Or hadn’t you heard? There is a huge controversy over the safety of cosmetics ingredients, but so far it’s been largely unseen, and that might be because there’s less below the surface than some think. In recent years, a consumer group has raised complaints about product safety and what it sees as the Food and Drug Administration’s inadequate response. The industry has vigorously responded with “Like heck!” or words to that effect, and said the group’s accusations are bogus. FDA, the agency with regulatory power over cosmetics in the U.S., appears to still be thinking about what it will ultimately do.

Cosmetics include lipstick, makeup, perfume, nail polish, skin moisturizers, shampoos, toothpastes, hair colors and deodorants. The federal Food, Drug and Cosmetic Act defines cosmetics (as many of us would) 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.” Not included, interestingly enough, is soap. Cosmetics products are not pre-approved by FDA for their safety or anything else before hitting the market, except for color additives they may contain. The law places on cosmetics companies the legal responsibility to assure that their products are safe and are labeled in accordance with FDA regulations.

Meanwhile, a September 2007 meeting on international cooperation on cosmetics regulation was held in Brussels. It was aimed at making international cosmetics marketing easier by increasing the consistency of regulatory requirements of different nations. The meeting was between government officials and industry trade groups from around the world, and it yielded a list of six topics on which further cooperation will be attempted: Good Manufacturing Practices; Ingredients labeling; Nanotechnology; Market surveillance; Authorized substances; and Animal testing and alternative methods.

The cosmetics industry likes the idea of standardization in these areas, as it will help their products move around the world, made in one place but sold elsewhere.
 
Francine Lamoriello, of the trade group Cosmetic, Toiletry and Fragrance Association, hopes these international efforts start modestly, though, and says industry hopes any such efforts are “in the context of each country’s regulatory system.” In other words, they quite sensibly don’t want to see the adoption of detailed, firm standards for worldwide application. They prefer standards and principles that each country can use to guide its own regulatory measures. Those measures might not be mandatory regulations, but simply guidance documents, she notes.

The advocacy organization, Environmental Working Group, was quite irritated that it and groups like it were kept out of the Brussels meeting. EWG said FDA is not doing its job in protecting the public, and that safety should be a bigger priority than working on international harmonization. They wrote FDA a letter claiming that there are many cosmetics products sold in the U.S. that violate the industry’s own safety standards or contain substances that are banned from use in cosmetics in other countries (though they are not banned here).

EWG has been pointing an accusing finger at cosmetics and FDA for several years, and they have raised several points. For example, there is an FDA regulation that requires cosmetics-containing ingredients that have not been shown to be safe to feature a label statement that says, “WARNING—The safety of this product has not been determined.”

However, virtually no products exist that feature the warning. The industry says this demonstrates that few if any products need it, and notes that there is an industry panel that reviews the safety of ingredients. On the contrary, EWG says many products should feature the warning but don’t. EWG thinks these are the products FDA should be taking action against.

In 2005, FDA warned the cosmetics industry that the agency planned to take action against cosmetics that contained ingredients that weren’t substantiated as safe but whose labels lacked the warning statement. A review of FDA Warning Letters issued by FDA since 2005 finds none of them was based on that violation. (They also said they would issue industry guidance on what constitutes proper safety information, but so far, not yet.)

If you look at the Warning Letters the agency did send to cosmetics companies since 2000, they show that FDA is not completely inactive in the field. FDA’s Warning Letters to cosmetics makers were issued for a range of alleged violations, including that the products were actually unapproved drugs or medical devices, that they were misbranded for various reasons (other than lacking the label warning), or that they were adulterated for containing unapproved color additives or for bacterial contamination.

No recent Warning Letters could be found in which a cosmetic product was cited for failing to have the regulatory warning statement, however. And an FDA spokesman told me that FDA is not aware of any products whose labels should contain the label statement but don’t. Does that mean, as EWG alleges, that FDA could be, but isn’t, enforcing that warning requirement on lots of products?

Not necessarily.

It is not at all clear that the EWG accusations are correct. The CTFA says the group’s report called “Skin Deep,” containing many of the same allegations, is “filled with mistakes and unfounded conclusions.” (You can see the report, and CTFA’s responses, on their respective Web sites.) Also, the mere presence of substances in products does not make them unsafe, as they may be present in insignificant levels. FDA may well be using its scarce resources elsewhere because cosmetics generally are safe. The kinds of questions EWG is raising are large and policy-based, and will take a great deal of time and effort to address.

So while efforts are underway toward international harmonization, there is still an EWG petition hanging around in the background, raising questions about product safety. FDA has not yet responded to the petition, and at press time it wasn’t familiar with the EWG letter and report the group sent before the international meeting, so FDA couldn’t respond to its accusations.

But whenever FDA does respond to the EWG petition, it’s likely you will hear a lot more about the cosmetics safety issue.

For related articles visit packworld.com/regulatory

Eric can be reached at greenberg@efg-law.com, and visit his firm’s Web site at www.ericfgreenbergpc.com.