ValidCare Launches National Program to Share CBD Real World Evidence with FDA

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Leading CBD product companies deploy the CBD+me™ platform to collect consumer data to address the FDA’s questions on the safety and efficacy of cannabis-derived products

“The FDA has invited the CBD industry to offer safety and efficacy data to support its science-based approach to regulations,” said Vince Saunders, CEO of CBDAmerican Shaman. “We are excited to gather and share additional data through a trusted, independent party. Transparency is good for everyone.”

ValidCare, the market intelligence platform for the canna-based product industry, announced a first-of-its-kind National Consumer Experience Program to gather CBD Real World Evidence (RWE) directly from consumers through November, 2019. The goal of the industry-wide program is to collect large amounts of consumer data via its CBD+me™ app to inform the U.S. Food and Drug Administration’s (FDA) questions on the safety and efficacy of cannabis-derived products. Data will be shared with the FDA while protecting company-specific intellectual property and consumer identities.

Recent comments from the FDA reinforce the need for safety and efficacy data to appropriately regulate the pathway for hemp-derived cannabidiol (CBD). Lowell Schiller, Principal Associate Commissioner for Policy at FDA, suggested CBD should stand for “Collect Better Data” when speaking at a hemp industry event in mid-August(1). “The FDA has invited the CBD industry to offer safety and efficacy data to support its science-based approach to regulations,” said Vince Saunders, CEO of CBDAmerican Shaman. “We shared significant in-house data with FDA during the comment period in July. Now, we are excited to gather and share additional data through a trusted, independent party. Transparency is good for everyone. We appreciate ValidCare’s sponsorship and encourage all CBD brands to join this important program.”

ValidCare has invited participation by all CBD product companies, including members of US Hemp Roundtable, Hemp Industries Association and/or those having achieved US Hemp Authority certification. The following companies have enrolled to date: Barleans, CBDAmerican Shaman, CBDistillery, Comfort Leaf, Elixinol, Functional Remedies, GenCanna Global, Lazarus Botanicals, MedTerra, Queen City Infusions and Restorative Botanicals.

These companies are inviting their customers to download a branded version of ValidCare’s free CBD+me app, then track their experiences with cannabis-derived products. Companies will have access to CBD Real World Evidence related to their products and consumers. “It is great to see so many leading brands demonstrate confidence in their products and their commitment to American consumers and the regulatory process. Their leadership will help benefit the entire industry,” said Patrick McCarthy, CEO, ValidCare.

“Our industry is at a critical juncture and needs to work with FDA to help validate the efficacy of hemp-derived products and instill consumer confidence in product quality,” said Chase Terwilliger, CEO, CBDistillery. “With our commitment to product quality and safety for consumers, gaining experiential data from our customers can help us create even better products and experiences.”

The CBD+me platform is available to consumers 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), journal the products they’re using and record the effects, including adverse product event reports.

References
1)    Lowell Schiller, JD, FDA. National Industrial Hemp Council, 2019. https://www.fda.gov/news-events/speeches-fda-officials/remarks-national-industrial-hemp-council-2019-hemp-business-summit-08132019

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About ValidCare
ValidCare, LLC is the market intelligence platform for the cannabis-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 canna-based products. ValidCare’s proprietary app (CBD+me™) 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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