Replies to post #50867 on CV Sciences Inc (CVSI)

[Wolf-man jack]

SpaceLady...Hopefully this will backup your “Intended use” comment. After reading the full study, there was no mention of disease or disease remedies mentioned.

https://www.fda.gov/regulatory-information/search-fda-guidance-documents/small-entity-compliance-guide-structurefunction-claims

Basic Legal Requirements for Structure/Function Claims.
What are structure/function claims?
The Dietary Supplement Health and Education Act of 1994 (DSHEA) added section 403(r)(6) to the Federal Food, Drug, and Cosmetic Act (FD&C Act)(2). This section of the law states that a dietary supplement may bear certain statements on its label or in its labeling if the claim meets certain requirements. Section 101.93(f) simply restates part of the definition of the types of claims that may be made under section 403(r)(6) of the FD&C Act. Section 101.93(f) reads:
(f) Permitted structure/function statements. Dietary supplement labels or labeling may, subject to the requirements in paragraphs (a) through (e) of this section, bear statements that describe the role of a nutrient or dietary ingredient intended to affect the structure or function in humans or that characterize the documented mechanism by which a nutrient or dietary ingredient acts to maintain such structure or function, provided that such statements are not disease claims under paragraph (g) of this section. If the label or labeling of a product marketed as a dietary supplement bears a disease claim as defined in paragraph (g) of this section, the product will be subject to regulation as a drug unless the claim is an authorized health claim for which the product qualifies.


Can I use citations of publications that relate to my product's intended use in labeling if the publication title or the journal name mentions a disease name?
Yes, but some limitations apply. If the citation implies treatment or prevention of a disease, it is a disease claim. Thus, if in the context of the labeling as a whole its presence implies treatment or prevention of disease (for example, by placement on the immediate product label or packaging, inappropriate prominence, or lack of relationship to the product's express claims), the citation is a disease claim.
If the citation is used in labeling, its context determines if it is a disease claim. A citation that is used in the bibliography section of labeling, is included in a balanced discussion of the scientific literature, is not excessively prominent relative to other citations, and provides legitimate support for a structure/function claim made for the product would not be a disease claim.
4. Claims that use the term "disease" or "diseased."