“I don’t know whether they were using the term ‘food additive’ as a form of art, meaning specifically food additive petitions, as opposed to a GRAS (generally recognized as safe) notification or something like that,” noted Al-Mondhiry, a partner in Washington, D.C., with the law firm Amin Talati Wasserman LLP, in an interview.
FDA’s long-held position—that CBD cannot be lawfully marketed in food or dietary supplements because, essentially, the cannabis-derived compound was first studied as a drug—has dissuaded many U.S. corporate behemoths from entering the category, stemming demand.
Online public records suggest NIHC was joined at the meeting by several other organizations, including Green Roads, whose co-founder, Arby Barroso, spoke during the teleconference.
Al-Mondhiry said someone from the government inquired whether companies were submitting food additive petitions to FDA.
Miller said he met last week for around 45 minutes with about a dozen officials from FDA, U.S. Department of Health and Human Services (HHS) and the White House.
Lastly, a CBD-based medicinal product was recently the subject of a Commission decision granting marketing authorisation, ( 30 ) on the basis of Article 10(2) of Regulation (EC) No 726/2004. ( 31 )
( 3 ) Regulation of the European Parliament and of the Council of 17 December 2013 establishing a common organisation of the markets in agricultural products and repealing Council Regulations (EEC) No 922/72, (EEC) No 234/79, (EC) No 1037/2001 and (EC) No 1234/2007 (OJ 2013 L 347, p. 671).
1. Applicability of Regulations No 1307/2013 and No 1308/2013
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However, it might be considered that national legislation prohibiting the importation of CBD oil from another Member State, where that oil is extracted from the whole plant, interferes with the proper functioning of the common organisation of the market in hemp, governed by Regulation No 1308/2013, within the meaning of the case-law cited in point 47 above. It is settled case-law that the Treaty provisions prohibiting quantitative restrictions or measures having equivalent effect are an integral part of the common organisation of the market in the sector concerned. ( 20 ) All measures of a Member State which are capable of hindering, directly or indirectly, actually or potentially, trade within the European Union are to be considered as measures having an effect equivalent to quantitative restrictions on imports within the meaning of Article 34 TFEU. ( 21 ) Accordingly, national legislation prohibiting the importation of CBD oil where it is extracted from the whole hemp plant, in particular from its leaves and flowers, must be regarded as a measure having equivalent effect within the meaning of Article 34 TFEU. Such legislation makes it impossible to import CBD oil into France, since, as the French Government stated at the hearing, it is very difficult from a technical point of view, and unviable from an economic point of view, to produce CBD from hemp fibre and seeds.
( 10 ) Directive of the European Parliament and of the Council of 6 November 2001 on the Community code relating to medicinal products for human use (OJ 2001 L 311, p. 67).
ECLI identifier: ECLI:EU:C:2020:383
The cultivation, importation, exportation and industrial and commercial use of cannabis varieties not possessing narcotic properties or of products containing such varieties may be authorised, on a proposal from the Director-General of the Agency, by order of the Ministers with responsibility for Agriculture, Customs, Industry and Health.