Showing posts with label tobacco. Show all posts
Showing posts with label tobacco. Show all posts

Wednesday, August 21, 2019

Can a poison be available over the counter?



Dr KK Aggarwal

The Karnataka state has classified nicotine as a poisonous substance under the Karnataka Poisons Rules, 2019 under the Poisons Act, 1919.

Applicable laws

1. Section 02: Power of the state government to regulate possession for sale and sale of any poison: (1) The [State Government] may by rule regulate within the whole or any part of the territories under its administration the possession for sale and the sale, whether wholesale or retail, of any specified poison.

2. Section 03: Power to prohibit importation into the states of any poison except under licence: The [Central Government] may, by notification in the [Official Gazette], prohibit except under and in accordance with the conditions of a licence, the importation into [India] [across any customs frontier defined by the Central Government] of any specified poison, and may by rule regulate the grant of licences.

State government has amended the Karnataka Poisons (Possession and Sale) Rules, 2015 to notify nicotine as a Class A poison. As per the new rule, sale and consumption of nicotine tablets of only 2 mg and 4 mg dosages will be allowed for deaddiction.

Question: Can a poison be allowed to be sold as an over the counter (OTC) drug (nicotine gums and patches) under schedule K of the Drugs and Cosmetics Act?

Even if they classify it as carcinogen, is it comparable to tobacco?

Let us see what WHO has to say (https://www.who.int/features/qa/cancer-red-meat/en/).

“9. Processed meat was classified as carcinogenic to humans (Group 1). Tobacco smoking and asbestos are also both classified as carcinogenic to humans (Group 1). Does this mean that consumption of processed meat is as carcinogenic as tobacco smoking and asbestos?

No, processed meat has been classified in the same category as causes of cancer such as tobacco smoking and asbestos (IARC Group 1, carcinogenic to humans), but this does NOT mean that they are all equally dangerous. The IARC classifications describe the strength of the scientific evidence about an agent being a cause of cancer, rather than assessing the level of risk.”

If not, bringing it as a poison does not make a case of banning it under the new rules. Remember tobacco is an over-the-counter product.

Friday, August 9, 2019

Some definitions related to tobacco and other common addictions



Dr KK Aggarwal

Here is a list of definitions of various terms related to tobacco and other common addictions as to what do they actually mean. This will help to understand the nuances between the various terminologies. You are welcome to add to this list.

·         Smoke is produced as a result of combustion (temperature > 800o C). When combustion occurs, new chemicals are formed via the process of oxidation. Hence, smoke contains several new chemicals different from those initially burned. Smoke can be produced by burning coal, wood, cigarettes, bidis, etc.

·         Smoking is a practice in which a substance is burned and the resulting smoke breathed is absorbed into the bloodstream. The most common form of smoking is cigarette smoking or recreational drug use.

·         Second hand smoke: Smoke that fills restaurants, offices or other enclosed spaces when people burn tobacco products such as cigarettes, bidis and water-pipes.

·         Third hand smoke: It is not exactly smoke, but the “invisible” chemical residual of tobacco smoke contamination that sticks to clothing, wall, furniture, carpet, cushions, hair, skin and other materials in the environment after the cigarette has been extinguished.

·         Vaping: Act of inhaling and exhaling a vapor or an aerosol. E-cigarettes do not produce tobacco smoke, but an aerosol, which is commonly termed as “vapor”.

·         Vapor: When a substance becomes gaseous, at a temperature that is lower than its point of combustion (180-250oC), it is considered as vapor. Unlike smoke, the chemicals in vapor are the same as those found in the vaporized substance.

·         Aerosol: Suspension of tiny particles of liquid, solid or both within a gas.

·         Electronic nicotine delivery systems (ENDS) and Electronic Non-Nicotine Delivery Systems (ENNDS): Products that heat a solution to create an aerosol which frequently contains flavourants, usually dissolved into Propylene Glycol or/and Glycerin; the aerosol is inhaled by the user. Most common example are e-Cigarettes that that do not burn or use tobacco leaves but instead vaporise a solution the user then inhales. All ENDS (but not ENNDS) contain nicotine. 

·         Heated tobacco products: Also known as “Heat-not-Burn” products, they produce aerosols containing nicotine and other chemicals, upon heating of the tobacco, or activation of a device containing the tobacco, which are inhaled by users, through the mouth.

·         Sheesha: Fruit-flavored tobacco, which is roasted in a foil along with charcoal and passed into a small chamber of water through a glass-bottomed pipe. It is then inhaled slowly. 

·         Smokeless tobacco: It is tobacco that is not burned. It is also known as chewing tobacco, oral tobacco, spit or spitting tobacco, dip, chew, and snuff. 

·         Chewing or spit tobacco: Tobacco in the form of loose leaves, plugs, or twists of dried tobacco that may be flavored. It is chewed or placed between the cheek and gum or teeth.

·         Guṭkha or pan masala is a chewing tobacco preparation made of crushed areca nut, tobacco, catechu, paraffin wax, catechu, slaked lime, flavoring agents and sweeteners

·         Khaini contains dry tobacco, slaked lime

·         Betel quid or pan: Contains betel leaf, areca nut, catechu, slaked lime and tobacco

·         Snuff or dipping tobacco: Finely ground “smoke-free and spit-free”” tobacco packaged in cans or pouches and may have flavorings added. Dry snuff is sold in a powdered form and is used by sniffing or inhaling the powder up the nose, while moist snuff is put between the lower lip or cheek and gum.

·         Snus: Type of moist snuff first used in Sweden and Norway. It’s often flavored with spices or fruit, and is packaged like small tea bags. Snus is held between the gum and mouth tissues and the juice is swallowed.

·         Standard drink: Definition of standard drink differs in countries: US = 14-15 gm alcohol equivalent to 12 oz beer, 5 oz wine and 1.5 oz 80 proof liquor; UK 8 gm alcohol, Japan 19.75 gm alcohol and India 10 gm alcohol
o     Alcohol content differs in various drinks: Beer 5%; Malt liquor 7%; Table wine 12%; Fortified wine (sherry, port) 17%; Cordial liquor (aperitif) 24%; Brandy (single jigger) 40% and 80 proof gin, Vodka, whisky 40%
o     Moderate drinking means less than 2 drinks per day (women) and less than 3 drinks per day (men) and for people aged more than 65, less than two drinks per day
o     Heavy drinking means more than 7 drinks per week or 3 drinks per occasion (women) or more than 14 drinks per week or 4 drinks per occasion (men).
o     Binge drinking means 4 or more drinks at one time (women) or 5 or more at one time (men)

·         Charas, hashish, ganja and bhang: are obtained from the cannabis plant.

o    Marijuana is another name for cannabis obtained from the Cannabis plant
o    Charas is the separated resin from the cannabis plant
o    Ganja is prepared from the flowering or fruiting tops of the cannabis plant
o    Bhang is prepared from the leaves (and seeds) of the cannabis plant.

(The Narcotic Drugs and Psychotropic Substances Act,1985 has banned the production and sale of cannabis resin and flowers, but permits use of leaves and seeds)



Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA


Saturday, June 22, 2019

HR/June 19/7: Safer nicotine products




·           E-cigarettes are estimated to be 95% safer than smoking cigarettes
·           Snus is not inhaled, so there is no risk of respiratory disease which accounts for nearly half of all smoking-related deaths; and no risk to bystanders. There is no significant association with premature deaths, diabetes, pancreatic and oral cancers, heart disease or strokes
·           It is estimated that by 2021, over 55 million people will be using e-cigarettes or heat-not-burn tobacco products and that the global market will be worth USD $35 billion
·           Use of heat-not-burn products in Japan has seen cigarette sales fall by 27% in two years, an unprecedented national decrease in smoking
·           In Sweden snus has been instrumental in reducing smoking related mortality to the lowest in the EU
·           If the EU ban on snus is lifted, then around 320,000 premature deaths a year could be prevented in the EU
·           As Norwegian smokers switch to snus, the smoking rate among young Norwegian women has dropped to a world record of 1%
·           Over 50% of the UK’s 3 million e-cigarette users are ex-smokers
·           39 countries have inappropriately banned SNP including countries whose smoking prevalence is predicted to rise
·           62 countries regulate e-cigarettes under tobacco legislation.

(Source: No Fire, No Smoke Global State of Tobacco Harm Reduction, 2018 (2018). London: Knowledge-Action-Change)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA

Thursday, May 2, 2019

US FDA clears heat-not-burn tobacco device for sale


The US Food and Drug Administration has cleared a heat-not-burn tobacco device designed as an alternative to conventional cigarettes, for sale in the United States.

The product consists of a tube that gently heats up sticks of tobacco instead of burning them, making what is inhaled less harmful than conventional cigarette smoke.

The FDA said the marketing of the devices is “appropriate” for public health because “the products produce fewer or lower levels of some toxins than combustible cigarettes.” The agency also said it has placed stringent marketing restrictions on the products in an effort to prevent minors from using the device.

The review, which took almost 2 years, took into consideration the risks and benefits to the population as a whole. It included how the products may impact youth use of nicotine and tobacco, and the potential for the products to completely move adult smokers away from use of combustible cigarettes.

By using heat instead of flame the device eliminates 90-95% of toxic compounds in cigarette smoke.

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA


Monday, February 25, 2019

Can vaping be the answer for cancer prevention?



Emirates also has lifted the ban on the sale of vaping products

Earlier this week, the Emirates Authority for Standardisation and Metrology (ESMA) announced the lifting of a ban on the sale of e-cigarettes.  For the first time now, e-cigarettes and vaping devices will be legally sold in the UAE under new regulations, known as UAE.S 5030, which allow the sale of electronic cigarettes, electronic pipes, electronic shisha devices plus the liquid refills.

Under the new standards, Esma will regulate all nicotine components used in e-cigarettes including other details such as technical specifications, weight, list of ingredients, import, packaging, and labeling, among others.

Manufacturers will be allowed to sell the battery-powered products as long as they meet new standards and carry health warnings. E-cigarettes are expected to be available in stores from mid-April this year.

This carefully considered decision was made with the sole aim of protecting public health.

Until now it has been against the law for retailers to sell e-cigarette products, although it is not an offence to own or use one and they are widely available online. Legalizing these businesses will allow the relevant authorities to oversee the quality of products they sell and to enforce the prominent display of appropriate health warnings.

In recent years, there has been a significant cultural shift from traditional cigarettes to vaping. In some countries, electronic cigarettes are promoted as an effective way to quit smoking.

Is vaping safer than smoking?

Use of e-cigarettes or “vaping” has always been looked upon with suspicion. This is despite accumulating evidence, which shows them to be safer than the conventional combustible cigarettes.

Although generally perceived to be considerably similar, vaping and smoking are not alike. It therefore becomes important to understand the distinction between vaping and smoking.

Smoking is a practice in which a substance (tobacco) is burned and smoke is produced, which is inhaled into the lungs and is absorbed into the blood. When combustion occurs, new chemicals are formed via the process of oxidation. Hence, smoke contains thousands of new chemicals different from those initially burned.

E-cigarettes do not produce tobacco smoke, but an aerosol, which is commonly termed as “vapor”. Vaping is the act of inhaling and exhaling a vapor or an aerosol. Unlike smoke, when vapor is produced, no new chemicals are formed. The chemicals that are in vapor are the same as those found in the vaporized substance.

Therefore, the major and the most important difference between smoke and vapor is the presence of toxic tar and carbon monoxide in smoke. “People smoke for the nicotine, but they die from the tar” (BMJ. 1976) as it is the tar, which contains most of the mutagenic and carcinogenic agents in tobacco smoke.

An evidence review of e-cigarettes and heated tobacco products published in 2018 by the Public Health England has said “vaping is at least 95% less harmful than smoking.” “An advantage of e-cigarettes is that particular constituents can be removed or minimised in a way that is not feasible with tobacco cigarettes.”

As vaping does not involve combustion, no tar is produced and the resultant vapor has no carcinogens that are normally found in the cigarette smoke.

Long-term NRT-only and e-cigarette–only use, but not dual use of NRTs or e-cigarettes with combustible cigarettes, is associated with substantially reduced levels of measured carcinogens and toxins relative to smoking only combustible cigarettes, concluded a study reported in Annals of Internal Medicine in 2017.

According to a study published in Tobacco Control in 2017. “e-cigarette emissions have much less carcinogenic potency than tobacco smoke”.

In a report by its Tobacco Advisory Group titled “Nicotine without smoke. Tobacco harm reduction” and published in April 2016, the Royal College of Physicians has said, “Although it is not possible to precisely quantify the long-term health risks associated with e-cigarettes, the available data suggest that they are unlikely to exceed 5% of those associated with smoked tobacco products, and may well be substantially lower than this figure.”

Do e-cigarettes help smokers to quit?

A key observation of the Public Health England report (2018) was that “in the first half of 2017, quit success rates in England were at their highest rates so far observed and for the first time, parity across different socio-economic groups was observed. It is plausible that e-cigarettes have contributed to this.”

The RCP further says, “Large-scale substitution of e-cigarettes, or other non-tobacco nicotine products, for tobacco smoking has the potential to prevent almost all the harm from smoking in society. Promoting e-cigarettes, NRT and other non-tobacco nicotine products as widely as possible, as a substitute for smoking, is therefore likely to generate significant health gains in the UK.”

A study reported as recently as January 2019 in the New England Journal of Medicine found that e-cigarettes were nearly twice as effective as conventional nicotine replacement products, like patches and gum, for quitting smoking. The success rate was 18% among the e-cigarette group as compared to 9.9% among those using traditional nicotine replacement therapy. 

Can vaping be the answer for lung cancer

Lung cancer is number one cancer in males in urban India and is linked to tobacco smoking. In one of the harm reduction conference organised by us it was concluded that there is no evidence that nicotine causes lung cancer. In a country like India amongst smokers to prevent lung cancer either they should quit or shift to less harmful non-tobacco inhalation products.  

e-cigarettes cut exposure to carcinogens (HT)

A recent study sponsored by JUUL Labs and conducted by Deletion Labs, and independent global research facility found that electronic cigarettes reduce harmful exposure to addictive nicotine and chemicals known to cause cancer and present a safe alternative to smoking. The study presented before the Society for Research on Nicotine & Tobacco 2019 annual meeting in San Francisco on Saturday has found that some advanced e-cigarettes reduce the exposure to carcinogens.
The study found that electronic nicotine delivery systems reduce harmful exposure to chemicals known to cause cancer and present a safe alternative to smoking. The study was based on a clinical analysis of biomarkers of smokers, non-smokers and people who vaped (used electronic cigarettes) using a closed nicotine-salt pod system (NSPS).
The study ‘e-cigarettes cut exposure to carcinogens (HT) Changes in Biomarkers of Exposure Associated with Switching for 5 Days from Combusted Cigarettes to Nicotine Salt Pod System’ by Joanna Jay et all explored whether switching from cigarettes to ENDS may potentially reduce exposure to key toxicants. 
Data was presented from a randomized, open-label, parallel-group, inpatient study of adult smokers that examined changes in primary urine and blood biomarkers of exposure (BOEs), relative to baseline, following a 5-day exclusive use period of the nicotine salt pod system (“NSPS”, JUUL Labs, Inc.) with one of four flavors at 5% nicotine strength (Virginia Tobacco, Mint, Mango, Crème), abstinence, or continued use of usual brand combustible cigarettes.
In the study ninety subjects were randomized into one of six cohorts: use of JUUL system (n=15 for each of the four flavors), use of usual cigarette (n=15), or abstinence (n=15).  Total nicotine equivalents, and the following biomarkers were measured in 24-hour urine collections: NNN, NNAL, 3-HPMA, MHBMA, S-PMA, HMPMA, CEMA, and 1-OHP. COHb was measured in blood. 
All subjects randomized to the use of NSPS (n=60 ITT) and usual cigarettes (n=15) completed the study; four subjects from the abstinence arm terminated early (n=11; 73% completion rate in-arm). Over the course of 5 days, mean total nicotine equivalents increased by 9% in the pooled NSPS group vs. 26% in the usual cigarette group (p>0.05).
Decreases in the mean levels of all non-nicotine BOEs were observed in the abstinence group and all four NSPS groups at Day 5 compared to baseline (Day -1); the cigarette group demonstrated increases in all BOEs except for 1-OHP and HPMA. The eight non-nicotine urine BOEs were reduced by an aggregate 85.3% in the abstinence group and 85.0% in the pooled NSPS group (99.6% relative reduction in aggregate biomarkers; p>0.05).
Similar reductions were seen in the pooled NSPS and abstinence groups for each individual BOE (p>0.05 for each analyte). In the usual cigarette group, these BOEs increased by an aggregate of 14.4% (pooled NSPS vs. usual cigarette; p<0.001 for each analyte). COHb was likewise reduced by 71.8% in the pooled switching group vs. 69.1% in the abstinence group (p>0.05), while increasing by 13.3% in the usual cigarette group (p<0.001).
These results support the hypothesis that complete switching from cigarettes to the NSPS may lead to meaningful reductions in multiple key, short-term biomarkers of exposure observed with combustible use. 
Incomplete switching from cigarettes to NSPS (dual-use) was not studied.
Main points
1.      The urine biomarkers for adult smokers who used NSPS for five days and those who didn’t smoke were almost at par, with the NSPS group reporting an aggregate mean reduction of 99.6% relative to the reduction associated with five days of abstention.
2.       The subjects were all healthy smokers between the ages of 22 and 62 years, with a minimum 12-month history of smoking 10 or more king-size manufactured, combustible cigarettes each day.
3.       The study found equivalent reductions in select short-term biomarkers of exposure between adult smokers who exclusively switched to JUUL products and those who abstained from smoking over a five-day period. (Source Hindustan Times)

Dr KK Aggarwal
Padma Shri Awardee
President Elect Confederation of Medical Associations in Asia and Oceania   (CMAAO)
Group Editor-in-Chief IJCP Publications
President Heart Care Foundation of India
Past National President IMA