Foods and Cosmetics Safety

The Infant Formula Act
by Food and Drug Administration (FDA)

(Page 3 of 5)

In 1979, a syndrome associated with chloride deficiency was diagnosed in about 130 infants in the United States. Development of the syndrome was associated with prolonged exclusive feeding of two chloride-deficient soy formulas, Neo-Mull-Soy and Cho-Free. In 1978, the manufacturer had reformulated the products by discontinuing the addition of salt (sodium chloride). The resulting products contained an inadequate amount of chloride, an essential nutrient for infant growth and development.

To better protect infants consuming infant formula, Congress amended the FD&C Act by passing the Infant Formula Act of 1980. Under this act, the FDA requires manufacturers to follow quality control procedures, analyze each batch of formula for required nutrients, test samples for stability during the shelf life of the product, code containers identifying each batch, and maintain and make records available to FDA inspectors.

The Nutrition Labeling and Education Act

The Nutrition Labeling and Education Act passed in 1990, required most packaged foods to bear nutrition labeling. Food nutrition information, serving sizes, and terms such as "low fat" and "light" were standardized. The NLEA also provided for health claims.

Health claims, as defined by the NLEA, are statements supported by significant scientific agreement that show a risk reduction relationship between a food or food component and a disease or health-related condition. Examples include folic acid in breakfast cereals (reduction in risk of neural tube defects), fiber in fruits and vegetables (reduction in risk of coronary heart disease), and calcium in dairy products (reduction in risk of osteoporosis). The FDA authorized seven health claims in 1993 as part of the NLEA, and has authorized several more since then. Some examples include calcium and osteoporosis; sodium and hypertension; and fruits, vegetables, and grain products that contain fiber, particularly soluble fiber, and coronary heart disease.

In 1993, the Nutrition Facts panel, which contains basic per-serving nutritional information, was required on foods under the NLEA. "The Nutrition Labeling and Education Act was so significant because it required that food manufacturers give consumers clear and reliable information on everything from calories, fat and sodium to protein and vitamins in a format that was consistent among products and easily understood," says Janice Oliver, the CFSAN's deputy director.

The FDA's regulation of food and its education programs have kept pace with new technology, scientific advances, and the types of foods being offered to consumers, Oliver says. "The agency has continued to use state-of-the-art science and technology to ensure that consumers are given the information they need to prepare healthy, nutritious meals for themselves and their families."

Seafood Hazards

The FDA established the Seafood Hazard Analysis and Critical Control Point Regulations in 1995. The regulations went into effect in December 1997. Based on a system developed by NASA to ensure safe food for astronauts, the HACCP is a science-based approach that requires processors to identify potential hazards that could cause food to be unsafe to eat, establish and monitor targeted critical control points to minimize risks, and keep records of the results.

Before the HACCP, industry relied on the general sanitation requirements of the FDA's Good Manufacturing Practice Regulation and testing of finished products to remain in compliance with FDA requirements. "HACCP is a more effective approach in that it is proactive rather than reactive in preventing hazards from occurring in foods," Oliver says. "The focus is on establishing a plan that identifies steps to be monitored in the process that are critical to assure the safety of foods and to correct any deviation in that step at the time it occurs."

Food Safety Initiative

In 1997, the Clinton Administration proposed a $43 million Food Safety Initiative to strengthen food safety practices and policies and to reduce foodborne illness in the United States. Federal agencies worked together to produce a 50-page report titled "Food Safety From Farm to Table."

The HACCP was the centerpiece of the inspections segment of the initiative. After the Seafood HACCP Regulation, the USDA developed a HACCP program for meat and poultry processing plants in 1998. The FDA established the Juice HACCP Regulations in 2001, and they went into effect in 2003 and 2004.

And in 1999, the FDA established new requirements to improve egg safety to reduce illness associated with Salmonella enteritidis. Both of these rules went into effect in 2000. Also, as part of an effort to improve the safety of imported and domestic fresh produce, the CFSAN and the USDA issued guidelines in 1998 to minimize food safety hazards for fresh fruits and vegetables. This step led to the development of the Good Agricultural Practices and the Good Manufacturing Practices for imported foods.

The Food Safety Initiative also allowed Web sites to update technology and to build a national fingerprinting database of bacterial deoxyribonucleic acid (DNA). This technology gave scientists the tools to see whether the bacteria's DNA "fingerprint" matched that of another patient or food, to identify a common source of infection. This approach speeds up the detective work to determine when an outbreak has occurred so there can be a quicker response.

The initiative also called for FoodNet Web sites to create a more powerful network for detecting, responding to, and preventing foodborne illness. The FDA, the CDC, and the USDA support FoodNet.

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.