Andrew C. von Eschenbach, M.D.
Food and Drug Administration
5600 Fishers Lane
Rockville, Maryland 20857
Re: Nico Worldwide, Inc., Manufacturer of “Nic Lite™”
Dear Dr. von Eschenbach:
On behalf of the Campaign for Tobacco-Free Kids (“Campaign”) and Public Citizen Health Research Group (“Public Citizen”), we are writing to urge the Food and Drug Administration (“FDA”) to direct Nico Worldwide, Inc. (“Nico Worldwide”) to immediately cease marketing “Nic Lite™,” a bottled water product containing significant amounts of highly addictive nicotine (two cigarettes worth per 8 ounces), and to initiate an appropriate enforcement action against Nico Worldwide. Although FDA informed Nico Worldwide on June 29, 2006 that Nic Lite™ is an unapproved new drug, not a dietary supplement, Nico Worldwide continues to illegally market and sell Nic Lite™ as a dietary supplement. As described below, since Nico Worldwide has continually and willfully flouted FDA’s consistent rulings that bottled water containing nicotine is a drug, not a dietary supplement, including FDA’s ruling on July 1, 2002 to this effect, and has continued to mislead consumers regarding the nature and safety of Nic Lite™, we also urge FDA to initiate an investigation into whether Nico Worldwide should be prosecuted criminally.
On June 29, 2006, Vasilios H. Frankos, Ph.D., Acting Director, Division of Dietary Supplement Programs, Office of Nutritional Products, Labeling and Dietary Supplements, sent a letter to Joseph R. Knight, Chief Executive Officer of Nico Worldwide, regarding Nico Worldwide’s notice to FDA of its structure/function claim for Nic Lite. In that letter, Dr. Frankos informed Mr. Knight that Nic Lite™ “does not meet the definition of a dietary supplement” and that it is “an unapproved new drug whose marketing violates the [Federal Food, Drug, and Cosmetic Act (“the Act”)].” FDA June 29, 2006, Letter at 1, attached as Exhibit A. Dr. Frankos’s letter served as a warning to Nico Worldwide that it was marketing Nic Lite in violation of the Act. As of July 10, 2006, Nico Worldwide’s websites (www. nicoworldwide.com and www.nichonica.com) are still fully operational. The websites describe Nic Lite™ as a dietary supplement, provide names of retailers who sell Nic Lite™ and assert a series of drug claims (e.g., nicotine can improve learning and has potential for treating Alzheimer’s disease). Even the structure/function claim at issue in Dr. Frankos’s letter still appears on Nico Worldwide’s websites (i.e., “There is substantial evidence that nicotine is present in certain human foods.”). The websites also make unsubstantiated claims about the safety of nicotine, going so far as to describe it as “almost absolutely safe.”
Given Dr. Frankos’s letter, there can be no dispute that, as of June 29, 2006, Nico Worldwide was on notice that it was marketing and selling Nic Lite™ in violation of the Act. There is also strong evidence suggesting that Nico Worldwide knew, or should have known, as early as 2002, that FDA had already determined, in response to a citizen petition filed by the Campaign and seventeen other public health organizations (Docket No. 01P-0573) (“Campaign’s citizen petition”), that bottled water containing nicotine is not considered a dietary supplement under the Act, but instead is considered an unapproved new drug. In addition, Nico Worldwide’s submission in July 2004 of three suitability petitions seeking FDA permission to market Nic Lite™ as a generic drug and the agency’s rejection of one of those petitions provides further evidence that Nico Worldwide has known, at least since July 2004, that Nic Lite™ was an unapproved new drug under the Act. The nature of the Campaign’s citizen petition and FDA’s ruling are described below, as are the suitability petitions submitted by Nico Worldwide.
Campaign’s Citizen Petition
On December 18, 2001, the Campaign and seventeen other public health organizations filed a citizen petition with the FDA regarding Nicotine Water, a bottled water product containing nicotine that was manufactured at the time by another company, S & F Garret and later by its successor-in-interest, Quicktest 5. The petition argued that Nicotine Water was a drug for purposes of the Act, and not a dietary supplement. The petition argued in the alternative that Nicotine Water was a “food” containing a hazardous, unapproved food additive (nicotine) under the Act. On July 1, 2002, FDA granted the petition.
In its letter granting the petition, FDA explained that Nicotine Water was not a dietary supplement because “the principal active ingredient in Nicotine Water is nicotine or nicotine polacrilex. Both are active ingredients in FDA-approved drugs (including Nicoderm CQ, Prostep, Habitrol, and Nicorette).” FDA July 1, 2002 Letter, at 5, attached as Exhibit B. FDA further concluded that: “As marketed, Nicotine Water is a drug; and [as] marketed, Nicotine Water is a new drug and an unapproved new drug.” Id. S & F Garret had “promoted and described Nicotine Water as useful in the treatment or mitigation of [nicotine addiction, a] disease.” Id.
FDA’s decision on Nicotine Water was highly publicized. A press release posted on FDA’s website and articles appearing in The New York Times and The Washington Post announced FDA’s ruling that Nicotine Water was an unapproved drug, not a dietary supplement. See, e.g., Sherri Day, “Nicotine-Laced Water Is A Drug, F.D.A. Rules,” The New York Times, July 3, 2002 (“Federal regulators said yesterday that nicotine-laced bottled water, which is being marketed as a dietary supplement, is an unapproved drug and cannot be sold in the United States without federal clearance.”); Marc Kaufman, “Nicotine Water is Drug, FDA Ban Says,” The Washington Post, July 3, 2002 (“The Food and Drug Administration ruled yesterday that nicotine water – advertised widely as an alternative to smoking – is an unapproved drug and cannot be sold to consumers. In announcing the ban, the FDA said that the company making Nico Water had improperly claimed that the product was a dietary supplement that didn’t need approval by the agency.”). Accordingly, news of FDA’s ruling on Nicotine Water was readily available to Nico Worldwide, and it was incumbent on the company to ascertain FDA’s position on nicotine water products before labeling and marketing Nic Lite™as a dietary supplement.
Nico Worldwide’s Suitability Petitions
On July 2, 2004, Nico Worldwide, LLC (presumably a predecessor or affiliate of Nico Worldwide) submitted three suitability petitions to FDA requesting permission to file an Abbreviated New Drug Application (“ANDA”) for the following three nicotine water products: (1) water containing nicotine (Docket No. 2004P-0281); (2) water containing nicotine polacrilex (Docket no. 2004P-280); and (3) water containing nicotine base bitartrate (Docket No. 2004P-282). The petitions asserted that the three different versions of Nic Lite™ were nothing more than different dosage forms of the approved GlaxoSmithKline drug, Commit®, a smoking cessation product in lozenge form.
On May 26, 2005, FDA denied the petition for the nicotine polacrilex product, and in doing so stated: “The Agency has determined that [Nico Worldwide’s] proposed change in dosage form raises questions of safety and effectiveness, and has concluded that clinical trials are required for these specific drug products.” FDA May 26, 2005, Letter at 1, attached as Exhibit C. According to the chronological list of petitions and advisory opinions posted on FDA’s website, the petitions for Nico Worldwide’s nicotine product and nicotine base bitartrate product are still pending.
Nico Worldwide’s submission of the three suitability petitions to FDA demonstrates that Nico Worldwide knew in July 2004 that Nic Lite™was an unapproved drug. Therefore, Nico Worldwide has knowingly and intentionally been marketing and selling an illegal product.
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Based on the foregoing, the Campaign and Public Citizen request that FDA direct Nico Worldwide to cease marketing Nic Lite™ immediately, initiate an appropriate enforcement proceeding, including seizure, if necessary, against Nico Worldwide and open an investigation into whether Nico Worldwide should be prosecuted criminally.
Sidney M. Wolfe, M.D.
1600 20th Street, N.W.
Washington, D.C. 20009
TEL: (202) 588-7735
FAX: (202) 588-7796
Director, Public Citizen’s
Health Research Group
William B. Schultz
Alexandra W. Miller
Zuckerman Spaeder LLP
1800 M Street, N.W.
Washington, D.C. 20036
TEL: (202) 778-1800
FAX: (202) 822-8106
Counsel for Campaign for Tobacco-Free Kids
cc: Sheldon T. Bradshaw, Chief Counsel
Margaret O’K. Glavin, Associate Commissioner for Regulatory Affairs
Deborah M. Auter, Director, Office of Compliance,
Center for Drug Evaluation and Research