STATEMENT OF SENATOR EDWARD M. KENNEDY
FDA REFORM AND COSMETIC PREEMPTION
For Immediate Release
Contact: Jim Manley
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
manufacturersą 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 labelling 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 labelling 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
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'
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
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
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
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.
Edward F. Kennedy