What's in Your Lipstick? Cosmetics Industry Stays Unregulated

By Padmini Parthasarathy

The Food and Drug Administration regulates what we eat and what we ingest. It has even been known to to recall the occasional neck massager. But one industry falls outside the FDA’s regulatory purview. Cosmetics and personal care products do not have to be cleared before they hit the market. We want to know that someone accountable is scrutinizing our baby formula and protein shakes before we put them in our and our loved ones’ bodies. Why is makeup any different?

However, there are some stirrings in Washington and among advocacy groups to shine a little more light in this pretty and pretty big industry.

What’s in Your Lipstick?

The cosmetics and personal care products industry is worth $71 billion annually. But the FDA has no authority to require pre-market safety assessment as it does with drugs and consumables. According to the Campaign for Safe Cosmetics, 89 percent of all cosmetics have not been evaluated for safety by any publicly accountable institution.

Responding to concerns about the levels of lead in lipsticks, the FDA studied 400 lipsticks on the market. It found trace levels of lead in almost all of them. Though the FDA can regulate how much of the toxic substance can be in color additives, it doesn’t have the authority to regulate how much is in the tube of lipstick in total. The Center for Disease Control has concluded that no amount of lead in the bloodstream is safe. Also, the FDA does not take into account that women apply lipstick between two and 14 times a day.

Johnson & Johnson made a commitment to remove all harmful chemicals by 2015 in response to outrage about two potentially harmful chemicals—formaldehyde and 1.4-dioxane—in its baby shampoo.  

"It made sense for their business because their brand was about being trusted. The baby products should be the low-hanging fruit," says Margie Kelly, Media Relations Manager for the Campaign for Safe Cosmetics.

Johnson & Johnson is an exception to the rule. Most companies have made no such commitment.


Because of gaping loopholes in federal law, companies can get away with using virtually any ingredient with no pre-market safety assessment.

To keep federal oversight at bay, the cosmetics industry trade group (then the Cosmetic, Toiletry, and Fragrance Association, now the Personal Care Products Council (PCPC)), created a system of voluntary self-regulation in 1976 through the Cosmetic Ingredient Review Panel. The CIRP has operating guidelines that are designed to insulate it from the PCPC, but they are still funded by the Council.

On its website, the Council has issued a "Code of Conduct" with no teeth. Under the list of recommended measures, there is a disclaimer: "The Code should not be construed as a legal standard. All companies have an independent obligation to ascertain that their cosmetic products comply with all current laws and regulations."

A few of the companies affiliated with the PCPC have complied piecemeal with the code. Johnson & Johnson has taken its pledge to remove potentially harmful additives. Avon has also pledged to remove triclosan, a suspected endocrine disruptor, from its products. But to date, none of the major manufacturers of cosmetics have signed the Compact for Safe Cosmetics, which requires that companies:

       1. Meet EU standards banning chemicals linked to cancer and birth defects globally,

       2. Conduct an inventory of all ingredients to determine whether they use chemicals that pose health hazards including cancer, hormone disruption, genetic mutation, reproductive toxicity, developmental harm, and neurotoxicity,

       3. Implement substitution plans that replace chemicals of concern with safer alternatives, and

       4. Report on their progress in meeting these goals to the public.

"We’ve found that there’s a real lack of commitment to transparency overall. We want cosmetics to be safe before they’re put on the market. Not only should we regulate them, but also ensure that the products are safe," Kelly tells VITAMIN W.

Things Fall Apart

Last March, Representatives Jan Schakowski (D-Ill) and Ed Markey (D-Mass) introduced a bill that would update regulatory standards. The bill requires that a regulatory body:

      1. Establish labeling requirements,

      2. Establish a safety standard that provides a reasonable certainty of no harm from exposure to a cosmetic or an ingredient in a cosmetic and that protects the public from any known or anticipated adverse health effects associated with the cosmetic or ingredient, and

      3. Issue guidance prescribing good manufacturing practices for cosmetics and ingredients.

Shortly after the bill was introduced to the House, it was referred to a subcommittee. No action has been taken since.

The PCPC and cosmetics companies argue that the links between the alleged toxins and adverse health effects are tenuous at best. They were in talks with the FDA to potentially come to an agreement about a new regulatory framework. The talks fell through when the FDA pulled out. Deputy Commissioner for Food and Veterinary Medicine Michael Taylor issued an uncharacteristically strongly worded letter to the folks at the PCPC after the fallout.

"The result of these changes [to the draft legislation on FDA oversight] is a bill that creates the appearance of a modernized cosmetics regime, but a reality that actually prevents federal and State governments from protecting Americans from unsafe cosmetics. Because your proposal meets none of the safety goals on which we had all agreed last year, I have difficulty seeing a path forward in this process," Taylor writes.


Image via flickr cc