Label Claim Substantiation
A lot of research went into putting together the formula for Quit Tea. There was existing research on many of the herbs in Quit Tea studied alone for the purpose of quitting smoking. And there is a lot of research into both the side effects of quitting smoking, and herbs that help with these specific issues. We conducted extensive research into common problems when quitting smoking, herbs that were known for helping with quitting smoking, and also other herbs that might help with some of the unaddressed issues. We also important that no effects of the herbs would cancel out another herb, and that they were all water soluble.
FDA Regulations On Quit Smoking Aids
Nicotine addiction is a disease, and so any product that is intended to treat nicotine addiction must be approved by the Food and Drug Administration (FDA). Quit Tea and Quit Support are NOT claiming to treat the nicotine addiction. Quit Tea and Quit Support are herbal supplements that are focused on temporarily supporting willpower, and helping to replace the habit of smoking, the behavioral aspect. These products are also intended to be used to support a smoking cessation plan.
According to an FDA ruling dated January 6, 2000: Federal Register 65, number 4, page 1030, FDA agrees that certain smoking alternative claims may be acceptable structure/function claims, if they do not imply treatment of nicotine addiction, relief of nicotine withdrawal symptoms, or prevention or mitigation of tobacco related illnesses. ‘‘Smoking alternative,’’ ‘‘temporarily reduces your desire to smoke’’ and ‘‘mimics the oral sensations of cigarette smoke’’ may be acceptable (for products that otherwise meet the definition of a dietary supplement), if the context does not imply treatment of nicotine addiction, e.g., by suggesting that the product can be used in smoking cessation, or prevention or mitigation of tobacco-related diseases. For example, such claims would not be disease claims if the context made clear that they were for short-term use in situations where smoke is prohibited or socially unacceptable. ‘‘To be used as a dietary adjunct in conjunction with your smoking cessation plan,’’ however, is a disease claim because it is a claim that the product aids in smoking cessation, thereby implying that the product is useful in treating nicotine addiction. As noted earlier, a claim that the product is useful in counterbalancing the effects of a drug in depleting a nutrient or interfering with the metabolism of a nutrient would be acceptable as a structure/function statement.
Studying Quit Tea
Before selling Quit Tea we found 65 people willing to try Quit Tea and fill out surveys before attempting to quit smoking, then at weeks 1, 4, and 9. All the results are up on the website.
You will see that we asked each participant “How Does Quit Tea Make You Feel?” A majority of the respondents answered affirmatively for “Less Desire To Smoke” and “Relaxed.” A significant number responded affirmatively for “More Energy” and “Reduced Appetite.” Based on herbal research, the herbs in Quit Tea were supposed to provide these specific benefits, and after the survey responses we felt confident making the unsubstantiated claims.
Specific Research on Herbs in Quit Tea
There have been studies done on St Johns Wort for smoking cessation. Of course, there is only about 210 mg of St Johns Wort in each cup of Quit Tea, delivering 2/3s the hyperforin, instead of the standard 300 mg dose in most studies. The studies show that St Johns Wort acts similar to an SSRI like Zyban, which has been approved by the FDA for the on-label indication of smoking cessation. On average, people using Quit Tea drink more than 3 cups a day.
The low amount of Valerian also helps someone through the cravings, but the dose is low enough to not cause drowsiness. Valerian has been studied for insomnia, but in 900 mg single doses. A cup of Quit Tea only has also slightly over 200 mg. People report feeling calm or relaxed, only a few report feeling drowsy.
Red Clover is often cited in studies for smoking cessation. Many of the other herbs have shown to help other aspects important to quitting smoking, such as licorice root for lung health.
There is also a significant amount of evidence to indicate that the “Substitution Strategy” for quitting smoking is the key to long term success. While no studies have been done specifically for smoking cessation, there are many. The most famous is the study of substituting nail grooming for nail biting. And there is much psychological research to show that a new habit can be formed in 66 days.
Temporarily Supports Willpower
The basis for this claim is that the ingredient St Johns Wort is found to have similar response mechanisms as the drug bruproprion, brand name Zyban, which has been tested and approved as a smoking cessation aid.
Cigarette smoking results in nicotine absorption into the blood stream and crosses the blood brain barrier. This in turn causes a release of dopamine into the synaptic cleft of the dopaminergic, pleasure-seeking pathways in the brain. Following a lowering of nicotine intake, dopamine reuptake into the axon terminal vesicles occurs. Bupropion is thought to exert its main effect by inhibiting this dopamine reuptake, probably by its influence on the dopamine transporter system (Warner et al 2005).
St Johns Wort has been studied as a smoking cessation aid. There was some increase in smoking cessation rates, the data was insignificant. However, no significant side-effects were noted with St Johns Wort.
Despite this study being inconclusive, the basis for our claim is a study of St Johns Wort versus standard antidepressants. The conclusion was that St Johns Wort works similarly to an SSRI antidepressant with fewer side effects.
“The available evidence suggests that the hypericum extracts tested in the included trials a) are superior to placebo in patients with major depression; b) are similarly effective as standard antidepressants; c) and have fewer side effects than standard antidepressants. The association of country of origin and precision with effects sizes complicates the interpretation.”
Supports A Quit Smoking Plan
A plan to quit smoking can be something proscribed by a physician or developed with a counselor, help from a expert book, or on one’s own. Quit Tea and Quit Support support adherence to the plan, but reducing the stress and anxiety often associated with making the difficult changes involved in giving up the habit of smoking.
Valerian is often studies for the use of insomnia and has been proven effective. It has also been studied for indications of generalized anxiety disorder.
We claim that Valerian helping to reduce feelings of anxiety helps adherence to a smoking cessation plan.
“Our results suggest that acupuncture and hypnotherapy may help smokers quit. Aversive smoking also may help smokers quit; however, there are no recent trials investigating this intervention. More evidence is needed to determine whether alternative interventions are as efficacious as pharmacotherapies.”
Helps Replace The Habit Of Smoking
Behavioral modification therapy, cognitive behavioral therapy, and other therapies, group and individual are meant to help end the habit of smoking. These therapies address the behavioral aspect of cigarette smoking through mindfulness training, or habit inversion.
We are claiming that Quit Support, in combination with Quit Tea, a smoking alternative, can help replace the habit of smoking. This is often referred to as the Substitution Strategy for Quitting Smoking, replacing one habit with another habit. We are not claiming that these products are behavioral therapies, we are claiming that these products help with the replacement. Quit Tea is a product that mimics that hand to mouth habit of smoking, and Quit Support provides herbs that support that habit inversion for the reasons of the other claims.
Behavioral modification has been shown to be effective for smoking cessation, in group settings, and in individual settings.
“Individual counselling is commonly used to help people who are trying to quit smoking. The review looked at trials of counselling by a trained therapist providing one or more face-to-face sessions, separate from medical care. All the trials involved sessions of more than 10 minutes, with most also including further telephone contact for support. The review found that individual counselling could help smokers quit, but there was not enough evidence about whether more intensive counselling was better.”
“Group programmes are more effective for helping people to stop smoking than being given self-help materials without face-to-face instruction and group support. The chances of quitting are approximately doubled. It is unclear whether groups are better than individual counselling or other advice, but they are more effective than no treatment. Not all smokers making a quit attempt want to attend group meetings, but for those who do they are likely to be helpful.”
Promotes Relaxation & Reduces Stress
We are claiming that the herbs, minerals, and amino acids in Quit Support and Quit Tea help reduce feelings of stress and anxiety. The list of ingredients includes: Ginseng, valerian, St Johns Wort, magnesium, l-theanine, astragalus, gamma amino butyric adic, lemon balm, skullcap, and catnip.
These are called anxiolytics, anxiety reducing ingredients have been studied for smoking cessation, and while the results were not conclusive, they also did not rule out the possibility of anxiety reducing products that help with smoking cessation.
“Anxiety can contribute to increased smoking, and may be a smoking withdrawal symptom. Medications to reduce anxiety (anxiolytics) may theoretically help smokers trying to quit. There have not been many trials, and none of them showed strong evidence of an effect on quitting.”
“There is no consistent evidence that anxiolytics aid smoking cessation, but the available evidence does not rule out a possible effect.”
Improves Lung Health & Function
We are claiming that some of the herbs in Quit Tea and Quit Support helpful for lung health and function. The lung naturally clean themselves out through mucus. Smokers often have a build up of tar in the lungs which prevents the cleaning function in the lungs. After quitting smoking the lung resume clearing themselves out. However, there are herbs that help support this normal process by increasing the fluidity of the mucus in the lungs, and removing mucus as an expectorant.
Mullein is used by herbal practitioners to clear excess mucus from the lungs, cleanse the bronchial tubes, and reduce inflammation that is present in the respiratory tract.
Plantain leaf has been used for hundreds of years to ease cough and soothe irritated mucous membranes. Clinical trials have found it favorable against cough, cold, and lung irritation. Plantain leaf has an added bonus in that it may help relieve a dry cough by spawning mucus production in the lungs.
Licorice is very soothing and softens the mucous membranes of the throat and especially the lungs and stomach and at the same time cleanses any inflamed mucous membrane that needs immune system support. . It reduces the irritation in the throat and yet has an expectorant action. It is the saponins (detergent-like action) that loosen the phlegm in the respiratory tract, so that the body can expel the mucus. Compounds within this root help relieve bronchial spasms and block the free radical cells that produce the inflammation and tightening of the air ways.
These herbs have been known to have expectorant properties, and expectorants have been shown to improve mucus removal from the lungs helping to increase lung health and function. There are many prescription expectorants that have been studies.
To adhere to a smoking cessation plan it requires mental and physical energy, stamina. There are a class of herbs known as adaptogenic. The herbs in Quit Tea and Quit Support that help support adrenal function to increase energy are ginseng root, licorice, and astragalus. Ginseng especially has been studied to help improve mental and physical stamina.
Ginseng has been used to treat disease and to combat aging for thousands of years. Currently, ginseng occupies a prominent position in the herbal “best-sellers” list and is the most widely used herbal product throughout the world. This review aimed to identify all double-blind and single-blind randomized, placebo-controlled trials assessing the effects of ginseng on cognitive function. Five trials investigating the effects of ginseng on healthy participants had extractable information for efficacy and were included in the review. Ginseng appeared to have some beneficial effects on cognition, behavior and quality of life. More rigorously designed studies are needed on this important issue.
Smoking introduces thousands of known toxin into the body through the lungs. We are claiming that the ingredients in Quit Tea and Quit Support support the body’s natural toxin removal process, known as detoxing. The herbs we claim help with detoxing are burdock and milk thistle.
Milk thistle (Silybum marianum (L) Gaertneri) extracts have been used as medical remedies since the time of ancient Greece. The liver deals with a large portion of your body’s toxic load, which is why milk thistle seed extract, which helps to protect and promote liver health, is so important.
An analysis of 16 milk thistle trials by the National Institutes of Health also concluded that the supplement helped protect the liver. Alcohol and hepatotoxic viruses are the major causes of liver diseases. Several trials have studied the effects of milk thistle for patients with liver diseases.