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Section 909 of the FD&C Act authorizes FDA to require tobacco product manufacturers to establish and maintain records, make reports, and provide such information as the Agency may by regulation reasonably require to ensure that a tobacco product is not adulterated or misbranded and to otherwise protect public health

Once the dominant cartels importing non-taxed cigarettes were Galician-based gangs using high-speed boats, but they switched to higher margin crimes in the 1990s, such as cocaine smuggling, and faced a subsequent wave of arrests

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