Foods and Cosmetics Safety

Trans Fats
by Food and Drug Administration (FDA)

(Page 5 of 5)

To help consumers choose heart-healthy foods, the FDA announced in 2003 that food labels would have to include the amount of trans fat content. This is the first substantive change to the Nutrition Facts panel on foods since 1993, when nutrition labeling became mandatory. The requirement for listing trans fat takes effect in January 2006.

Trans fat is made when manufacturers add hydrogen to vegetable oil, a process called hydrogenation. Trans fat can be found in vegetable shortenings, some margarines, crackers, cookies, snack foods, and other foods made with or fried in partially hydrogenated oils. This process increases the shelf life and flavor stability of foods that contain these fats. Like saturated fat and dietary cholesterol, trans fat raises the risk of heart disease.

"This is an important change because the health of all consumers depends heavily on what we eat on a daily basis over a lifetime," Oliver says.

What's Ahead?

Prompted by a rising obesity rate, the FDA formed an Obesity Working Group in 2003. The working group developed an action plan to deal with the nation's obesity epidemic from the FDA's perspective. In March 2004, the group released "Calories Count: Report of the Obesity Working Group."

"Obesity will be a focus of the future because of the alarming number of adults and children in the United States who are overweight or obese, and because these are associated with increased risk of serious illness and death," Oliver says. "We will be looking at ways to both enhance the food label and improve our consumer education efforts in this area."

The FDA also worked with other Department of Health and Human Services agencies and the USDA to release the Dietary Guidelines for Americans in 2005. These guidelines are the government's science-based advice to help Americans choose diets that will meet nutrient requirements, promote health, support active lives, and reduce risks of chronic disease.

Another key area for the future is food allergens. The Food Allergen Labeling and Consumer Protection Act, passed in 2004, requires protein source labeling of any food that is or contains an ingredient that is a major food allergen. The major food allergens are peanuts; soybeans; cow's milk; eggs; fish; crustacean shellfish, such as shrimp and crabs; tree nuts; and wheat or ingredients that contain protein derived from these foods. Major food allergens account for the vast majority of food allergies in the United States.

"The labeling requirements of this act take effect beginning January 1, 2006," Brackett says. "The act requires that foods containing one or more of the major food allergens be labeled to disclose the allergen. Each year roughly 30,000 persons require emergency room treatment and 150 die because of allergic reactions to food."

The dynamic of the food supply has changed considerably in the last century, Brackett says. "Americans get food from all over the world and eat more food prepared outside the home." For this reason, the FDA encourages consumers to take proper safety precautions, such as keeping hands and surfaces clean and cooking food to proper temperatures.

"There are so many messages in the media that it can be hard for consumers to know what matters," he says. "As we face the increasing globalization of the food supply, we will keep reaching out to the public. We want to stay in touch with their interests and give them the information they need to stay healthy."

Cosmetics

The regulatory requirements governing the sale of cosmetics are different from those that apply to most other FDA-regulated products. Under the Federal Food, Drug, and Cosmetic Act cosmetics and their ingredients, with the exception of color additives that are not coal-tar hair dyes, are not required to undergo approval by the FDA before they are marketed in products sold to the public. The FDA generally regulates these products after they have been released in the marketplace.

Manufacturers may use any ingredient or raw material, except for color additives (other than coal-tar hair dyes) and a few prohibited substances, to market a product without a government review or approval. Cosmetic firms are to ensure that the products they market are safe as used and properly labeled. Under the FD&C Act, it is prohibited to market an adulterated or misbranded cosmetic in interstate commerce. The agency can take regulatory action if it has information to support that a cosmetic is adulterated or misbranded. The FDA also works with the U.S. Customs Service and Border Protection to monitor imported cosmetics.

The FD&C Act defines cosmetics as articles intended to be applied to the human body for cleansing, beautifying, promoting attractiveness, or altering the appearance, including the components of such articles. Examples are perfumes, lipsticks, makeup, and hair dyes. Under the law, the term "cosmetic" includes both finished products and ingredients. If a product's intended use is to cure or prevent disease, or to affect the structure or function of the body, however, it may be a drug under the law. Some products are both drugs and cosmetics. For example, a dandruff treatment is a drug. A shampoo to clean and beautify hair is a cosmetic. An anti-dandruff shampoo is both a drug and a cosmetic. Products that are labeled to contain a sunscreen for sun protection are regulated as over-the-counter drugs. Cosmetic products marketed with sun-protection claims are regulated as both drugs and cosmetics.

The FDA has taken a number of advisory and judicial actions against adulterated and misbranded cosmetics and drug products marketed as cosmetics. These include the "wrinkle remover" court cases of the 1960s and a series of Warning Letters from the 1980s to the present concerning drug claims on cosmetic products.

Another important law pertaining to cosmetics is the Fair Packaging and Labeling Act. Under authority of the FPLA, the FDA requires an ingredient declaration on every cosmetic product offered for sale to consumers. Ingredients also must be listed in descending order of quantity.

In the 1970s, the FDA established the Voluntary Cosmetic Registration Program, through which firms may register their establishments and file cosmetic product formulations. The VCRP provides the FDA with important information about cosmetic products and ingredients on the market in the United States.

The FDA has published a number of regulations and guidance documents specifying warning statements required for certain cosmetics, as well as requirements for the way in which required information must be displayed on cosmetic labels. Most recently, a "Sunburn Alert" was published for cosmetic products that contain alpha hydroxy acids, ingredients that may be found in anti-wrinkle products.

Scientists at the CFSAN's Office of Cosmetics and Colors continue to keep abreast of new ingredients and safety concerns. For example, current research at the OCAC includes cosmetic applications of nanotechnology and its implications for cosmetic safety.

About the Author

www.fda.gov
FDA is A United States government body that oversees medical devices, including contact lenses, intraocular lenses, excimer lasers and eyedrops. In the US, these products must be approved by the FDA before they can be marketed.