Compliance, Regulatory & Quality Professionals

Since June 2009, the FDA has regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products following the passage of the Family Smoking Prevention and Tobacco Control Act. This legislation granted the FDA authority over the manufacturing, distribution, and marketing of tobacco products. In May 2017, the FDA issued its first guidance document covering all newly regulated products, including Electronic Nicotine Delivery Systems (ENDS) such as e-cigarettes and e-cigars. All tobacco products must be registered and listed with the FDA, and new products require approval through the PreMarket Tobacco Application (PMTA) process, which emphasizes public safety.

The FDA has not recognized the marijuana plant as a medicine and has not approved any marketing applications for cannabis to treat diseases or conditions. However, the agency has approved one cannabis-derived drug and three cannabis-related drug products, which are available only by prescription from a licensed healthcare provider.

The FDA has issued warning letters to firms marketing CBD products for therapeutic uses, as it has not approved such claims. Additionally, many states have implemented regulations regarding the taxation, use, and prescription of cannabinoid products. Manufacturers, distributors, and sellers must stay informed about both federal and state regulations to ensure compliance.

CFR Compliance LLC™ offers expertise in navigating FDA regulations and state-specific requirements related to tobacco and cannabinoid products. Our services include:  

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• Regulatory Affairs

• Site Evaluation, Assessment and mock FDA audit

• Product Specification Development

• Regulatory Strategy

• PreMarket Tobacco Application (PMTA)

• Engineering Studies

• FDA meetings

• Remediation for Form 483, Warning Letter and Consent Decree

• PreApproval Inspections (PAIs)

• Process/Product Transfer and Engineering

• Process Validations

• Supply Chain and US Customs Compliance

• GMP Inspection support

• GMP Training

• Quality Engineering