Who requires safety testing?

The public does! Everyone wants to feel safe knowing products they use on a daily basis are safe and will not cause them, their loved ones, animals, or the environment harm. Therefore, here in the U.S., the Food and Drug Administration (FDA), the Environmental Protection Agency (EPA), the Consumer Product Safety Commission (CPSC), and the Occupational Safety and Health Administration (OSHA) are charged with the responsibility for making sure products on store shelves are safe for American families. Because of these government regulations, the risk of serious injury or death from the use of consumer products on the market today has been minimized.

Food and Drug AdministrationFDA logo

The Food and Drug Administration touches the lives of virtually every American every day. It is the FDA's job to see that the food we eat is safe and wholesome, the cosmetics we use won't hurt us, the medicines and medical devices we use are safe and effective, and that radiation-emitting products such as microwave ovens won't do us harm. Feed and drugs for pets and farm animals also come under FDA scrutiny. FDA also ensures that all of these products are labeled truthfully with the information that people need to use them properly.

The FDA is one of our nation's oldest consumer protection agencies. Its approximately 9,000 employees monitor the manufacture, import, transport, storage and sale of about $1 trillion worth of products each year. It does that at a cost to the taxpayer of about $3 per person.

First and foremost, the FDA is a public health agency, charged with protecting American consumers by enforcing the Federal Food, Drug, and Cosmetic Act and several related public health laws. To carry out this mandate of consumer protection, FDA has some 1,100 investigators and inspectors who cover the country's almost 95,000 FDA-regulated businesses. These employees are located in district and local offices in 157 cities across the country.

Foods

The Center for Food Safety and Applied Nutrition (CFSAN), part of the FDA, is responsible for promoting and protecting the public's health by ensuring that the nation's food supply is safe, sanitary, wholesome, and honestly labeled, and that cosmetic products are safe and properly labeled.

Click me!The Center regulates $240 billion worth of domestic food, $15 billion worth of imported foods, and $15 billion worth of cosmetics sold across state lines. This regulation takes place from the products' point of U.S. entry or processing to their point of sale, with approximately 50,000 food establishments (includes more than 30,000 U.S. food manufacturers and processors and over 20,000 food warehouses) and 3,500 cosmetic firms. These figures do not include the roughly 600,000 restaurants and institutional food service establishments and the 235,000 supermarkets, grocery stores, and other food outlets regulated by state and local authorities that receive guidance, model codes, and other technical assistance from FDA. FDA enhances its programs by supporting state and local authorities with training and guidance to ensure uniform coverage of food establishments and retailers.

Drugs

Click me!The Center for Drug Evaluation and Research (CDER), part of the FDA, has oversight responsibilities for prescription, over-the-counter and generic drugs. CDER's best-known job is to evaluate new drugs before they can be sold. The Center's review of new drug applications not only prevents quackery, but it provides doctors and patients with the information they need to use medicines wisely. The Center makes sure that safe and effective drugs are available to improve the health of consumers. CDER ensures that prescription and over-the-counter drugs, both brand name and generic, work correctly and that the health benefits outweigh known risks.

From aspirin to cancer treatments, CDER ensures that the benefits of drug products outweigh any known risks. This responsibility includes products that many consumers usually do not associate as drugs, such as fluoride toothpaste, dandruff shampoos and sunscreens. CDER carefully evaluates the benefits and risks of drugs and ensures that consumers have access, as quickly as possible, to promising new treatments. The Center oversees the research, development, manufacture and marketing of drugs. CDER ensures truth in advertising for prescription drugs and monitors the use of marketed drugs for unexpected health risks. If unexpected risks are detected after approval, CDER takes action to inform the public, change a drug's label, orif necessaryremove a product from the market.

Cosmetics

Within the FDA, the Center for Food Safety and Applied Nutrition (CFSAN) also oversees the safety and labeling of cosmetic products.

The FDA is only able to regulate cosmetics after products are released to the marketplace. Neither cosmetic products nor cosmetic ingredients are reviewed or approved by the FDA before they are sold to the public.

Although the Food, Drug & Cosmetic Act does not specifically mandate animal testing for cosmetic safety, the FDA strongly urges cosmetic manufacturers to conduct whatever tests are appropriate to establish that their cosmetics are safe. In the United States, manufacturers bear a responsibility to ensure their products are safe for consumer use. In fact, cosmetic products that have not been adequately tested for safety must have warning statement on the front label which reads, "WARNINGThe safety of this product has not been determined."

Unlike drugs, pre-market approval for cosmetics is not required by the FDA. However, if a safety problem with a cosmetic product arises after it's been marketed, the FDA can take action to obtain the manufacturer's safety data on the product. Because there is not yet enough information on alternatives to animal testing to validate their use in ensuring human safety, the FDA at this point will only accept animal safety data.

The FDA continues to work with other governments and private organizations to develop validated alternatives to animal testing in assessing cosmetic safety, and considerable progress has been made in some areas. Nevertheless, until a method has been proven to be reliable and accepted by the scientific community, FDA believes that the use of animals remains necessary to ensure the safety of cosmetic ingredients and products.

Environmental Protection Agency

EPA logoThe Environmental Protection Agency’s (EPA) mission is to protect human health and to safeguard the natural environment — air, water, and land — upon which life depends. For 30 years, EPA has been working for a cleaner, healthier environment for the American people.

The EPA employs 18,000 people in headquarters program offices, 10 regional offices, and 17 labs across the country. EPA employees are highly educated, technically trained, and more than half are engineers, scientists, and environmental protection specialists. A large number of employees are legal, public affairs, financial, and computer specialists. The EPA is led by the administrator who is appointed by the President of the United States.

Consumer Product Safety CommissionCSPC logo

The Consumer Product Safety Commission is an independent federal regulatory agency. This agency was created as part of the 1972 Consumer Product Safety Act that was passed by Congress to protect the public "against unreasonable risks of injuries associated with consumer products." The CPSC works to save lives and keep families safe by reducing the risk of injuries and deaths associated with consumer products. This is done by:

The CPSC doesn't report to nor is it part of any other department or agency in the federal government. The CPSC currently has about 480 employees who are responsible for monitoring the safety of over 15,000 kinds of consumer products, from automatic-drip coffee makers to toys to lawn mowers.

Occupational Safety and Health Administration

OSHA logoThe Occupational Safety and Health Administration (OSHA), is responsible for regulating safety in America’s workplaces. To accomplish this, OSHA works in partnership with the more than 100 million working men and women and their six and a half million employers who are covered by the Occupational Safety and Health Act of 1970. Since the agency was created in 1971, workplace fatalities have been cut in half and occupational injury and illness rates have declined 40 percent.

OSHA began Fiscal Year 2003 with a staff of 2,303, including 1,123 inspectors. The agency's budget request is $454 million. This staff establishes protective standards, enforces those standards, and reaches out to employers and employees through technical assistance and consultation programs.

 

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