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.

Tobacco Product Manufacturing Practices

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

Tobacco Registrations and Listings

EAS can assist with the FDA’s facility registration and product and ingredient listing requirements.

Tobacco Recall Assistance

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.

Strategies to Prepare for and Meet the Requirements of the Tobacco Control Act

The FDA regulates the traditional and deemed tobacco industries according to the Family Smoking Prevention and Tobacco Control Act (Tobacco Control Act), signed into law on June 22, 2009. The Act includes requirements for facility registrations, product and ingredient listings, HPHC submissions and pre-market approval of new tobacco products (i.e. SEs. PMTAs, MRTPs). In addition, the Act requires the FDA to issue good manufacturing practices (GMPs) for the tobacco industry, which will be called tobacco product manufacturing practices (TPMPs). Once tobacco facilities are registered the FDA has the authority to inspect them to ensure compliance with all requirements of the Tobacco Act. EAS Consulting Group’s staff and a team of consultants are recognized as the leading experts in Tobacco compliance and can provide training on specific compliance issues to assist companies in meeting the requirements and preparing for the regulations that are issued under the Tobacco Control Act. Subjects for which EAS can be provided training include:

  • 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.

Tobacco Employee and Management Training

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.

Foreign Facility Inspections

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.

483 and Warning Letter Responses

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.

Expert Witnesses in Legal Cases

In the industries regulated by FDA, such as those in the pharmaceutical, medical device, food, dietary supplement, and cosmetic business, compliance issues are of great importance. When disputes arise, the regulatory compliance status of a product or facility is often a key issue and can make a significant difference in how the matter will be resolved. In such cases, it is critical to have the assistance and advice of experts who are both experienced and knowledgeable in FDA regulations and industry practices, and who will be perceived as independent and objective. Whether a dispute is resolved via mediation or litigation it is imperative to have a well-respected and knowledgeable expert witness acting on your company’s behalf. EAS independent advisors and consultants are routinely called to serve as expert witness in a variety of cases and provide the in-depth, detailed attention required in these cases.

EAS offers one of the most experienced groups of consultants available on FDA regulatory compliance issues. We offer a team of former high-level FDA officials and industry professionals who will share their expertise with our clients. Our consultants have an average of over 25 years of regulatory experience and include some of the most well-known and highly respected names in the industry. As new standards and regulations proliferate, EAS keeps abreast of the changing regulatory landscape, allowing us to deliver up-to-the-minute policy advice to our clients. Our experts have the knowledge, qualifications, and experience necessary to explain and clarify the issues to our clients and the courts while establishing credibility and persuasiveness as witnesses.

EAS offers assistance in adjudicating insurance claims and servicing as an expert in depositions and civil litigation cases. With high-level experts in all areas of FDA regulations, EAS is well recognized as representing the industry in all manner of court cases.