have started to appear. It highlights three particular “alarm bells” – two in Europe and one in the USA. All come from “heavyweight players” in the risk assessment field, and all, the group says, have been “linked closely with some of the biggest business in the food and pharma sectors on the planet”.
The first “alarm” concerns a warning from the Federal Institute for Risk Assessment in Germany (BfR) in November 2018 that hemp-derived foods and supplements could be exposing German consumers to excessive levels of TCH (the psychoactive component in hemp). BfR’s report suggested that consumers consuming a range of hemp-derived food and supplements, could find themselves in a therapeutic range for THC and experience psychomotor (movement, reaction, coordination) impairment.
The second alarm is a new exposure study on THC in hemp-derived products conducted by the European Food Safety Authority (EFSA), which warns of the risks to consumers of a proliferation of THC-containing products on the market in the European Union.
ANH’s third alarm relates to the gathering volume of information on the US FDA’s website about safety concerns over CBD products. These warnings go “well beyond concerns about THC contamination,” says ANH, and cover the “the full gamut of risks, including dire warnings about CBD causing liver injury…drowsiness, gastrointestinal distress, changes in food and …male reproductive toxicity”.
Routinely banished
ANH says that in all these cases health risks are overstated, lack evidence or are based on exposures that consumers are unlikely to encounter. The group warns that safety has been used “time and time again to banish non-medical products and supplements from the market, irrespective of the benefits they might provide to citizens”. Instead of applying risk-benefit analysis, food and food ingredients “found to pose any measurable or theoretical risks to health, especially if they’re regraded as non-essential nutrients, are routinely banished from public access in Europe using novel food or medicine law as the legal instrument”.
ANH is urging companies in the CBD market to work with it, other companies and trade associations “to counter the safety challenges being metered out by the likes of the BfR, EFSA and the FDA”.