Diethanolamine (DEA) is not a drug or medication. Rather DEA is a chemical used as one of the multiple ingredients in many cosmetic products. Cosmetic products with DEA are typically found in emulsifiers, foaming agents, and other cosmetics applied to the skin. An emulsifier is a surface-active agent (such as soap) that promotes the formation and stabilization of a substance in which different substances are mixed. An emulsifier keeps the component ingredients from separating.
The general rule is that a cosmetics manufacturer may use any ingredient in their products except for most color additives and those specifically prohibited or restricted from cosmetics.
The only requirements are that the ingredients and the finished cosmetic are as follows:
- Safety: The product must be safe;
- Labeling: The product must be properly labeled;
- Lack of Adulteration: Any specific substance should not result in the cosmetic being adulterated or misbranded under laws enforced by the federal Food and Drug Administration (FDA).
What Are the Adverse Effects of DEA?
Recently, a study by the National Toxicology Program (NTP) determined that DEA is carcinogenic in lab animals. The National Toxicology Program is a U.S. Department of Health and Human Services program. It provides the scientific basis for federal government programs, activities, and policies that promote health or prevent disease. It was founded in 1978 and generated, interpreted, and shared information about environmental substances, especially those potentially hazardous to our health.
In 1998 the NTP did a study that found a connection between the topical application of DEA, application to the skin, and certain DEA-related ingredients and cancer in laboratory animals. No research study has established a link between DEA and human cancer development. Some experts believe that products containing DEA can probably harm humans. Studies are in progress to determine whether the chemical poses a risk to humans.
What Is the Current Status of DEA?
While the FDA has not taken any actions against products containing DEA byproducts, they have published the results of their toxicology reports. DEA is not yet known to cause cancer, but research is being conducted to determine the risk to humans.
DEA and DEA-related ingredients work as emulsifiers or foaming agents in cosmetics. They are also used to adjust a product’s pH. Information filed with FDA’s Voluntary Cosmetic Registration Program suggests that DEA and DEA-related ingredients are used much less frequently in cosmetic products than when the NTP completed its study.
What Is the Voluntary Cosmetics Registration Program?
Cosmetics do not have to have FDA approval because they are put on the market and sold to consumers. They are not subject to mandatory establishment registration or ingredient reporting. It is a company’s responsibility to ensure that its cosmetic products and ingredients are safe and labeled properly in compliance with the U.S. Food and Drug Administration (FDA) regulations.
The Voluntary Cosmetic Registration Program (VCRP) is an FDA reporting system for manufacturers, packers, and distributors of cosmetic products distributed commercially in the U.S.
There are two parts to the Voluntary Cosmetic Registration Program. A company may participate in one or both:
- Cosmetic Manufacturing Establishment Registration with the FDA: Cosmetic manufacturers or packers whose products are in commercial distribution in the U.S. should register their cosmetic establishments with the FDA and use a separate form to register each cosmetic manufacturing location. Only cosmetics manufacturers and packers should register, not cosmetic distributors. The FDA assigns a registration number to each cosmetic establishment registered;
- Cosmetic Product Ingredient Statement (CPIS) Filing with the FDA: A cosmetic manufacturer, packer, or distributor should file a statement for each cosmetic product the firm has offered for commercial distribution in the U.S. A company that does labeling for a manufacturer or one that serves as a packer may file these forms with the distributor’s permission.
Information filed with FDA’s Voluntary Cosmetic Registration Program suggests that DEA and DEA-related ingredients are used much less frequently in cosmetic products than when the NTP completed its study in 1998.
The FDA believes that there is no reason for consumers to be concerned about the DEA or DEA-related ingredients in cosmetics. However, if a person wants to avoid any cosmetics containing DEA or DEA-related ingredients, they need to review the label on the outer container of cosmetics that are sold to consumers in retail outlets, e.g., the stores in which most people buy cosmetics. There is a statement that lists the ingredients on the container. The law requires that this label be attached to the container.
The following is a list of some of the most commonly used ingredients that may contain DEA:
- Cocamide DEA;
- Cocamide MEA;
- DEA-Cetyl Phosphate;
- DEA Oleth-3 Phosphate;
- Lauramide DEA;
- Linoleamide MEA;
- Myristamide DEA;
- Oleamide DEA;
- Stearamide MEA;
- TEA-Lauryl Sulfate;
- Triethanolamine.
If the FDA determines that a substance such as DEA poses a risk to human health, the agency would advise the industry and the public and would consider its legal options under the authority of the Federal Food, Drug, and Cosmetic Act for protecting the health and safety of consumers.
Again, the best advice for consumers of cosmetic products now is to avoid products with DEA if they are not comfortable with it.
What If I Believe I Have Been Harmed by DEA?
If a person believes that DEA has harmed them, they would want to consult a personal injury lawyer. It might be challenging to make a case. The known risk of DEA is cancer. So, if a person would have to have developed cancer, they would have to prove that they had used a cosmetic that contains DEA or a DEA-related chemical. They would probably have to prove that they have used this cosmetic for quite some time. If DEA were to cause cancer in a person, it would probably only develop with repeated exposure to the chemical.
The fact that there are, at present, no research studies that support the claim that DEA causes cancer in humans would be a significant issue in any lawsuit that might be filed.
But a personal injury lawyer might be able to make a case for strict product liability against the manufacturer and distributors of the cosmetic product that contains the DEA or the DEA-related chemical. The law of strict product liability allows a consumer to recover compensatory damages if a defect in a product injures them. Defects are generally one of three types, design defects, manufacturing defects, and warning defects.
Compensatory damages would reimburse a person for lost income, the cost of medical care, and their pain and suffering.
A person might make a case for a design defect, arguing that a cosmetic manufacturer should not have formulated a cosmetic product with DEA or a DEA-related chemical. It could be argued that a product that contains DEA is not safe per FDA requirements if it contains DEA.
Or, a person might make a case for a warning defect with the argument that a cosmetic manufacturer should have warned consumers if a product contained DEA, that it is known to cause cancer in animals.
Do I Need a Lawyer’s Help with My DEA Issue?
If you believe that DEA has caused your cancer in a cosmetic product, you want to consult a class action attorney. Your attorney can review your present facts and determine if they make a case for strict product liability. Your lawyer can advise whether you have a case and, if so, how best to pursue it.
