Author: Timothy Donahue

  • Study Finds CBD Cream Helps Repair Skin Damage

    Study Finds CBD Cream Helps Repair Skin Damage

    Credit: ZayNyi

    Topically applied nanoparticle-encapsulated cannabidiol cream helped prevent and repair damage to the skin from ultraviolet A radiation, according to a study.

    “The impacts of ultraviolet (UV) radiation are well described from accelerated skin aging to skin cancer and, while sunscreens and other protective measures are certainly helpful, none of them are full proof,” Adam Friedman, professor and chair of dermatology at George Washington University School of Medicine & Health Sciences and a member of Healio Dermatology’s Peer Perspective Board, told Healio. “We need other ways to address these exposures and cumulative exposures to UV radiation.”

    According to a study conducted by Friedman and his colleagues and published in the Journal of the American Academy of Dermatology, CBD has anti-inflammatory and antioxidant properties that could potentially mitigate damage from ultraviolet A exposure, according to reports.

    “UVA radiation is, in some cases, more dangerous than ultraviolet B,” Friedman explained. “For one, it doesn’t burn even close to as much as UVB, so you don’t really know you’re getting exposure.

    “It also gets through clouds and penetrates deeper into the skin, which causes accelerated skin aging by destroying the support structures in the skin like collagen [and] elastin, as well as preventing rebuilding,” he added.

    As a result, Friedman and his colleagues evaluated the potential of CBD as a topical photoprotective and possible reparative agent against UVA-induced skin damage in a prospective, single-center, pilot clinical trial.

    In the study, 19 participants (age range, 22 to 64 years; Fitzpatrick skin types I-III) applied nano-CBD cream, formulated for the skin, or vehicle cream to random, blinded areas of the buttocks twice-daily for 14 days. The treated sites were then irradiated with three or less UVA minimal erythema doses. After 24 hours, the researchers obtained and examined punch biopsies for histology, immunohistochemistry and real-time polymerase chain reaction.

    Results showed that 21% of the participants had less observable erythema on the parts of their skin that were treated with CBD cream vs. the areas that were treated with vehicle. Histology results confirmed that CBD-treated skin had reduced UVA-induced epidermal hyperplasia — a thickening of the epidermis — compared with the vehicle-treated skin (mean change from baseline, 11.3% vs. 28.7%; P = .01).

    Immunohistochemistry also detected reduced cytoplasmic/nuclear 8oxo-guanine glycosylase 1 staining in CBD-treated skin vs. vehicle-treated skin, meaning the CBD-skin experienced less oxidized DNA modification (P < .01).

    According to Friedman, their study also showed that in 50% of individuals, CBD cream stopped UVA-induced deletion of ND4 — a specific injury to DNA that occurs from UVA exposure — compared with vehicle-treated skin. Additionally, no side effects were reported.

    So, what is the future of CBD cream in this indication? Will it replace sunscreen? According to the researchers, it absolutely will not.

    “This isn’t a sunscreen,” Friedman emphasized. “The idea here is not that this will replace sunscreen but that it will prevent or repair damage.”

    Friedman explains that the sun harms the skin by breaking it down and inhibiting the mechanisms that allow collagen to rebuild. However, CBD may be able to regulate that damage.

    “It’s not just that CBD is inhibiting the sun,” he said. “I think it’s actually having a biological effect on the skin and helping move things just like how our own endocannabinoid system would do this.”

    Practically applied, Friedman describes that the use of CBD cream to combat UVA rays could be akin to a moisturizer that is put daily on the skin.

    While this study showed CBD’s potential as a sun-protectant for the skin, Friedman believes that its indications could expand.

    “This isn’t simply about UV exposure,” he said. “We used UV exposure as a way to induce injury to show that CBD can be reparative and protective. But I think it’s not just in the setting of UV, it’s also in general in terms of overall skin health.”

  • Kentucky Judge Dismisses Vape Registry Lawsuit

    Kentucky Judge Dismisses Vape Registry Lawsuit

    Credit: Andreykr

    A Kentucky judge has dismissed a lawsuit challenging the constitutionality of a 2024 law banning the sale of some vaping products.

    In doing so, Franklin Circuit Court Judge Thomas Wingate sided with the lawsuit’s defendants — Allyson Taylor, commissioner of the Kentucky Department of Alcoholic Beverage Control, and Secretary of State Michael Adams — who filed a motion to dismiss.

    Greg Troutman, a lawyer for the Kentucky Smoke-Free Association, which represents vape retailers, had argued that the law was too broad and arbitrary to pass constitutional muster because it is titled “AN ACT relating to nicotine products” but also discusses “other substances.”

    The state constitution states that a law cannot relate to more than one subject. Wingate found the law doesn’t violate the state constitution, according to media reports.

    The law’s title “more than furnishes a clue to its contents and provides a general idea of the bill’s contents,” stated Wingate. He wrote that the law’s “reference to ‘other substances’ is not used in a manner outside of the context of the bill but rather to logically indicate what is unauthorized.”

    The lawsuit centers around House Bill 11, which passed during the 2024 legislative session and goes into effect Jan. 1. Backers of the legislation said it’s a way to curb underage vaping by limiting sales to “authorized products” or those that have “a safe harbor certification” based on their status with the U.S. Food and Drug Administration (FDA).

    Opponents have said it will hurt small businesses, lead to a monopoly for big retailers and could drive youth to traditional cigarettes.

    Altria, the parent company of tobacco giant Phillip Morris, lobbied for the Kentucky bill, according to Legislative Ethics Commission records. Based in Richmond, Virginia, the company is pushing similar bills in other states. Altria, which has moved aggressively into e-cigarette sales, markets multiple vaping products that have FDA approval.

    “The sale of nicotine and vapor products are highly regulated in every state, and the court will not question the specific reasons for the General Assembly’s decision to regulate and limit the sale of nicotine and vapor products to only products approved by the FDA or granted a safe-harbor certification by the FDA,” Wingate wrote in a Monday opinion. “The regulation of these products directly relates to the health and safety of the Commonwealth’s citizens, the power of which is vested by the Kentucky Constitution in the General Assembly.”

  • Poland Mulls Minimum Sales Age for Vape Products

    Poland Mulls Minimum Sales Age for Vape Products

    Credit: Velishchuk

    Polish Health Minister Izabela Leszczyna wants to ban e-cigarette sales to minors starting Jan. 1, 2025, reports Polskie Radio.

    The government is currently soliciting public input on a draft amendment to the Act on Protection of Health Against the Consequences of Tobacco and Tobacco Products, which would prohibit e-cigarette sales to people under 18, irrespective of nicotine content.

    The authors of the draft stress that this measure is essential to curb e-cigarette use among young people. They also note that nicotine-free e-liquids are not without risk as they may contain substances like formaldehyde and acetaldehyde.

    Proponents of the legislation also worry that flavored e-cigarettes may entice youths who might otherwise avoid tobacco products.

  • Vape Products Tied to Reduced Smoking Prevalence

    Vape Products Tied to Reduced Smoking Prevalence

    Photo: Rain

    A new analysis conducted on the latest available U.S. National Health Interview Survey (NHIS) data through 2022 showed that population-level data suggest that smoking prevalence has declined at an accelerated rate in the last decade in ways correlated with increased uptake of e-cigarette use.

    Since their market introduction, the question of whether combustion-free products could be a useful tool in the fight against cigarette smoking or simply a substitute has divided the scientific community. Over the years, technological innovation and the development of various products on the market have modified the health risk parameters related to the use of these tools, creating the basis for a redefinition of public health policies.

    To date, vaping is at the center of scientific debate: both for adult smokers who cannot quit and see these products as a way to reduce exposure to toxic substances released by cigarette smoke, and for the concern over use by at-risk groups, such as younger individuals. Many experts believe that vaping represents a gateway to smoking.

    According to the Center of Excellence for the acceleration of Harm Reduction, evidence for the gateway effect has not been detected in population-level studies on the prevalence of e-cigarette use and smoking among young people; indeed, smoking prevalence remains at an all-time low among U.S. adolescents and young adults, despite increases in e-cigarette use.

    The new analysis “Increased e-cigarette use prevalence is associated with decreased smoking prevalence among U.S. adults” published in the Harm Reduction Journal  is an update on a previous analysis modeling population-level prevalence that assessed whether and how much the introduction of e-cigarettes in the U.S. may be correlated with declining smoking prevalence among populations of U.S. adults using the NHIS .

    Results showed that population-level data continue to suggest that smoking prevalence has declined at an accelerated rate in the last decade in ways correlated with increased uptake of e-cigarette use.

    “We found that as ecig use increases at the population level, smoking prevalence tends to decrease, which is what you’d expect to observe if e-cigarettes were used as an alternative to cigarette smoking in the real world” said Floe Foxon, Pinney Associates researcher and author of the analysis, in a statement

    “We also found that this possible substitution between e-cigarette use and smoking was most pronounced in groups that used e-cigarettes the most, which again would be expected if e-cigarettes were being used instead of cigarettes. While it is important to note that the study does not infer causality and that these methods have limitations noted in the paper, they do appear to support a growing body of literature including other simulation studies, econometric research, and randomized controlled controls which suggest that e-cigarettes substitute for cigarettes among adults.”

  • FDA Almost Finished Reviewing PMTA Products

    FDA Almost Finished Reviewing PMTA Products

    Photo: thodonal

    The U.S. Food and Drug Administration is almost done reviewing premarket tobacco product applications (PMTAs) for mass-market vaping products.

    In a July 22 progress report the agency said it had taken action on 185 of 186 marketing applications for e-cigarette products covered by a 2022 court order, which applied to products with significant market share that filed applications by Sep. 9, 2020.

    The manufacturers of those orders have received either a marketing denial order (MDO) or FDA authorization.

    Observers say the one application still under review is Juul. The FDA issued an MDO to Juul in 2022, but quickly stayed its order and agreed to further review the application. In June, the FDA rescinded the denial order, returning Juul’s products to full scientific review.

    In its report, the FDA says it has also issued more than 18 million refuse-to-accept decisions, over 67,000 refuse-to-file decisions, and approximately 46,000 MDOs—most of them for bottled e-liquid made by small- to medium-sized manufacturers.

    The new progress report is the most recent in a series of reports mandated by the U.S. District Court for Maryland as part of its decision that forced the FDA to move the PMTA submission deadline forward.

  • More Warnings for Sellers of Elf Bar, Lost Mary Vapes

    More Warnings for Sellers of Elf Bar, Lost Mary Vapes

    Credit: Chris Titze Imaging

    The U.S. Food and Drug Administration announced on July 25 that it had issued warning letters to 80 brick-and-mortar retailers in 15 states for selling unauthorized e-cigarette products, including Elf Bar and Lost Mary. 

    The regulatory agency also filed complaints for civil money penalties (CMPs) against eight other retailers who failed to take action after being previously warned about selling unauthorized e-cigarettes.

    “These warning letters and CMPs are a result of FDA’s ongoing monitoring of multiple surveillance systems to identify products that are popular among youth or have youth appeal. The 2023 National Youth Tobacco Survey, according to an FDA release, found that more than 50 percent of youth who use e-cigarettes reported using the brand Elf Bar.

    Additionally, the brand Lost Mary—manufactured by the same firm as Elf Bar—was identified as popular or youth-appealing following an agency review of retail sales data and emerging internal data from a youth-use survey. 

    The FDA generally sends warning letters the first time an investigation or inspection reveals a violation. Warning letter recipients have 15 working days to respond with the steps they will take to correct current violations and prevent future violations. However, failure to promptly correct the violations may result in additional FDA action, including CMPs.

    For the retailers receiving the eight CMPs, the FDA previously issued warning letters for to them for selling unauthorized tobacco products. Follow-up inspections revealed that the retailers had failed to correct the violations, and the agency is now seeking $20,678 from each retailer.

    These actions are the latest in the FDA’s ongoing efforts to address the marketing and sale of unauthorized e-cigarettes that appeal to youth. Throughout the last year, the agency has conducted inspections of retailers to identify those selling unauthorized e-cigarettes, including in May, March, and February. As a result of these actions, the FDA has issued more than 690 warning letters and more than 140 civil money penalty actions to retailers for the sale of unauthorized e-cigarettes.

    To date, the FDA has authorized 34 e-cigarette products and devices. These are the only e-cigarette products that currently may be lawfully marketed and sold in the United States. Further information on tobacco products that may be legally marketed in the United States is available in the FDA’s Searchable Tobacco Products Database.

  • Cannabis Investor Accused in ‘Ponzi-Like’ Scheme

    Cannabis Investor Accused in ‘Ponzi-Like’ Scheme

    Credit: Somchairakin

    The U.S. Securities and Exchange Commission filed a lawsuit on Monday against California businessman Robert Newell and one of his former companies, Black Hawk Funding. They alleged that Newell orchestrated a $38 million “Ponzi-like” scheme to defraud investors.

    The lawsuit, filed in U.S. District Court in the Central District of California, alleges that 63-year-old Newell raised $37.7 million from about 200 investors nationwide between 2016 and 2019 to ostensibly invest in legal marijuana businesses. Instead, he “engaged in various undisclosed and unauthorized uses of the funds, including making Ponzi-like payments to investors and paying for the expenses of unrelated entities.”

    Newell founded Black Hawk Funding in 2011, originally with a focus on the real estate industry, but he pivoted to cannabis following recreational legalization in California in November 2016, according to the lawsuit. Newell acted as the principal financial adviser to three private funds: Verde Ventures Inc., Verde Holdings Inc., and Verde Partners Inc, according to Green Market Report.

    Another separate corporation, National Asset Valuation Services, was also created by Newell “as a conduit to misappropriate money” from two of the three funds, the SEC lawsuit alleges.

    “Newell engaged in a scheme and deceptive course of business to defraud investors by creating a false impression that the Verde Funds were more successful than they were, which allowed Newell to continue raising funds from investors and to enrich himself at the expense of the investors,” the SEC alleged in the suit.

  • BAT Chief Says US Needs Crackdown on Illegal Vapes

    BAT Chief Says US Needs Crackdown on Illegal Vapes

    Credit: Iama Sing

    A surge of illegal vaping products originating from China is negatively impacting the sales of legal alternatives to cigarettes in the U.S., according to the CEO of British American Tobacco.

    Tadeu Marroco advocated for stricter penalties for individuals importing unauthorized vapes into the U.S. “What we are seeing with the lack of enforcement is a reduction of the legal market of vapor,” the CEO said.

    BAT is one of the tobacco producers waiting for the U.S. Food and Drug Administration’s long-delayed completion of its review of marketing applications for vaping products. BAT is a major player in the vaping industry worldwide and in the U.S. with its Vuse brand.

    The delay is leading manufacturers of illicit products to take advantage of the uncertainty by continuing to sell them, Marroco said. The FDA needs to “decide publicly what are the products that are allowed to stay in the market and the products that need to be taken out of the market,” he added, according to Bloomberg.

    The FDA and the U.S. Department of Justice have formed a federal task force spanning multiple agencies to stop the distribution of illegal e-cigarettes. As of early June, the FDA had issued 1,100 warning letters to makers, importers and distributors of unauthorized new tobacco products, including e-cigarettes, and fined more than 55 manufacturers and 140 retailers.

    BAT has launched two claims with the International Trade Commission, one related to patent infringement and another about the importation and marketing practices of illegal vapes.

    The company reported first-half results earlier Thursday, in which it said it’s unlikely to hit a £5 billion ($6.4 billion) revenue target in 2025 for vapes, heated tobacco and nicotine pouches, blaming the lack of a U.S. clampdown on illicit products.

  • BAT Reports First-Half Results, Revenues Down

    BAT Reports First-Half Results, Revenues Down

    Photo: BAT

    British American Tobacco reported revenue of £12.34 billion ($15.88 billion) for the first half of 2024, down 8.2 percent from the comparable 2023 period. The decline was driven by unfavorable currency exchange rates and the sale of BAT’s businesses in Russia and Belarus following Russia’s invasion of Ukraine.

    Reported revenue from new category products, which include vapes, heated tobacco and nicotine pouches, declined 0.4 percent to £1.65 billion. Smokeless brands now account for 17.9 percent of BAT’s group revenue, up 1.4. percentage points from fiscal year 2023

    Profit from operations was £4.26 billion on a reported basis, down 28.3 percent from the first half of 2023. BAT attributed the decline to its December 2023 decision to write down the value of some of its traditional cigarette brands in the United States to reflect the diminishing outlook for combustible tobacco products, along with its exit from Russia and Belarus.

    The company said it’s unlikely to hit its £5 billion revenue target in 2025 for new category products, blaming fierce competition from illicit vapes in the United States. The U.S. accounted for more than 40 percent of BAT’s revenues in 2023, primarily from traditional tobacco products, according to Reuters.

    Tadeu Marroco

    In a statement, BAT CEO Tadeu Marroco welcomed the U.S. Food and Drug Administration’s recent marketing authorization of its Vuse Alto device and tobacco flavor consumables, but expressed concern about the continued lack of enforcement against unauthorized single-use vapes, which makes it difficult for authorized brands to compete in that market.

    Nonetheless, Marroco said BAT is on track to deliver its full-year guidance. “Focusing on ‘quality growth’ is delivering better returns on more targeted investments across all three new categories,” he said. “In H1 2024, we increased organic new category contribution by £165 million—at constant rates—and I am particularly pleased with the growth of modern oral. We expect to deliver further improvement in revenue and profitability across our new categories for the full year.”

  • PMI Mysteriously Postpones U.S. Launch of IQOS

    PMI Mysteriously Postpones U.S. Launch of IQOS

    Credit: F Armstrong Photo

    Philip Morris International has postponed the test launch of its IQOS heated tobacco device in the U.S. to the fourth quarter, reports Reuters. The company declined to say why.

    The pilot was earlier scheduled to run in Austin, Texas, in the second quarter, for which the company reported results on the day.

    Anti-tobacco activists have been seeking to derail the U.S. introduction of IQOS, arguing among other things that PMI exaggerates the number of people who have quit smoking regulator cigarettes using IQOS.

    In a joint letter to the U.S. Food and Drug Administration dated June 27, six health groups cited yet-to-be published independent studies contradicting PMI’s findings about how many IQOS users completely switch to the device from cigarettes.

    Meanwhile, PMI said the impact of the EU ban on flavored heated tobacco in the European Union has had a “slightly greater” impact on IQOS sales than previously assumed.

    This led the company to temper its expectations for volume growth in the heated tobacco category to around 13 percent for the full year, down from between 14 percent and 16 percent expected earlier.