Nicotine water not a supplement, says FDA
violates the Federal Food, Drug and Cosmetic Act and is not a
dietary supplement - a move that could potentially counter
criticism the agency is negligent and does not fulfill its
regulatory mandate.
NICLite, marketed by Californian company Nichonica as a dietary supplement, was first sold in April to smokers at Los Angeles International Airport as a means to tide them over during smoke-free flights. But following a letter from the American Herbal Products Association (AHPA), the US Food and Drug Administration wrote to Nichonica denouncing NICLite's structure-function claim.
The case highlights the gray area surrounding FDA's jurisdiction over dietary supplements and the agency's questionable ability to protect consumers or the credibility of dietary supplement makers.
The FDA determined in 2002 that products described as "nicotine water" should be regarded as unapproved new drugs and not dietary supplements.
Nonetheless, Nichonica wrote to the agency on two occasions - in August 2004 and October 2005 - notifying it of their structure function claim.
"Dietary nicotine may help maintain a healthy smoke free lifestyle," it was written in the second Nichonica letter.
There are four milligrams of nicotine in each eight-ounce bottle of NICLite and the company claims the product "will help change the way many people think about nicotine and also enhance a countless number of lives".
Nichonica backs its dietary supplement claim by citing a 1993 New England Journal of Medicine article:
"There is considerable evidence that nicotine is present in certain human foods, especially plants from the family Solanaceae (such as potatoes, tomatoes, and eggplant). Of course, the route of absorption is quite different in eating as compared with inhaling."
However, the company does not give any indication as to how nicotine could be beneficial. The crux of the controversy however is in its self-proclamation as a dietary supplement.
"NICLite is classified as a Dietary Supplement by the FDA, and is the only Nicotine Replacement Product that has the added health benefit of drinking purified, clean tasting water," claims Nichonica on its product website.
While the justification the company uses for its claim is vague, the FDA's response on this issue is anything but:
"This letter is to advise you that NICLite does not meet the definition of a dietary supplement," wrote Vasilios Frankos, acting director of the FDA's Division of dietary supplement programs, "Rather…this product is an unapproved new drug whose marketing violates the FD&C Act."
But some would argue that leniency on the part of the FDA has brought about infringements by rogue products such as NICLite.
Under the Dietary Supplement Health and Education Act (DSHEA), the FDA only oversees post-market approval of dietary supplements, unlike drugs which require pre-market approval.
In the past, it was not this regulatory distinction that led supplement makers to criticize the FDA, but rather the agency's supposed lack of post-market enforcement.
As part of DSHEA, the FDA approves new dietary ingredients not used in food or dietary supplements before 1994.
"Given our understanding that nicotine was not marketed as a dietary supplement or as a food before its authorization for investigation as a new drug, a product that includes nicotine is not a dietary supplement," wrote Frankos in the letter, "If you have any evidence to the contrary, please let us know."
The FDA letter, addressed to Nichonica CEO Joseph Knight, concludes that NICLite cannot be legally marketed, yet does not issue any specific warning or threats of action that will be taken.
A recent ABC News story brought attention to NICLite, which prompted AHPA to write to the FDA.
Nichonica did not return NutraIngredients-USA.com's phone calls in time for publication of this article.
In a June statement, the maker of NICLite said it planned to launch the product in more than 50 airports across the US.
