FDA’s Final Guidance for Homeopathic Drug Products

FDA’s Final Guidance for Homeopathic Drug Products Monday, January 16, 2023Written 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[…]

The Coming NDI Draft Guidance Enforcement Discretion

The Coming NDI Draft Guidance Enforcement Discretion  Friday, June 17, 2022Written by: Jim Lassiter So the other regulatory shoe is about to drop, with the issuance of recent news from the FDA, regarding the current NDI Draft Guidance and FDA’s intention to exercise enforcement discretion for the “thousands” of New Dietary Ingredients that FDA is[…]

Vitamin D and its Correlation to Covid-19

Vitamin D and its Correlation to Covid-19 Wednesday, June 3, 2020Written 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).[…]

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Alkemist Labs Warns Dietary Supplement Industry of Falsified Documents

Alkemist Labs Warns Dietary Supplement Industry of Falsified Documents Tuesday, June 2, 2020Written 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.  It appears that dietary supplement companies are altering the COA report that laboratories, such as Alkemist Labs,[…]