Regulatory in brief / CBD, Norway, COVID-19

Regulatory in brief / CBD, Norway, COVID-19

23 December 2020 - Deborah Wilkes

The US Food and Drug Administration (FDA) has issued a number of warning letters to cannabidiol (CBD) companies, the Norwegian Medicines Agency (NoMA) is expanding the list of general-sale medicines, and the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued an exceptional use authorisation for a COVID-19 rapid test to be used by members of the public.

US FDA issues CBD warning letters

The US Food and Drug Administration (FDA) has sent warning letters to a number of companies selling cannabidiol (CBD) products illegally.

The FDA said all five warning letters addressed the “illegal marketing of unapproved CBD products claiming to treat medical conditions”.

Letters have been sent to Bee Delightful, G&L Wellness, New Leaf Pharmaceuticals and Wellness BioSciences, as well as NextL3vel Services Group which does business as This Stuff Is Good For You.

Amy Abernethy, the FDA’s principal deputy commissioner, said “many questions remain regarding the science, safety, effectiveness and quality of products containing CBD”.

She added that the FDA remained “focused on exploring potential pathways for CBD products to be lawfully marketed while also educating the public about these outstanding questions of CBD safety”.

Norway adds to general-sale list

The Norwegian Medicines Agency (NoMA) is expanding the list of medicines that can be sold in general-sale retail outlets.

From 1 January 2021, two vaginal thrush treatments supplied in combination packs will be available outside pharmacies. One contains an econazole 150mg vaginal pessary plus 1% cream, while the other contains a clotrimazole 500mg vaginal capsule plus 10mg/g cream.

The move comes after a consultation announced in July 2020. Following the consultation, NoMA decided not to add nasal sprays containing fluticasone, mometasone, triamcinolone and budesonide to the general-sale list.

MHRA authorises self-test kit for COVID-19

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has issued an exceptional use authorisation for a COVID-19 rapid test to be used by members of the public.

The authorisation was given to the Department of Health and Social Care to allow use of the NHS Test and Trace COVID-19 Self-Test Kit to detect infection in asymptomatic people.

The product is an antigen lateral flow test which can give a result in 30 minutes.

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