FDA Urged To Crack Down On Supplements For Nicotine Addiction

The Center for Science in the Public Interest urges the US Food and Drug Administration to seize products from marketers of 15 dietary supplements that claim to treat nicotine addiction. In an April 24 letter, the advocacy group says none of the marketers could present evidence in support of claims promising quick relief from addiction and/or results comparable to FDA-approved Rx and OTC drug products.

The US Food and Drug Administration should take enforcement action against marketers of 15 dietary supplements making unsupported claims to treat nicotine addiction, says food and health advocacy group the Center for Science in the Public Interest.

“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 addition to tobacco, they are doing real harm,” CSPI President Peter Laurie said in a statement April 24, the same day the firm sent a letter to FDA Center for Drug Evaluation and Research Director Janet Woodcock.

With the exception of two products, all formulas named in the letter are marketed by US-based companies (see table). They include Eliminiction from Always Be Healthy, LLC, Kick It (Grandma’s Herbs) and Nicoban (Supplement Spot).

The non-US-manufactured products are EZ Quit, from Christchurch, New Zealand-based UltraHealth and Vice Breaker from Ontario-based Nutratec Life Sciences.

In the letter, also addressed to Steven Tave, director of the Office of Dietary Supplement Programs, and Ned Sharpless, FDA acting commissioner, CSPI points out that smoking is responsible for nearly one in five deaths in the US, or 480,000 deaths a year. FDA-approved smoking cessation products can be the difference for the less than 10% of smokers who successfully quit every year, the watchdog notes.   

“Smoking is a leading cause of preventable death, and the FDA has approved prescription and over-the-counter products to help smokers quit,” observes Laurie, who also served as associate commissioner of FDA from 2014 to 2017.

FDA has approved two prescription drugs – Pfizer Inc.’s Chantix (varenicline) and GlaxoSmithKline PLC’s Zyban (buproprion) – as well as OTC nicotine replacement therapies consisting of patches, gums and lozenges.

OTC cessation aids include Johnson & Johnson’s Nicoderm patch (nicotine 7mg, 14mg or 21mg) and Nicorette gum (nicotine polacrilex) and Dr. Reddy's Laboratories Ltd.’s Habitrol patch (nicotine 7mg, 14mg or 21mg).

CSPI urges the agency to identify the dietary supplements as “indirect health hazards” under the agency’s 2015 Health Fraud Compliance Policy Guide, which establishes how the agency targets the most urgent public health issues, categorizing the biggest priorities into direct and indirect hazards.

“Those seeking treatment are both numerous and vulnerable” and the products directly compete with FDA-approved treatments, the non-profit says.

The products also align with the agency’s principles for unapproved drug enforcement priorities under the Federal Food, Drug and Cosmetic Act, including lacking evidence of effectiveness and competing with lawfully marketed drugs, CPSI says.

According to the consumer advocacy group, the products are misbranded because they do not have an approved new drug application or an abbreviated new drug application, as needed for products carrying drug claims.

“We respectfully urge the FDA to issue warning letters and bring other enforcement actions that require cessation of sales of these and other such products and allow inspectors to seize products,” CSPI says.

‘Excellent Alternative’? ‘Better Option’?

CPSI identified the products on Amazon and other online retail sites, where the supplements were promoted with “extravagant explicit and implied claims,” CPSI said. These included Nicoban’s claim that its product could help consumers “stop smoking forever” and EZ Quit’s promise to “help you to become smoke-free immediately.”

Some of the offending products claimed to be as effective or more effective than FDA-approved smoking-cessation products, the watchdog group says. For example, Clear Airways is promoted as an “excellent alternative to patches, gums, lozenges,” and Eliminiction is positioned as a “better option” than Chantix and Nicorette.

One company – Health Formula Inc. – says its NicRx product contains herbal formula lobelia to help consumers quit smoking and reduce nicotine withdrawal and addiction. CPSI notes that FDA banned lobelia-containing smoking cessation products from the OTC marketplace in 1993 because there was no credible evidence that it worked in helping with nicotine addiction.

The watchdog group contacted the 15 companies selling smoking-cessation supplements online and asked them for evidence that their products facilitated quitting, the advocacy group noted. Only about half the companies responded and of those:

• four claimed they knew of studies but didn’t specify any;

• two claimed evidence was positive customer reviews;

• two conceded they had no studies; and

• one claimed traditional use in China as support.

FDA: Action Will Be Taken ‘As Needed’

An FDA representative acknowledged that the agency received CSPI’s letter.

“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 rep said.

The rep added, “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.”

The agency notes it has taken a number of steps to support development of safe and effective novel nicotine replacement therapies to help smokers kick the habit. For example, FDA’s Nicotine Steering Committee created in late 2017 has helped develop a more flexible framework to support innovation to that end. (Also see "FDA's Nicotine Replacement Standards Review Could Open Door For E-Cigarettes" - HBW Insight, 29 Nov, 2017.)

The agency has also released two related draft guidances, the first released in August 2018 and the second in February 2019. (Also see "FDA Helps E-Cigarettes Navigate NDA Process With Nonclinical Tests Guidance" - HBW Insight, 3 Aug, 2018.)

CPSI suggested FDA should take the same “strong action” it did in January 2018 in response to a letter from the non-profit in December 2017 identifying unapproved drugs marketed for the treatment of opioid addiction. In that letter, the nonprofit identified eight supplement products making opioid-withdrawal claims without sufficient science to support the statements. (Also see "Opioid-Withdrawal 'Aids' Warrant Immediate FDA, FTC Action – CSPI" - HBW Insight, 15 Dec, 2017.)

FDA and the Federal Trade Commission, which also was notified, subsequently announced joint warning letters to 11 US firms regarding 12 products identified as unapproved drugs.  (Also see "Drug Abuse Withdrawal Supplement Marketers Warned, Claims And Sales Continue" - HBW Insight, 24 Jan, 2018.)

 

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