After two decades of experience in the hemp industry, Paul Benhaim founded Elixinol – ostensibly, as the company’s website states, to “[manufacture] and [provide] the highest-quality CBD oil and hemp extracts in the world.” And so that CBD oil users can be assured of that quality, Elixinol extensively tests its extracts and provides certificates of analysis for its products that are available to view at a click. The manufacturer’s wares have even received a “stamp of approval” from The Realm of Caring Foundation, a Colorado-based non-profit and advocate for cannabinoid therapy research and education. Those wanting to assess Elixinol’s extracts for themselves can choose from its range of oral tinctures – with potencies of 300 mg, 600 mg and 3,600 mg – as well as topical balms and capsules. Plus, the company gives 5 percent of the proceeds from every sale to charity – so buyers may not only feel good after their purchases, but they’ll do some good, too.
Your product is not generally recognized as safe and effective for the referenced uses and, therefore, the product is a “new drug” under section 201(p) of the Act [21 U.S.C. § 321(p)]. New drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from the FDA, as described in section 505(a) of the Act [21 U.S.C. § 355(a)]; see also section 301(d) of the Act [21 U.S.C. § 331(d)]. FDA approves a new drug on the basis of scientific data submitted by a drug sponsor to demonstrate that the drug is safe and effective.