The analysis in the final rule has been revised based on comments the FDA received and now also considers the costs and benefits associated with a rule issued by the Substance Abuse and Mental Health Services Administration (SAMHSA) on January 19, 1996, governing a program of State-operated enforcement activities to restrict the sale or distribution of tobacco products to individuals under the age of 18.
Tobacco products are legally available for sale to people under the age of 12 because of FDA regulations. 