NV Nutrition, LLC
3 extracted findings
FDA source excerpt, selected passage
The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your nutrovape vaporizer products and nutriair diffuser products are not intended for ingestion. Therefore, your products do not meet the definition of a dietary supplement under the FD&C Act.
Findings and supporting evidence
Model-assisted readings, not an exhaustive interpretation. Compare with the extracted source findings below.
Findings extracted from the letter
Selected FDA passages, not the complete letter.
01
The FD&C Act defines the term “dietary supplement” in section 201(ff)(2)(A)(i), 21 U.S.C. 321(ff)(2)(A)(i), as a product that is “intended for ingestion.” Your nutrovape vaporizer products and nutriair diffuser products are not intended for ingestion. Therefore, your products do not meet the definition of a dietary supplement under the FD&C Act.
Source passage selected by the model
02
Your nutrovape vaporizer products and nutriair diffuser products are drugs under section 201(g)(1) of the FD&C Act, 21 U.S.C. 321(g)(1), because they are intended for use in the cure, mitigation, treatment, or prevention of disease and/ or intended to affect the structure or any function of the body.
Source passage selected by the model
03
Your nutrovape vaporizer products and nutriair diffuser products are not generally recognized as safe and effective for the above referenced uses and, therefore, these products are “new drugs” under section 201(p) of the FD&C Act, 21 U.S.C. 321(p). With certain exceptions not applicable here, new drugs may not be legally introduced or delivered for introduction into interstate commerce without prior approval from 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 submitted by a drug sponsor to demonstrate that the drug is safe and effective. No approved applications are in effect for your products.
Source passage selected by the model