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.

Bulgaria’s Proposed E-Cigarette Ban Awaits EU Approval, Covering Both Disposable and Reusable Devices
Bulgaria’s Proposed E-Cigarette Ban Awaits EU Approval, Covering Both Disposable and Reusable Devices
Bulgaria’s parliament has passed a bill to fully ban the sale, promotion, and use of both disposable and reusable e-cigarettes. The legislation is still pending approval from the European Union.
Jun.09 by 2FIRSTS.ai
Product | VOOPOO Launches New Open-System Vape ARGUS Klyc with Magnetic Cap Design
Product | VOOPOO Launches New Open-System Vape ARGUS Klyc with Magnetic Cap Design
VOOPOO debuts ARGUS Klyc, its first open-pod vape in the ARGUS lineup with a protective cap. The 5–30W device features RGB lighting and has appeared on UK retail sites marked “COMING SOON.”
Jun.11 by 2FIRSTS.ai
UK Consumers have gradually shifted towards rechargeable products
UK Consumers have gradually shifted towards rechargeable products
Disposable e-cigarette usage in the UK is declining as consumers shift towards refillable products, particularly among 16-24 year-olds.
Apr.22 by 2FIRSTS.ai
The Rise of a Global Black Market in Nicotine Pouches
The Rise of a Global Black Market in Nicotine Pouches
As global demand for oral nicotine products surges, a shadow supply chain is quietly taking hold—powered by counterfeit manufacturing, brand exploitation, and regulatory blind spots. A 2Firsts investigation has uncovered how unauthorized ZYN and VELO pouches, priced as low as $1 per can, are sold in bulk on Chinese B2B platforms and exported to Western markets with little oversight.
May.06
US Brand ALP Launches First On-Demand Nicotine Pouch Delivery Service with Delivery Platform
US Brand ALP Launches First On-Demand Nicotine Pouch Delivery Service with Delivery Platform
Nicotine pouch brand ALP announced a strategic partnership with delivery platform Gopuff to launch an on-demand delivery service for US consumers. The collaboration sets a precedent for instant delivery in the nicotine pouch category.
May.07 by 2FIRSTS.ai
Malaysia Tightens E-Cigarette Regulations, Expands Enforcement to Ads, Packaging, and Sales
Malaysia Tightens E-Cigarette Regulations, Expands Enforcement to Ads, Packaging, and Sales
Malaysia’s Health Ministry has unveiled stricter e-cigarette regulations, covering registration, advertising, packaging, and display—aimed at protecting minors. The health minister noted the rules are dynamic and will be updated as new evidence arises. As for calls for a total ban, he said that falls under local government authority.
Apr.25 by 2FIRSTS.ai