A public interest group this week requested FDA take action against marketers of dietary supplements that claim to help consumers quit smoking, asserting the companies were unable to produce evidence that their products are effective.
Fifteen companies “explicitly or implicitly” claim to help smokers quit smoking or provide treatment for nicotine addiction, but the products lack adequate scientific substantiation to support the claims and are unapproved new drugs, according to the Center for Science in the Public Interest (CSPI).
The products also compete with FDA-approved prescription and over-the-counter (OTC) drugs, despite lacking safety and efficacy review required by FDA for approved drugs, CSPI wrote in a letter to Ned Sharpless, M.D., FDA’s acting commissioner, and other FDA officials. The letter also was sent to Andrew Smith, director of FTC’s Bureau of Consumer Protection.
“Smoking is a leading cause of preventable death, and the FDA has approved prescription and over-the-counter products to help smokers quit,” said Peter G. Lurie, M.D., president of CSPI, in a press release announcing CSPI’s findings and letter to FDA. “These dietary supplement manufacturers offer no evidence to back up their dramatic claims. If these products divert smokers from therapies that actually work and prolong their addiction to tobacco, they are doing real harm.”
According to the U.S. Centers for Disease Control and Prevention (CDC), 34 million Americans smoke tobacco and more than 480,000 deaths are attributed to smoking per year. CDC reports most smokers become addicted to nicotine, a drug found naturally in tobacco, which may be as addictive as heroin, cocaine or alcohol.
According to CSPI, many products display “tempting names,” including EZ Quit, Kick It, Nicoban, Nicotine Quit, Smoke Away and Vice Breaker, as well as “extravagant explicit and implied claims that using the products would help smokers to quit and even make it easy to quit,” such as “stop smoking forever,” “aids in overcoming smoking addiction” and “will help you to become smoke free immediately.”
Among the 15 products cited by the public interest group was Fountain Hills, Arizona-based Greenbush Natural Products’ Organic Red Clover Flowering Tops, which, according to CSPI, claims on its website red clover “has been found to be helpful in quitting smoking.”
CSPI’s letter to FDA noted that, when asked whether scientific studies support the claim, a Greenbush representative pointed to “small scale studies, plus at least one larger scale study in Japan.” However, when questioned again about the studies and recommended dosage, the representative replied, “I haven't been able to find the details of any of the studies, only references to the studies. So I don't know exactly what they were using, or at what dosage.”
The representative added, “Since it is nearly impossible to take too much red clover, the general rule for dosing would be to make sure you are getting enough of it. If you are using the red clover capsules, an average dose would be 2 capsules three times per day.”
Joel Faville, owner of Greenbush Natural Products, presented no qualms about modifying the company’s marketing materials.
“Red clover is not primarily a stop smoking aid,” he said in an email. “If someone pointed out that we should not make any reference to stopping smoking on the red clover page, we would remove it. It is not an essential part of marketing for our red clover.”
Faville added, “We are a small company, and we want to comply with whatever the current policies are.”
At press time, INSIDER’s review of the company website showed the claim is no longer on the company website.
Clear Airways by Edgewater, New Jersey-based Vinity, another supplement marketer named in the letter, claims to “help kick the habit.” Vinity provided a white paper to INSIDER citing studies supporting various botanicals in its product and stated the company should not be on CSPI’s list.
The white paper referenced a study showing Rhodiola rosea L. extract (20 mg/kg) abolished affective and somatic signs in mice induced by nicotine withdrawal in a dose-dependent fashion (J Psychopharmacol. 2011 Mar;25(3):402-10); a study evaluating the effect of Passiflora incarnata Linn. on nicotine sensitization in a rat model (Pharm Biol. 2012 Oct;50(10):1310-6); and others.
CSPI also reviewed claims by West Palm Beach, Florida-based The Quit Company LLC, a marketer, online retailer and information resource providing services and products to help consumers quit smoking. The Quit Company claims the products provide “the nutrients that smokers typically lack, making it easier to adhere to a smoking cessation plan” and helps “temporarily support willpower for a new healthy, smoke-free life," according to CSPI’s letter.
The Quit Company was the only company—per CSPI’s review—to include study links as support for its claims, including a link to a double-blind, placebo-controlled study as substantiation for its Quit Nutrition product. The study showed N-acetylcysteine (NAC), an ingredient contained in the product, led to fewer withdrawal symptoms in heavy smokers who quit smoking for 3.5 days compared to placebo (Eur Addict Res. 2011;17(4):211-6). However, the NAC in its Quit Nutrition product is part of a 975 mg per serving proprietary blend , whereas the study indicated NAC alone at a dose of 3,600 mg/d.
As support for its Quit Support product, the company website provides a link to registration for a study completed in 2012 evaluating the effects of S-Adenosyl-L-methionine (SAMe), an ingredient contained in the product. “SAMe did not increase smoking abstinence rates,” the study concluded. “Abstinence and tobacco withdrawal data from this clinical trial suggest that SAMe holds little promise for the treatment of tobacco dependence.” (J Altern Complement Med. 2012 Sep;18(9):854-9).
Matthew Bucklin, founder of The Quit Company, emphasized the need for more solutions to help smokers.
“In the next century, tobacco will kill 1 billion people globally and cost $100 trillion in treating illness, lost wages and other related expenditures [according to the World Health Organization]," he said in an emailed statement. "The focus for treatment has solely been on the addiction, overlooking all the other reasons smokers continue to use tobacco. The dependency to smoking is a complex set of chemical, psychological, behavioral, neurological and social factors, unique to each individual. The problem is highly complicated, the cost is unsustainable, and the toll on human life is overwhelming. At this point we need more solutions, not fewer."
CSPI also raised concerns over the sale of products containing lobelia, a botanical banned by FDA in OTC smoking cessation supplements in 1993 for lack of evidence of effectiveness, in various products.
Nicoban by Benbrook, Texas-based Supplement Spot, a marketer and online retailer of supplements and personal care products, claims to help consumers “break free from nicotine addiction the natural way” and to “stop smoking in as little as just 7 days,” according to the company website. The product contains lobelia powder, along with other botanicals.
EZ Quit, manufactured by New Zealand-based UltraHealth and sold in the U.S. via Amazon retailer HerboPharma, also names lobelia as the active ingredient powering EZ Quit’s ability to “keep you calm, relaxed and in control to kick the addiction for good.”
Supplement Spot and UltraHealth did not immediately respond to requests for comment. Several other companies mentioned in CSPI’s letter did not immediately respond to inquiries or could not be reached for comment.
But after this article was published, the president of Supplement Spot, Casey Borgers, shared an email he sent directly to CSPI. In an email to CSPI, he said Nicoban has helped many individuals quit smoking.
"It’s been ages since we’ve made any adjustments to the Nicoban product page and we are highly scrutinized by the State of Texas Health Department," Borgers wrote to CSPI. "The state has never had any issues with Nicoban and we find them stricter than the FDA."
But he said Supplement Spot made made some changes to the Nicoban webpage based on observations made in CSPI's letter to FDA.
"I trust that you will review our changes and respond with constructive comments in order to do what’s right by the law and by the consumer," Borgers wrote to CSPI.
In its letter to FDA, CSPI asked the agency to qualify the cited products as an enforcement priority under the agency’s Health Fraud Compliance Policy Guide because the products claim to treat a condition that is significant; the scientific data supporting the efficacy of the products is weak; the consumers seeking treatment are numerous and vulnerable; and the products directly complete with FDA-approved treatments.
The issue at hand is whether claims are lawful and adequately substantiated, an FDA spokesperson said in an email.
“In general, the agency remains concerned when products marketed as dietary supplements are marketed with unsubstantiated or otherwise unlawful claims that could keep some people from accessing appropriate and recognized therapies, such as those to help smokers quit cigarettes,” the agency spokesperson said. “The FDA has and will continue to monitor the marketplace and take action as needed against companies selling products that make these unlawful claims, as well as encourage consumers to avoid purchasing products that claim to prevent, treat or cure diseases without any proof they will work.”
A spokesman for FTC, which polices advertising claims to ensure they are truthful and not deceptive, declined to comment on the letter. But in 2018, at FTC’s request, a federal district court temporarily stopped a company’s advertising of dissolvable oral film strips the agency alleged were deceptively marketed as effective smoking cessation, weight loss and sexual performance aids.
In regulations adopted in 2000, FDA suggested certain smoking-alternative statements are acceptable structure/function claims for dietary supplements, if the claims don’t imply treatment of nicotine addiction, relief of nicotine withdrawal symptoms, or prevention or mitigation of tobacco related illnesses.
Per the Dietary Supplement Health and Education Act of 1994 (DSHEA), structure/function claims must be truthful and not misleading.
Specific examples of possibly acceptable structure/function claims cited by FDA include “smoking alternative,’’ ‘‘temporarily reduces your desire to smoke’’ and ‘‘mimics the oral sensations of cigarette smoke.” But the products must otherwise meet the definition of a dietary supplement, and the context of the claim must 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,” FDA stated in its regulations published in the Federal Register.
Further differentiating between a non-permissible disease claim and a permissible structure/function claim, FDA wrote, “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.”