FDA WARNING_LETTER - Nutra Pure LLC - February 25, 2019

The FDA issued a Warning Letter to Nutra Pure LLC on March 28, 2019, following a February 2019 review of their website, cbapure.com. The FDA determined that Nutra Pure LLC's "Hemp Oil" and "CBD Softgels" products, promoted as containing cannabidiol (CBD), are unapproved new drugs and misbranded drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act).

The products are deemed drugs because website claims establish their intended use for disease diagnosis, cure, mitigation, treatment, or prevention (e.g., Alzheimer's, anxiety, depression, fibromyalgia, skin conditions, inflammation). CBD products are excluded from the dietary supplement definition because CBD is an active ingredient in the FDA-approved drug Epidiolex, and substantial clinical investigations into CBD have been made public.

As unapproved new drugs, their introduction into interstate commerce violates sections 301(d) and 505(a) of the FD&C Act. They are also misbranded under section 502(f)(1) because they lack adequate directions for use by a layperson for conditions requiring professional supervision, violating section 301(a).

The Federal Trade Commission (FTC) also reviewed the website for potential violations of Sections 5(a) and 12 of the FTC Act, concerning unsubstantiated advertising claims. Nutra Pure