A significant provision of the Family Smoking Prevention and Tobacco Control Act is the requirement for tobacco manufacturers to operate in compliance with current good manufacturing practices (cGMP). One good approach to understanding these requirements is to read the underlying regulations. For finished pharmaceuticals this is 21 CFR Part 211.
The consequences of non-compliance can be dire and range from warning letters, to fines, to consent decrees. A consent decree is a form of injunctive relief against the violator which can include forced changes to current manufacturing practices as well as significant fines and reimbursement to the government for inspection costs.
Examples of recent FDA enforcement actions include: