May 24, 1999

Dockets Management Branch
Food and Drug Administration
Dept. of Health and Human Services, Room 1-23
12420 Parklawn Dr.
Rockville, MD 20852-1745

RE: DOCKET #99P-1340/CP 1
Petition to have Eternity eau de parfum by Calvin Klein declared misbranded

Dear Sir or Madam:

The FDA Consumer Magazine (9/95) states, "It is against the law to distribute cosmetics that contain poisonous or harmful substances that might injure users under normal conditions." This statement leads most consumers to erroneously trust that these products are safe. The typical American consumer believes that, because these products fall under the jurisdiction of the FDA and are "regulated" by such, they must have been "approved" in order to be allowed on the market for sale to the public. They do not know that, under current law, the FDA does not require pre-market approval nor are the cosmetic manufacturers required to test their products for safety.

Most American consumers do not know that the products not adequately substantiated for safety are required to carry the warning statement: "Warning -- The safety of this product has not been determined" (21 CFR 740.), and that this requirement has been ignored by the entire fragrance industry without any consequences. The absence of such a warning statement on Eternity, as well as any fragrance product, is a violation of the rights and the trust of American consumers.

The escalating "personal" use of fragrance products is widespread and, in my opinion, has become nothing short of an invasive, obtrusive, objectionable, and harmful intrusion -- a silent chemical assault -- into common air space. American consumers have become obsessed with fragrance products, which has led to this silent epidemic of chemical poisoning of our bodies and our environment. The inevitable consequences from this continuous invasion of harmful chemicals will have long-term irreversible effects. The tobacco war is not over -- Many of the same harmful chemicals are permeating our air under the image of innocence and the "protected" name of "fragrance."

No regulations exist to prohibit the use of almost 900 neurotoxic chemical compounds that the National Institute of Occupational Safety and Health found were used in the cosmetic and perfume industries, and consumers are virtually unable to know what they are being exposed to because of the Perfume Manufacturers¼ Trade Secret Protection, preventing them from obtaining pertinent information needed in order to make informed choices.

It is particularly important to enforce the warning-statement requirement on these products, since those of us who query the manufacturer about the safety of their product do not necessarily receive accurate information. The analysis of Eternity¼s ingredients is not consistent with the response that I received from the manufacturer, Calvin Klein, regarding this product¼s safety. As you can see from the enclosed copy of the letter, the manufacturer states they "have well established safety profiles. We formulate with no known carcinogens, neurotoxins or respiratory irritants." The purpose of the warning statement may be to inform consumers, but I believe it would also deter this type of deception.

Such information should be provided to consumers for all such substances intentionally added to consumer products irrespective of their concentration in the product. Some may say "the dose makes the poison," but what is the dose when there are 10 people in one room wearing Eternity or other fragrances with similar chemicals? These products contain volatile ingredients and are designed for maximum effect, which can be quite debilitating when there are several people in a room, each trying to make his or her individual scent "speak" louder than others. Inhaled chemicals can be much more harmful than topical exposures, and all physicians agree that chemical exposures can be harmful to any and all body systems. Currently, these consumers have no way of knowing that they are being exposed to substances that are indeed quite harmful to their health.

Indoor air can be ten times more polluted than outdoor air, and recent studies have demonstrated that fragrance chemicals can significantly contribute to indoor air pollution. Our society readily accepts fragrance chemicals which neurologically promote calming effects and which are regarded as "therapeutic." However, fragrance chemicals which neurologically stimulates violence in the brains of high school students is ignored. Many children are suffering from "sick schools," and yet fragrance chemicals are excluded from EPA considerations because they are "cosmetics."

Fragrances were targeted as one of the six categories of chemicals that should be given high priority for neurotoxicity testing by the National Academy of Sciences. They reported that 95% of the chemicals used in fragrances are derived from petroleum and include such chemicals as benzene derivatives, aldehydes, and other known toxins and sensitizers capable of causing cancer, birth defects, central nervous system disorders, asthma, and allergic reactions.

In view of the escalating incidence of cancer as well as a 58% increase in asthma over the past decade, this information is crucial. Nearly 72% of asthmatics have adverse reactions to perfume, and at least 35 million Americans are afflicted with allergic reactions and hypersensitivity diseases-- among the most costly of US health problems -- according to the National Institute of Health.

Consumers have a right to be informed of carcinogenic and neurotoxic chemicals, reproductive toxins, respiratory irritants, and sensitizing agents added to their products, so that they can make informed choices. Additionally, manufacturers of these products must act responsibly and be held accountable to American consumers for these intentional deceptions regarding the safety of their products.

The time has come to take this issue off the back burner and move it to the forefront of the 21st century. As Einstein said, "The significant problems we have cannot be solved at the same level of thinking with which we created them." The Eternity product is clearly a health hazard, and I urge you to declare it misbranded. Once consumers are informed about these products, most Americans will probably breathe a lot easier.

Sincerely,

Marie Annette

Enclosure:
(1) Copy of letter from Calvin Klein Cosmetics