CTP’s Office of Small Business Assistance
Need help understanding and complying with FDA's tobacco laws and regulations?
Here, we introduce you to the Center for Tobacco Products’ Office of Small Business Assistance (OSBA), the resources it offers, and how you can reach out for help with more specific questions.
- Do I need an order from FDA permitting me to market a tobacco product, and if so, what kind of application should I be submitting?
- How can I reinforce my employees’ understanding of our responsibility to refuse to sell tobacco products to those who are underage, and how can I emphasize to consumers coming into my store how seriously we take our obligation under the law?
These are four examples of the wide range of questions the Center for Tobacco Products’ Office of Small Business Assistance receives about how to comply with the Tobacco Control Act (TCA) and related regulations. The office, a part of CTP’s Office of Compliance and Enforcement, was established to answer questions from regulated industry, including small tobacco product manufacturers and retailers, as well as from tobacco product consumers and the general public.
“Small tobacco businesses can face special challenges with legal compliance,” according to Dustin Harris, who oversees the Center’s Office of Small Business Assistance, because they “generally have fewer resources, fewer employees, and less revenue than their larger counterparts.” The OSBA was established to work directly with small businesses on the issues they face. The office provides targeted relief such as additional time to comply with certain legal requirements, assistance with applications, and help in navigating regulatory requirements.
OSBA responds to thousands of questions each year about the law and compliance that come in via phone, email, and mail. Inquiries spiked in 2016—to 4,777, compared to 2,479 the previous year—after the deeming rule extended FDA’s tobacco regulatory authority to products such as e-cigarettes. The deeming rule meant that many small businesses, including vape shops, were affected for the first time by federal tobacco regulation. “We recognize the law can be difficult to interpret for people unfamiliar with legal terminology,” Harris says, “and we’re happy to help them understand the legal requirements that apply and how to meet them.”
Why Comply? Benefits to Businesses, Public Health
Complying with the law can protect companies from FDA regulatory actions and penalties such as warning letters, civil money penalties, and no-tobacco-sale order complaints. And, from the perspective of public health, following the law translates into reduced tobacco-related disease and death. Harris’s example: “As the first line of defense for preventing minors from purchasing tobacco products, retailers who comply with the law by refusing to sell to minors can help prevent our nation’s youth from becoming the next generation of Americans to die prematurely from tobacco-related disease.” The troubling recent surge in youth use of e-cigarettes highlights the importance of compliance by retailers—and manufacturers, as well—to stop this dangerous trajectory.
For tobacco businesses with questions about how they can fulfill their legal responsibilities, while improving public health, OSBA recommends checking out FDA resources online first.
Online Resources: Clarification at a Click
OSBA offers resources online to help businesses understand and comply with tobacco regulatory requirements. For starters, consider “FDA’s Deeming Regulations for E-Cigarettes, Cigars, and All Other Tobacco Products," which focuses on how the deeming rule affects tobacco retailers and manufacturers, big and small.
Find a list and description of additional resources, as well as links to them, on “Small Business Assistance for Tobacco Product Industry." In a nutshell, materials that can help small businesses with compliance include:
- Retailer Education Materials: “This is Our Watch” Toolkit, FDA Age Calculator
- Compliance Webinars
- Guidance Documents, Including “Small Entity Compliance Guides”
- Compliance Dates Under Deeming
Still Have Questions? Please Reach Out to OSBA for Help
Want additional help to interpret the law as it relates to your business’s individualized circumstances? “We’re here to help,” says Harris. The office receives many types of questions, which are “triaged to CTP experts on the particular subject matter to provide customers with the most accurate, timely responses possible.” Some establishments have reached out for help with the process of registering their establishment and listing their products online. And, retailers have called with questions after receiving a warning letter or civil money penalty, and staff have provided information about the process and what follow-up actions would be appropriate for the business to take.
OSBA welcomes calls and emails from tobacco product consumers and the general public who have questions or concerns about the law. The office also handles reports about adverse reactions such as allergic responses or injuries that might be associated with tobacco products.
OSBA welcomes you to reach out to us for technical assistance, help finding the right resources, or the opportunity to communicate your small-business viewpoint to FDA. For those wanting to report a potential tobacco product violation or an adverse reaction, you can use FDA’s online form or report using the email, phone, or mailing information listed here.
1-877-287-1373 (Monday–Friday, 9:00 a.m.–4:00 p.m. Eastern Time)
FDA/CTP Office of Compliance and Enforcement
Document Control Center
Building 71, Room G335
10903 New Hampshire Ave.
Silver Spring, MD 20993