FDA Warns of Nicotine Candy as Public Health Crisis

Aug.19.2022
FDA Warns of Nicotine Candy as Public Health Crisis
The FDA has issued a warning to Krave Nic, a Florida-based candy maker, to remove their nicotine candy from the market.

The FDA has declared it a "public health crisis waiting to happen" and has issued a warning to a Florida manufacturer to pull its nicotine-laced gummies off the market. The incident is notable because few people were aware of the product's existence prior to the FDA's announcement, including news releases, Twitter posts and social media attaboy posts from tobacco control organizations such as Truth Initiative. Gregory Conley, president of the American Vaping Association, tweeted, "The FDA has just cancelled a product used by 23 Americans on a regular basis." "The long, legendary history of tobacco control has been to distract attention with shiny new objects while cigarettes continue to be sold.


Krave Nic, a soft candy manufacturer based in Florida, has been cited by the FDA for selling candy containing synthetic nicotine without submitting a premarket tobacco application (PMTA) or obtaining marketing authorization from the agency. Earlier this year, the FDA received authorization over synthetic nicotine, and since July 14th, selling any products with synthetic nicotine without authorization is technically illegal. The warning letter includes a comprehensive press release from the FDA's Center for Tobacco Products, featuring quotes from FDA Commissioner Robert Califf and CTP Director Brian King, suggesting that nicotine candy may pose a serious public health threat.


We remain firmly committed to using regulatory and law enforcement resources to curb all illegal marketing of tobacco products, especially those that are easily confused with items consumed frequently by young people, such as candy," said Gold. According to the FDA, Krave's nicotine gum (which contains 1 milligram of nicotine per box, with 12 pieces per box) poses a significant risk to children. "Studies have shown that ingestion of 1 to 4 milligrams of nicotine, depending on the child's weight, can cause severe toxicity in children under six," the press release said. "However, nicotine poisoning in young people of any age can lead to nausea, vomiting, stomach pain, increased blood pressure and heart rate, seizures, respiratory failure, coma and even death.


The FDA has approved nicotine gum and lozenges that are produced by pharmaceutical companies and sold over-the-counter. These products contain more nicotine than Krave gum and have appealing flavors. They are sold in large quantities and available in tens of thousands of stores nationwide. "Nicotine gum is a public health crisis waiting to happen among our young people, especially as we enter a new school year," said Califf. "We want parents to understand these products and the potential health consequences for children of all ages, including the toxicity to toddlers and the allure of these addictive products to our young people. When illicit products enter the market, the FDA will not sit idly by.


This statement is a prime example of an institution that goes too far in its efforts to be correct, losing all sense of purpose and proportionality, and now flailing in the shadows. As we have explained, when faced with external pressure, the FDA often attacks insignificant threats with absurd ferocity.


Today's action should serve as a wake-up call to the manufacturers of these illegal products, and the FDA is actively working to investigate any wrongdoing and seek corrective measures," said CTP Director King. The warning letter gives Krave Nic 15 working days to respond, "describing the actions taken to address any violations and bring your products into compliance." According to Krave's website, this should not be difficult as these products have already been discontinued. It is unclear at this time whether these gummies were eliminated due to the FDA's letter or a lack of retail interest.


Statement


This article is compiled from third-party information and is intended solely for industry exchange and learning.


This article does not represent the views of 2FIRSTS, and 2FIRSTS cannot confirm the authenticity and accuracy of the content. The translation of this article is only intended for industry communication and research purposes.


Due to limitations in our translating ability, the translated article may not fully express the same meaning as the original text. Therefore, please refer to the original text for accuracy.


In regards to any domestic, Hong Kong, Macau, Taiwan, or foreign-related statements and positions, 2FIRSTS maintains complete alignment with the Chinese government.


The compilation of information is owned by the original media and authors. If there is any infringement, please contact us for deletion.


This document has been generated through artificial intelligence translation and is provided solely for the purposes of industry discourse and learning. Please note that the intellectual property rights of the content belong to the original media source or author. Owing to certain limitations in the translation process, there may be discrepancies between the translated text and the original content. We recommend referring to the original source for complete accuracy. In case of any inaccuracies, we invite you to reach out to us with corrections. If you believe any content has infringed upon your rights, please contact us immediately for its removal.

Central Asia Anti-Vaping Campaign Gains Momentum
Central Asia Anti-Vaping Campaign Gains Momentum
Kazakhstan's 2024 e-cigarette ban spawned a black market. Despite fines up to 18.4 million tenge and imprisonment, illegal sales continue via encrypted apps. It hiked prices, pushed some to traditional cigs. Critics and supporters have opposing views, and other Central Asian nations face similar issues.
May.12
Lower Saxony State in Germany Expands Smoking Ban to E-Cigarettes
Lower Saxony State in Germany Expands Smoking Ban to E-Cigarettes
The state parliament of Lower Saxony, Germany, has passed a new law extending existing public smoking bans to include e-cigarettes and cannabis vaporizers. The legislation was introduced by the Social Democrats and Greens, with support from the Christian Democrats.
May.21 by 2FIRSTS.ai
Cambodia’s E-Cigarette Ban Extends to Foreign Investment—Is China or Vietnam Involved?
Cambodia’s E-Cigarette Ban Extends to Foreign Investment—Is China or Vietnam Involved?
In April 2025, Cambodian Prime Minister Hun Manet publicly rejected an investment application for an e-cigarette factory from an unnamed country, which has drawn widespread international attention. Has China, Vietnam, or some other third country already begun industrial layout in Cambodia?
May.07 by 2FIRSTS.ai
Photo Gallery| FEELM, Alfakher, RELX, and Many Other Brands Launch Transparent Oil Tank Products
Photo Gallery| FEELM, Alfakher, RELX, and Many Other Brands Launch Transparent Oil Tank Products
2Firsts conducted an in-depth visit to the exhibition hall and observed on-site that many brands, including FEELM, Alfakher, and RELX, have launched transparent oil tank products.
Jun.18
Australia's New Vaping Law Leads to the Collapse of the Legal Market and a Surge in Black - market Transactions
Australia's New Vaping Law Leads to the Collapse of the Legal Market and a Surge in Black - market Transactions
Australia’s new vaping law has led to the collapse of the legal market and a surge in black - market transactions. The new regulations, which limit sales to pharmacies, have seen low participation and transaction volumes in the legal market, while black - market dealings have soared. Critics say the policy has fueled organized crime, and experts are calling for legalization and regulation to address the crisis.
Jun.23 by 2FIRSTS.ai
FDA & CBP Seize Nearly 2 Million Illegal E-Cigarette Products
FDA & CBP Seize Nearly 2 Million Illegal E-Cigarette Products
The FDA and CBP seized nearly 2 million unauthorized e-cigarettes in Chicago this February, worth $33.8 million. Most came from China, involving brands like Snoopy Smoke and Raz. The FDA sent warning letters to 24 importers for using false labels to evade inspection.
May.23 by 2FIRSTS.ai