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Tag: Elf Bar

  • FDA Issues Warning Letters to 189 Retailers

    FDA Issues Warning Letters to 189 Retailers

    Credit: Monticello

    The U.S. Food and Drug Administration issued warning letters to 189 retailers for selling unauthorized products, specifically Elf Bar and Esco Bars, according to a press release.

    “The FDA is prepared to use all of its authorities to ensure these and other illegal and youth-appealing products stay out of the hands of kids,” said FDA Commissioner Robert M. Califf. “We are committed to a multipronged approach using regulation, compliance and enforcement action and education to protect our nation’s youth.”

    The warning letters were the result of a nationwide retailer inspection blitz over the past several weeks, according to the FDA.

    “All players in the supply chain—including retailers—have a role in keeping illegal e-cigarettes off the shelves,” said Brian King, director of the FDA’s Center for Tobacco Products. “This latest blitz should be a wake-up call for retailers of Elf Bar and Esco Bars products nationwide. If they’re waiting for a personal invitation to comply with the law, they might just get it in the form of a warning letter or other action from the FDA.”

    Elf Bar and Esco Bar products do not have the required marketing authorization from the FDA. The FDA has authorized 23 tobacco-flavored e-cigarette products and devices to date. The distribution and sale of unlawfully marketed products is subject to compliance and enforcement action.

    As of June 16, the FDA has issued more than 570 warning letters to firms for manufacturing, selling and/or distributing illegal tobacco products, including e-cigarettes, and filed civil money penalty complaints against 12 e-cigarette manufacturers.

  • Elf Bar Avoids Recall Notice

    Elf Bar Avoids Recall Notice

    Image: Veranika | Adobe Stock

    Authorities are satisfied with Elf Bar’s response to the controversy over the company’s products that did not meet legal requirements, reports ECigIntelligence, and there was no need for a mandatory recall.

    Elf Bar worked quickly to recall the product with retailers, and the company has confirmed that it was not subject to any formal recall or withdrawal notice issued by regulators.

    The products in question cannot be legally sold, however.

  • Elf Bar Comments on E-Liquid Controversy

    Elf Bar Comments on E-Liquid Controversy

    Image: carmenbobo | Adobe Stock

    After U.K. retailers announced they would remove Elf Bar 600 products from shelves due to illegal levels of e-liquid, Elf Bar called a meeting with the Medicines and Healthcare products Regulatory Agency (MHRA). Elf Bar subsequently released a statement regarding the controversy.

    “Recent press reports alleged questions around the compliance of the Elf Bar 600 on the U.K. market,” a company press release stated. “Subsequent to these allegations, we immediately initiated a full investigation of the Elf Bar 600 in the U.K. market and have found that some products exceeded the permitted e-liquid fill level. Although this issue means the products are not compliant in full with U.K. regulations, we did not find any issues with nicotine strength or anything that might mean the products’ safety is compromised in any way.

    “MHRA indicated that their recommendation is for the product to be withdrawn from the market.

    “We agree with this recommendation and will voluntarily carry out a withdrawal of noncompliant Elf Bar 600s from the U.K. market. We will be assisted in ensuring the withdrawal is carried out effectively, and without causing any unnecessary market disruption, by a Trading Standards Primary Authority. We will update all of our distribution and retail partners when we have agreed how this corrective action will be enacted.

    “Although the investigation and definition of corrective actions for the Elf Bar 600 has been undertaking, we have also committed to investigate all other vape products that we export to the U.K. We will take any actions we deem to be required to ensure compliance across our entire product set.”

    Elf Bar was joined by the U.K. Vaping Industry Association (UKVIA) and the IBVTA in the meeting.

    “Although Elf Bar is not a member of the UKVIA, as the industry’s lead trade association, it was key that we were present at such a critical meeting to represent the interests of all businesses in the sector impacted by this highly regrettable situation,” the UKVIA said in a statement. “The decision by Elf Bar to voluntarily withdraw its noncompliant products, recently highlighted in the media, is absolutely the right one.

    “If the industry is going to be accepted as playing a leading role in helping Britain achieve its smoke-free targets, it has to demonstrate the highest levels of compliance, standards and responsibility, which the UKVIA expects.”

  • Elf Bar Exceeds Legal U.K. E-Liquid Volumes

    Elf Bar 600 products have been pulled from shelves in multiple U.K. stores after it was discovered that the products contained e-liquid volumes at levels at least 50 percent higher than what is legal, reports The Daily Mail (the article states the liquids were over nicotine limits, but there is no evidence of that. The UK limits nicotine strength to no more than 20mg/ml).

    The company stated that it “inadvertently” broke the law and “wholeheartedly apologized.”

    Experts described the situation as “deeply disturbing” and warned of risk to youth, among which the products are very popular.

    Elf Bar, which launched in 2021, sells 2.5 million Elf Bar 600s in the U.K. every week, accounting for two in three of all disposable vapes sold.

    The legal limit on e-liquid in vapes is 2 mL, but tests commissioned by the Mail on three flavors of Elf Bar 600s found volume levels between 3 mL and 3.2 mL.

    Mark Oates, director of consumer advocacy group We Vape, said, “The Mail’s findings on Elf Bars are deeply worrying, and it is clear there have been failings on multiple levels.

    “Not only are the levels of e-liquid too high, but checks to make sure these guidelines are adhered to either haven’t occurred or are insufficient. Anyone supplying vapes in the U.K. market should be following the legislation.

    “It is incredibly frustrating when major players in this sector appear to behave in a way that damages the reputation of something as beneficial as vaping, and we expect the matter to be fully investigated by the Medicines and Healthcare products Regulatory Agency (MHRA).”