Regulation
Fragrance is an international commodity. The USA, Western Europe, and Japan are the major consumers of fragrance materials. Regulation in these areas and Canada are summarized.
USA
Regulation of fragrance is fragmented at best. There is no one agency that
is responsible for the regulation of scented products. While there are some pertinent
regulation in place, there is little monitoring and even less enforcement of these
regulations.
FDA
The FDA regulates scented products that are considered cosmetics.
The Food, Drug, and Cosmetic Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance without affecting the body's structure or functions. (FDA Cosmetic Labeling Manuel October 1991)
Cosmetics are not required to be safety tested before marketing. If the safety has not been substantiated, a warning label is required.
"It is the responsibility of the manufacturer and distributor to assure the safety of each ingredient and finished product. Without substantiation of safety, Title 21 of the Code of Federal Regulations (21 CFR), Part 740.10 requires that the product carry the following warning on the label:"
"Warning: The safety of this product has not been
determined."
FDA:
Prohibited Ingredients and Related Safety Issues
The FDA has not established what constitutes safety, but it is generally accepted by both the FDA and industry that products should be safe for the intended purpose and any incidental contact that may occur with that use. The primary purposes of fragrance are to impart a scent to a product, mask the odor of other ingredients, or in some cases alter mood. In using these products there is exposure to the skin, upper airways, olfactory pathways to the brain, and the lungs. These routes also provide entry points into the body.
The major focus of the fragrance industry has been on skin effects. There is little available health and safety data on respiratory, neurological, or systemic effects. Most chemical data on fragrance materials clearly state they have not been fully tested. There are no warnings on labels stating:
"Warning: The safety of this product has not been determined."
A petition was filed by the Environmental Health Network of California in May of 1999, asking that the fragrance "Eternity" by Calvin Klein be declared misbranded because it contained materials in which the safety had not been substantiated and did not carry the required warning label.
Over a 1200 comments have been sent in support of the petition, yet the FDA has not taken any action. The reason for lack of action cited by the FDA is not the petition lacks merit, but rather that fragrances are not a priority.
A few materials are prohibited by law. A few others have voluntary restrictions in place by the industry. Other than these materials, any material may be used in a fragrance formula. The specific ingredients in the formula do not have to be revealed, only the word "fragrance" must appear on the label.
Further fragrance materials used to cover or mask the odor of other ingredients may not be listed at all. Many companies do list them as "masking fragrance" in the list of ingredients. Yet these same products may be labeled as "unscented" or "fragrance free".
One such product is Vaseline Intensive Care brand lotion, Advanced Healing made by Unilever. This product has "FRAGRANCE FREE" clearly stated on the front label. On the back of the product, it states: "The fragrance-free, hypo-allergenic formula is ideal for sensitive skin." Yet this product contains masking fragrance and does not list it in the list of ingredients.
The FDA was informed after a fragrance sensitive consumer used the product and suffered an asthma attack and no action was taken. The FDA acknowledged that masking fragrance can be problematic for consumers that are severely sensitive to fragrance. (Private communication with FDA Office of Cosmetics and Colors)