Post Marketing Safety of Plus CBD™ Products, a Full Spectrum Hemp Extract: A 2-Year Experience.

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. 2020 May 25;1-12.

doi: 10.1080/19390211.2020.1767255. Online ahead of print.

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Stephen M Schmitz et al. J Diet Suppl. .

Abstract

The market for products featuring hemp extracts is large and growing larger. However, safety concerns have been raised by medical and regulatory agencies. Post marketing surveillance of full spectrum hemp extract (FSHE) products manufactured and distributed by CV Sciences (CVSI) and traded under the brand PlusCBD™ was conducted over a 2-year period (2018-2019). The safety of these products was assessed by analyzing adverse events reports. From a total of approximately five million product units sold during the 2-year period, 1,429 (0.03%) adverse events (AE) were reported in 1,151 unique customers. Of those, only two were classified as serious AEs. For orally ingested products, the most common types of AEs reported were gastrointestinal (e.g. abdominal discomfort), while for topically applied products, the most reports mentioned dermatological symptoms (e.g. rashes). There has been no evidence of liver toxicity associated with CVSI products. Based on this longitudinal dataset, the products manufactured using CVSI’s proprietary processes are safe and well tolerated at the recommended doses.

Keywords: CBD; DSHEA; adverse event; cannabidiol; dietary supplement; full spectrum hemp extract (FSHE); nutravigilance; pharmacovigilance; serious adverse event; supplement safety.

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