I received some news today that shocked me (if it is not simply a lie). And that is that the Chair of the Senate Health Committee apparently believes that S7234/A9529 does NOT ban the sale of ecigs to adults, but only to minors.
I immediately wrote an email to him and all the members of the Senate Health Committee (and to the staffer/director of the Health Committee). I will also be snail mailing it. I am posting it here instead of the CASAA forum because I was so agitated by the news I didn't want to wait and consult with everybody, so wrote it as an individual. Here it is, in the hopes that others will incorporate some of its thrust into their contacts with Senators, as we still need to push very hard to defeat S7234:
The Honorable Thomas K. Duane
Chair, Senate Health Committee
430 State Capitol Building
Albany, NY 12247
Re: S7234 - Currently pending before Senate Health Committee
Would it ban sales to adult consumers, or only sales to minors?
Dear Senator Duane:
It has come to my attention that you are of the belief that S7234, if passed as currently written, would only ban sales of electronic cigarettes to minors. Indeed, that is what S6621 would accomplish, and I would support that bill without reservation.
However, S7234 is identical to A9529, and Linda Rosenthal, its Assembly sponsor, has gone on record stating that it is intended, in fact, to ban the sale of electronic cigarettes to adults, as well as to minors. You can hear her state this explicitly within the first four minutes of this recording of the discussion in the Assembly on April 21, 2010, held just prior to the unfortunate passage of A9529. http://www.youtube.com/watch?v=Yc2iMn7EZ5Q
It is Section 2 of S7234/A9529 that creates the problem for adult consumers. It states, in part:
S 2. The public health law is amended by adding a new section 1399-mm-1 to read as follows:
S 1399-MM-1. PROHIBITION OF PRODUCTS NOT DEFINED AS tobacco PRODUCTS OR APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION. 1. PRODUCTS CONTAINING OR DELIVERING NICOTINE INTENDED OR EXPECTED FOR HUMAN CONSUMPTION THAT ARE NOT tobacco PRODUCTS, AS DEFINED IN SECTION THIRTEEN HUNDRED NINETY-NINE-AA OF THIS ARTICLE, SHALL NOT BE DISTRIB UTED OR SOLD UNLESS SUCH PRODUCTS HAVE BEEN APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION FOR SALE AS TOBACCO USE CESSATION OR HARM REDUCTION PRODUCTS OR FOR OTHER MEDICAL PURPOSES AND ARE BEING MARKETED AND SOLD SOLELY FOR THAT APPROVED PURPOSE.
Assembly Member Rosenthal is acting under the misguided and mistaken impression that electronic cigarettes are not “tobacco products”, but are rather smoking cessation aids, and she intends that her bill require prior approval of the products by the FDA before they should be allowed to be sold in New York State at all.
Thus should S7234/A9529 pass as written, it is evident that the legislation would invite litigation precisely on the question whether electronic cigarettes are “tobacco products” allowed to be sold to adult consumers in New York, or instead are prohibited altogether unless and until “approved” by the FDA.
This result would be tragic indeed for the thousands of New York consumers who have already made the switch from traditional tobacco cigarettes to the smokeless and thus orders of magnitude less harmful electronic cigarette, and for the multitudes who would be prevented from doing so in the near future.
The likely litigation would also constitute a legal battle that, I submit, is not appropriately carried out on the state level at all, but that rather should be deferred to the federal courts, in the midst of deciding it as we speak. (Smoking Everywhere v. FDA, Civil Case No. 09-771 (RJL) now on interlocutory appeal, with the briefing schedule in the Court of Appeals set to conclude by July 22, 2010, with a view toward oral argument in September 2010).
Key to understanding the current rather unclear legal status of electronic cigarettes in the US at this time is that when they were first imported, the FDA had no regulatory oversight whatsoever over tobacco products. See, FDA v. Brown & Williamson, 529 U.S. 120 (2000), http://www.law.cornell.edu/supct/html/98-1152.ZS.html.
First imported into the US in late 2006 or early 2007, electronic cigarettes were never intended as a “smoking cessation” device, but rather simply as an alternative to smoking conventional cigarettes. (The first import ruling locatable at the US Customs and Border Protection website is dated August 22, 2006. http://rulings.customs.gov/index.asp?p=4&qu=electronic+cigarette).
However, as sales and consumption of electronic cigarettes grew exponentially within the US, cutting into the profits of pharmaceutical and tobacco industry giants alike, by early 2009 the FDA began detaining shipments and issuing letters to retailers, as well as statements to the media, informing that it now regarded electronic cigarettes it had reviewed to be “new drugs” requiring approval under Chapter 5 of the FDCA before being marketed in the US. For example, here is the statement of one FDA spokesperson as reported at News24 on February 28, 2009:
"In the US, the Food and Drug Administration has "detained and refused" several brands of electronic cigarettes because they were considered unapproved new drugs and could not be legally marketed in the country, said press officer Christopher Kelly. He did not give more details, but said the determination of whether an e-cig is a drug is made on a case-by-case basis after the agency considers its intended use, labeling and advertising." http://www.news24.com/News24/Technol...477587,00.html
That FDA detention and refusal of electronic cigarette shipments into the US ultimately resulted in the lawsuit cited above, currently pending in the US District Court for the District of Columbia, filed in April 2009 by Smoking Everywhere and later joined by NJOY. The court was asked to enjoin the FDA from regulating electronic cigarette products as a drug device combination, and from denying their entry into the US.
Of major import during the pendency of the lawsuit, on June 22, 2009 the Family Smoking Prevention and Tobacco Control Act (FSPTCA) was signed into law, granting regulatory authority over tobacco products to the FDA for the first time in US history. The parties fully briefed the impact this new legislation would have on the issues presented in the lawsuit, and the District Court’s decision granting a preliminary injunction in favor of Smoking Everywhere and NJOY was rendered on January 14, 2010. http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf
The court agreed with the plaintiffs that the FSPTCA supported their argument that electronic cigarettes were not subject to regulation as a drug or drug-device combination: “Under the Tobacco Act, FDA may now regulate tobacco products, which the Act defines as ‘any product made or derived from tobacco that is intended for human consumption,’ 21 U.S.C. §321 (rr) (l), but it cannot regulate those products as it would a drug or device under the FDCA, id. §387a (a). There being no dispute that the nicotine in plaintiffs' electronic cigarettes is naturally distilled from actual tobacco and is intended for human consumption (FDA Supp. Br. [#41] at 5 n.3), plaintiffs assert that their electronic cigarettes qualify as a tobacco product and are therefore exempt from regulation as a drug-device combination.” Id, at 9-10.
The court also agreed with the plaintiffs that the fact that they advertise their products as a healthier alternative to traditional smoking does not mean that electronic cigarettes qualify as a drug-device combination under the FDCA: “The Court has already concluded based on the information before it that the electronic cigarettes marketed by plaintiffs are not intended for treating the disease of nicotine addiction. To the extent those products are marketed as providing the same experience as traditional cigarettes but without the negative health consequences associated with tar and smoke, they fall within the plain meaning of ‘modified risk tobacco product,’ which the Tobacco Act defines as any tobacco product ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.’ ld. §387k(b)(1). To treat as a drug any tobacco product that merely claims to be a healthier alternative would effectively nullify the provisions relating to modified risk tobacco products, which represent Congress's implicit acknowledgment that those products were outside of FDA's jurisdiction prior to the Tobacco Act.” Id, at 25-26.
Thus the court went on to rule: “In sum, absent substantial evidence of the manufacturer's objective intent that its electronic cigarettes affect the structure or function of the body in a way distinguishable from ‘customarily marketed’ tobacco products or that its electronic cigarettes have the therapeutic purpose of treating nicotine withdrawal, there is no basis for FDA to treat electronic cigarettes, as they are marketed by the plaintiffs in this case, as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette. Thus, the plaintiffs are substantially likely to succeed on their claim that FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA.” Id, at 26.
To the FDA’s claims that electronic cigarettes constituted a danger to public health, the court responded: “While FDA's interest in protecting public health and safety is, in the abstract, paramount to plaintiffs' purely economic interests, given the particular facts and circumstances of this case, I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public. Furthermore, now that FDA has regulatory power over electronic cigarettes through the Tobacco Act, any harm to the public interest or to third parties caused by an injunction that merely forbids FDA from regulating electronic cigarettes as a drug-device combination is greatly diminished.” Id, at 30-31.
In sum, given the ever mounting evidence that electronic cigarettes are in fact a much healthier alternative to smoking conventional cigarettes for those who choose to switch to them instead (see links below), it would be a devastating blow to public health in New York State for lawmakers to blindly follow the disingenuous and misleading statements of those working to effect their outright ban, primarily lobbyists for so-called health groups who are merely fronting for their funders in the pharmaceutical industry.
http://www.aaphp.org/special/joelstobac/ecigcontext.pdf
http://tobaccoanalysis.blogspot.com/2009/07/comparison.html
http://www.harmreductionjournal.com/content/6/1/29
http://www.healthnz.co.nz/2010%20Bullen%20ECig.pdf
http://www.newswire.co.nz/2010/04/health-campaigner-e-ciggies-a-step-towards-ending-nicotines-evil/
http://tobaccoharmreduction.org/wpapers/011v1.pdf
Thus I urge you to either amend S7234 to delete its possibly ambiguous but definitely contentious section 2, thereby rendering it a sensible bill to prohibit the sale of electronic cigarettes to minors only, or reject it altogether and instead support S6621, which already unambiguously prohibits sale to minors only.
Very truly yours,
Yolanda Villa, Esq.
xc: Denise Soffel, Ph.D.
Senate Health Committee members
I immediately wrote an email to him and all the members of the Senate Health Committee (and to the staffer/director of the Health Committee). I will also be snail mailing it. I am posting it here instead of the CASAA forum because I was so agitated by the news I didn't want to wait and consult with everybody, so wrote it as an individual. Here it is, in the hopes that others will incorporate some of its thrust into their contacts with Senators, as we still need to push very hard to defeat S7234:
The Honorable Thomas K. Duane
Chair, Senate Health Committee
430 State Capitol Building
Albany, NY 12247
Re: S7234 - Currently pending before Senate Health Committee
Would it ban sales to adult consumers, or only sales to minors?
Dear Senator Duane:
It has come to my attention that you are of the belief that S7234, if passed as currently written, would only ban sales of electronic cigarettes to minors. Indeed, that is what S6621 would accomplish, and I would support that bill without reservation.
However, S7234 is identical to A9529, and Linda Rosenthal, its Assembly sponsor, has gone on record stating that it is intended, in fact, to ban the sale of electronic cigarettes to adults, as well as to minors. You can hear her state this explicitly within the first four minutes of this recording of the discussion in the Assembly on April 21, 2010, held just prior to the unfortunate passage of A9529. http://www.youtube.com/watch?v=Yc2iMn7EZ5Q
It is Section 2 of S7234/A9529 that creates the problem for adult consumers. It states, in part:
S 2. The public health law is amended by adding a new section 1399-mm-1 to read as follows:
S 1399-MM-1. PROHIBITION OF PRODUCTS NOT DEFINED AS tobacco PRODUCTS OR APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION. 1. PRODUCTS CONTAINING OR DELIVERING NICOTINE INTENDED OR EXPECTED FOR HUMAN CONSUMPTION THAT ARE NOT tobacco PRODUCTS, AS DEFINED IN SECTION THIRTEEN HUNDRED NINETY-NINE-AA OF THIS ARTICLE, SHALL NOT BE DISTRIB UTED OR SOLD UNLESS SUCH PRODUCTS HAVE BEEN APPROVED BY THE UNITED STATES FOOD AND DRUG ADMINISTRATION FOR SALE AS TOBACCO USE CESSATION OR HARM REDUCTION PRODUCTS OR FOR OTHER MEDICAL PURPOSES AND ARE BEING MARKETED AND SOLD SOLELY FOR THAT APPROVED PURPOSE.
Assembly Member Rosenthal is acting under the misguided and mistaken impression that electronic cigarettes are not “tobacco products”, but are rather smoking cessation aids, and she intends that her bill require prior approval of the products by the FDA before they should be allowed to be sold in New York State at all.
Thus should S7234/A9529 pass as written, it is evident that the legislation would invite litigation precisely on the question whether electronic cigarettes are “tobacco products” allowed to be sold to adult consumers in New York, or instead are prohibited altogether unless and until “approved” by the FDA.
This result would be tragic indeed for the thousands of New York consumers who have already made the switch from traditional tobacco cigarettes to the smokeless and thus orders of magnitude less harmful electronic cigarette, and for the multitudes who would be prevented from doing so in the near future.
The likely litigation would also constitute a legal battle that, I submit, is not appropriately carried out on the state level at all, but that rather should be deferred to the federal courts, in the midst of deciding it as we speak. (Smoking Everywhere v. FDA, Civil Case No. 09-771 (RJL) now on interlocutory appeal, with the briefing schedule in the Court of Appeals set to conclude by July 22, 2010, with a view toward oral argument in September 2010).
Key to understanding the current rather unclear legal status of electronic cigarettes in the US at this time is that when they were first imported, the FDA had no regulatory oversight whatsoever over tobacco products. See, FDA v. Brown & Williamson, 529 U.S. 120 (2000), http://www.law.cornell.edu/supct/html/98-1152.ZS.html.
First imported into the US in late 2006 or early 2007, electronic cigarettes were never intended as a “smoking cessation” device, but rather simply as an alternative to smoking conventional cigarettes. (The first import ruling locatable at the US Customs and Border Protection website is dated August 22, 2006. http://rulings.customs.gov/index.asp?p=4&qu=electronic+cigarette).
However, as sales and consumption of electronic cigarettes grew exponentially within the US, cutting into the profits of pharmaceutical and tobacco industry giants alike, by early 2009 the FDA began detaining shipments and issuing letters to retailers, as well as statements to the media, informing that it now regarded electronic cigarettes it had reviewed to be “new drugs” requiring approval under Chapter 5 of the FDCA before being marketed in the US. For example, here is the statement of one FDA spokesperson as reported at News24 on February 28, 2009:
"In the US, the Food and Drug Administration has "detained and refused" several brands of electronic cigarettes because they were considered unapproved new drugs and could not be legally marketed in the country, said press officer Christopher Kelly. He did not give more details, but said the determination of whether an e-cig is a drug is made on a case-by-case basis after the agency considers its intended use, labeling and advertising." http://www.news24.com/News24/Technol...477587,00.html
That FDA detention and refusal of electronic cigarette shipments into the US ultimately resulted in the lawsuit cited above, currently pending in the US District Court for the District of Columbia, filed in April 2009 by Smoking Everywhere and later joined by NJOY. The court was asked to enjoin the FDA from regulating electronic cigarette products as a drug device combination, and from denying their entry into the US.
Of major import during the pendency of the lawsuit, on June 22, 2009 the Family Smoking Prevention and Tobacco Control Act (FSPTCA) was signed into law, granting regulatory authority over tobacco products to the FDA for the first time in US history. The parties fully briefed the impact this new legislation would have on the issues presented in the lawsuit, and the District Court’s decision granting a preliminary injunction in favor of Smoking Everywhere and NJOY was rendered on January 14, 2010. http://www.casaa.org/files/SE-vs-FDA-Opinion.pdf
The court agreed with the plaintiffs that the FSPTCA supported their argument that electronic cigarettes were not subject to regulation as a drug or drug-device combination: “Under the Tobacco Act, FDA may now regulate tobacco products, which the Act defines as ‘any product made or derived from tobacco that is intended for human consumption,’ 21 U.S.C. §321 (rr) (l), but it cannot regulate those products as it would a drug or device under the FDCA, id. §387a (a). There being no dispute that the nicotine in plaintiffs' electronic cigarettes is naturally distilled from actual tobacco and is intended for human consumption (FDA Supp. Br. [#41] at 5 n.3), plaintiffs assert that their electronic cigarettes qualify as a tobacco product and are therefore exempt from regulation as a drug-device combination.” Id, at 9-10.
The court also agreed with the plaintiffs that the fact that they advertise their products as a healthier alternative to traditional smoking does not mean that electronic cigarettes qualify as a drug-device combination under the FDCA: “The Court has already concluded based on the information before it that the electronic cigarettes marketed by plaintiffs are not intended for treating the disease of nicotine addiction. To the extent those products are marketed as providing the same experience as traditional cigarettes but without the negative health consequences associated with tar and smoke, they fall within the plain meaning of ‘modified risk tobacco product,’ which the Tobacco Act defines as any tobacco product ‘sold or distributed for use to reduce harm or the risk of tobacco-related disease associated with commercially marketed tobacco products.’ ld. §387k(b)(1). To treat as a drug any tobacco product that merely claims to be a healthier alternative would effectively nullify the provisions relating to modified risk tobacco products, which represent Congress's implicit acknowledgment that those products were outside of FDA's jurisdiction prior to the Tobacco Act.” Id, at 25-26.
Thus the court went on to rule: “In sum, absent substantial evidence of the manufacturer's objective intent that its electronic cigarettes affect the structure or function of the body in a way distinguishable from ‘customarily marketed’ tobacco products or that its electronic cigarettes have the therapeutic purpose of treating nicotine withdrawal, there is no basis for FDA to treat electronic cigarettes, as they are marketed by the plaintiffs in this case, as a drug-device combination when all they purport to do is offer consumers the same recreational effects as a regular cigarette. Thus, the plaintiffs are substantially likely to succeed on their claim that FDA cannot regulate and thereby exclude their electronic cigarettes from the United States on the basis that those products are an unapproved drug-device combination under the FDCA.” Id, at 26.
To the FDA’s claims that electronic cigarettes constituted a danger to public health, the court responded: “While FDA's interest in protecting public health and safety is, in the abstract, paramount to plaintiffs' purely economic interests, given the particular facts and circumstances of this case, I am not convinced that the threat to the public interest in general or to third parties in particular is as great as FDA suggests. Together, both Smoking Everywhere and NJOY have already sold hundreds of thousands of electronic cigarettes, yet FDA cites no evidence that those electronic cigarettes have endangered anyone. Nor has FDA cited any evidence that electronic cigarettes are any more an immediate threat to public health and safety than traditional cigarettes, which are readily available to the public. Furthermore, now that FDA has regulatory power over electronic cigarettes through the Tobacco Act, any harm to the public interest or to third parties caused by an injunction that merely forbids FDA from regulating electronic cigarettes as a drug-device combination is greatly diminished.” Id, at 30-31.
In sum, given the ever mounting evidence that electronic cigarettes are in fact a much healthier alternative to smoking conventional cigarettes for those who choose to switch to them instead (see links below), it would be a devastating blow to public health in New York State for lawmakers to blindly follow the disingenuous and misleading statements of those working to effect their outright ban, primarily lobbyists for so-called health groups who are merely fronting for their funders in the pharmaceutical industry.
http://www.aaphp.org/special/joelstobac/ecigcontext.pdf
http://tobaccoanalysis.blogspot.com/2009/07/comparison.html
http://www.harmreductionjournal.com/content/6/1/29
http://www.healthnz.co.nz/2010%20Bullen%20ECig.pdf
http://www.newswire.co.nz/2010/04/health-campaigner-e-ciggies-a-step-towards-ending-nicotines-evil/
http://tobaccoharmreduction.org/wpapers/011v1.pdf
Thus I urge you to either amend S7234 to delete its possibly ambiguous but definitely contentious section 2, thereby rendering it a sensible bill to prohibit the sale of electronic cigarettes to minors only, or reject it altogether and instead support S6621, which already unambiguously prohibits sale to minors only.
Very truly yours,
Yolanda Villa, Esq.
xc: Denise Soffel, Ph.D.
Senate Health Committee members
Last edited:
BRAVA!
