The Family Smoking Prevention and Tobacco Control Act (TCA) of 2009 provided the FDA authoritative oversight of the manufacture, distribution, and marketing of all tobacco products, including cigarettes, cigarette tobacco, roll-your-own tobacco, smokeless tobacco, and any other tobacco products. In addition, the 2016 Deeming Rule expanded the definition of a tobacco product to also include electronic cigarettes and other electronic nicotine delivery systems (ENDS), cigars, pipe and hookah tobacco, nicotine gel, and dissolvable nicotine products all known as “deemed” products.
All domestic tobacco firms must register and list their products with the FDA and no new products can be introduced to the market without going through a submission and pre-approval process. Tobacco products that were not distributed to U.S. consumers prior to February 15, 2007, are considered “new” products and can only enter the market through a Premarket Tobacco Application (PMTA), Modified Risk Tobacco Product (MRTP) application, or Substantial Equivalence (SE) Report. These require an extensive amount of product information, assessments, and testing; all of which require the use of controlled processes and documentation that are overseen by a Quality Unit to ensure the consistent manufacture of a product that will meet the assigned product specification. Even for current tobacco products, Section 902 and 906(e)(1) of the TCA dictates that a tobacco product is considered adulterated if the methods used in, or the facilities or controls used for, its manufacture, packing, or storage do not meet current Good Manufacturing Practices (cGMPs). The FDA has not yet issued these for tobacco and deeming products but intends to call these Tobacco Product Manufacturing Practices (TPMPs). EAS tobacco consultants have expertise in the development and implementation of a Quality System that complies with cGMPs and can assist tobacco manufacturers with preparations for the forthcoming TPMPs.
EAS also facilitates clients understanding of current FDA thinking through the monitoring of FDA tobacco activities, dockets, regulation, and new developments.
FDA is developing new TPMPs which once complete will be the new standard by which all tobacco firms must comply. EAS is regularly called upon to review tobacco manufacturing procedures and quality systems for both large and small facilities. The finalization of the TPMPs will give tobacco firms a clear picture of FDA expectations.
- Implementing FDA recognized quality systems
- Maintain compliance with standards for things such as tar and nicotine
- Preparation for FDA mandated biannual facility inspections
EAS can assist with the FDA’s facility registration and product and ingredient listing requirements.
A product recall is a time-consuming and expensive endeavor. Whether the recall is voluntary or requested, the recalling firm must have a procedure in place to ensure all violative product is removed from the marketplace. From ingredient/component suppliers to manufacturing/processing/labeling, to the distribution of the products within the U.S. market, firms should take a proactive approach to ensure the compliance of their product and reduce the potential for a recall. EAS can assist with the performance of a mock recall to assess your readiness to execute an actual recall. In the unfortunate event of a recall, EAS consultants can advise on the recall process.
From ingredient/component suppliers to manufacturing/processing/labeling, to the distribution of the products within the U.S. market, firms should take a proactive approach to ensure the safety of their product and reduce the potential for a recall. EAS can assist with the performance of a mock recall to assess your readiness to execute an actual recall.
- Preparing for Tobacco GMPs – what may be required
- How to host and manage an FDA inspection
- How to write and implement FDA acceptable Standard Operating Procedures (SOPs)
- How to prepare and utilize Quality Agreements
- How to select and qualify Contract Manufacturers and Laboratories
In addition, EAS can provide any specific and customized training that our clients may require.
EAS is frequently requested to bring our popular public training programs in-house, offering a dedicated training for employees and customizing the content as-needed to focus on specific areas of need. Two common training requests for the tobacco industry include:
- Strategies to Prepare for and Meet the Requirements of Tobacco Control Act
- Preparing for Tobacco Product Manufacturing Practices
Or join us at one of our upcoming training programs coming to a city near you.
FDA must be permitted to inspect the facility at any time in accordance with the FD&C Act to determine compliance with FDA regulations for safety and to identify any potential problems before the products enter the U.S. marketplace.
EAS Consulting Group is available to provide a mock FDA inspection of foreign facilities to determine deficiencies and/or to develop a corrective action plan either before FDA makes its initial inspection or if FDA finds deficiencies that need correction.
In the event that FDA issues a 483 or warning letter or the Department of Justice files a consent decree, EAS can assist with a timely and appropriate response. EAS also assists as a third-party expert for review, audit, and evaluation of facilities and documentation, and can formulate a remediation plan and response in compliance with FDA requirements.