On March 4, 2015, the U.S. Food and Drug Administration (FDA) announced a policy change that will have big repercussions for public health. The FDA issued a guidance document that will allow the tobacco industry to circumvent the Tobacco Control Act, and introduce new or modified products with little or no review. After rescinding this guidance in the face of an industry lawsuit, the agency reissued the guidance on September 8, without making significant changes to the policies outline in the guidance.
The Tobacco Control Act requires tobacco companies to receive authorization from the FDA before they can begin to market a new product. For decades, tobacco manufacturers have manipulated their products to make them more addictive and attractive. As a result of these industry practices, many products sold today are more deadly than those sold in the past.
All of that was supposed to end when the Tobacco Control Act was passed in 2009. This law makes the FDA the gatekeeper of the tobacco product retail market. The agency must authorize the sale of all new products before they can be marketed. The process is intended to keep products off the market that would harm public health even more than the tobacco products that are currently killing 480,000 Americans each year.
Despite Congress’ effort to stem the tide of new products flooding the market, the tobacco industry is still selling brand new products and modified products without the FDA’s authorization. While the agency has the power to firmly clamp down on this activity by enforcing the law, instead the FDA has decided that it will simply allow the tobacco industry to continue selling these unauthorized products, and has created a new process that will allow the tobacco industry to begin selling thousands more new products before the agency authorizes their sale.
This practice defies the letter and the spirit of the Tobacco Control Act. The law requires the FDA to protect public health, but this action only serves tobacco industry interests.
Please take the time to explain to the FDA that using the agency’s enforcement discretion to promote industry at the expense of public health is a terrible idea.
If you have any questions about this action or anything else related to the FDA’s regulation of tobacco products, don’t hesitate to email us.