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.
I’d love to hear how it worked for you! I’m sorry you have renal failure and congestive heart disease, my mom who is 51 has stage 5 renal failure and congestive heart disease as well, I just bought a cartridge with CBD vape oil and want her to try it. But she’s unsure so I’d really love to hear from you how it may have helped you. I hope things get better for you. I take care of my mom and know the daily stress and struggle it can bring. Again I’m sorry to hear you we’re diagnosed with those diseases.