onsumers are increasingly concerned about potentially toxic ingredients in their cosmetics and personal care products. Product safety is a top priority as new research suggests that some product ingredients long thought to be safe, can have detrimental health effects. Consumers have also come to the realization that they need to be proactive in their quest for safe products, as the assumption that the brand company will look out for their best interests is not always justified.

So what is a person to do if they have questions or concerns regarding their specific cosmetic or personal care product? The best thing to do is to call the company directly. You can get a feel for the level of company responsibility by a simple phone conversation. One of our associates recently did just that, and was actually shocked by the company response.

The concern was over a few ingredients in a moisturizing cream. In these days of COVID-19 precautions, increased handwashing has created an almost epidemic of dry, irritated hands, causing an upsurge in usage of moisturizing products and skin protectants. One such product, a well-known, and dermatologist recommended brand, had ingredients known by our associate, who is also a chemist, to be potentially contaminated with cancer-causing byproducts. The ingredients in question are Phenoxyethanol and PEG (Polyethylene Glycol).

The issue is not so much these two ingredients in and of themselves (although emerging research is showing some potential concerns), but with contaminants that are a natural byproduct of their manufacture. The contaminants of concern are ethylene oxide and 1,4–dioxane. The United States Environmental Protection Agency (EPA), as well as The International Agency for Research on Cancer (IARC) and the National Toxicology Program, all classify ethylene oxide as a human carcinogen. Evidence in humans indicates that ethylene oxide can cause leukemia, lymphoma, multiple myeloma, and breast cancer. The EPA and National Toxicology Program have classified 1,4-dioxane as a probable human carcinogen.

While some countries prohibit products containing ethylene oxide and 1,4-dioxane, there are ways around the restriction. For example, both substances are on Health Canada’s Prohibited Ingredient Hotlist, but because they are often present as “natural” contaminants, products containing them may not be subject to regulation. The United States Food and Drug Administration (FDA) has set no enforceable regulations for these contaminants, but has made recommendations for processes that minimize ethylene oxide and 1,4-dioxane levels in finished products, and has set guidance for supposedly safe levels. The problem is that some products still contain levels of containments over the FDA suggested limits.

Take 1,4-dioxane for example. The FDA has set a “safe level” of less than 10 ppm. Since the early 1980’s the FDA has done random, off the shelf product surveys, and, while the number of products containing 1,4-dioxane above 10 ppm has dropped dramatically, some products still contained higher levels. The latest survey conducted in 2018, was a random selection of 82 products targeted to children, who are more susceptible to the effects of carcinogens than adults. While most of the products came in under the 10 ppm guideline, a couple of the products did not. While it is encouraging that many manufacturers are taking steps to keep levels of cancer-causing contaminants low, not all are. It is also important to note that because these carcinogens are contaminants, and not added ingredients, the FDA does not require listing these on the product label. With all this in mind, some experts recommend consumers take a “trust, but verify” approach, and reach out to brand manufacturers directly if they have concerns about products they use.

When our associate was finally able to connect to a quality assurance representative, he inquired about the two contaminants, and asked about the steps they take to ensure the products are free of such contaminants. Crickets. Nothing. Nada. The QA rep had no knowledge of the processes that were used to minimize contaminants, and had no data to actually support that their products were safe. Our associate found this astounding, but being persistent, embarked on a quest to get answers. After many weeks, and several conversations with multiple people within the organization, the answer was the same – no information could be provided. Not because they did not want to provide it – they simply did not have it!

The company’s position was that since they sourced their ingredients from multiple suppliers, they relied on the suppliers to ensure compliance. While they stated they followed all FDA guidance, when asked if they knew what the FDA guidance was regarding these contaminants, they did not have a clue. They also did not conduct any testing to determine if the levels of contaminants in their products were below FDA recommended limits. In addition, they did not have any documentation from their suppliers to show THEY were in compliance. In the end, our associate told the company that he was not comfortable with their quality assurance protocol, would not be using their products in the future, and wanted a refund for unused product, which was given without hesitation.

It is important to stress that our associate was not asking for proprietary information, or specific data sets – he simply wanted to hear that the company was aware of the issue and tested to make sure the products were safe. Their position was that it was “someone else’s problem”, namely their suppliers. If the company verified that the suppliers actually do testing, reviewed the data that backs up their suppliers’ claims, and conducted quality assurance testing on the final product themselves, that would be OK, but none of that was being done.

Most of us make the assumption that the cosmetic and personal care items we use daily have been rigorously safety tested and free of any harmful substances. While this is probably true for the most part, it is not always the case, even for large, established brands. Most people are also surprised to learn that while there are areas that the FDA regulates very closely, many times the FDA is responsive - they go into action only AFTER complaints have been made about a product.

There are lessons in this story for both consumers and product manufacturers. Manufacturers need to know that consumers are becoming more aware of the potential hazards of product ingredients. They need to take any extra steps required to ensure consumer safety, and provide adequate transparency to create confidence and brand loyalty. For the consumer, the lesson is simple – trust but verify. Have a concern? Make an inquiry. If you don’t feel comfortable with the response, don’t support the product. Switch to a product by a manufacturer that takes the necessary steps to make sure consumers are protected. If enough people did that, manufacturers would be sent a clear message that quality assurance practices and safety are at the forefront of consumer concerns.

September 2021