In 1938, the United States Federal Food, Drug, and Cosmetic Act passed Congress, giving the U.S. Food and Drug Administration the power to regulate food, drugs and cosmetics. Surprisingly, under this act, the FDA does not need to approve cosmetic products or ingredients prior to being available on the market (link) According to the FDA, “Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing”. This leaves a gaping hole where they should be held accountable to protecting consumers. Additionally, a lot of these companies’ marketing techniques and verbiage can be misleading, and products that appear safe, natural, and even organic oftentimes aren’t.
The Food and Drug Administration (FDA) estimates over 12,500 ingredients are used in cosmetics, not counting fragrances. Additionally, over 80,000 chemicals on the EPA’s inventory list are used for manufacturing and can be found in common household products like cleaning solutions. Many of the chemicals found in these products are known carcinogens and hormone disrupters, some being linked to allergies, reproductive defects, and even cancer. According to the Toronto Indoor Air Conference of 1990, women who are stay-at-home moms have a 54% higher death rate from cancer than those who work outside the home. The EPA has not yet reviewed the toxicity levels of over 60,000 chemicals grandfathered in as chemicals approved for manufacturing under the Toxic Substances Control Act of 1976. Furthermore, the EPA continues to approve chemicals lacking toxicity information for manufacturing, making it highly unlikely that this figure will have improved since then.
Federal regulations of chemicals in general has proven dismal over the past several decades. In order to make informed decisions and limit our exposure to harmful chemicals, we as consumers need to be educated on policies and regulations that affect us. Below you will find answers to some questions that will help you to make those decisions.
How does the law define a cosmetic?
The Federal Food, Drug, and Cosmetic Act (FD&C Act) defines cosmetics by their intended use, as “articles intended to be rubbed, poured, sprinkled, or sprayed on, introduced into, or otherwise applied to the human body...for cleansing, beautifying, promoting attractiveness, or altering the appearance” [FD&C Act, sec. 201(i)]. Among the products included in this definition are skin moisturizers, perfumes, lipsticks, fingernail polishes, eye and facial makeup preparations, cleansing shampoos, permanent waves, hair colors, and deodorants, as well as any substance intended for use as a component of a cosmetic product.
How does the law define a drug?
The FD&C Act defines drugs, in part, by their intended use, as “articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease” and “articles (other than food) intended to affect the structure or any function of the body of man or other animals” [FD&C Act, sec. 201(g)(1)].
How can a product be both a cosmetic and a drug?
Some products meet the definitions of both cosmetics and drugs. This may happen when a product has two intended uses. For example, a shampoo is a cosmetic because its intended use is to cleanse the hair. An antidandruff treatment is a drug because its intended use is to treat dandruff. Consequently, an antidandruff shampoo is both a cosmetic and a drug. Among other cosmetic/drug combinations are toothpastes that contain fluoride, deodorants that are also antiperspirants, and moisturizers and makeup marketed with sun-protection claims. Such products must comply with the requirements for both cosmetics and drugs.
In general, the FDA regulates:
In general, the EPA regulates:
"Generally, drugs must either receive premarket approval by FDA or conform to final regulations specifying conditions whereby they are generally recognized as safe and effective, and not misbranded. Cosmetic products and ingredients are not subject to FDA premarket approval authority, with the exception of color additives. Cosmetic firms are responsible for substantiating the safety of their products and ingredients before marketing."
Cleaning products are largely regulated based on how they are marketed (link). The Environmental Protection Agency (EPA), for example, regulates general purpose disinfectants and cleaning products while the FDA will regulate hand sanitizers which are classified as “drugs.”
Under the Toxic Substances Control Act (TSCA) of 1976, the EPA has authority to regulate new and existing chemicals for manufacturing, including those used in cleaning products. If a company is going to manufacture or import a new chemical, it submits a pre-manufacture notice to the EPA, at which point the EPA assesses and make a determination to approve, regulate or ban the substance. Unfortunately, companies may claim a chemical to be a “trade secret” which makes it much harder for the EPA to assess its safety. This is also how companies can avoid listing these ingredients on their product labels. While the EPA requires companies to list ingredients that are active disinfectants or potentially harmful on their product labels, “trade secrets” constitute a loophole and may remain vague (link). 13,596 chemicals produced since 1976 are protected under the veil of “confidential business information” according to the Environmental Working Group. And approximately 17,000 of the 83,000 plus chemicals on the EPA’s inventory list are void of any information whatsoever. Furthermore, over 60,000 chemicals were grandfathered in to the EPA’s existing inventory, meaning they didn’t require additional approval prior to manufacturing and to this day have not been evaluated by the EPA for safety. It is still unclear how many of those are still in production as the EPA does not maintain active statuses for each chemical’s current usage in the marketplace.
In 2016, the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Act) was signed into law amending the TSCA and changing the regulations of chemicals in the US. Some improvements were made, including requiring the EPA to take affirmative action on a chemical’s manufacture or import. Meaning, if a chemical poses an “unreasonable risk,” or there is insufficient information to make that determination, the EPA must take regulatory action prior to that chemical entering the marketplace in order to abolish that risk. The law also requires the EPA to begin risk evaluations of 10 existing chemicals from the EPA’s TSCA Work Plan within 180 days of the law’s enactment. 20 risk evaluations must be ongoing within 3 1/2 years of the law’s enactment.
When President Donald Trump took office in January, 2017, he required that for every new regulation implemented, two existing regulations must be eliminated to offset costs of the new regulation. While it was an attempt to “clean house” and reduce excess government spending, this did have an adverse effect on the Lautenberg Act, as the EPA under the current administration is continuing to approve chemicals into the market with little toxicity data (link). Moreover, Nancy B. Beck, Trump’s high ranking appointee to the EPA and former Washington state toxicologist, rewrote a rule making it more difficult to track the health consequences of a chemical, undermining the EPA’s ability to regulate it (link). The EPA’s Office of Water confidentially warned the New York Times of its concerns that those changes would undervalue potential health and environmental risks. The chemical industry strongly backs these changes as they lessen regulatory burdens on manufacturing. While this is a win for capitalism and chemical manufacturing, the negative trickle down effects to consumers being exposed to these chemicals is risky.
1,4-dioxane, according to the EWG, is a byproduct of an ingredient processing method called ethoxylation, which is used to reduce the risk of skin irritation for petroleum-based ingredients (link). The US Department of Health and Human Services considers it to be a human carcinogen. It can be found in paint strippers and waxes, but is also in cosmetics such as shampoo, dishwashing liquid soap, baby lotion, hair lotion, and bath foam.
Short-term exposure to relatively high levels of 1,4-dioxane has proven to cause kidney and liver damage. Accidental worker exposure has even caused industrial deaths from adverse nervous system effects. Although it is undetermined how long-term low-level exposure to 1,4-dioxane affects people, it is worth noting that occupational studies have found higher rates of spontaneous abortion, stillbirths, premature births, and low birth weights of babies born to workers exposed to 1,4-dioxane, in combination with other solvents (link).
Life-long exposure from 1,4-dioxane found in drinking water causes cancer in animals, according to studies. While research is lacking for humans, it is concerning because it has been found polluting drinking water for 90 million Americans in 45 states (link). Alarmingly, there is no federal maximum contaminant level on the amount of 1,4 dioxane in drinking water, so water contamination goes unregulated.
The Agency for Toxic Substances and Disease Registry states that 1,4-dioxane is present in small amounts in many products, including food, pharmaceuticals, detergents, and cosmetics. But it is likely present in higher levels in shampoos, detergents and cosmetics. As a precaution, exercise care when purchasing cosmetics that may contain 1,4-dioxane. Ingredients to look out for include: