WHY IMPLEMENT A HACCP-BASED TOBACCO PRODUCT SAFETY SYSTEM?
The "Family Smoking Prevention and Tobacco Control Act" of 2010 (TCA), places regulatory control of tobacco product safety in the U.S. under control of the Food Drug and Cosmetic Act (21 USC 301 et seq). Tobacco products of various descriptions (smoking and non-smoking) are now regulated by the U.S. Food and Drug Administration. While some aspects of the law are still be implemented as of 2012, manufacturers of most tobacco products now join the list of consumable (food, drugs) and non consumable (medical devices, cosmetics) products whose safety and marketing activities will be monitored and controlled by the U.S. Food and Drug Administration.
The primary mission of the U.S. Food and Drug Administration is to ensure the safety and label accuracy of products for which it has assigned regulatory enforcement responsibility. The marketing and safety assurance activities are independent from a regulatory enforcement perspective. It is possible for a company to commit a prohibited act without introducing an unsafe or hazardous product under FDA jurisdiction (such as food or tobacco).
The implementation of safety control over consumable products such as food and drugs is dictated by the manufacture's controls over its raw materials and product manufacturing process. The tobacco control act, establishes similar requirements for tobacco products under Sec. 906(3)(1)(A) of the TCA. Tobacco companies are expected to implement controls to prevent contamination of tobacco products which can lead to their adulteration. At the present, there are two choices to accomplish this:
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establish and operate manufacturing facilities under Good Manufacturing Practices or
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implementation of a HACCP program.
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possibly, raw material testing for chemical pesticide residues may also apply but the regulation is still unclear
The U.S. FDA has established GMP requirements for several product categories such as a) food, b) cosmetics, c) drugs or OTC medicines and d) dietary supplements. There are presently no specified GMPs for tobacco products, although there is plenty of guidance available for tobacco manufacturer's to model when producing their product. GMP programs are designed to mitigate the threat to product safety. In order to be in compliance with GMP requirements, the facility must implement documented programs covering facility design and operation, hygeine controls, pest control, maintenance, employee behavior, raw material safety, and segregation, together with with provision for corrective action whenever it is required. It is the failure to ensure GMP conditions in manufacturing operations that is evidence the facility has produced adulterated product and is in violation of the Food Drug and Cosmetic Act.
HACCP (Hazard Analysis And Critical Control Point) programs provide companies a structured model for determining whether the raw materials and product manufacturing scheme can yield product in a safe and wholesome manner. HACCP plans are based upon a risk assessment process that follows 7 principles in their development. The company implementing a HACCP plan can develop a customized approach when ensuring product hazards are prevented or eliminated from their manufacturing scheme.
These 7 principles of HACCP are proven to work in the identification, control, or elimination of hazards to product safety. There are 3 categories of potential product safety hazards that are addressed in the hazard analysis process, including:
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chemical cross-contamination,
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foreign matter inclusion, and
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biological threats.
There are distinctions in potential hazards that may exist throughout the manufacturing of smoking and non-smoking products. HACCP plans are most effective when they have been developed by teams of individuals with knowledge of the manufacturing process, the capability of process equipment, and the safety risks inherent in their raw materials. Hazard analysis is the primary activity of concern when developing a HACCP plan. Hazard analysis can only be undertaken after one to several prerequisite programs that prevent specific product safety hazards, are in place. Prerequisite controls for potential product hazards are often customized to reflect the design and operation of the facility, the nature of the raw materials, and the product manufacturing process.
Our training program to help tobacco companies ensure their compliance with Sec. 906(3)(1)(A) of the TCA, meets the requirements of the International HACCP Alliance and the trainer is also recognized by the IHA. Our training follows the universally accepted methods in its adherence to the 7 Principles of HACCP as recognized by the U.S. Food and Drug Administration, the U.S. Department of Agriculture, and the Codex Alimentarius. This is a 2 day lecture - workshop in which attendees will :
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Learn the 3 major classes of hazards that can be traced to raw materials or the product assembly process,
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Learn the value of prerequisite programs and GMP conditions to prevent or eliminate most potential product safety hazards,
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Learn the principles of hazard risk analysis and use this model in developing and documenting their company's HACCP plan.
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Quizzes and exercises establish competancy leading to our certificate of attainment, and includes a) required 100% attendance at all workshop sessions, b) completion of exercises, and c) 75% on final quiz.
This workshop is presently limited to on-site training with companies who have a minimum of 7 individuals. Please call our office at 201-370-1636 or e-mail cathy@sqfguy.com to request additional information.
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