Zinc is an essential element for a healthy body. Zinc is involved in numerous aspects of cellular metabolism (National Institute of Health). According to Food and Nutrition Board, zinc is also essential in for proper taste and smell. The recommended daily allowance for adult males is 11mg and 8mg for female adults. Adults are above the age 19 y.o. According to the Academy of Sciences, 40mg of zinc is what the average adult may tolerate on a daily basis.
Denture adhesive is utilized to secure dentures in the mouth. It also provides a barrier that prevents food from entering the area between the dentures and the gums/roof of the mouth (http://www.poligrip.com/faqs). Incidentally, denture adhesives are classified by the Food and Drug Administration as medical devices under the Food, Drug and Cosmetic Act. Moreover, the FDA has also classified this product as a low-risk device (Class I). “Class I devices are subject to the least regulatory control. They present minimal potential for harm to the user and are often simpler in design than Class II or Class III devices. Class I devices are subject to “General Controls” as are Class II and Class III devices (FDA).”
Several studies have attempted to observe the association of excessive absorption of zinc to the suppression of copper and iron absorption. The suppression of these of vital elements and the correlation to neurological disorders for the 35 million denture users in the US, has stirred relevant debate over the past five years. According to recent lawsuits, claims have been made that Poligrip® and Fixodent® may have been linked to zinc poisoning and neuropathy. Case studies of four denture wearing patients that utilized denture adhesives at University of Texas Southwestern Medical Center in Dallas (UTSMC) revealed that zinc concentrations ranged from 17, 000 micrograms to 34,000 micrograms. 1/1000 of a milligram denotes the smallest unit in the metric system. So caution must be advised when interpreting this result.
Neurologists and molecular biologists have also duly noted that there must balance between zinc and copper in the body. Considering that both trace elements are crucial in neurological health. According to the case studies at UTSMC, the zinc concentrations found in their four denture-wearing patients may have been correlated to a number of neurological symptoms, which comprise: weakness in hands, cognitive decline, and poor balance.
Before claims are validated, attorneys and other medical specialists should peruse the Material Data Safety Sheet (MDSS). The MDSS is a form containing data regarding the properties of a particular substance. In terms of product stewardship and safety, it provides personnel and health care workers with toxicity and health effects of the substance in question. Toxicity is the degree to which a substance is able to damage an exposed organism. The central concept of toxicology is that effects are dose-dependent (United Nations). According to the FDA, an adverse event was reported by a 78-year old patient with liver cancer. In the particular case, the FDA will be compelled to examine to hepatotoxicity of this patient’s claim. Evaluating this claim will also take considerable time, due to recent administration change and recent appointment of Department of Health and Human Services Commissioner.
According to Proctor and Gamble’s MDSS for Fixodent Control®, the principal hazardous components as defined by OSHA, 29 CFR 1910.1200, and/or WHMIS under the HPA; were Silicon Dioxide and Mineral Oil. While observing hazardous components, it is important to understand the concentration % level and the exposure limit. The Silicon Dioxide ranged from 1-5% and the Mineral Oil 10-30%. Silicon Dioxide a chemical compound- is an oxide of silicon. Silica is mostly found in quartz and sand. Hydrated silica another form of silicon is utilized in toothpaste to remove plaque and is listed by the Food and Drug Administration as safe (FDA).
“GlaxoSmithKline Consumer Healthcare stands by the safety and efficacy of Super Poligrip®, which is approved and regulated by the Food and Drug Administration (FDA). Although we can’t comment on this person’s claim, we want to assure consumers that Super Poligrip is safe and effective when used as directed. When someone uses Super Poligrip for their dentures, the vast majority of the zinc in the product remains in the adhesive and is not released into the mouth. Thus the potential for absorption of zinc through the gums is minimal. Although it is expected that a small amount of Super Poligrip would be swallowed when used as directed, the amount of zinc that is released into the stomach and absorbed into the bloodstream is very small. Therefore, the possibility of experiencing adverse effects from exposure to zinc in Super Poligrip is highly unlikely when the product is used as directed. Zinc is an essential mineral that is found in almost every cell in the body and in foods like red meat, poultry, whole grains and beans and is necessary for the maintenance of good health and nutrition. Zinc is a very common ingredient in many over- the- counter and FDA approved products.”
Like GlaxoSmithKline (GSK) Proctor and Gamble (PG) also asserts that most of the zinc remains within the adhesive and not released into the mouth. If this is true, those pursuing litigation will find it difficult to prove their claims. MDSS may serve as crucial arguing points for both PG and GSK, as litigation mounts for both companies. Furthermore, as more adverse events are reported to the FDA, this places the FDA back into the spotlight.
Centers for Disease Control. [Online]. Diet and Dental Health, A Study of Relationships. Retrieved from http://www.cdc.gov/nchs/data/series/sr_11/sr11_225.pdf on March 2, 2009.
GlaxoSmithKline. [Online]. Retrieved from http://www.poligrip.com/faqs.aspx#poliused on March 2, 2009.
Proctor and Gamble. [Online]. Material Safety Data Sheet. Retrieved http://www.pg.com/content/pdf/01_about_pg/msds/health_care/oral_care/Fixodent_Control.pdf on March 2, 2009.
National Institute of Health, Office of Dietary Supplements. Dietary Supplement Fact Sheet: Zinc. Retrieved from http://ods.od.nih.gov/factsheets/zinc.asp on March 2, 2009.
Reuters Health. [Online]. Excess use of denture cream tied to nerve damage. Retrieved from http://www.reuters.com/article/healthNews/idUSCOL56970020080905 on March 2, 2009.
United Nations. [Online]. Part 3 Health Hazards. Retrieved from http://www.unece.org/trans/danger/publi/ghs/ghs_rev02/English/03e_part3.pdf on March 2, 2009.
Food and Drug Administration. [Online]. GLAXOSMITHKLINE SUPER POLIGRIP ORIGINAL DENTURE CREAM DENTURE ADHESIVE CREAM. Retrieved on http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfMAUDE/Detail.CFM?MDRFOI__ID=842834 on March 2, 2009.
Food and Drug Administration. [Online]. Device Classes. Retrieved from http://www.fda.gov/cdrh/devadvice/3132.html#class_1 on March 2, 2009.