High on innovation, but CBD faces regulatory uncertainty


Various Nicholas Hall publications, notably OTC.NewDirections and OTC New Products Tracker, provide in-depth coverage of medical cannabis developments owing to the category’s huge potential to boost future consumer healthcare growth. High levels of innovation, both in terms of positioning and delivery format (like those detailed below), continue to characterise the category, but recent regulatory moves by the WHO and EU mean that the status of CBD supplements remains far from settled.

Looking at delivery format innovations, recent developments include a new mouth spray in the UK (Natures Aid CBD Oil Spray from Thornton & Ross / Stada) and a new nasal spray in the USA (Rhinodol from New Leaf Pharmaceuticals). The latter claims to deliver the highest concentrations of medical CBD at an affordable cost (US$69.99). According to New Leaf, the oral administrative route provides the lowest bioavailability, owing to the digestive processes that occur when CBDs enter the blood stream (a significant amount of CBD goes into the liver and is broken down into unusable compounds).

Screen Shot 2019-02-18 at 11.32.30

Screenshot from New Leaf Pharma’s website

Meanwhile, attitudes to CBD and cannabis are changing at a regulatory level. According to news sources, a leaked World Health Organisation internal letter to the UN Secretary-General recommends that whole-flower cannabis and its resins should be removed from Schedule IV of the Single Convention on Narcotic Drugs (1961), the most restrictive international drug category. Cannabis scheduling was discussed at the Expert Committee of Drug Dependence 41st meeting in November 2018 but the discussions have not been published. The letter also clarified that cannabidiol should not be scheduled within the International Drug Control Conventions, while tinctures and extracts of cannabis should also be deleted from Schedule I. WHO recommendations will be voted on by the UN’s Commission on Narcotic Drugs, which could take place in March 2019.

In Europe, marketers of CBD supplements are facing new regulatory hurdles. The European Food Safety Authority has amended the entry for cannabinoids on the Novel Foods register, which now states: “Extracts of Cannabis sativa L. and derived products containing cannabinoids are considered novel foods as a history of consumption has not been demonstrated. This applies to both the extracts themselves and any products to which they are added as an ingredient (such as hemp seed oil). This also applies to extracts of other plants containing cannabinoids. Synthetically-obtained cannabinoids are considered as novel.”

This means that CBD supplements are now classed as a novel food in Europe and manufacturers face the prospect of having to take their products off the market while they apply for approved novel food status, which can take around a year. In December 2018, Austria banned the sale of CBD extracts, stating that the ingredients fall under the EU’s Novel Foods regulations and cannot be marketed without authorisation.

Join Nicholas Hall at our upcoming New Jersey meeting, hosted with our partners Everything Health. Based on the theme, Innovate, Digitize, Integrate, the meeting takes place on 26-27 June, with representatives from Perrigo, MarketHub, Google and many others, joining us to discuss and debate topics including:

  • Market Trends and Innovation
  • Key Developments in the Cannabis Market
  • Connected Health
  • Consumer Insights using Artificial Intelligence  

OTCs in Action Episode 36: Naloxone to the rescue

OTCinActionheaderAccording to the World Health Organization, around 69,000 people die from opioid overdose each year. Timely administration of the Rx drug, naloxone, can counteract the effects of overdose – although tragically, most overdoses occur far from a medical setting. Last week, Health Canada announced that it is working with local governments in provinces and territories to assess the rescue drug’s Rx-to-OTC switch, while Adapt Pharma Limited submitted a New Drug Application to the US FDA for Narcan (naloxone) Nasal Spray. An FDA workshop earlier this summer focused on expanding access to naloxone and the injectable delivery of the drug – was seen as a barrier to switch.

site of overdose

Source: CDC, Adapt Pharma, LLC

The overdose crisis and the generic availability of naloxone is creating the bottom-up model of switch. Traditional Rx-to-OTC switches are manufacturer-driven, with clinical and actual use studies conducted by drug owners and submitted to regulatory bodies. In the case of naloxone, expanded access is already being expedited at local government level in the US and Canada. In the beginning of 2015, California joined New Mexico, Washington, New York, Rhode Island, and Vermont in making naloxone available from pharmacists without a prescription. In many states / provinces and cities in the US and Canada, programmes equipping emergency first responders, including police officers, with naloxone, have been highly successful. Addiction clinics also provide opioid users with take-home naloxone kits and training for their families and friends in how to inject it in case of an opioid overdose. Data collected at local level should provide Health Canada and the FDA with compelling evidence in favour of an Rx-to-OTC switch of naloxone.