Initial Findings from Study of Hemp-Derived Cannabidiol (CBD) Reports Zero Adverse Events

Initial Findings from Study of Hemp-Derived Cannabidiol (CBD) Reports Zero Adverse Events

National Consumer Experience Program on CBD Reveals 3 out of 4 Consumers Experience Benefits from Use, No Reported Adverse Events

Study Highlights:

  • ValidCare’s National Consumer Experience Program (NCEP) began gathering consumer experience data in September 2019
  • Initial reports show 3 out of 4 users experience benefits from the use of hemp-derived CBD
  • There were zero reports of Adverse Events
  • 20 percent of CBD consumers report multiple benefits from use
  • 91 percent of consumers report using full or broad spectrum hemp oil, with 9 percent reporting use of CBD isolate

Executive Summary:

In August 2019, ValidCare announced a National Consumer Experience Program (NCEP) to gather Real World Evidence on hemp-derived cannabidiol (CBD) for the U.S. Food and Drug Administration (FDA), based on a specific request made to the CBD industry for more data on the use of CBD.

In September, ValidCare launched an updated consumer platform specifically to gather Real World Evidence in support of the FDA and the industry. The CBD+meTM app is free for consumers and allows interested CBD users to download the app from the Apple App Store or Google Play, create a simple profile, answering several questions about their condition(s), use of products, health and wellness goals, and demographic data. Consumers then login to the app on an ongoing basis, and journal information about their experiences with CBD products.

A number of leading CBD product suppliers joined the ValidCare program to help roll out the customized user platform to their customers, helping sign up more than 2,000 participants in the study to date.

During the first 60 days of data collection, zero adverse events were reported. Three out of four participants reported they felt “better” to “much better” after using products containing CBD.

Consumers who used CBD reported having chronic pain, mental health issues such as stress or anxiety, sleep disorders, general health and wellness, digestive health and several additional categories.

Who is Using CBD, How Do They Use It?

More than 2,000 consumers are currently participating in the study, journaling their product experiences using the CBD+me consumer app. Participants range in age from 19 to 82 years old, with an average age of 48. More females than males are reporting their CBD experiences using the app, with 56 percent of users being women.

Participants have provided over 2,000 product reviews representing more than 100 CBD products from over 20 companies, including tinctures, balms, capsules, edibles and beverages, as part of the study.  91 percent of consumers participating in the study use full or broad spectrum hemp oil, with 9 percent reporting use of CBD isolate. 86 percent of CBD product users take it orally, with 75 percent reporting they use of an oil-based tincture.

Users of CBD Primarily Consuming Orally


Why Are People Using Products Containing CBD?

As consumers initially create a profile on the app, they select the condition, health concern or wellness goal that motivates their use of CBD products.  The first 60 days of data indicates study participants selected the following reasons:

  • 43 percent selected chronic pain
  • 22 percent selected mental health; of these, over 75 percent say they experience anxiety or stress
  • 18 percent selected general wellness
  • Additional reasons for use include health concerns related to the central nervous system, digestive health, sleep disorders, cancer and other

Reasons People Report Using Products with CBD



Zero Adverse Effects:

Notably, zero adverse events were reported by program participants, which supports similar data from other submissions during the FDA’s recent open comment period. Approximately five percent of users reported mild side effects including dry or sore throat and difficulty concentrating.

Early Findings Indicate Positive Benefits and Improvements:

Overall, initial data from more than 2,000 consumers indicate that 76.2 percent of CBD product users reported they felt “better” to “much better” after they used CBD products.

20 percent of participants reported an unexpected positive side benefit to their CBD use, such as general pain relief, improved mood and better sleep.

ValidCare intends to conclude the National Consumer Experience Program and report final data to FDA in January 2020.