CV Sciences Inc (CVSI)

[Wolf-man jack]

Re: Wolf-man Jack Post # of 52762
This is what I found positive for CVSI. CVSI will rebound once the weaks sell off and those that see an opportunity will add to their positions or Curaleaf sellers will come aboard, imo

Here is what was included in the letter and why The FDA has hinted to GRAS. Also CVS will most likely take Curaleaf products off their shelves, and this is too a positive for CVSI products located in those stores. Imo Wolf


Your “CBD Lotion,” “CBD Pain-Relief Patch,” “CBD Tincture,” and “CBD Disposable Vape Pen” products

are not generally recognized as safe and effective

for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C 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 sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the drug is safe and effective.


From the Curleaf warning letter...

“products are not generally recognized as safe and effective for the above referenced uses and, therefore, the products are “new drugs” under section 201(p) of the FD&C 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 sections 301(d) and 505(a) of the FD&C Act, 21 U.S.C. 331(d) and 355(a). FDA approves a new drug on the basis of scientific data and information demonstrating that the