In June 2009, the U.S. Congress enacted the Family Smoking Prevention and Tobacco Control Act, granting the FDA the authority to regulate the manufacturing, distribution, and marketing of all tobacco products. Consequently, the FDA began requiring that all tobacco products be approved, registered, and listed before they can be marketed in the U.S.

In contrast, cannabis-related products face a different regulatory framework. Regulation and marketing of cannabinoids are influenced by their source (e.g., hemp) and tetrahydrocannabinol (THC) levels. These products are regulated by both the FDA and the DEA, and most states have also enacted regulations that address taxation and medical prescription requirements.

​

Services offered by Prologos Law:

• ENDS, cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products.

• FDA Administrative Proceedings

• Form 483, Warning Letters and Consent Decree

• Action Indicated Notices

• US Customs Product Entry

• Product Exports

• PreMarket Tobacco Application (PMTA)

• Site Evaluation, Assessment and mock FDA audit

• FDA meetings

• Pre-Approval Inspections (PAIs)

• GMP Inspection support

• Training