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WVA Sues FDA for PMTA Impact on Small Business

The United States Vaping Association (USVA) is suing the U.S. Food and Drug Administration for its handling of the premarket tobacco product application (PMTA) and its impact on small businesses.

The USAVA, a trade association that represents the small businesses, suit alleges that the FDA failed to properly consider the impact the “seemingly impossible and expensive” PMTA process would have on small businesses.

“In the deeming rule, the FDA spoke as if vapor applicants would be able to substantially rely on public data, or on 70 studies the FDA itself was conducting at that time,” the USVA wrote in a statement. “In the end, the FDA wrote an impossibly burdensome PMTA rule that is putting a lot of people in this industry out of business. Yet, in fact the FDA claimed that there would be no significant impact on small businesses.”

The lawsuit asks for relief for the businesses that are members of the USVA that includes:

  • Declare the PMTA Final Rule in violation of the Regulatory Flexibility Act; 
  • Remand the PMTA Final Rule to the FDA; and 
  • Enjoin the FDA from enforcing the PMTA Final Rule against any members of the USVA, and to take such actions as are necessary and proper to remedy their violations deriving from any such actual or attempted enforcement.

The suit also criticizes the FDA prioritizing manufacturers with the greatest market share, companies that were more well funded to tackle the PMTA process. Some of the larger companies also were allowed to make changes to issues with their PMTA submissions where smaller companies with the same issues received marketing denial orders for those issues.

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New e-cigarette policies in the UK, Malaysia, and Thailand attract attention

Recently, the new policies of three important overseas e-cigarette market countries have attracted the attention and praise of domestic practitioners, who have expressed their optimism about the future development prospects of e-cigarettes. One is that the British government officially supports the use of e-cigarettes as a smoking cessation tool; the other is that Malaysia will legalize and tax nicotine e-cigarettes; and the other is that Egypt abolished the sale, import and marketing of e-cigarettes since 2015 Ban.

1. In October, the UK government website updated the latest policy on e-cigarettes. The Medicines and Healthcare Products Regulatory Agency (MHRA) is issuing updated guidelines to pave the way for smokers who wish to quit smoking to issue medicinal-licensed e-cigarette products . The British medical regulatory agency will work with e-cigarette manufacturers to evaluate the safety and effectiveness of the product. This will help the UK achieve its goal of becoming smoke-free by 2030.

2. In October, Malaysian Minister of Health Khairy Jamaluddin notified the World Health Organization that the country will regulate and levy taxes on e-cigarette products to prevent young people from contacting e-cigarette products. At present, Malaysia has banned the sale of consumer products containing nicotine. If the New Deal means that Malaysia may legalize the production, import and sale of nicotine e-cigarettes.

3. In September, Egypt abolished the ban on the sales, import and marketing of e-cigarettes since 2015. This decision will undoubtedly pave the way for the enactment of appropriate regulations to curb the illegal trade of electronic cigarette devices and tools “e-cigarettes”, which will help eliminate the growing crisis in Egypt due to this illegal trade.

Egypt is now aligned with the global and Middle Eastern markets, including the UAE, Saudi Arabia and Kuwait, all of which have legalized the marketing and consumption of e-cigarettes. The decision to remove the ban has been well received by the largest and most important manufacturers and consumers. By encouraging small and medium-sized enterprises, this will greatly benefit Egypt’s overall investment environment and manufacturers’ investment, opening new stores, and importing rechargeable e-cigarette equipment and tools into the market, thereby creating new job opportunities.

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Biden pardons all federal offenses of simple marijuana possession in first major steps toward decriminalization

President Joe Biden is taking his first major steps toward decriminalizing marijuana, fulfilling a campaign pledge to erase prior federal possession convictions and beginning the process of potentially loosening federal classification of the drug.

Biden on Thursday pardoned all prior federal offenses of simple marijuana possession, a move that senior administration officials said would affect thousands of Americans charged with that crime.

Smoking weed is now more popular than smoking tobacco

The announcement comes a month ahead of critical November elections that will determine control of Congress. Some candidates – in particular Pennsylvania Democratic Lt. Gov. John Fetterman, who is running for his state’s US Senate seat – have made the issue of marijuana legalization central to their campaigns. When Fetterman and Biden met last month, the candidate said he would raise the issue with the President. At the same time, Democrats have sought to rebuff allegations they are soft on crime, an issue that has risen to the top of some voters’ agendas in certain swing districts.

As part of the announcement, Biden also encouraged governors to take similar steps to pardon state simple marijuana possession charges, a move that would potentially affect many thousands more Americans.

And the President will task the Department of Health and Human Services and Attorney General Merrick Garland to “expeditiously” review how marijuana is scheduled under federal law, the first step toward potentially easing a federal classification that currently places marijuana in the same category as heroin and LSD.

“No one should be in jail just for using or possessing marijuana,” Biden said in a video announcing his executive actions. “It’s legal in many states, and criminal records for marijuana possession have led to needless barriers to employment, housing, and educational opportunities. And that’s before you address the racial disparities around who suffers the consequences. While white and Black and brown people use marijuana at similar rates, Black and brown people are arrested, prosecuted, and convicted at disproportionate rates.”

“Too many lives have been upended because of our failed approach to marijuana. It’s time that we right these wrongs,” the President said.

The moves Biden announced Thursday stop short of full decriminalization, which has enjoyed growing support among both political parties. But they are the first significant steps taken by a US president toward removing criminal penalties for possessing marijuana.

The President and a small circle of White House aides had been wrangling for weeks over the changes, complicated both by Biden’s own personal skepticism about decriminalization and not wanting to dictate changes to the Justice Department.

Biden’s own view on marijuana is a product of both his age and the years he spent as the chairman of the Judiciary Committee in the Senate working on crime bills. During the 2020 campaign, aides argued that he was waiting for new studies to come out that would inform a shift in his position – but even without any such studies, Biden was eventually moved by arguments about the lack of fairness and justice, particularly along racial lines.

White House aides were also watching the calendar with the midterms in mind, hoping that the changes long sought by criminal justice advocates will help build enthusiasm among Black voters, younger voters and a wider array of core Democratic voters.