“The safety and benefit results of this observational study are impressive and are consistent with previous data submitted to the FDA. Hopefully this will help remove the regulatory log jam we’re experiencing,” said Robert Kaufmann, MD, Chief Medical Officer at CBD American Shaman.
DENVER (PRWEB) December 09, 2019
In a study of over 2,000 U.S. adults this year, users of hemp-derived cannabidiol (CBD) reported zero severe adverse events during the duration of the study. In fact, 3 out of 4 participants reported they felt “better” to “much better” after using products containing CBD. Consumers provided experiential data on products ranging from full or broad spectrum hemp extracts containing CBD to CBD isolates.
These preliminary findings are part of a National Consumer Experience Program underway by ValidCare, LLC, a market intelligence and research solutions company for hemp-based product businesses. The program is a direct response to the U.S. Food and Drug Administration’s (FDA) invitation to the industry to offer safety and efficacy data to support its science-based approach to regulating hemp-derived cannabidiol (CBD) in consumer goods.
ValidCare’s initial report comes on the heels of a statement released by the FDA on November 27th, stating that due to a lack of scientific information supporting the safety of CBD in food, the FDA cannot yet conclude that CBD is generally recognized as safe (GRAS) among qualified experts for its use in human or animal food.
Says ValidCare CEO Patrick McCarthy, “The FDA has made their position clear. They need more data to effectively rule on hemp-derived CBD’s safety for human and animal consumption. It’s our mission to provide it.”
ValidCare’s data was collected over 45 days this fall with self-reported inputs from consumers using the company’s CBD+me app. More than 2,000 respondents comprising men and women ages 19 to 82 participated in journaling their CBD product use and outcomes. 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.
Key findings from the study include:
- The average age of CBD users is 48 years old, with slightly more females (56%) reporting
- 86% of CBD product users take it orally, with 75% reporting use of an oil-based tincture
- 91% of consumers report using full or broad spectrum hemp oil, with 9% reporting use of CBD isolate
- Consumption amounts were safe thus far, more studies needed
- There were zero reports of severe adverse events resulting from CBD use
- One in six (18%) say they use CBD for general wellness
- One in five (20%) report an unexpected side benefit to their CBD use, such as general pain relief, improved movement and better sleep
- Three quarters of respondents (75%) reported they felt “better” to “much better” after CBD products use
- Only 5% report mild side effects including dry or sore throat and difficulty concentrating
“These initial findings are just the beginning for what we believe will be a compelling and useful data set to provide to the FDA as well as business and consumers,” said McCarthy. “We’ve partnered with several product suppliers to date and we’re now opening the program up to additional industry-leading companies who share our desire to bring the level of gravity and rigor the FDA is looking for.”
Leading brands are using ValidCare’s CBD+me platform to collect consumer data on the safety and use of hemp-derived products. The program, which includes members of U.S. Hemp Roundtable and Hemp Industries Association, as well as companies who have achieved U.S. Hemp Authority certification, runs through January 2020.
Added McCarthy, “Over 85% of reported CBD use in our data set involved products that bare the Hemp Authority seal of certification, where we can be confident of product origin and quality. What I worry about is the plethora of products on the market that do not meet these stringent standards and expose American consumers to undue risk. We hope our data will help the FDA create sensible regulations that remove these bad actors.”
“The safety and benefit results of this observational study are impressive and are consistent with previous data submitted to the FDA. Hopefully this will help remove the regulatory log jam we’re experiencing,” said Robert Kaufmann, MD, Chief Medical Officer at CBD American Shaman, a ValidCare member and research partner. “These products are being used for real health and wellness reasons by millions of Americans, from kids to AARP-aged adults, who report experiencing real benefit. We need guidance on how to best collaborate with the FDA to make sure this ‘super-food’ is available for safe consumption.”
ValidCare expects to share its initial findings with the FDA during a private CBD listening session on December 16th, and will make its complete report public early next year. Brand partners in all markets will benefit from the collection and aggregation of this data, which will also be available to help suppliers by providing feedback on current consumer experiences.
ValidCare welcomes participation by all American consumers through its secure CBD+me app, available for free in the Apple App Store or Google Play. Consumers set up a profile and wellness goals for themselves or their loved one(s) and journal the products they’re using and record the effects, including adverse product event reports. All personal information is anonymized to protect an individual’s identity and privacy .
For more information about the ValidCare platform may visit http://www.validcare.com or call 844-825-4322.
ValidCare, LLC is the market intelligence and research platform for the hemp-derived product industry, powered by real-time consumer experiences. Through the ValidCare community, participants including consumers, product suppliers, researchers, and providers, come together to study, educate, measure and document the consumer experience using hemp-based products. ValidCare’s app based platform supports ongoing two-way communication, combining self-reported consumer data with advanced machine learning to deliver aggregated insights that help improve product quality, consistency, effectiveness, and the adoption of industry standards. For more information, visit http://www.validcare.com or call 844-825-4322.
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