The easiest way of protecting consumers is to recall the product in question, by either removing it from the market or correcting the problem at its source, the manufacturer or producer.
FDA recalls are almost always voluntary and usually occur when the company itself notices something amiss and recalls the product on its own, or when the federal agency inspects a manufacturing facility and determines the potential for a recall.
There are other times when companies will recall a product, such as when the FDA get reports of health problems through various reporting systems, or when the CDC contacts the agency. In illnesses associated with food products, Dorothy J. Miller, Director of FDA’s Office of Emergency Operations, says that FDA generally first hears of these kinds of problems from CDC.
“CDC hears about such problems from state health departments that have received and submitted illness reports,” she says. “An ongoing outbreak means that we have an emergency, and when there’s a public health crisis like this, you need to tell the public immediately.”
Products that are subject to recall by the FDA
The scope of the FDA’s regulatory authority is very broad and closely related to other government agencies. The list of consumer products governed under the FDA is mind-boggling, and it is no wonder that consumers often can’t figure out exactly which department within the FDA to contact when a problem arises.
However, here’s a list of FDA-regulated products:
1. Foods, including dietary supplements, bottled water, food additives, infant formulas, and other foods.
2. Human and Animal drugs, both prescription and over-the-counter, and medical devices.
3. Biologics, including vaccines, blood products, cellular and gene therapy products and tissue products.
4. Electronic products that give off radiation, such as microwaves, sun lamps, and laser products.
5. Cosmetics, including color additives, nail polish, perfumes, and skin moisturizers.
6. Veterinary products like pet foods, livestock feed, and medications and shampoos.
7. Tobacco products.
Consumers may not realize this, but the Federal Trade Commission (FTC) is a related agency of the FDA and regulates many types of advertising. They are always on the lookout for fraudulent and deceptive ads that make false claims. We have seen this recently in the number of warnings about over-the-counter dietary supplements.
In November 2015, Digital Journal reported on the FDA’s efforts in bringing the dietary supplement industry under compliance with federal guidelines. Investigations by seven federal agencies resulted in the Department of Justice bringing joint civil and criminal actions against more than 100 makers and marketers of potentially dangerous dietary supplements have been unsealed.
FDA Recall Classifications
Digital Journal readers will notice that when a recall announcement is reported on, there will often be a recall classification added. Recalls are categorized into three classes, depending on the hazard level.
Class I recall: This is the highest level recall and means the product is dangerous and could cause serious harm or even death. In a food product, this could mean there is a pathogen, such as Listeria, or there could be undeclared allergens, a label mix-up on a medication, or a defective heart pacemaker.
Class II recall: These products might cause a temporary health problem, but not be life-threatening. An example might be a medication that has less than the needed drug to be effective.
Class III recall: These recalls don’t usually pose a threat to anyone’s health, but they are a violation of the FDA’s labeling or manufacturing laws. Examples could include the lack of label not being printed in English on retail food or a minor defect in packaging.
It should be noted that not all recalls are announced in the media, but they do go into the FDA’s weekly Enforcement Report. However, when the public’s safety is at risk, the recalls, along with any updates are published.
The U.S. Department of Agriculture’s Food Safety and Inspection Service (FSIS) is tasked with the job of regulating the safety and labeling of our meats, poultry, eggs, and seafood products. In Part 2 of this series, we will look at USDA practices and recalls.
