Foods and Cosmetics Safety

Dietary Supplements, Genetically Engineered Foods
by Food and Drug Administration (FDA)

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The FDA is also the principal federal agency responsible for regulatory oversight of the safety and labeling of dietary supplements. The Dietary Supplement Health and Education Act passed in 1994, establishes specific labeling requirements, provides a regulatory framework, and authorizes the FDA to establish current GMP regulations for dietary supplements. The DSHEA defines "dietary supplements" and "dietary ingredients" and classifies them as food.

Unlike new drugs, dietary supplements are regulated like foods. They don't have to go through review by the FDA for safety or effectiveness or be approved before they can be marketed. But manufacturers must provide pre-market notice and evidence of safety for any supplements they plan to sell that contain certain dietary ingredients that were not in the market before the DSHEA.

In 2000, the FDA published a rule on dietary supplements that defined the type of labeling claim that can be made on product labels regarding the effect of supplements on the structure or function of the body. In 2003, the FDA published a proposed rule for current GMP requirements for dietary supplements to prevent mistakes with ingredients, the presence of contaminants, mislabeling, and improper packaging.

"At the core of DSHEA enforcement efforts is our commitment to work with industry to encourage the legitimate manufacture, sale and use of supplements while enforcing the law aggressively against fraudulent product claims and other illegal practices," Brackett says.

For example, in 2004, the FDA banned dietary supplements containing ephedra, a naturally occurring substance found in plants, because of concern over their cardiovascular effects.

Genetically Engineered Foods

Genetically engineered foods are produced from crops whose genetic makeup has been altered through a process called recombinant DNA technology, or gene splicing, to give the plant a desirable trait.

The USDA makes sure the plants do not have an adverse effect on the agricultural environment; the Environmental Protection Agency ensures that pesticides introduced into the plants are safe for human and animal consumption and for the environment; and the FDA ensures that foods made from the plants are safe to eat.

The FDA first published guidelines for genetically engineered foods in 1992. The first genetically engineered whole product was a tomato, and it went on the market in 1994. Since then, FDA has evaluated data on more than 65 other genetically engineered foods demonstrating that they are as safe as their conventional counterparts.

The CFSAN's Adverse Event Reporting System

The CFSAN launched CAERS in 2003 to centrally help track and monitor adverse events. The CFSAN's scientists have developed rapid methods to detect microbial and viral food contaminants, and the FDA works with public and private sector partners to complete and operate two nationwide high-tech systems for rapid identification and control of outbreaks of foodborne disease.

Fighting Terrorism

After the terrorist attacks on Sept. 11, 2001, the FDA conducted food supply vulnerability assessments, and received additional resources for strengthening its field staff of food inspectors and lab specialists. The agency has also worked closely with the CDC and the USDA to establish the Food Emergency Response Network, a national network of laboratories ready to respond to a food security emergency.

Under the authority of the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, signed by President George W. Bush in June 2002, the FDA developed four new regulations that address provisions of the law. They require food facilities to register with the FDA, to receive prior notice of imported food shipments before food arrives in the United States, and for people who receive and distribute food to keep records of their food sources and recipients. The fourth regulation establishes procedures for the FDA to detain any food for up to 30 days for which there is credible evidence or information that the food poses a threat of serious adverse health consequences or death to humans or animals.

"The possibility of food products being used as a vehicle for an attack is particularly worrisome because such an event potentially affects everyone in the United States," Brackett says. "FDA has made great strides in implementing the food-related provisions of the Bioterrorism Act. The law improves the agency's ability to prevent, prepare for, and respond to bioterrorism and other public health emergencies that affect the U.S. food supply."

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.