FDA WARNING_LETTER - Vitamin Derivatives, Inc. - November 21, 2014

An FDA inspection on November 19-21, 2014, revealed that Vitamin Derivatives, Inc. distributed 1-alpha-hydroxy vitamin D3 (Alpha D3) for use in broiler feed in interstate commerce. The FDA determined this substance is an unsafe food additive under section 409(a) of the Federal Food, Drug, and Cosmetic Act (the Act) and is adulterated under section 402(a)(2)(C)(i) of the Act.

The FDA states that 1-alpha-hydroxy vitamin D3 is not Generally Recognized as Safe (GRAS) for its intended use in broiler feed, is not subject to a prior sanction, and lacks an approved food additive regulation. Previous submissions from the firm in 2009 and 2011, asserting GRAS status, were evaluated by the FDA and found to have deficiencies in manufacturing chemistry, human safety, and target animal safety data. The FDA informed the firm in 2012 that their GRAS notice did not provide a sufficient basis for GRAS determination.

Despite stating in 2010 that sales would cease until GRAS status was achieved, the firm continued distributing Alpha D3 from November 2011 to September 2014. The FDA's own review concluded the product is not GRAS, citing a lack of publicly available information, expert consensus on safety, and insufficient target animal safety