Aluminum

What is Aluminum?

Aluminum is found primarily in bauxite ore, and is one of the most common elements in the environment. Aluminum is a soft, lightweight metal, normally with a dull silvery appearance. Aluminum (as the metal) is nontoxic. The metal is used in many industries to manufacture a large variety of products and is very important to the world economy. Structural components made from Aluminum and its alloys (combinations with other metals) are vital to the aerospace industry and very important in other areas of transportation and building. Aluminum is also important in consumer goods packaging.

Because Aluminum is present in soil, most human exposure comes from foods we eat and the water we drink. In addition, Aluminum-based raw materials are used extensively in cosmetics, pharmaceuticals and over-the-counter (OTC) drug products. In cosmetics, they function as pigments and thickening agents. Aluminum compounds also function as active ingredients in OTC drugs such as antacids and antiperspirants (APs).

Why are Aluminum-containing ingredients used in cosmetics and personal care products?

Depending on the product form (solid or liquid), many antiperspirants frequently contain Aluminum salts to reduce the flow of sweat from the skin. These salts work by dissolving in sweat and temporarily inhibit the flow of sweat to the surface of the skin. This reduces the amount of sweat on the skin for a number of hours after the antiperspirant is applied. Aerosol and roll-on antiperspirants products typically contain ACH (Aluminum Chlorohydrate), whereas sticks, gels and other solid products are most likely to contain an Aluminum salt referred to as AZAG (Aluminum Zirconium Tetrachlorohydrex GLY). These Aluminum salts provide a safe and effective means of controlling sweat. In fact, Aluminum salts are the only active ingredients that are approved by the FDA for use in antiperspirants. Some people may be concerned about the use of aluminum in antiperspirants and other everyday products, believing that it can damage health.

Is Aluminum safe for use in cosmetics and personal care products?

Aluminum is the third most naturally abundant element in the environment, found in food, water, pharmaceutical as well as a wide range of consumer products. The overwhelming mass of toxicity data available does not indicate any risk of harmful effects from using any cosmetic products that contain Aluminum. The amount of Aluminum absorbed through the skin from antiperspirants is significantly less than average daily exposure from food and water. Antiperspirants are designed to work on the surface of the skin, and so the products would not work if there was a significant amount absorbed. Published literature along with industry studies demonstrates a negligible potential for Aluminum salts to penetrate the skin (1). If a small amount were absorbed, this would be tiny in comparison to the amounts we consume in the foods we eat daily.

Some people may be concerned about the use of Aluminum in antiperspirants and other everyday products, believing that it can damage health. It has been suggested that Aluminum may be a possible contributory factor for Alzheimer's disease. The ‘Aluminum hypothesis’ was first put forward in 1965 when it was shown that the injection of Aluminum compounds into rabbits caused tangle like formations in nerve cells (reference 2). However, these experimental tangles differ in structure and composition from the tangles that are found in the brains of Alzheimer’s patients. Since then a number of other circumstantial links between Aluminum and Alzheimer’s disease have been claimed. However, experts and research bodies including the Alzheimer's Association and the FDA have concluded that at the present time, there is no evidence that convincingly demonstrates a link between Aluminum and Alzheimer’s disease. The FDA has concluded that although "the literature shows the issue of aluminum toxicity and Alzheimer's disease remains controversial and is not resolved," the available evidence is "insufficient to link aluminum to Alzheimer's disease."

There have been rumors on the Internet and in the popular press claiming that antiperspirants may be linked to breast cancer. Leading cancer research organizations have stated that there is no plausible biological mechanism by which antiperspirants could cause breast cancer. The National Cancer Institute (NCI) has said that “no conclusive research” links antiperspirants and the subsequent development of breast cancer, though the NCI observed that the results of some studies suggest that additional research is needed. http://www.cancer.gov/cancertopics/factsheet/Risk/AP-Deo

A study reported in the Journal of the National Cancer Institute (JNCI), October 16, 2002, conclusively debunks the rumor circulating on the Internet which falsely states that antiperspirant use causes breast cancer. Researchers from the Fred Hutchinson Cancer Research Center and the University of Washington both(Seattle) conducted an extensive population-based case-control study. They concluded that “These findings do not support the hypothesis that antiperspirant use increases the risk for breast cancer.” The researchers also said that “there was no evidence” of risk for breast cancer from the use of deodorants. Furthermore, according to the American Cancer Society, there have been many extremely thorough epidemiological studies of breast cancer risk and they have not found antiperspirant use to be a risk factor for breast cancer, much less the “leading cause” of the disease.

The FDA now requires all antiperspirant products to include a warning statement that advises people with kidney disease to consult a physician before using the product. Since the kidneys play a large role in eliminating Aluminum from the body, the FDA decided it was prudent to alert consumers who have some kidney function impairment to the fact that their exposure to Aluminum from use of antiperspirants might need to be discussed with their doctor. “Kidney disease” is a non-specific term that is used to describe a broad range of kidney dysfunctions. In general, the new warning statement is meant for kidney disease patients who are on an Aluminum-restricted diet and who may not be able to excrete the low levels of Aluminum in the body that may result from antiperspirant use. More information on this issue can be found on the web site of the American Society of Nephrology, the professional medical society for doctors specializing in kidney disease.

Link to the American Society of Nephrology: http://www.asn-online.org/facts_and_statistics/

What are the regulations for the use of Aluminum-containing ingredients in cosmetics and personal care products?

The use of Aluminum in cosmetic products and OTC drugs is regulated by the Food and Drug Administration (FDA). They may be regulated as cosmetics or as Over-The-Counter (OTC) drugs. Aluminum powder is FDA approved as safe for use for coloring cosmetics. When used in a cosmetic product, per FDA regulations, the safety of the ingredient must be substantiated by the manufacturer of the product. When the ingredient is used as an OTC drug active ingredient, such as in antiperspirants, a manufacturer can only use the aluminum active ingredients that have been approved as safe and effective by the FDA in the OTC antiperspirant monograph and these products can only be used according to the guidelines established in this monograph.

More information about FDA regulation of Aluminum and Aluminum-containing ingredients:
Use as a color:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr...
Use as an antiperspirant:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?fr...
Use for food purposes:
http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfcfr/CFRSearch.cfm?CF...

Based on this information, there is no evidence of harm from the use of antiperspirants or deodorants. Antiperspirants and deodorants are safe and consumers should not be unnecessarily alarmed.

References:

1 - Flarend et al., Food Chem Toxicol. 2001 Feb;39(2):163-8
2 - Wisniewski, H.M., Terry, R.D., Peña, C., Streicher, E., Klatzo, I. Experimental production of neurofibrillary degeneration. J. Neuropath. & Exp. Neurol., 1965, 24: 139.

Link to FDA Final Rule for Antiperspirant Drug Products for a discussion on Aluminum and Alzheimer’s disease:
http://www.fda.gov/cder/otcmonographs/Antiperspirant/antiperspirant_FR_2...

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