Following the issuing of the U.S. Food and Drug Administration (FDA)’s proposed requirements for tobacco product manufacturing processes to the Federal Register, the Premium Cigar Association (PCA) issued a response on the proposed rules.
Regarding the recent court ruling that the FDA acted arbitrarily and capriciously in deeming premium cigars subject to the Act, the PCA has taken the position that FDA lacks jurisdiction to apply this rule to premium cigars. The PCA says it will submit to the agency (and potentially the court system) that the proposed rule “should not, cannot, and will not reach premium cigars.”
As a part of the response, the PCA pointed out the rule has economic impacts that could cause serious harm to the business of many manufacturers, and potentially lead to overall market contraction of premium cigars on retail shelves. The PCA points out how this could have impacts to smaller operations.
On the surface, the FDA positioned the idea of ensuring that the public health is protected and products comply with the Federal Food, Drug, and Cosmetic Act. The FDA has cited an example of ensuring that the manufacture and distribution of tobacco products are not contaminated with any foreign substance.
One major point the PCA pointed out is that the FDA is proposing a framework for tobacco products that is similar to what is used in the pharmaceutical and food industries. Three concepts that are seen in these industries are Track/Traceability, Reporting Adverse Effects (Complaints) and Recordkeeping.
Track and Traceability involves documenting the requirements and processes involved in making products such as premium cigars. In addition, a finalized production record for each batch of finished and documented products would be established. Traceability would involve showing proof a finished product meets the requirements set forward, is using valid ingredients, and other things such as labeling and packaging products from qualified supplies. Demonstrating traceability can involve costly procedures and systems to demonstrate compliance.
Reporting adverse effects (or what is termed Complaints) would require finished and bulk tobacco product manufacturers to establish and maintain complaint-handling procedures for the receipt, evaluation, investigation, and documentation of all complaints. An example of this can be “this cigar gave me a headache” as a complaint that might be submitted. Like Track and Traceability, cigar companies would now need to implement and carry out procedures to support the handling of complaints.
Recordkeeping also involves adding an additional burden on tobacco manufacturing. This would require that the documents and records required to be maintained, including those not stored at the establishment, be made readily accessible during the four-year retention period to the FDA for inspection and photocopying or other means of reproduction.
Other burdens include specific requirements on manufacturing procedures around the facilities themselves. This includes requirements to ensure that buildings and facilities are of suitable construction, design, and location to facilitate cleaning and sanitation, maintenance, and proper operations. In addition, manufacturers would be required to ensure that facility grounds are maintained in a condition to prevent contamination and to control the water used in the manufacturing process
There would also be a burden to the staff at these facilities. The proposed rules would require manufacturers to document and demonstrate managers can carry out implementing the requirements to produce cigars.
The PCA says it is convening a working group of premium cigar manufacturers and discussing the specifics of the proposed rule with their legal and regulatory teams to discuss the best course of action. At the same time, the PCA pointed out that a comment period of at least 180 days has already started, and it is reviewing with stakeholders what the scope of those comments will be.