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Tobacco, Hemp, and CBD

The FDA has regulated cigarettes, cigarette tobacco, roll-your-own tobacco, and smokeless tobacco products since June 2009, after Congress passed and the President signed the Family Smoking Prevention and Tobacco Control Act. This Act gave the agency authority to regulate the manufacturing, distribution, and marketing of tobacco products. In May 2017, the FDA published the first edition of a guidance guidance document that applies to all categories of newly regulated products, including ENDS (e.g., e-cigarettes and e-cigars). All tobacco products require registration and to list their products with the FDA. Moreover, no new products can be introduced to the market without going through a an FDA approval process known as PreMarket Tobacco Application (PMTA), where the meeting standard is public safety.

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The U.S. Food and Drug Administration (FDA) has not recognized or approved the marijuana plant as medicine. To date, the agency has not approved a marketing application for cannabis for the treatment of any disease or condition. However, the agency has approved one cannabis-derived and three cannabis-related drug products. These approved products are only available with a prescription from a licensed healthcare provider.

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The FDA is aware that some firms are marketing CBD products to treat diseases or for other therapeutic uses, as such the agency has issued several warning letters to such firms. In addition, many states have enacted regulations intended for the taxation, use, and legal prescription of cannabinoids products. All manufacturers, distributors, and sellers must be aware of all the regulatory developments to be in compliance with the FDA, and each state where the products are marketed. 

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CFR Compliance LLC™ has the resources and experience that assist navigating this new FDA regulatory subject. Some of our services:  

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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

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