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FDA Compliance

The ‘Teeth’ of FDA’s Food Safety Law

Registration suspensions and mandatory recalls are a couple of the new enforcement options for the FDA

Published: Tuesday, August 16, 2011 - 12:46

The Food Safety Modernization Act (FSMA), signed into law by President Obama in January 2011, has been called “historic” because it puts the focus of the Food and Drug Administration (FDA) on prevention—working to ensure that unsafe foods are not distributed in the first place.

FDA commissioner Margaret A. Hamburg says the law directs the agency to oversee food safety in a way that applies “the best available science and good common sense to prevent the problems that can make people sick.”

What lends the new law additional importance is that it provides the FDA with new enforcement and inspection authorities.

“These new authorities are critical for the law’s success,” says Michael R. Taylor, FDA’s deputy commissioner for foods. “They give the food companies strong additional incentives for keeping their products safe, and that helps us achieve the new law’s goal, which is to protect consumers from unsafe food.”

Food-born outbreaks are a significant public health burden that increases the cost of the nation’s health care, and as Taylor has emphasized, many of them can be prevented. Keeping food-born outbreaks from happening in the first place is what the FDA intends to do by implementing the following key provisions.

Preventive measures

Expanded administrative detention. The law gives the FDA more authority to prevent the release into the marketplace of adulterated or misbranded food, including potentially harmful food.

Food adulteration can be caused by many factors, including bacterial or chemical contamination; filth or decomposition; the presence of an unsafe food additive; being prepared, packed, or held under insanitary conditions; and leaving valuable materials out of the product or substituting other, inferior materials.

Misbranding food can be caused by ways that include not declaring certain ingredients or major food allergens, and not complying with nutrition information content on labeling.

This tool allows the FDA to effectively remove the food from distribution channels while the agency pursues legal or other enforcement actions. 

Records inspection. The law expands the FDA’s authority to gain access to records about potentially hazardous foods. In addition to examining the records tied to a particular food that could pose a health hazard, the agency can now inspect records related to any other food it believes is likely to be affected in a similar manner.

Authority to deny entry. Under the FSMA, if a food producer in another country does not permit the FDA to inspect its facility, the FDA can refuse to allow food from that facility into the United States.

Enforcement measures

The new law also strengthens the FDA’s enforcement tools in the event that potentially unsafe food has already entered the marketplace.

Suspension of registration. The law authorizes the FDA to suspend the registration of a facility under certain circumstances if the food it manufactured, processed, packed, received, or held presents a serious health hazard. A facility with a suspended registration will not be able to legally offer food for sale in the United States until the FDA lifts the suspension.

Mandatory recall. Before the FSMA, the FDA had to rely on a firm’s voluntary decision to remove food from the marketplace that could be hazardous to humans or animals. Under the new law, the agency can order a recall if the company does not cease distribution itself and recall its product. If there is reason to believe that the food is adulterated or misbranded and that use of the product could result in serious illness or death, the FDA can order that distribution to be halted and all implicated products recalled. Additionally, the FDA has launched a new search engine where consumers can quickly and easily check on new and recent recalls.

The FDA is also directed by the law to upgrade its ability to track both domestic and imported foods. To do this, the FDA will establish pilot projects to test how to rapidly identify recipients of food—this is critical information the FDA needs to rapidly find the source of a food-born outbreak and to understand its scope.

“Product tracing doesn’t prevent an outbreak, as it’s more about response,” says Bill Correll at the FDA’s Center for Food Safety and Applied Nutrition. “However, it can prevent further illnesses during an outbreak when the FDA can determine the source, contain further exposure, and get the product recalled and out of distribution and consumer households.”

Positive feedback

The new FDA authorities have been widely acclaimed by consumer advocates as well as industry.

Caroline Smith DeWaal, the veteran food safety director of the Center for Science in the Public Interest, has hailed the FSMA as a far-reaching improvement over previous food safety laws. “The bill contains important provisions for prevention, standard setting, and enhanced enforcement,” she says. “It will significantly reinforce the FDA’s food safety program and help the agency advance in its public health mission.”

Kathy Means, vice president of the Produce Marketing Association, says that members of her organization “regard FSMA as a law that takes a good, comprehensive look at food safety. It sets the expectations for food safety measures by the industry, and it sets the priorities for the FDA—all of which is important for keeping our food safe.”

 


FDA has new authorities to inspect food-producing facilities and enforce
safeguards mandated by the Food Safety Modernization Act (FSMA).

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FDA

The U.S. Food and Drug Administration (FDA) is responsible for protecting the public health by assuring the safety, efficacy, and security of human and veterinary drugs, biological products, medical devices, our nation’s food supply, cosmetics, and products that emit radiation. The FDA is also responsible for advancing the public health by helping to speed innovations that make medicines and foods more effective, safer, and more affordable, and helping the public get the accurate, science-based information they need to use medicines and foods to improve their health.