FDA CDC News

FDA Files Civil Money Penalty Complaints Against Four E-Cigarette Product Manufacturers

Published

2 years ago

February 22, 2023

Daily News Staff

Action Is the First of its Kind Against Manufacturers Violating the Law

Today, the U.S. Food and Drug Administration announced it has filed civil money penalty (CMP) complaints against four tobacco product manufacturers for manufacturing and selling e-liquids without marketing authorization. This is the first time the FDA has filed CMP complaints against tobacco product manufacturers to enforce the Federal Food, Drug, and Cosmetic (FD&C) Act’s premarket review requirements for new tobacco products.

It is illegal to manufacture, sell, or distribute e-liquids that the FDA has not authorized. The FDA previously warned each of the companies that, by making and selling their e-liquids without marketing authorization from the FDA, they were in violation of the FDA’s premarket requirements for tobacco products and that failure to correct these violations could lead to an enforcement action, such as a CMP. Despite the agency’s warning, these companies continue to make and sell their unauthorized e-liquids to consumers.

“Holding manufacturers accountable for making or selling illegal tobacco products is a top priority for the FDA,” said Brian King, Ph.D., M.P.H., director of the FDA’s Center for Tobacco Products. “We are prepared to use the full scope of our authorities to enforce the law—especially against those who have continued to violate the law after being warned by the agency.”

As of Feb. 21, the FDA has filed CMP complaints against the following four manufacturers:

BAM Group LLC doing business as VapEscape
Great American Vapes LLC doing business as Great American Vapes
The Vapor Corner Inc. doing business as Vapor Corner Inc., The Vapor Corner, and Vapor Corner
13 Vapor Co. LLC doing business as 13 Vapor

Currently, under the FD&C Act, the maximum CMP amount is $19,192 for a single violation relating to tobacco products. The FDA typically seeks the statutory maximum allowed by law and is doing so in these four cases. The companies the FDA has filed CMP complaints against can pay the penalty, enter into a settlement agreement, request an extension of time to file an answer to the complaint, or file an answer and request a hearing. Companies that do not take action within 30 days after receiving the complaint risk a default order imposing the full penalty amount.

“These latest enforcement activities are part of a comprehensive approach to actively identify violations and to deter illegal conduct,” said Dr. King. “These actions should be a wakeup call that all tobacco product manufacturers—big or small—are required to obey the law.”

All new tobacco products, including all e-cigarettes, on the market without the statutorily required premarket authorization are marketed illegally and are subject to FDA enforcement action. The FDA closely monitors manufacturer compliance with the law and may take action when violations occur. Between Jan. 2021 through Feb. 17, 2023, the FDA has issued more than 550 warning letters to firms—both large and small—for manufacturing, selling, and/or distributing new tobacco products without marketing authorization from the FDA. After receiving warning letters, a majority of these companies have complied and removed their products from the market. Manufacturers that continue to violate the law risk subsequent enforcement. In addition to CMPs, the agency also has authority to take other enforcement action, as appropriate, including seizures, injunctions, and criminal prosecutions.

Manufacturers must submit a marketing application to the FDA and receive authorization to legally sell a new tobacco product in the United States. The FDA encourages manufacturers to learn more about the three pathways to submit an application for new tobacco products.

Related Information

Source: FDA

Author

Daily News Staff

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Major Ice Cream Recall: Wells Enterprises Pulls Thousands of Products Nationwide

Published

3 days ago

May 18, 2025

Rod Washington

scooping chocolate ice cream

Wells Enterprises, Inc., America’s largest privately held, family-owned ice cream manufacturer, has initiated a nationwide voluntary recall affecting more than 50,000 gallons of ice cream and frozen yogurt products due to potential plastic contamination.

Key Recall Details

Affected Products: Nearly 18,000 three-gallon containers across 22 varieties

Popular Brands Involved: Blue Bunny, Halo Top, and other Wells Enterprises products

Distribution: Products shipped to 103 distribution centers nationwide

Best-By Dates: March through October 2026

Recall Classification: FDA Class II recall

Consumer Safety Alert

The company took immediate action after discovering the possibility of foreign material (plastic) in select products. While no injuries have been reported, consumers are urged to:

Check product codes against the recall list

Stop using affected products immediately

Return items to the place of purchase for a full refund

Contact Wells Enterprises customer service with questions

Affected Product Information

The recall specifically impacts 3-gallon bulk containers of various ice cream and frozen yogurt flavors. Wells Enterprises, known for producing popular brands including Blue Bunny, Halo Top Creamery, and The Cheesecake Factory At Home ice cream products, initiated the voluntary recall on April 25, 2025.

For More Information

Consumers can visit the FDA’s official website or follow STM Daily News’ Food and Drink section for the latest updates on this recall and other food safety alerts.

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Coca-Cola Recall Alert: Thousands of Cans Pulled From Shelves in Two States

Published

2 months ago

March 27, 2025

Hal Machina

selective focus photography of red coca-cola can lot on box — Photo by Craig Adderley on Pexels.com

In a significant recall notification, Coca-Cola has announced the withdrawal of over 10,000 cans of its popular beverage due to concerns over foreign object contamination. This announcement was initially made on March 6, and affected cans were sold in the states of Illinois and Wisconsin.

This week, the U.S. Food and Drug Administration (FDA) classified the risk level of this recall as Class 2. This designation indicates that consuming the affected Coca-Cola “may cause temporary or medically reversible adverse health consequences,” although the chances of serious health consequences are deemed to be remote.

Which Coca-Cola Products Were Recalled?

The recall impacts a total of 864 packs of 12 cans of Coca-Cola, amounting to 10,368 cans in total. The specific details of the recalled products are as follows:

Product Description: Coca-Cola Original Taste, 12 Fl Oz
Can UPC: 0 49000-00634 6
12-Can Pack UPC: 0 49000-02890 4
Date Code: SEP2925MDA
Time Stamp: 1100-1253

Which States Are Affected?

The recall specifically concerns Coca-Cola cans distributed in the following states:

Illinois
Wisconsin

Why Were the Coca-Cola Cans Recalled?

The FDA has reported that these Coca-Cola cans were recalled due to contamination with a foreign object, in this case, plastic. Such contaminants can inadvertently enter food and beverage products at various stages during the production process, posing a safety risk if ingested. It is important to note that the FDA report did not indicate any associated injuries related to this specific recall

If you have purchased Coca-Cola cans with the above UPC codes in Illinois or Wisconsin, it is recommended that you refrain from consuming the affected products. Instead, please return them to the store where you purchased them for a full refund or exchange. Staying informed about product recalls is crucial to consumer safety, and it is always advisable to check for the latest updates from the FDA and Coca-Cola regarding product safety issues. For any additional questions, feel free to reach out to Coca-Cola directly or visit the FDA’s website. Stay safe!

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FDA CDC News

Alert: Kroger Issues Food Recalls Affecting Multiple States

Published

3 months ago

February 7, 2025

Hal Machina

Senior woman with tablet computer in the store.

As of early February 2025, Kroger has announced a series of food recalls affecting customers across at least 15 states, as well as several subsidiary stores nationwide. The recalls, initiated due to safety concerns, include a variety of products that consumers should be aware of.

Twelve Hummus Tubs from King Harvest

Kroger subsidiary stores Fred Meyer and QFC, located in Alaska, Idaho, Oregon, and Washington, have recalled the following King Harvest hummus tubs, each weighing 10 oz:

King Harvest Lemon Hummus
King Harvest Classic Hummus
King Harvest Roasted Garlic Hummus
King Harvest Toasted Onion Hummus
King Harvest Chipotle Hummus
King Harvest Spinach Hummus
King Harvest Black Olive Hummus
King Harvest Sesame Hummus
King Harvest Jalapeño Hummus
King Harvest Balsamic Hummus
King Harvest Sun Dried Tomato Hummus
King Harvest Roasted Pepper Hummus

These products were recalled on February 5, 2025, due to a defect in their plastic tubs that may lead to the presence of plastic foreign objects within the containers. Kroger has advised customers, “Customers who purchased any of the item(s) below should not eat the product.” It remains unclear whether this recall is connected to a previous incident from September 2024 involving similar concerns.

DJs Boudain Products in Texas and Louisiana

Kroger stores in Texas and Louisiana have also issued a recall for the following DJs Boudain products:

DJs Boudain Hot Jalapeño Boudain, 12 oz
DJs Boudain Boudain Sausage, 24 oz
DJs Boudain Boudain Sausage, 16 oz

These items were recalled on February 1, 2025, due to potential contamination with pieces of a pen. This recall is part of a broader action directed by the U.S. Department of Agriculture (USDA), which called for around 17,720 pounds of boudain sausage link products to be removed from stores across Louisiana, Mississippi, and Texas.

Gerber Products for Teething Children

In addition, two Gerber products intended for teething children were recalled from Kroger stores across multiple states, including Ohio, Virginia, Michigan, Indiana, Illinois, Missouri, Kentucky, Tennessee, Alabama, North Carolina, West Virginia, Texas, and Louisiana. The affected products are:

Gerber Soothe N Chew Teething Sticks Banana, 3.2 oz
Gerber Soothe N Chew Teething Sticks Strawberry Apple, 3.2 oz

These products were removed from shelves due to potential choking hazards. Kroger has assured customers that those who purchased these items can return them for a full refund. This recall is part of a nationwide action announced by the Food and Drug Administration (FDA). Gerber has expressed regret over the situation, stating, “The recall was initiated after receiving consumer complaints of choking incidents. To date, one emergency room visit has been reported to the firm…We sincerely apologize for any concern or inconvenience this action represents to parents, caregivers, and retail customers.”

Conclusion

Customers who have purchased any of the recalled products are urged to refrain from consuming them and to return the items for a refund. It is always advisable to stay informed about food recalls to ensure the safety of you and your family. For more updates on recalls and food safety, keep an eye on announcements from Kroger and the relevant health authorities. Stay safe!

Read the article in Newsweek: https://www.newsweek.com/kroger-food-recalls-issued-15-states-full-list-products-impacted-2027160

https://stmdailynews.com/

Author

Hal Machina

Hal Machina is a passionate writer, blogger, and self-proclaimed journalist who explores the intersection of science, tech, and futurism. Join him on a journey into innovative ideas and groundbreaking discoveries! View all posts journalist