Understanding Oklahoma's Vape Registration Requirements: A Guide for Manufacturers
Are you a manufacturer of vapor products looking to sell or distribute your products in the State of Oklahoma? If so, it's crucial to understand the regulations outlined in Oklahoma State Statute Title 63 Section 1-229.35. This statute, which came into effect on July 1, 2023, imposes specific requirements on manufacturers of vapor products intending to market their products in Oklahoma. Let's delve into what this statute entails and what you need to do to ensure compliance.
The Attestation Requirement
According to the statute, every manufacturer of a vapor product must execute and deliver an attestation to the Oklahoma Alcoholic Beverage Laws Enforcement (ABLE) Commission. This attestation serves as a certification, made under penalty of perjury, that certain conditions specified in the statute have been met. It's a crucial step in the process of bringing vapor products to market in Oklahoma.
Directory Listing
On October 1, 2023, the Oklahoma ABLE Commission is mandated to post a directory listing all manufacturers who have provided attestations compliant with the statute. This directory serves as a reference point for retailers and consumers, ensuring that only approved vapor products are available for sale in the state.
Compliance Requirements
To be included in the directory and legally sell vapor products in Oklahoma, manufacturers must adhere to several requirements:
- Submission of Documents: Manufacturers must submit the attestation document and a list of products in a required Excel spreadsheet format. These documents must be submitted to the Oklahoma ABLE Commission.
- FDA Authorization: Manufacturers must provide proof that the U.S. Food and Drug Administration (FDA) has authorized the sale of their products at the time of submission. This ensures that products meet federal standards for safety and quality.
- Appendices and Responses: Manufacturers must include all relevant appendices, including products submitted to the FDA and their responses. This information will be scrutinized to ensure alignment with Oklahoma state laws.
- Marketing Denial Orders (MDO): If a manufacturer has been issued a Marketing Denial Order (MDO) by the FDA, but is appealing the decision, additional documentation is required. This includes relevant court documents authorizing the sale of products during litigation with the FDA.
Ensuring Compliance
For manufacturers, ensuring compliance with Oklahoma's vape registration requirements is essential to accessing the Oklahoma market and avoiding legal penalties. Here are some key steps to ensure compliance:
- Thorough Documentation: Maintain thorough documentation of all submissions to the FDA, responses, and any legal proceedings related to MDOs or appeals.
- Stay Informed: Stay updated on any changes to Oklahoma state laws and regulations regarding vapor products. This includes keeping abreast of any updates or announcements from the Oklahoma ABLE Commission.
- Seek Legal Counsel if Needed: If you have any questions or concerns regarding compliance with Oklahoma's vape registration requirements, consider seeking guidance from legal experts specializing in FDA regulations and state laws.
Navigating the regulatory landscape for vapor products in Oklahoma requires careful attention to detail and compliance with state laws. By understanding the requirements outlined in Oklahoma State Statute Title 63 Section 1-229.35 and diligently following the necessary steps for registration, manufacturers can ensure their products are legally available for sale in the state.
For more information on the Oklahoma tobacco and vape registry visit the Oklahoma ABLE Commission page here.
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