FDA To Regulate Cosmetics Makers—Partly

New powers granted to the Food and Drug Agency (FDA) give the agency the ability to shut down cosmetic companies making products like shampoo, makeup, and toothpaste that expose consumers to injury or disease.

The updated regulations come from the Modernization of Cosmetics Regulation Act (MOCRA) of 2022, which was tucked into the massive Consolidated Appropriations Act funding bill of 2023. MOCRA empowers the FDA to regulate aspects of cosmetics and personal care products in ways many Americans likely assumed it already was.

The act also creates federal standards for product registration and manufacturing practices, as well as record keeping, recalls, and documentation to substantiate safety claims.

Updated Regulations Long Overdue

MOCRA is the first statutory change to FDA’s authority over cosmetics makers since 1938.

Over the decades, several scandals drove demands for changes, from tainted products to questionable chemical additives. Most people know about the danger of exposure to asbestos, lead, and formaldehyde but don’t necessarily think these substances are in cosmetics. Unfortunately, they sometimes are, either by accident or by design. So are chemicals like parabens, PFAS (polyfluoroalkyl substances), and phthalates that are increasingly linked to side effects ranging from cancer and reproductive problems to developmental toxicity and prenatal risks to allergies and sensitivities. In fact, some would say it’s a chemical jungle out there.

MOCRA arose from mounting calls for greater regulation of the $169 billion-a-year personal care product industry. That outcry has been spurred, in part, by a growing awareness of how much chemical exposure actually exists. For instance, an average adult uses nine personal care products every day, with up to 126 unique chemical ingredients, reports the Environmental Working Group (EWG), a U.S.-based research and advocacy nonprofit active in the areas of drinking water pollution, toxic chemicals, agricultural subsidies, and corporate accountability. Groups like EWG have long worked to draw attention to the fact that the FDA does not regulate cosmetic products the way many assume.

“[T]he FDA largely relies on the personal care products industry to regulate itself as a way to address the risks its products pose,” says the EWG. “Of more than 10,000 chemicals used to formulate cosmetics, just eleven have ever been banned or restricted by the federal Food and Drug Administration.” Many of these products are applied directly to the skin, enabling the ingredients to “be absorbed directly into the bloodstream,” says the group.

New, Partial Oversight

MOCRA empowers the FDA to take direct action against cosmetic makers and will eventually require them to document how their products affect consumers.

The manufacturer, packer, or distributor of a cosmetic product whose name appears on the product label must soon maintain records of health-related adverse events linked to a cosmetic or personal care product and report any serious adverse events to FDA within fifteen days of learning about it. This was not the case before.

Moreover, the definition of adverse events has been broadened in the act to include possible occurrences with cosmetics and personal care items such as “significant disfigurement (including serious and persistent rashes, second- or third-degree burns, significant hair loss, or persistent or significant alteration of appearance), other than as intended, under conditions of use that are customary or usual.”

Under the act, cosmetics and personal care product companies will now have to register with the FDA and can lose their registration like manufacturers of other types of products for safety violations. Companies also must disclose their ingredients to the FDA and “fragrance allergens” must appear on labels for the safety of consumers.

Finally, the FDA will now have the authority to order a recall of cosmetic and personal care products as it does with other product categories and which it never had the power to do before. Compliance requirements will be gradually introduced over the next one to two years as no part of the act is immediately enforced.

“Although more is needed to ensure the safety of chemicals used in cosmetics, this update is a welcome step in the right direction,” Scott Faber, EWG senior vice president for government affairs said in a statement.

“The FDA will now have many of the same commonsense, basic tools the FDA already has for oversight of other product categories,” he said.

The act does fall short, however. It doesn’t require or resource the FDA to actually review safety records for chemicals of concern, nor ban or restrict chemicals.

“The hard work of banning or restricting chemicals will now fall to the states,” said EWG President and Co-founder Ken Cook in the statement. “The cosmetics provisions in the end-of-year spending bill preserve the ability of states to ban toxic chemicals from cosmetics, as California, Colorado and Maryland have recently done.”

“Some of the most extreme voices in the cosmetics industry and their fellow travelers wanted to eviscerate state powers, but EWG insisted on preserving the ability of states to ban or restrict chemicals of concern,” Cook added.

Better Regulation Was Sorely Needed

Even as consumers have become more aware of toxic chemicals lurking in their personal products, labels can omit important information. For example, research published in the journal Environmental Science and Technology Letters in 2021 found that more than half of the products that were tested contained the controversial PFAS yet almost none “included the chemicals on their ingredients labels.”

And even when they appear on the label, chemical names can be confusing. Will those who wish to avoid parabens—preservatives that function as endocrine-disrupting chemicals as The Epoch Times has previously reported—recognize the host of parabens that are prefixed with words like methyl, ethyl, propyl, isopropyl, and butyl?

According to a survey conducted by the website asbestos.com, one in three consumers never reads the label on the personal care items they use. “Many people examine the labels of their food products, or what goes in their bodies, before making a purchase,” says the site. “But, according to our survey results, one in three people never look at the ingredients of new cosmetics, or what goes on their bodies.”

Why Are Toxic Chemicals in Our Products? 

It is worth noting that some of the personal care product ingredients rapidly falling out of favor today were created for defensible reasons. “[M]any of these harmful ingredients are included to keep the products safe,” writes Marcy Laub for Harvard University. “Antimicrobials, antifungals, and preservatives are what allow that tube of Chapstick or jar of lotion to sit in your medicine cabinet until you’ve used it all up.” While compounds like parabens have rapidly become bad guys, without them “bacteria and other microorganisms would quickly render these products rotten,” she writes.

But other undesirable chemicals are in products simply to make the product look, feel, or smell better.

“Cosmetic products must please the senses of a consumer to positively influence their buying decision,” says an article on the material selection website Special Chem. In addition to attractive packaging and fragrance, “The feel and texture of the product can also trigger various sensations and reactions,” the site notes. “The first impression made by the product texture plays an important role in the selection of personal care products.”

Ingredients used to create texture rely on an “optimal combination of emulsifiers, thickeners, emollients and other additives,” says the site. Emulsifiers are additives that encourage the suspension of one liquid’s droplets into another’s. Synthetic thickeners increase viscosity and can include carbomers which are acrylic acid polymers.

Are Consumers Driving Demand for Toxins?

Many of us grew up reading “lather, rinse, repeat” on our shampoo bottles and love lather. But now we are learning that to create lather bubbles, foaming agents like sodium lauryl sulfate, cocamide DEA, MEA, or TEA are added. These chemicals are no longer considered completely safe, especially compared with natural foaming agents derived from plant and animal sources.

Moreover, lathering does not really make us “cleaner.” Though lather suspends dirt by producing greater “surface tension” in water—which facilitates the dirt rinsing off—not as much lather as we think is really required to do the job, say environmentalists.

Consumers also need to face the fact that we like fragrance—it is alluring—but its presence usually signals that petroleum, phthalates, chemicals that make plastics more durable, and the carcinogens benzophenone and styrene, are also present. Are rich lather and fragrance worth exposing ourselves to such chemicals? We need to look at our own buying habits because they shape demand.

Earlier Legislation Introduced

Rep. Jan Schakowsky (D-Ill.), the senior chief deputy whip and chairwoman of the Consumer Protection and Commerce Subcommittee of the House Energy and Commerce Committee had made previous attempts to better regulate cosmetic products. In 2021, she introduced the Safer Beauty Bill Package of four bills to Congress, supported by Reps. Doris Matsui (D-Calif.), Lizzie Fletcher (D-Texas), and Lisa Blunt Rochester (D-Del.). The bills aimed to better protect consumers, provide more clarity about ingredients, and more but the bills didn’t get traction in Congress and didn’t move forward.

“Americans are often left in the dark about harmful mystery ingredients in personal care products; consumers deserve confidence that the products that they use will not hurt them,” said Schakowsky when she introduced the bills. Schakowsky’s Safer Beauty bills were supported by 134 groups made up of health practitioners, environmentalists, parents, those in the beauty business, and more.

Conclusion

The Modernization of Cosmetics Regulation Act of 2022 is good news for everyone who uses soap, shampoo, shaving cream, conditioners, and the like, but it doesn’t guarantee the FDA will protect consumers from toxic chemicals. Makers of cosmetics and personal care products can be held more accountable, however, and if their business practices are faulty, they can be unregistered; if their products are unsafe, they can be recalled. Still, it is still up to consumers to reject personal care products that contain unwanted chemicals intended to lure us. Some say, if you can’t pronounce the ingredients, don’t buy the product.

To learn more about risks from cosmetic and personal care products—which, sadly, include cancers—visit the MD Anderson Cancer Center at the University of Texas’ “Beauty products and Cancer: Are you at risk?” site.

To learn more about which products to avoid and which may be safer, the websites of the many safety and environmental groups supporting Congresswoman Schakowsky’s Safer Beauty bills are a good place to start.

Finally, don’t rule out making your own skin care, hair care, or makeup products which can be fun, creative, and money-saving!