Safety of Zinc gluconate
Tuesday, December 2nd, 2008In September 2003, zicam faced lawsuits from users who claimed that the product negatively affected their sense of smell, and sometimes taste. However, Zicam advocates assert that instructions on the container clearly indicate proper use, which will allow users to avoid these problems. In January 2006, 340 lawsuits were settled for $12 million.[9] In early 2004, at the height of the controversy, Matrixx Initiatives, Inc., the maker of Zicam, claimed that only a small number of people had experienced problems and that anosmia (loss of smell) can, amongst others, also be caused by the common cold itself. Matrixx also claimed that zinc gluconate dissolves into zinc ions and gluconate, and that both are naturally occurring compounds which are found in all human tissues. They also claim that Zicam is a buffered gel which is formulated to have a neutral pH. The plaintiffs countered Matrixx, claiming that many of the patients had experienced a strong and very painful burning sensation when they used the product, indicating damage to the nasal tissue. No part of the settlement targeted the product’s removal from sale, and the nasal gel continues to be available at drug stores throughout the USA. The two creators of Zicam have come under scrutiny. Robert Steven Davidson received his PhD from an unaccredited university which has since closed while Charles B. Hensley has been cited by the US Food and Drug Administration for selling unapproved drugs over the Internet.[10]
The U.S. Food and Drug Administration (FDA) considers zinc gluconate to be generally recognized as safe (GRAS) when used in accordance with good manufacturing practice, although this does not constitute a finding by the FDA that the substance is a useful dietary supplement.[11]