On April 24, 2014, the U.S. Food and Drug Administration(FDA) announced that it was officially “deeming” e-cigs, e-hookah, vape pens, and other tobacco products subject to the Federal Food, Drug, and Cosmetic Act (FD&C Act). This article covered the proposed regulation at the time. On May 10, 2016 the FDA published the final rule on the new deeming law.
What Are Tobacco Products and What’s Being Regulated?
The Food Safety Modernization Act (FSMA) is the Food and Drug Administration’s (FDA) most comprehensive reform of food safety regulation. The full Act can be found here. The FDA’s main goal is to make food safer through every step of the process, starting at farms. Imported food is also covered under FSMA, which makes sense as imported food now accounts for approximately 15% of food consumption in the U.S. Rather than focusing on the inspection and response to contamination, the goal of the FSMA is to prevent contamination. Diaz Trade Law covered the changes on June 11, 2015 here.
President Obama signed the FSMA into law on January 4, 2011. FSMA will be implemented slowly in a staggered manner and will be fully implemented by the end of 2017. Implementation varies based on the particular food, company size, and situation, since the FSMA applies to such a broad category. Diaz Trade Law can assist you in learning the basic requirements for FDA regulated products here.
Companies affected by the FSMA will be any company in the food supply chain. Any company that imports, distributes, grows, produces, packages, transports or sells any type of food must be compliant. The company that owns the food is the company responsible for creating a food safety plan. That means that companies that store, carry, or transport the food do not need a food safety plan, but they still must be FSMA compliant.
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