CV Sciences Inc (CVSI)

[HopeSkeptic]

GRAS study for CVSI was conducted in 2017 and finished late 2017 by AIBMR Life Sciences. They then published the study in Journal of Toxicology with first submission early 2018 and came out in June 2018. https://www.hindawi.com/journals/jt/2018/8143582/

After a company invests in self-affirmed GRAS, 6-12 months for FDA to acknowledge. CVSI may have submitted this info to FDA this summer and could be acknowledged by FDA early in the new year perhaps. https://ir.cvsciences.com/press-releases/detail/73/cv-sciences-inc-announces-landmark-publication-on-the

Here is a full explanation of the Self-affirmed GRAS process - its critical

https://www.experts.com/Articles/Safety-of-Novel-Food-and-Dietary-Supplement-Ingredients-By-Sanford-Bigelow

"As the food and dietary supplement industries consolidate, having your products containing novel ingredients on firm safety and regulatory grounds facilitate time-honored practices for sustaining and growing your business."

"GRAS self-affirmation conducted independently of the FDA is legal determinations that allow manufacturers to use novel ingredients and substances not listed in the Code of Federal Regulations. In making these independent determinations, the manufacturers assumes the responsibility of using a substance (as they already do for their products), that the data is publicly available to support a position for general recognition of safe use, and has determined that the substance may be safely used in food in a manner proposed by the manufacturer. Thus, one distinction between GRAS substances and food additives is the common knowledge aspect provided for by publicly available evidence for determining GRAS status. Dietary ingredients, too, do not require safety determinations to depend on publicly available evidence.

Manufacturers of ingredients used in food or dietary supplement products, who market ingredients to food and/or dietary supplement producers, can opt to share their GRAS self-affirmation with their customer, or if the customer wants some level of regulatory acceptance and recognition, the FDA established in 1997 a voluntary notification process in which the ingredient manufacturer can notify the FDA of the GRAS self-affirmation, which takes 6-12 months for FDA's acknowledgement of the manufacturer's GRAS self-affirmation. Most food and dietary supplement product manufacturers are satisfied once the FDA publishes their acknowledgement letter for the manufacturer's GRAS self-affirmation."