- - Friday, July 7, 2017

ANALYSIS/OPINION:

Most likely in the past 24 hours you have used a personal care or cosmetic product, right? Did you know there is very little to no regulations of the personal care and cosmetics industry? Surprising, isn’t it?

Even more concerns are being raised by a study just published in the journal JAMA Internal Medicine, reporting that complaints of adverse health events related to cosmetic and personal care products more than doubled in just one year (findings from 2015 to 2016). And while cosmetics promise to make us well-kept and in some cases healthier, this new study from Northwestern University indicates that some products could actually cause injury or, even, harm.

While I am not being an alarmist, it is vital we think about how these products are being used—by us, our loved ones, newborns and pregnant woman – and how to recognize and report adverse health incidences.

Facts are that the United States has the largest cosmetics market in the world, and its revenue is expected to exceed a whopping $62 billion – and expected to maintain significant growth through 2018. While the industry has grown and developed, truth is that in terms of regulations, we haven’t modernized the system in the last 50 years.

To that end, the lion’s share of the underlying problem of adverse health effects is from a lack of regulations for cosmetic consumer goods and, too, the underreporting of adverse events by consumers or the companies directly to the U.S. Food and Drug Administration. You may be further surprised to learn that there are products that have caused irritations and remained on the market. And too, terms like organic, hypoallergenic or “natural” aren’t regulated, which means they have very little meaning.

Every day, there are millions upon millions of people throughout our country placing their trust in these products –

Dr. Nina’s What You Need To Know: About Cosmetics and Personal Care Products Lack of Regulation

What are cosmetics? They are defined as products used for beautification, cleansing, or altering our physical appearance. They include makeup, skin care, shampoos and conditioners, hairsprays and gels, soaps, and lip balms, to name a few. And, too, there are a number of “cosmeceuticals” on the market—cosmetics that claim to have medicinal properties and contain bioactive ingredients with drug-like properties. They include anti-aging, hair growth, and acne eliminating products. It should be noted that the term cosmeceuticals is a marketing term and not a legal definition.

Who regulates cosmetics and cosmeceuticals? Both are under the purview of the Food and Drug Administration — however they are very lightly regulated (and, too, the FDA does not recognize cosmeceuticals as a separate class of beauty products). While the agency has some labeling requirements, companies can easily avoid listing a product’s ingredients by claiming doing so would give away trade secrets.

Additionally, what you may be very surprised to learn is that if there are complaints made to the manufacturer, they are not obligated to report them to the FDA nor pull them from distribution. So, let’s say a soap caused you to experience an irritation or blister and you tell the company, the company is not legally required to forward your complaint to the FDA.

Also, the FDA does not have the authority to remove products from the market, even if they contain toxic chemicals such as lead, mercury, formaldehyde, and lesser-known hazards that have emerged as what regulators call “chemicals of concern.”

Do cosmetics and personal care products need to be tested and approved before being sold? Currently, under the federal Food, Drug, and Cosmetic Act, cosmetic products and ingredients do not require FDA approval before they go on the market. The exception is color additives (other than those used in most hair dyes). The FDA states that companies and individuals who market cosmetics have the legal responsibility to ensure the safety of their products.

Call to Action: Drugs and medical devices undergo rigorous and vigorous clinical trials that take years and can reach—and even exceed a billion dollars. Once on the market, there is careful surveillance for adverse events and the medicine or device can be recalled.

And, yes, it is true that cosmetics have an inherently decreased risk—they are not ingested, injected, or implanted in the human body—however, they have the potential to cause harm. Skin products can be absorbed through the skin or cause irritation or burns; hair products can cause hair loss; and lip balms can cause blistering or be toxic if ingested (when we lick our lips).

Further, there are chemicals in cosmetics that are endocrine-disruptors—meaning when they enter our body, they disrupt our hormone system. They can mimic our hormones and cause increases or decreases in our body’s hormone level or cause cells to die early.

Recently, the Personal Care Products Safety Act was introduced and is making its way through Congress with the goal to create a uniform set of rules to protect consumers. It aims at expanding the FDA’s authority over cosmetics by: requiring the manufacturer to report adverse events to the FDA; the FDA having the authority to recall harmful products; and an annual review by the FDA of the safety of at least 5 ingredients. Legislation of this sort will help increase safety.

Be Aware: No one wants to learn that their trusted personal care products are made with hazardous chemicals. Thankfully, most are not. And there are steps you can take to reduce toxic exposures in your home and protect the health of your family. Because the beauty industry is largely unregulated, it is up to you to do your own research.

Go online and check out the safety ratings and consumer reports (there are even apps available). The Environmental Working Group has a database of information on hundreds of cosmetic companies and products with safety ratings for each.

Be aware that there are no legal or government mandated standards for personal care products labeled as “pure,” “natural,” or “organic.” A product can be 99.9% synthetic, but if it contains even a tiny bit of something natural like water (in the amount of 0.1%), the company can advertise it as natural!

Look beyond packaging, magazine ads, and testimonials by friends and neighbors. If the product appears too good to be true, it oftentimes is.

Check the labeling to see if they advertise what you are NOT getting (e.g. formaldehyde-free). A manufacturer cannot mislabel a product, but they do not have to list all chemicals or contents.

Choose products with simpler ingredient lists and fewer synthetic chemicals and avoid synthetic fragrances

If you experience an adverse event with a cosmetic product, file a complaint to the FDA—there is an easy-to-use online reporting form called FDA MedWatch

And, too, you can support action for more regulation. Call your state representatives to let them know that you want more protections when it comes to personal care and cosmetic products.

Currently, we have a situation of passive surveillance where products get put on the market and then we wait for complaints to arise. I join with other medical health professionals in the hopes that this information helps in your awareness and actions you can take to help yourself and your loved ones — besides waiting for more oversight to achieve the high levels of safety we have a right to expect.

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