Team Articles and Posts
The Looming Future of NDI’s
Wednesday, February 15, 2023
Written By: Jim Lassiter
There is always a common thread in considering the possibilities and future of regulatory matters when it comes to the food and dietary supplement industries. That commonality equates to an ever-tightening noose for just about every aspect of the requirements for compliance.
Written By: Jim Lassiter
There is always a common thread in considering the possibilities and future of regulatory matters when it comes to the food and dietary supplement industries. That commonality equates to an ever-tightening noose for just about every aspect of the requirements for compliance.
FDA’s Final Guidance for Homeopathic Drug Products
Monday, January 16, 2023
Written By: Jim Lassiter
The Food and Drug Administration has been guided by the Law (meaning the Federal Food Drug and Cosmetic Act of 1938 with amendments) and is obliged to implement the Law through the development of regulation and guidance. When the legislation was first enacted, an interesting recognition was incorporated into this Law.
Written By: Jim Lassiter
The Food and Drug Administration has been guided by the Law (meaning the Federal Food Drug and Cosmetic Act of 1938 with amendments) and is obliged to implement the Law through the development of regulation and guidance. When the legislation was first enacted, an interesting recognition was incorporated into this Law.
The Coming NDI Draft Guidance Enforcement Discretion
Friday, June 17, 2022
Written By: Jim Lassiter
So the other regulatory shoe is about to drop, with the issuance of recent news from the FDA, regarding the current NDI Draft Guidance and FDA’s intention to exercise enforcement discretion for the “thousands” of New Dietary Ingredients that FDA is certain are out in the marketplace without proper notification. What does that all really mean?
Written By: Jim Lassiter
So the other regulatory shoe is about to drop, with the issuance of recent news from the FDA, regarding the current NDI Draft Guidance and FDA’s intention to exercise enforcement discretion for the “thousands” of New Dietary Ingredients that FDA is certain are out in the marketplace without proper notification. What does that all really mean?
Vitamin D and its Correlation to Covid-19
Wednesday, June 3, 2020
Written By: Gabriela Cotne
Crystalline vitamin D2 (C28H44O, CAS Reg. No. 50-14-6), also known as ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. The ingredient is produced by ultraviolet irradiation of ergosterol isolated from yeast and related fungi and is purified by crystallization as described in 21 CFR 184.1950(1).
Written By: Gabriela Cotne
Crystalline vitamin D2 (C28H44O, CAS Reg. No. 50-14-6), also known as ergocalciferol, is the chemical 9,10-seco(5Z,7E,22E)-5,7,10(19),22-ergostatetraen-3-ol. The ingredient is produced by ultraviolet irradiation of ergosterol isolated from yeast and related fungi and is purified by crystallization as described in 21 CFR 184.1950(1).
Alkemist Labs Warns Dietary Supplement Industry of Falsified Documents
Wednesday, May 27, 2020
Written By: Joel Villareal
Alkemist Labs recently made a strong warning to the dietary supplement industry of falsified documents, particularly Certificate of Analysis (COA) lab reports.
Written By: Joel Villareal
Alkemist Labs recently made a strong warning to the dietary supplement industry of falsified documents, particularly Certificate of Analysis (COA) lab reports.