Consumer advocacy group presses FDA to take enforcement against smoking-cessation drugs sold as supplements

In the letter, CSPI said that it investigated 15 companies selling smoking-cessation products on Amazon.com or advertising smoking-cessation supplements on the internet. The organization characterized its findings as “disturbing​.”

“The unapproved products described in this letter bear claims that are remarkably similar to those on [FDA-approved] products and risk diverting consumers from these proven-effective products​,” according to the letter, referring to OTC drugs such as Chantix, Zyban, and Nicotrol.

Out of the 15 contacted companies, CSPI said 10 companies responded while five did not, despite repeated inquiries. CSPI had asked these companies to provide evidence of their products’ claims, and of those responding:

• 4 claimed they knew of studies, but didn’t specify any (even when asked);
• 2 claimed their evidence was positive customer reviews;
• 2 conceded they had no studies;
• 1 claimed traditional use in China; and
• 1 offered no studies or evidence.

The full letter and list of companies can be found HERE​​

“These products warrant FDA enforcement action under the agency’s own principles for enforcement priorities for unapproved drugs,”​ CSPI argued in its letter, addressed to Acting FDA Commissioner Ned Sharpless.

In a press release announcing the letter, CSPI highlighted that enforcement against these companies should be a priority under the agency’s Health Fraud Compliance Policy Guide, since “those seeking treatment are numerous and vulnerable, and the supplements directly compete with FDA-approved treatments.​”

Supplement trade groups: ‘We’re happy to work with [CSPI]’​

The Council for Responsible Nutrition, a dietary supplements industry trade group, said it shared the concerns of CSPI about products mismarketed as dietary supplements that claim to help address smoking cessation.

“​​FDA has long considered nicotine addiction to be a disease and claims to help treat it as being the purview of drugs, not supplements,”​ Steven Mister, president and CEO of CRN, told us. “We join CPSI in this regard to urge FDA to use its legal authority and take action against products fraudulently marketed as dietary supplements. The mainstream dietary supplement industry is committed to providing consumers with high-quality products that promote better health and wellness.”​

The Natural Products Association, another dietary supplements trade group, emphasized that smoking cessation has been regarded as a disease claim “and rightfully so”​ since the final structure/function rule was established.

But NPA’s president and CEO, Dr Daniel Fabricant, PhD, said that he is not sure what CSPI was trying to accomplish with the press release. “Smoking cessation claims are already illegal; do they want them to be ‘super-illegal?’”​ he told us.

“Why not turn over leads to the agency and ask for enforcement, being productive versus just trying to stay in the headlines? Or if they are uncomfortable turning over leads we’re happy to work with them through affiliates like the Natural Products Foundation who frequently refer matters of concern to the regulators,” ​he said.