Bacon had said that I might need to try two full droppers worth of the oil to really feel its benefits. I knew that I had an incredibly busy and stressful day ahead of me—I needed to fit in a five mile run before work, had lots to do at the office, was scheduled for a busy event in the middle of the day, and had a 2-hour meditation class later that night which would require a lot of mental clarity. Tentatively, I squirted two droppers of CBD oil into my bulletproof coffee and sipped away.
Generalized pain, for instance, has dozens upon dozens of high profile research and clinical studies that have been carried out in universities and laboratories around the globe. One of the most well-publicized of these studies took place back in 2008, in which results determined that “cannabinoid analgesics (pain relievers) have generally been well tolerated in clinical trials … with acceptable adverse event profiles (meaning acceptable effectiveness for practical use).
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.
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