FDA Tobacco Products Compliance
Our Former Federal Prosecutors and FDA Agents Assist with All Aspects of FDA Tobacco Products Compliance
FDA Tobacco Products Compliance Team Lead
FDA Tobacco Products Compliance Team Lead
Former DOJ Attorney
FDA Tobacco Products Compliance Team Lead
Former Senior DOJ Trial Attorney
The U.S. Food and Drug Administration (FDA) regulates tobacco products through the FDA’s Center for Tobacco Products (CTP) under the Food, Drug, and Cosmetic Act (FD&C Act) and various other pertinent sources of federal authority. It also regulates all tobacco products containing nicotine like e-cigarettes, vapes, and other types of tobacco-adjacent products (including nicotine-based products that do not contain tobacco). Manufacturers, retailers, and various other types of companies must comply with the FD&C Act, the FDA’s tobacco regulations, and a host of other federal laws and regulations, including the Tobacco Control Act—and failure to do so can lead to fines, no-sale orders, and other significant penalties.
At Oberheiden P.C., we have significant experience in the area of FDA tobacco products compliance. Along with senior-level attorneys who have devoted their entire careers to assisting companies with federal compliance, our team also includes former federal prosecutors and FDA agents. This breadth of experience affords deep insight into what it takes to maintain an effective FDA compliance program, and we rely on our experience to help our clients efficiently manage their federal compliance obligations.
Our FDA Tobacco Compliance Services
We provide comprehensive FDA tobacco products compliance services for manufacturers, retailers, and other companies throughout the United States and worldwide. All tobacco products (and many tobacco-adjacent products) sold in the U.S. are subject to the FDA’s oversight. We custom-tailor our compliance services to our clients’ specific obligations and needs, helping them implement comprehensive compliance programs without doing anything that isn’t necessary.
Tobacco Products Manufacturer Compliance
Companies that manufacture tobacco products in the United States and that manufacture tobacco products abroad for sale in the United States must meet extensive federal statutory and regulatory requirements. The FDA vigorously enforces these requirements through inspections, investigations, and enforcement actions.
We assist tobacco products manufacturers in the U.S. and abroad with all aspects of FDA compliance. This includes (but is not limited to) providing advice and representation for:
- Compliance Program Documentation and Training – All tobacco products manufacturers need to have policies and procedures that address all pertinent requirements under the FD&C Act, the FDA’s regulations, and all other applicable laws and regulations. Manufacturers must also ensure that all relevant personnel receive appropriate training so that they can implement these policies and procedures effectively. Our lawyers and consultants assist with developing custom-tailored FDA compliance program documentation and training personnel at all levels of our clients’ organizations.
- Substantial Equivalence Reports – In many cases, tobacco products manufacturers can bring new products to market by demonstrating that they are “substantially equivalent” to products that have already received FDA approval. We assist our clients with preparing substantial equivalence reports and demonstrating substantial equivalence to the FDA.
- Not Substantially Equivalent (NSE) Orders – If the FDA determines that a new product is not substantially equivalent to an existing product, it will issue a Not Substantially Equivalent (NSE) order. Since products that lack substantial equivalence must generally go through the pre-market authorization (PMA) process, we work with the FDA on behalf of our clients to resolve NSE orders without the need to submit a PMA application whenever possible.
- Pre-Market Authorization (PMA) – New and innovative tobacco products (and tobacco-adjacent products) are subject to FDA approval through the PMA process. We have extensive experience with the PMA process for tobacco products and other FDA-regulated products, and our lawyers and consultants assist our clients with doing everything necessary to secure FDA approval as efficiently as possible.
- FDA Inspections – The FDA may inspect tobacco products manufacturers’ facilities under various circumstances. When anticipating an FDA inspection, thorough preparation is critical. We rely on our knowledge and experience to help our clients take proactive steps to ensure that FDA inspections do not lead to unnecessary problems or delays in the approval, marketing, or distribution of their products.
Tobacco Products Retailer Compliance
Tobacco products retailers are subject to an entirely different set of rules and requirements. However, these rules and requirements are no less strict, and the FDA expects retailers to be able to affirmatively demonstrate compliance when called upon to do so. To assist tobacco products retailers with maintaining FDA compliance (and demonstrating compliance to the FDA when necessary), we provide services including (but not limited to):
- Compliance Program Documentation and Training – We develop custom-tailored FDA compliance policies and procedures for tobacco products retailers. We also provide training so that owners, executives, and relevant personnel have a clear understanding of what is (and isn’t) permitted when it comes to marketing and selling tobacco-based products (and tobacco-adjacent products) to consumers.
- FDA Inspections of Brick-and-Mortar Tobacco Product Retailers – The FDA conducts both announced and “undercover buy” inspections of brick-and-mortar tobacco product retailers. We help our clients ensure that they are prepared for these inspections and provide representation for all necessary interactions with the FDA.
- FDA Online Retail Inspections – The FDA also conducts inspections of online tobacco retailers. For online retailers, we assist with preparing for FDA inspections, ensure that our clients have the compliance protocols in place to withstand remote (and unannounced) FDA scrutiny, and communicate with the FDA on their behalf as necessary.
Compliance for Others in the Tobacco Products Industry
Along with advising manufacturers and retailers regarding FDA tobacco products compliance, we also advise importers, repackagers, distributors, and other companies as well. All companies involved in the tobacco products industry in the U.S. are subject to the FDA’s oversight, and all company owners and executives need to ensure that they are taking adequate steps not only to avoid FDA scrutiny, but also to withstand FDA scrutiny when necessary.
Misbranding and Adulteration Compliance
Misbranding and adulteration are two of the FDA’s biggest concerns regarding tobacco (and tobacco-adjacent) products. Companies accused of misbranding their products—whether intentionally or unintentionally—can face steep penalties, as can companies found responsible for failing to adequately prevent contamination and other issues during manufacturing, shipping, or storage. Our FDA compliance lawyers and consultants can explain everything you need to know and assist your company with taking the necessary steps to avoid misbranding and adulteration.
Under the FDA’s “deeming” rule for tobacco products, the Administration’s regulatory authority extends beyond tobacco-containing products to include delivery systems such as e-cigarettes and vape pens, as well as non-tobacco nicotine (NTN) products. Along with providing FDA compliance services for tobacco products manufacturers and retailers (among other companies), we provide compliance services to companies that manufacture, label, distribute, and sell tobacco-related products and NTN products as well.
Put our highly experienced team on your side
Dr. Nick Oberheiden
Founder
Attorney-at-Law
Lynette S. Byrd
Former DOJ Trial Attorney
Partner
Brian J. Kuester
Former U.S. Attorney
Hon. Kevin McCarthy
55th Speaker, U.S. House of Representatives (ret.)
Government Consultant
Mike Pompeo
Of Counsel
Former U.S. Secretary of State
John W. Sellers
Former Senior DOJ Trial Attorney
Linda Julin McNamara
Federal Appeals Attorney
Nicholas B. Johnson
Former Prosecutor
Roger Bach
Former Special Agent (DOJ)
Chris J. Quick
Former Special Agent (FBI & IRS-CI)
Michael S. Koslow
Former Supervisory Special Agent (DOD-OIG)
Ray Yuen
Former Supervisory Special Agent (FBI)
FAQs: Managing an Effective FDA Tobacco Products Compliance Program
What is the FDA Approval Process for Tobacco Products?
The FDA approval process for tobacco products depends on whether a new product is “substantially equivalent” to an existing product. If it is, then companies can generally secure approval by submitting a substantial equivalence report to the FDA. However, if there is no substantially equivalent product on the market, then it may be necessary to go through the FDA’s pre-market authorization process.
What Should I Expect During an FDA Compliance Check Inspection?
During compliance check inspections, the FDA looks for evidence of any and all forms of non-compliance with the laws, rules, and regulations that govern the manufacture and sale of tobacco products (and tobacco-adjacent products) in the United States. To protect themselves, retailers and other companies targeted in these inspections must not only have well-documented compliance programs, but they must be prepared to affirmatively demonstrate compliance to the FDA as necessary.
What Do Tobacco Products Manufacturers and Retailers Need to Know About FDA Warning Letters?
The FDA issues Warning Letters to tobacco products manufacturers, retailers, and other companies when it uncovers apparent evidence of noncompliance during an inspection. The first time the FDA finds a violation the FDA generally issues a warning letter to ensure marketers and retailers comply with the tobacco laws and regulations . As the FDA explains, “[f]ailure to promptly and adequately correct all violations and ensure compliance with all applicable laws and regulations may lead to enforcement action[].” As a result, a prompt response is critical, and entities in the tobacco industry that receive Warning Letters from the FDA should engage experienced counsel promptly.
What Do Tobacco Products Manufacturers and Retailers Need to Know About FDA Civil Monetary Penalty (CMP) and No-Tobacco-Sale Order (NTSO) Complaints?
Civil monetary penalties (CMP) and no-tobacco-sale order (NTSO) complaints are administrative enforcement actions that the FDA can initiate without court involvement. While CMP for tobacco-related violations can be substantial, the issuance of an NTSO complaint can have an even greater impact on a company’s bottom line. Here, too, experienced legal representation is critical, and companies that receive CMP or NTSO orders will need to engage counsel promptly to work with the FDA on their behalf.
Do I Need to Engage a Law Firm for FDA Tobacco Products Compliance?
To ensure compliance—and to ensure that they are prepared to demonstrate compliance to the FDA when necessary—all companies involved in the tobacco products industry should work with experienced legal counsel. As the consequences of noncompliance can be substantial, companies involved in all segments of the industry need to take adequate steps to avoid (and withstand) FDA scrutiny.
Schedule an Appointment with a Senior FDA Tobacco Products Compliance Lawyer Today
If you would like to know more about our firm’s FDA tobacco products compliance services, we encourage you to get in touch. Please call 888-680-1745 or contact us online to arrange a complimentary initial consultation.
