US FDA: New Nicotine Substitute 6-methyl Nicotine May Be More Addictive, And Several Chinese Companies Have Related Patents

US FDA: New nicotine substitute 6-methyl nicotine may be more addictive, and several Chinese companies have related patents

The U.S. Food and Drug Administration (FDA) said that new nicotine substitutes, such as 6-methyl nicotine, may be more addictive than nicotine. At present, there is limited research on 6-methyl nicotine, and it is not possible to draw clear conclusions about its health effects or addiction. It is reported that several Chinese companies have related patents.

 

According to Reuters on May 30, the U.S. Food and Drug Administration (FDA) and independent researchers said that although scientific data is still incomplete, nicotine substitutes such as 6-methyl nicotine used in upcoming e-cigarettes in the United States and overseas may be more potential and addictive than nicotine itself.

 

The FDA said that these synthetic substances have a chemical structure similar to nicotine and are not subject to U.S. tobacco and e-cigarette regulations designed to control traditional nicotine. This means that manufacturers can sell e-cigarettes containing synthetic nicotine analogs such as 6-methyl nicotine in the United States without obtaining FDA authorization, and the process of obtaining FDA authorization can be time-consuming, expensive, and often unsuccessful.

 

Big tobacco companies such as Altria Group and British American Tobacco have already seen a sharp drop in e-cigarette sales in the United States due to their inability to obtain FDA authorization to illegally sell disposable e-cigarettes containing traditional nicotine. Altria highlighted the emerging application of 6-methyl nicotine in e-cigarettes in a letter sent to the FDA on April 5, a copy of which was published on its website. The letter urged the FDA to deal with the black market threat of nicotine-containing e-cigarettes. The FDA has not yet commented on this.

 

The letter cited the "SPREE BAR", an e-cigarette using 6-methyl nicotine launched by Charlie's Holdings Inc in October.

 

Charlie's Holdings calls the 6-methyl nicotine solution used in the "SPREE BAR" "Metatine". According to its website, Metatine "may have similar toxicity to nicotine." Co-founder Ryan Stump acknowledged that more research is needed on 6-methyl nicotine, adding that the company dilutes it in its products. He stressed that "SPREE BAR" is only for adults, adding that flavors play an important role in the mission of helping smokers quit smoking, and they respect and comply with the laws of every market in which they operate.

 

Charlie's Holdings is reportedly developing new varieties of "SPREE BAR" and new products containing 6-methyl nicotine. The company will launch "SPREE BAR" this year, but did not disclose the specific listing location.

 

A store owner selling "SPREE BAR" in Colorado said that he has not received any negative feedback about the product.

 

Samuel Benaim, founder of Novel Compounds, said that they are buying the 6-methyl nicotine solution used in "SPREE BAR" from another US company. The solution is sold under the trade name "imotine" and is imported from overseas by Novel Compounds and modified for use by manufacturers.

Benham said tests found 6-methyl nicotine was no more harmful than nicotine, but more research was needed. He added that they had received legal advice that its products were not classified as tobacco products or drugs in the United States, and the company was committed to complying with the law.

 

In response to questions about 6-methyl nicotine and other nicotine substitutes, the FDA said in a statement:

 

"While more research is needed, some emerging data suggest that these nicotine analogs may be more effective than nicotine - which is already highly addictive and can alter adolescent brain development and have long-term effects on adolescent attention, learning ability and memory."

 

The FDA said it is considering the use of such synthetic compounds from an "agency-wide perspective" and will use all its resources to protect adolescents from other potentially harmful health products.

 

Three academic researchers said that current research on 6-methyl nicotine is too limited to draw definitive conclusions about its health effects or addiction levels.

 

Another company, Aroma King, sells 6-methyl nicotine nicotine pouches in the UK, which users simply insert under their lips to get a boost. The pouches are sold in cans. Aroma King said in a February blog post that its 6-methyl nicotine products are "less toxic," "less harmful" and "less addictive" than regular nicotine products.

 

In a statement to Reuters, Aroma King cited existing research, its own toxicology and other testing, and its suppliers, which classify 6-methyl nicotine as low toxicity under the EU's Classification, Labelling and Packaging (CLP) regulation for chemicals. Aroma King said 6-methyl nicotine was classified by its suppliers themselves, but did not disclose its suppliers.

 

Four Chinese companies are understood to have patents related to 6-methyl nicotine production in China, including Zinwi Biotech, which produces e-cigarette oils. Zinwi Biotech confirmed that it was researching 6-methyl nicotine but did not respond to further questions, including whether it had sold 6-methyl nicotine to date.