The Health Ministry announced on Sunday to the High Court of Justice that it is adopting the view that the new cigarettes (IQOS) produced by tobacco giant Philip Morris will be defined as a “tobacco product” and be subject to all the restrictions applying to cigarettes and smoking.
In addition, the Health Ministry said it does not object to the request for an interim order forbidding the continued sale of the IQOS without being subject the laws governing cigarettes. In conclusion, the ministry announced that it is keeping abreast of developments related to Philip Morris’ requests to the U.S. Food and Drug Administration to recognize the product as “lower risk.”
The ministry expressed its viewpoint after professional meetings between representatives of the Health Ministry, the Justice Ministry and the attorney general. In doing so, the government effectively is reversing Health Minister Yaakov Litzman’s decision to allow unrestricted sales of the IQOS until the FDA decision, at an unknown future date. Now the government is announcing that the IQOS will be considered an ordinary cigarette, a policy that will be reexamined by the ministry after the FDA decision.
IQOS is a cigarette that contains tobacco and nicotine, based on the principle of heating the tobacco instead of burning it. Philip Morris invested about $3 billion in its development and is presently launching it in various countries worldwide.
Litzman’s original decision positioned Israel as the only country in which the product was sold freely and without restrictions. Public health doctors in the Israel Medical Association claimed that the company is turning Israel into an “experimental laboratory,” and Israel’s citizens into laboratory mice.
The petition was submitted by the Association for Progressive Democracy in Israel, via attorneys Yifat Solel and Ohad Halevi. The petition was submitted in the wake of Litzman’s decision to allow Philip Morris to sell without restrictions or regulations until the FDA decision. Litzman made his decision against the opinion of Health Ministry and public health professionals, the Health Ministry legal adviser and even the attorney general. The association also demanded an interim order totally prohibiting the sale and distribution of the product until the FDA decision.
The petitioners were supported by the doctors’ associations and the Israel Cancer Association, which even turned to State Prosecutor Shai Nitzan a few days ago, demanding that he refrain from siding with Litzman and representing his opinion in the High Court. There is no way of knowing whether Litzman changed his mind or whether the State Prosecutor’s Office informed him that it would be unable to defend his view in the High Court.
That may be implied in the letter that the doctors received in response from Deputy Attorney General Raz Nizri, parallel to the government’s response to the High Court. “As a result of a meeting that I held with interested parties in the Health Ministry and the Justice Ministry, it was decided that at present there is room to apply to the IQOS the instructions applying to smoking and tobacco products according to the Restriction on Advertising and Marketing of Tobacco Products Law, and the Prevention of Smoking and Exposure in Public Places Act,” wrote Nizri to the doctors.
Nizri added, “The relevant groups in the Health Ministry intend to discuss regulation on the issue after the FDA decision regarding the requests submitted to it by Philip Morris.”
The Health Ministry’s change of heart is also a result of Philip Morris’ submission on Friday of a request to the FDA to allow them to start selling the IQOS cigarette in the United States under the classification of an ordinary tobacco product – in other words, subject to all the restrictions applying to advertising and sales and health warnings, like any ordinary cigarette. This request is a crucial stage prior to the launching of the sale of IQOS in the United States, since without such permission from the FDA, it is impossible to start selling a tobacco product in the United States.
The request was submitted in a parallel process – and not as an alternative – to the company’s original request that the IQOS itself also be recognized as a “lower risk” product. So on the one hand the company claims that this is a lower risk product, and on the other that it is a tobacco product for all intents and purposes. That may also mean that Philip Morris realizes that the FDA is not expected to allow it to define the IQOS as a lower-risk product.
The Health Ministry said, “The Health Ministry informed the High Court of Justice in response to a petition regarding regulation of IQOS, that while awaiting the FDA decision it is planning at this stage to apply to the product all the legally mandated restrictions on sales and advertising and smoking in public places, in addition to the company’s clarifications that it will impose a large part of these restrictions on itself.
“This viewpoint is based on information received recently in talks with the FDA, to the effect that the final decision on the product is expected in another year or more, and based on the information that the product has also been submitted for marketing approval on the track that doesn’t require proof to the FDA of reduced risk.”
Philip Morris replied: “We are surprised by the Health Ministry’s change of mind, to the effect that the product is subject to the advertising law, despite the clear opinion presented by the ministry until now that the product is not subject to this law. Already now the product is being sold in a responsible manner, and the company supports specific regulation that recognizes the unique and different characteristics of products with a potential to reduce risk, compared to continued smoking.
“In our opinion, which was submitted today to the High Court, the new interpretation by the Health Ministry is incorrect. Treating a lower-risk product exactly like a tobacco product for smoking will undermine the ability of adult smokers to receive full and accurate information about an alternative that is better than continued smoking."
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