Regulation and Products

We are working to ensure the law granting the U.S. Food and Drug Administration (FDA) the authority to regulate all tobacco products, including cigarettes, e-cigarettes, cigars and hookah is fully leveraged to protect children and adults.  

Regulation and Products Resources:

Flavors are a marketing weapon the tobacco manufacturers use to target youth and young people to a lifetime of addiction. The use of any flavored tobacco product among youth is concerning because it exposes them to a lifetime of nicotine addiction, disease, and premature death.

The U.S. Secretary of HHS, U.S. Surgeon General, and Commissioner of the FDA have all declared youth e-cigarette use to be an epidemic. E-cigarette use among high school students has risen by 78 percent in the last year and 48 percent among middle school students. Furthermore, e-cigarette use is most common among younger adults – not older adults. Action is needed to reverse these trends.

Our organizations are writing in connection with the April 30 action by the U.S. Food and Drug Administration (FDA) issuing a marketing order to Philip Morris International (PMI) and Philip Morris Products S.A. allowing the U.S. marketing of IQOS heated tobacco products, to be distributed in the U.S. exclusively by Altria Client Services LLC (Altria).

The undersigned public health organizations submit these comments on the above-listed tobacco product modified risk applications submitted by R.J. Reynolds Tobacco Company (“Reynolds”) for six Camel snus products. The subject applications should be denied for the reasons detailed in these comments.

The undersigned public health organizations submit these comments on the above-listed amended tobacco product modified risk applications submitted by Swedish Match North America, Inc. (“Swedish Match”) for multiple snus products (“General snus”). The subject applications should be denied for the reasons detailed in these comments.

We write to urge the Food and Drug Administration (FDA) to conduct a thorough investigation of, and take appropriate enforcement action against, the marketing of JUUL e-cigarettes with express or implied claims that the products help users stop smoking.

The Draft Guidance can be a step forward if it reduces youth access to the flavored products that have contributed so significantly to the problem of youth tobacco use. However, unless strengthened, the Draft Guidance falls short of the forceful action needed to address a public health crisis of this magnitude.

The undersigned organizations, committed to protecting and promoting the public health by reducing the use of tobacco products, respectfully submit comments on the draft guidance, “Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy Drug Products: Guidance for Industry.

The core interests of the ACS and the ACS CAN are to improve our scientific understanding of electronic cigarettes, or e-cigarettes, and other novel tobacco products, and to maintain robust and effective protections designed to minimize the risks posed to human research subjects. We appreciate the FDA updating its guidance in the use of investigational tobacco products (ITPs).