FDA WARNING_LETTER - Green Roads of Florida LLC - February 28, 2017
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The FDA issued a Warning Letter to Greenroads Health (Green Roads of Florida LLC) following a February 2017 review of their website, www.Greenroadhealth.com. The FDA determined that the company was taking orders for various cannabidiol (CBD) products, including oils, tinctures, capsules, edibles, and topical creams.
The FDA asserts that claims made on the website establish these CBD products as unapproved new drugs under section 201(g)(1)(B) of the Federal Food, Drug, and Cosmetic Act (the Act) [21 U.S.C. 321(g)(1)(B)]. Examples of drug claims include statements about CBD's potential to inhibit cancer growth, prevent cancer spread, and therapeutic uses for conditions like asthma, Alzheimer's disease, arthritis, autism, and bipolar disorder.
Since these products are not generally recognized as safe and effective for their intended uses, they are considered "new drugs" under section 201(p) of the Act [21 U.S.C. § 321(p)] and require prior FDA approval, which they lack, violating sections 301(d) and 505(a) [21 U.S.C. 331(d), 355(a)].
Furthermore, the products are deemed misbranded under section 502(f)(1
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