While most of America took at least a little time off this summer, there is no vacation break for governmental agencies such as the U.S. Food & Drug Administration (FDA), United States Department of Agriculture (USDA), and the Centers for Disease Control and Prevention (CDC) and their roles as watchdogs for the consumer.
While the Boar’s Head Listeria outbreak gathered much attention this summer – by the end of August it was reported that 9 people had died, and 57 had been hospitalized across 18 states – there are recalls, market withdrawals, and safety alerts issued almost daily.
Let’s take a closer look at recalls and the roles that the three agencies play.
Overlapping Roles in Consumer Protection: FDA, USDA, and CDC
While the FDA, USDA, and CDC have distinct primary responsibilities, their roles can sometimes overlap when it comes to protecting consumers from harmful products. Here's a breakdown of their jurisdictions and roles:
FDA (Food and Drug Administration)
- Jurisdiction: Foods, drugs, medical devices, cosmetics, and tobacco products.
- Recalls: The FDA is primarily responsible for recalls involving products within its jurisdiction. This includes food, drugs, medical devices, and certain cosmetics.
USDA (United States Department of Agriculture)
- Jurisdiction: Meat, poultry, and eggs.
- Recalls: The USDA's Food Safety and Inspection Service (FSIS) is responsible for recalls involving meat, poultry, and eggs.
CDC (Centers for Disease Control and Prevention)
- Jurisdiction: Public health and disease prevention.
- Recalls: While the CDC doesn't directly initiate recalls, it plays a vital role in investigating outbreaks of foodborne illness and other health hazards. If the CDC identifies a link between a product and an outbreak, it may work with the FDA or USDA to initiate a recall.
Overlapping Roles
- Multi-agency recalls: In some cases, a recall may involve products from multiple agencies. For example, if a food product contains both meat and a drug, both the USDA and FDA may be involved.
- Joint investigations: The FDA, USDA, and CDC often work together to investigate outbreaks of foodborne illness or other health hazards. This collaboration helps to identify the source of the problem and determine whether a recall is necessary.
In summary, while the FDA, USDA, and CDC have distinct primary responsibilities, their roles can overlap when it comes to protecting consumers from harmful products.
The FDA is primarily responsible for recalls involving food, drugs, medical devices, and certain cosmetics, while the USDA is responsible for recalls involving meat, poultry, and eggs. The CDC plays a vital role in investigating outbreaks of foodborne illness and other health hazards and may work with the FDA or USDA to initiate recalls.
Understanding the Different Classes of Recalls
Both the FDA and USDA use the same three-class recall system – a standardized way to classify recalls based on the severity of the health risk posed by the product.
“Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority,” explains the FDA.
The three-class recall system, as well as definitions for market withdrawals and medical device safety alerts:
- Class I Recall: A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
- Class II Recall: A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
- Class III Recall: A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
- Market Withdrawal: Occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal.
- Medical Device Safety Alert: Issued in situations where a medical device may present an unreasonable risk of substantial harm. In some cases, these situations also are considered recalls.
The FDA and USDA Role in Mandatory Recalls
There are times when a voluntary market withdrawal or safety alert are not enough to protect the public – in these cases the FDA or USDA will issue mandatory recalls.
Mandatory recalls are issued when a product poses a significant risk to public health or safety. These recalls are not voluntary actions by the manufacturer but rather are legally required by regulatory agencies like the FDA and USDA.
How a mandatory recall works:
- Who Issues the Recall: The FDA will issue mandatory recalls for foods, drugs, medical devices, and tobacco products; the USDA will issue mandatory recalls for meat, poultry, and eggs.
- Reasons for Mandatory Recalls: Mandatory recalls are typically issued when:
- There's a reasonable probability of serious adverse health consequences or death.
- The product is defective or contaminated in a way that poses a significant health risk.
- Consequences of Non-Compliance: If a manufacturer fails to comply with a mandatory recall, they may face severe penalties, including:
- Fines.
- Seizure of products.
- Criminal prosecution.
What Happens When a Mandatory Recall is Issued
Here are the typical steps when a mandatory recall is issued by the FDA or USDA:
- Public Notification: The FDA or USDA will issue a public announcement about the recall, providing details about the affected products, the reasons for the recall, and what consumers should do.
- Product Removal: Manufacturers are required to immediately stop the production and distribution of the recalled product.
- Consumer Notification: Manufacturers may be required to notify consumers who have purchased the product. This can be done through various channels, such as mail, email, or public announcements.
- Product Return or Disposal: Consumers may be instructed to return the recalled product to the place of purchase for a refund or replacement, or to dispose of it according to specific guidelines.
In summary, mandatory recalls are a serious matter, and both the FDA and USDA have the authority to enforce them to protect public health. Non-compliance with a mandatory recall can have severe consequences for manufacturers.
While You Were Away … The Latest Recalls, Market Withdrawals and Safety Alerts
As we said up top, there is no time for consumer watchdogs to rest. Here are the latest recalls, market withdrawals and safety alerts in recent weeks:
- Gilead: Veklury (remdesivir) for Injection: Drug recalled due to presence of glass particles.
- ANSWERS: Beef and Chicken Dog Foods: Pet food recalled due to potential salmonella and listeria.
- Bacalaitos Criollos: Codfish Frying Mix: Food recalled due to potential or undeclared allergen (fish).
- Lactaid: Lactaid 96 oz milk carton varieties: Food recalled due to potential or undeclared allergen (tree nuts – almond).
- a-1 On the Go: Kara Boondhi, Kerala Mixtures, and Spicy Murukku snack products: Food recalled due to potential or undeclared allergen (wheat).
- Vail-Bon: Vail-Bon Jie Yang Wan: Dietary supplement recalled due to product tainted with dexamethasone and chlorpheniramine.
- dynacare: Baby Power: Cosmetic recalled due to potential metal or chemical contaminants.
- Enjoy Premium: Coconut and Taro Cookies: Food recalled due to undeclared milk allergen.
- BionPharma: Atovaquone Oral Suspension 750 mg/ml: Drug recalled due to product found to be contaminated with Cohnella bacteria.
- 7-Eleven: Fudge Brownie: Food recalled due to undeclared walnuts.
- Hammond’s: Dark Chocolate Filled Mini Waffle Cones: Food recalled due to undeclared milk.
- Kandy: Whole Cantaloupe: Food recalled due to potential to be contaminated with Salmonella.
- Milo’s Poultry Farms & Tony’s Fresh Market: Eggs: Food recalled due to potential to be contaminated with Salmonella.
- Niitakaya: Shiso Katsuo Ninniku & Miso Katsuo Ninniku: Food recalled due to undeclared fish (bonito).
- Aslie Fine Foods: Cinnamon powder: Food recalled due to containing lead.
