The FDA’s Stance on Hemp-Derived CBD as a Dietary Supplement (Part 1)

美国FDA对大麻CBD作为膳食补充剂的立场(第一部分)

2019-07-22 18:00:00 cannalawblog

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Since the 2014 Farm Bill passed, products containing cannabidiol (“CBD”) derived from hemp (“Hemp-CBD”) have become widely popular and available in a wide range of stores and online. The Food and Drug Administration (“FDA”) has, for the most part, sat on the sidelines. The FDA has occasionally sent out warning letters to Hemp-CBD distributors who made medical claims about their products, but that was it. The days of relative non-enforcement may be over, as the FDA has recently seized Hemp-CBD products. This two-part series will take a look at how the FDA will regulate Hemp-CBD. Today’s post will focus on why the FDA does not currently view Hemp-CBD is a dietary supplement. Tomorrow, we’ll examine some issues with the FDA’s position and look at how the agency may regulate Hemp-CBD in the near future. The 2018 Farm Bill makes it explicit that it does not limit the FDA’s authority to regulate consumer products, and the FDA has made clear that it is focused on Hemp-CBD, making an announcement on Hemp-CBD just moments after the 2018 Farm Bill was signed by Trump. FDA’s jurisdiction over products is triggered by the Food, Drug & Cosmetics Act (“FDCA”). For the purposes of this post we’ll look at the following categories of products under the FDCA and FDA regulation: “Drug” is any article “intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals” or “intended to affect the structure or any function of the body of man or other animals. In addition, anything intended as a component of a drug is also drug. 21 USC § 321(g). The FDA’s jurisdiction is triggered by the intended use oof an item. The FDA determines intended use generally based on claims made by the distributers of a product, which are often uncovered on labeling, advertising, and other promotional activities related to a product. Drugs are tightly regulated by the FDA and subject to pre-approval before being introduced into interstate commerce. “Food” is any “article for use as food or drink for man.” Unlike drugs, which are determined by intended use, the FDA exerts its jurisdiction over food based on actual use. “Dietary supplement” is a product intended to supplement the diet that contains one or more of the following: (a) a vitamin; (b) a mineral; (c) an herb or other botanical; (d) an amino acid; (e) a dietary substance for use by man to supplement the diet by increasing the total dietary intake; or (f) a concentrate, metabolite, constituent, extract, or combination of any ingredient described in clause (a) through (e). 21 U.S.C. § 321(ff). Hemp-CBD appears to makes the most sense as “dietary supplement.” After all, it is is a concentrate of a botanical: hemp. Hemp-CBD could also be a food (based on actual use) or drug (based on intended use). The FDA’s warning letters mostly have focused on Hemp-CBD as a drug, but those letters and other statements by the FDA make it clear that the FDA does not believe that Hemp-CBD qualifies as a dietary supplement or food. For today’s post, we’ll focus on the dietary supplement side of things. Drug Exclusion Rule There is an exclusion clause in the definition of “dietary supplement” that generally disallows the use of an FDA approved “drug” as a dietary supplement. We will call this the “Drug Exclusion Rule.” The FDCA’s definition of “dietary supplement” excludes any article that is approved as a new drug or has been subject to a publicized Investigational New Drug (“IND”) clinical investigation, unless the substance was marketed in food or as a dietary supplement before the FDA approved it as a new drug or began the IND investigation. The FDA addresses numerous cannabis related issues on its “FDA and Marijuana: Questions and Answers” page (“FDA FAQs”). According to the FDA FAQs, products containing CBD cannot be sold as dietary supplements because CBD has been investigated and approved as a new drug, namely Epidiolex. Though the FDA FAQs is a nonbinding guidance document, it seems to indicate that the Drug Exclusion Rule applies to CBD, because of the approval of Epidiolex and IND investigations of CBD: The existence of substantial clinical investigations regarding CBD has been made public. For example, two such substantial clinical investigations include GW Pharmaceuticals’ investigations regarding Sativex and Epidiolex. (See Sativex Commences US Phase II/III Clinical Trial in Cancer Pain and GW Pharmaceuticals Receives Investigational New Drug (IND) from FDA for Phase 2/3 Clinical Trial of Epidiolex in the Treatment of Dravet Syndrome ).” However, to determine whether the Drug Exclusion Rule applies, the FDA also needs to prove that CBD was not marketed as a food or dietary supplement prior to those investigations, which started in 2014. Check back early next week, when I’ll take a close look at the FDA’s position on that issue, and take a look at how the agency may regulate Hemp-CBD in the near future.
自2014年农业法案通过以来,含有大麻二酚(CBD)的大麻制品(大麻二酚-CBD)已经变得非常受欢迎,在很多商店和网上都可以买到。在很大程度上,美国食品和药物管理局(FDA)对此置若罔闻。FDA偶尔会向大麻cbd经销商发出警告信,警告他们的产品存在医疗问题,但仅此而已。相对不强制执行的日子可能已经结束了,因为FDA最近查获了大麻cbd产品。 本系列文章分为两部分,将着眼于FDA将如何监管大麻cbd。今天的文章将关注为什么FDA目前不认为大麻cbd是一种膳食补充剂。明天,我们将研究FDA立场的一些问题,看看该机构在不久的将来可能如何监管大麻cbd。 2018年农业法案明确表示,它不限制食品和药品管理局监管消费品的权力,食品和药品管理局明确表示,它的重点是大麻cbd,在特朗普签署2018年农业法案后不久,就在大麻cbd上发布公告。FDA对产品的管辖权由《食品、药品和化妆品法》(“FDCA”)触发。 就这篇文章的目的而言,我们将着眼于以下根据FDCA和FDA法规的产品类别: “药物”是用于诊断、治疗、减轻、治疗或预防人类或其他动物的疾病,或旨在影响人类或其他动物身体的结构或任何功能的任何物品。此外,任何作为药物成分的东西也是药物。FDA的管辖权是由一个项目的预期使用oof触发的。FDA通常根据产品分销商的声明来确定产品的预期用途,这些声明通常是在与产品相关的标签、广告和其他促销活动中发现的。药品受到FDA的严格监管,在进入州际贸易之前必须经过预先批准。 “食物”是人类用来当食物或饮料的任何物品。不像药物是由预期使用来决定的,FDA对食品的管辖权是基于实际使用的。 “膳食补充剂”是一种旨在补充含有以下一种或多种维生素的膳食的产品:(a)维生素;(b)矿物;(c)草本植物或其他植物;(d)氨基酸;(e)一种供人使用的膳食物质,通过增加膳食总摄入量来补充膳食;或(f)第(a)至(e)条第321(ff)款所述任何成分的浓缩物、代谢物、成分、提取物或组合物。 大麻cbd似乎是最有意义的膳食补充剂。毕竟,它是一种植物的浓缩物:大麻。大麻cbd也可以是一种食物(基于实际使用)或药物(基于预期使用)。FDA的警告信大多集中在大麻cbd作为一种药物,但这些信件和FDA的其他声明表明,FDA不认为大麻cbd有资格作为一种膳食补充剂或食品。在今天的帖子中,我们将关注膳食补充剂方面的事情。 药物排除规则 膳食补充剂的定义中有一个排除条款,一般不允许使用FDA批准的药物作为膳食补充剂。我们称之为药物排除规则。FDCA年代膳食补充剂的定义不包括任何文章批准新药或已经受到(印第安纳州)公布的临床试验新药临床研究,除非这种物质在食品或膳食补充剂销售之前FDA批准了它作为一种新的药物或开始了印第安纳州的调查。FDA在其FDA和大麻问答页面(FDA faq)上处理了许多与大麻相关的问题。根据FDA常见问题,含有CBD的产品不能作为膳食补充剂销售,因为CBD已经作为一种新药被调查和批准,即Epidiolex。 虽然FDA faq是一份非约束性的指导性文件,但由于Epidiolex的批准和IND对CBD的调查,似乎表明药物排除规则适用于CBD: “关于CBD的大量临床调查已经公开。例如,两项实质性的临床调查包括GW制药公司关于Sativex和附睾酮的调查。(见Sativex开始美国癌症疼痛的II/III期临床试验,吉布达•伟士制药公司从FDA获得用于治疗Dravet综合征的2/3期临床试验的新药(ind))” 然而,为了确定药物排除规则是否适用,FDA还需要证明CBD在2014年开始调查之前并没有作为食品或膳食补充剂进行销售。下周初再来看看,那时我将密切关注FDA在这个问题上的立场,并看看该机构在不久的将来可能如何监管大麻cbd。

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