STATEMENT OF SENATOR EDWARD M. KENNEDY
FDA REFORM AND COSMETIC PREEMPTION
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For Immediate Release
202-224-2633
September 5, 1997

Mr. President, the most egregious and unjustified provision in this bill would cripple consumer protections by effectively pre-empting state regulation of over-the-counter drugs and cosmetics. I want to note for the record that these provisions were not included in the Chairman's original mark. They were not the subject of significant hearings. They have no place in a bill whose primary purpose is to reauthorize the Prescription Drug User Fee Act.

If the Congress was in earnest about addressing over-the-counter drug and cosmetic regulation, it would have undertaken a serious and detailed inquiry into the regulatory structure and authorities which assure that consumers are adequately protected before remotely contemplating the possibility of preempting active and essential state protections.

Pre-emption of cosmetic regulation is especially outrageous and shows a callous disregard for the health of American women and, in many cases, of the children they may be carrying in their wombs. Cosmetics are broadly used by Americans-- far more broadly than most prescription drugs, medical devices, or biologic products.

Whether the product in question is hair spray, shampoo, lipstick, or baby powder, or suntan lotion, and soap or toothpaste, every American routinely assumes that the product is safe.

But this confidence is too often unjustified--because Federal oversight of the $20 billion cosmetics industry is so limited. The basic Federal law regulating cosmetics has not been updated since 1938. The FDA has less than 30 employees overseeing this huge industry. The FDA has no authority to require manufacturers to register their plants and products. It cannot require manufacturers to file data on the ingredients in their products. It cannot compel manufacturers to file reports on cosmetic-related industries. It cannot require that products be tested for safety or that the results of safety testing be made available to the agency. It does not have the right of access to manufacturers¹ records. It cannot even require recall of a product.

A study by the General Accounting Office reported that more than 125 ingredients used in cosmetics are suspected of causing cancer. Twenty cosmetic ingredients may cause adverse effects of the nervous system, including headaches, drowsiness, and convulsions. Twenty cosmetic ingredients are suspected of causing birth defects. The GAO concluded that "cosmetics are being marketed in the United States which may pose a serious hazard to the public." GAO also found that additional Federal authority is necessary to adequately protect the public.

Mr. President, the cosmetics industry wants the public to believe that no effective regulation is necessary of desirable. They are masters of the slick ad and expensive public relations campaign. But all the glamorous pictures in the world cannot obscure the facts: this is an industry that is under-regulated and its products are too often hazardous.

A mother of a lovely little six year old girl in Oakland, California found this out when she applied a hair product to her child that resulted in second degree burns on the child's ears and neck. A 59-year old California women almost died from an allergic reaction to hair dye. A 47 year old woman had her cornea destroyed by a mascara wand.

Still another woman's hair caught fire as the result of an inflammable hair treatment gel. She lost her hair and was severely scarred. Beauty parlor employees are particularly vulnerable to asthma and other chronic diseases that result from exposure to chemicals in the products they use. Yet today, FDA cannot require labeling on products used in beauty parlors. In fact, for every one million cosmetic products purchased, there are more than 200 visits to the doctor to treat cosmetic-caused illnesses.

But these severe reactions may be only the tip of the iceberg. Long-term illnesses ranging from cancer to birth defects may not be linnked to their underlying cosmetic-related causes. As the GAO points out, "Available estimates of cosmetic-related injuries do not accurately reflect the extent to which consumers are exposed to toxic cosmetic products and ingredients. Because symptoms of chronic toxic effects may not occur until months or years after exposure, injury estimates generally account for only acute toxic effects."

In light of the limited Federal authority to protect the public against these hazards and even more limited Federal resources devoted to these problems, you would think that the Congress would want to encourage states to fill the regulatory vacuum. But, instead, this bill entirely bars states from regulating packaging and labeling and places severe limits on their ability to establish other forms of regulation. In fact, the language is so extreme that states are barred from establishing "any requirement relating to public information or any other form of public communication relating to the safety and effectiveness of a drug or cosmetic."

What does this mean for consumers? No warning labels. No information that a product contains carcinogens or can cause severe allergic reactions. No "keep out of reach of children" labels. No notification that a product has been recalled because it is dangerous or adulterated. The cosmetic industry seems to believe that, for purchasers of their products, ignorance should be bliss.

Some states have taken an active role in protecting consumers. More may do so in the future--but not if this bill becomes law. Minnesota has passed a hazardous product labeling bill requiring a warning on all products that are ignitable, corrosive, reactive, or toxic. You would think that all consumers should be entitled to that kind of information about products they put on their faces, spray on their hair, or bath in. But the cosmetics industry disagrees. California requires notification if products contain carcinogens, or reproductive toxins. You would think every consumer should be entitled to that information. But the cosmetic industry disagrees.

Texas is investigating hormone creams that may affect the reproductive health of young women. You would think that states should be encouraged to take this kind of action; but this law prohibits it. New York requires expiration dates on cosmetics, because products can break down or be subject to bacterial contamination after certain time periods. Most of us would think that this is basic, obvious information that every consumer should have--but not the cosmetic industry.

Mr. President, the last time the Senate looked at the issue of cosmetic regulation in the late 1970s, we held extensive hearings, we debated the issue and we passed a comprehensive bill that included additional authorities for the FDA. Today, we are considering a bill that resulted from no hearings, where there has been little debate and no expert testimony, in a product area that touches the American public every day.

It should be clear to anyone that cosmetics are as deserving of adequate regulation as they were twenty years ago. It defies logic that our single action in this important consumer product area is to preempt the States from acting where there is wide agreement that FDA has neither the authority or the resources to adequately fill the field. An attorney, now with Proctor and Gamble, wrote in a 1996 Food and Drug Law Journal article that although cosmetics are regulated by the Food and Drug Administration "the agency's regulation is extremely lenient." If lenient regulation led to the chamber of horrors documented in the Senate hearings twenty years ago, it is difficult to imagine the impact of preempting the states from acting.

Proponents of the bill will tell you that their language preempts State safety regulation only where the federal government has acted. But the actual statutory language is very broad and demonstrates a different intent. The industry admits that the language is drafted specifically to undermine federal judges that have narrowly interpreted federal preemption. For instance, if FDA sets a standard for lead in hair products, this bill would direct a conclusion that the lead level sets the standard for other, unrelated products that might have different routes of exposure.

Mr. President, I have no doubt that the industry will argue that any little action on FDA's part will preempt State action. Yet we have no assurance that FDA is actually up to the task of filling the void left by the states. Again, we have had no hearings, no public record, no expert testimony. In fact, the industry cannot cite one example of a burdensome state regulation that this law preempts -- instead they suggest that the benefit of this law is prospective. They claim they are concerned about what States might do in the future.

The stark reality is that, according to the cosmetic industry itself, the industry spends 70 percent of its lobbying dollars influencing State legislatures. I suppose we should really call this the "FDA Lobbying Relief Act." I find scarce comfort in the fact that this bill will relieve cosmetic lobbyists from having to lobby 50 states and who can now focus on Congress. Even worse, if this provision is enacted, the cosmetic lobbyists will spend their time getting FDA to act in some small way on a safety issue simply to create a broad scope of federal preemption of the States in that area.

This is irresponsible deregulation, putting the proverbial cart before the horse. Let me emphasize that if we want to truly reform the FDA's regulation of cosmetics, we should start with ensuring they are protecting the American public from unsafe cosmetic products. Once the American people can be confident that FDA has the authority and the resources to protect them -- that FDA is up to the task -- and then we can talk about state preemption. That is the way we have always approached state preemption in the past and that is the only responsible way to approach it now.

The proponents of this provision claim that by permitting States to petition for exemptions, there is adequate protection of States rights. In reality, the high procedural hurdles in this provision -- especially the extremely burdensome requirements of formal rulemaking -- ensures a lengthy process where industry will entangle States in years of hearings. Given the lack of a Federal presence in the area of cosmetic regulation, it is unconscionable to make the States jump through hoops in order to continue to protect or warn their own citizens.

I assure my colleagues that this is only the first instance where you will witness efforts at sweeping preemption in the absence of significant federal activity. We will be faced with a barrage of bills seeking to preempt State authority in the area of public health regulation. It is certainly ironic that this Congress is so determined to undermine States' rights.

Mr. President, let me emphasize again how this provision hinders States from protecting their citizens at the end of the day. The labeling and packaging of a cosmetic is preempted completely under this language. States will be unable to communicate safety concerns in the most effective and sensible manner -- through labeling and packaging. Even if the States retain some vestige of authority over cosmetics safety, this bill ties their hands and prevents them from giving the public the information it needs to make informed choices. "Right-to-know" under this provision becomes "right to no information."

And what about the FDA? Today, the FDA has fewer than 2 people working on labeling and packaging of cosmetics. In fact, most of the 30 people working in the FDA Office of Cosmetics work on the regulation of color additives and not actually on cosmetics. The reason for this underwhelming presence is simple: FDA has put limited resources in the cosmetic program because they simply do not have adequate legal authority to address cosmetic safety. If you can't enforce the law because there's no enforcement authority and because the standards are basically nonexistent, you aren't going to squander valuable personnel when there are drugs and medical devices to approve and foods to keep safe.

For example, if the FDA suspects a cosmetics safety problem exists -- as they do today with the use of alpha-hydroxy acid face creams -- the agency faces high hurdles in bringing any kind of regulatory action. FDA bears the burden of demonstrating by its own testing that the product is injurious to health. FDA cannot make the company demonstrate that they are selling a safe product. FDA can not even require companies to register their product formulations.

So today, FDA knows how many milligrams of aspirin are in a tablet, it knows how much sodium there is human or animal food -- and can require disclosure of this information to consumers -- but FDA does not know how much alpha-hydroxy acid is in face cream. And the agency can't even require the cosmetics companies to disclose the presence of a known carcinogen like alpha-hydroxy acid to consumers.

It's frankly no wonder that seventy percent of the cosmetics industry lobbying takes place at the States -- because that's where the action is. That's where the standards are being set and enforced. My colleagues don't have to take my word. We have a letter from the National Governors' Association, Association of Food and Drug Officials, and the Association of State Legislators voicing strong opposition to this provision. We have a letter from the conservative Republican Attorney General of California, Dan Lungren, strongly opposing this provision and speaking eloquently about the importance of the state laws on cosmetic safety.

In my own state of Massachusetts we have a bill pending in the legislature that would extend the same public health protections enjoyed by California under their "right-to-know" law, known as Proposition 65. Prop 65 is so successful, and so popular with California voters, that Senator Jeffords has excluded it from preemption. No one has refuted the positive impact that Proposition 65 has had on public health. But instead of taking a law that is working so effectively to protect the public, and encouraging other States to emulate California, today, we are debating whether to preempt every State but California.

Some of my colleagues have expressed satisfaction at the grandfathering of Prop 65. They should delay their celebrations. This bill grandfathers Prop 65 in its current form, which applies to reproductive toxins and carcinogens. But California will never be able to react to future scientific developments by warning its citizens about other hazardous substances.

For instance, the recent concern over endocrine disruptors and other hormone-like products may ultimately merit special labeling or packaging to warn consumers. We already know that hormone-containing creams are under State investigation. But this bill would utterly preempt California from ever requiring any kind of warning about these new or emerging dangers.

Mr. President, my colleagues may wonder why the FDA has not tried to expand its authority or resources in light of the problems with cosmetic safety. I would suggest we look to ourselves for the answer: we hold the pursestrings and we pass the laws. Make no mistake-- FDA has tried to find creative solutions to its lack of authority and lack of information.

A few years ago, the agency proposed establishing a cosmetics hotline to receive consumer complaints. FDA hoped to fill in gaps because their voluntary cosmetics adverse event reporting systems, which had dismal compliance rates of well below 40 percent. The majority of all cosmetics health problems were going unreported, and here was an ingenious solution. Of course, the reason the reporting systems were -- and are -- voluntary is because FDA doesn't have the authority to require companies to tell them what kind of problems consumers are having with their products. But mix a $20 billion industry, Congress and some heavy lobbying together and you get a congressional prohibition forbidding FDA from establishing the cosmetics hotline.

That brings us to today, Mr. President. Let's take a look at the federal authority that governs cosmetics. In the Federal Food Drug and Cosmetic Act there are 126 pages devoted to the regulation of drugs and devices. 55 pages are devoted to foods regulation. A full 8 pages of the Act is dedicated to definitions. Yet, less than 2 pages are devoted to cosmetic regulation -- 2 pages of statutory authority for a $20 billion industry.

In 1988, our colleague, then-Congressman Wyden held landmark hearings looking at the safety of cosmetics. The industry gave his subcommittee a list of 2,983 chemicals used in cosmetics. The National Institute of Occupational Safety and Health at NIH analyzed those 2,983 chemicals and found that 884 cosmetic ingredients had been reported to the Government as toxic substances. We've known for ten years that a third of cosmetic chemicals are toxic but we've done nothing to strengthen Federal consumer protections-- instead, we'd rather weaken State consumer protections.

Mr. President, we often refer to FDA's regulation of drugs as the international gold standard. Well, I would call refer to our country's regulation of cosmetics as the fool's gold standard. Cosmetic regulation in other countries is far superior to our own. The European Union requires full ingredient listing on packaging, documentary proof of good manufacturing practice and similar proof that extensive testing has been carried out on all products. Mexico recently adopted a regulation mandating expiration dates on all cosmetics. Although New York recently adopted such a rule, it may live a very short life-- the bill before us would preempt that regulation even if FDA does not have its own regulation in place.

Let's continue our world tour: Canada requires that manufacturers submit data showing that a product is safe under normal use conditions. Sweden is initiating product registration for cosmetics and Denmark is considering a similar law. Malaysia requires mandatory registration of cosmetics. The list goes on and on, Mr. President, but the point is clear. We are not content to lag behind other countries in protecting our citizens. We prefer to buck the trend and expose them to greater hazards. But as experience has shown, in other countries and in California with Proposition 65, industry can readily comply with meaningful safety standards when they are imposed.

Mr. President, I would urge my colleagues to bear a final point in mind. Unlike food or drugs, cosmetics are not essential to our health. No drug is perfectly safe, but we use them because their benefits are so clear. We need only mention this summer's unprecedented beef recall to illustrate that our food supply is not perfectly safe, but we all must eat. But cosmetics are a different matter. We are not compelled by sickness or necessity to use them. For that reason, we should be far less willing to accept injuries, sickness or deaths from such products. "