Philip Morris uses its US sales approval to weaken existing laws

On July 7, 2020, the U.S. Federal Drug Administration (FDA) approved Philip Morris International (PMI) to market its new tobacco products in the United States as a “modified risk tobacco product.” This decision is being used by PMI to aggressively promote its new product to new consumers and undermine public health policies.

An instrumentalization of the FDA decision

The FDA's decision was welcomed by its president, Calantzopolous, who made no secret of his intention to use it to reverse existing regulations.[1]

“The FDA’s decision provides an important example of how governments and public health organizations can regulate smokeless alternatives to differentiate them from cigarettes in order to promote public health.”

Gold FDA authorization required before any new product can be marketed in no way validates the tobacco company's claims of lower-risk products. In its decision, the FDA specifically notes that, "These products are neither safe nor 'FDA approved.'" The exposure modification orders do not permit the company to claim any other modified risk or make any express or implied representation that misleads consumers or indicates that the products are FDA approved or that the FDA deems them safe for consumers.

Thus the FDA's approval rejected claims that use of the product is less harmful than other tobacco products or reduces health risks.

However, PMI is deliberately using this authorization to pressure governments to open their markets to its new products.[2]The cigarette maker is also using the decision to promote its products outside the United States.[3] with arguments suggesting that they are lower risk. Finally, PMI is increasing public relations operations in order to position the company as "committed to a smoke-free world."

A lobby already engaged in several countries

In some countries, local PMI officials have used the FDA decision to explicitly lobby for changes to tobacco product regulations. In Mexico[4], Mario Masseroli, president of PMI Latin America and Canada has been in contact with the authorities to highlight the difference between IQOS cigarettes and conventional cigarettes. He said that a decision from the FDA cannot be ignored. He also made similar statements in Argentina[5], in Colombia[6], in Uruguay[7] and in Honduras[8].

In the Philippines, PMI Asia head Stacey Kennedy also lobbied health authorities to view the US FDA decision as a "starting point" to provide "the basis for public health policymaking."

In France, the president of Philip Morris has also made numerous interventions in the press to this same end.[9].

Keywords: Philip Morris, IQOS, FDA, ©Tobacco Free Generation

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 [1] Philip Morris International, FDA Authorizes Marketing of IQOS as a Modified Risk Tobacco Product, PMI website, July 7, 2020, accessed September 22, 2020[2] Business Standard: Philip Morris urges government to create regulatory environment for smoke-free alternatives. 2019[3] Glantz, SA. PMI is using the FDA to sell IQOS outside the US. 2019[4] S. Sanchez, Philip Morris has announced the sale of its IQOS in Mexico following its FDA recognition, Forbes Mexico, July 16, 2020, accessed September 22, 2020[5] Ansorena, The FDA authorized Philip Morris to sell Iqos devices as a better alternative to cigars, Forbes Argentina, July 7, 2020, accessed September 22, 2020[6] In Latin America products like IQOS are prohibited, but they are approved of traditional cigars that are more damaging”: Mario Masseroli, president of PMI in Latin America and Canada, Despejando Dudas, July 18, 2020, consulted on September 22, 2020[7] Mr. Malek, IQOS has FDA approval, but is not legal in Uruguay, The country, July 19, 2020, accessed September 22, 2020[8] Alternative smoking system receives FDA authorization in the USA, The Press, July 17, 2020, accessed September 22, 2020[9] Philip Morris France offers itself a platform in L’Opinion, Generation Without Tobacco, July 9, 2020, consulted on September 22, 2020National Committee Against Smoking |