Tobacco Health Certificate

Tobacco Health Certificate

A tobacco health certificate will be one of two submissions for newly regulated tobacco companies (vape, e-cig, e-liquid, cigar, hookah, etc.). The certificates must be submitted using the FDA’s Electronic Submission Gateway (ESG). The health certificates are due on one of two deadlines depending on the scale of operations. Those are February 8, 2017 or August 8, 2017 for “small scale tobacco product manufacturers.” A small scale tobacco product manufacturer is defined in the regulations based on number of full-time employees and annual revenue.

The tobacco health certificate begins with creating an ESG account. The FDA ESG is the central transmission point for sending information electronically to the FDA. It is a lengthy process that can take up to 3-weeks to complete. It involves Letters of Repudiation, account testing, and confirmation receipts all before sending the materials needed for the FDA tobacco health certificate. As with registration, the health certificate will require planning.

It is important to determine first if you need to file a tobacco health certificate. The FDA at this time intends to enforce the health document requirements of section 904(a)(1) with respect to finished tobacco products only. The FDA does not, at this time, appear ready to enforce these requirements with respect to products that are sold or distributed solely for further manufacturing.

The list of documents health documents that must be submitted varies. Generally, it includes documents that relate to health, toxicological, behavioral, or physiologic effects of current or future tobacco products, their constituents (including smoke constituents), ingredients, components, and additives.

The consequences for failing to complete this step are severe. The FDA Guidance makes that clear stating:

Failure to submit the required health documents has consequences. First, under section 903(a)(10)(A) of the FD&C Act (21 U.S.C. 387c(a)(10)(A)), a tobacco product is deemed misbranded if there is a failure or refusal to comply with any requirement prescribed under section 904. Additionally, the failure or refusal to furnish any information required by section 904 is a prohibited act under section 301(q)(1)(B) of the FD&C Act (21 U.S.C. 331(q)(1)(B)). Violations relating to section 904(a)(4) are subject to regulatory and enforcement action by FDA, including seizure and injunction.

Please contact our Washington D.C. or Charlotte N.C. office with any questions.

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Marc is dedicated to helping his clients navigate the complex world of FDA and USDA legislation. He represents FDA-regulated companies in the food, dietary supplement, beverage, cosmetic, medical device, and drug industries.

Marc is the author of two textbooks and a lecturer at Northeastern University. He is a member of the Washington State Bar Association and the D.C. Bar Association.

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