New FDA Proposal Takes Aim At Tobacco Industry Manufacturing And Distribution
The U.S. Food and Drug Administration announced a new proposal that could add more stringent oversight to the manufacturing process of tobacco products, including premium cigars. Introduced last week, the proposal would place additional requirements and standards on tobacco companies in regards to manufacturing, design, packing and storage, as well as identification, tracing and corrective actions for tobacco products that don’t meet certain specifications.
One of the major goals of the proposal is to avoid contamination of bulk tobacco before it’s used in the final product. Of concern to the FDA are foreign substances such as metal, plastics and glass. The proposed regulations would require manufacturers to adhere to new specifications for raw materials before passing inspection by the FDA. Traceability is also a major aspect of the proposal, as the guidelines would enable the FDA to “trace all components or parts, ingredients, additives and materials, as well as each batch of finished or bulk tobacco product, to aid in investigations of those that don’t meet specifications,” according to the organization’s press release.
The new proposal would apply to manufacturers of finished and bulk tobacco products, which includes producers of cigars, cigarettes, e-cigarettes and all other tobacco products currently regulated by the FDA. Such a proposal, if passed and applied to the cigar industry, would have a significant impact on the many intricate phases of the manufacturing process.
"This is another half-baked FDA proposal that could have significant ramifications to the business of specialty tobacco retailing,” said Scott Pearce, executive director of the Premium Cigar Association (PCA). “It’s a clear attempt to paint a broad brush on all tobacco products and extend existing manufacturing frameworks being used in the pharmaceutical sectors and food programs. This is something that would hit the smallest manufacturers the hardest and ultimately create barriers of entry to new businesses and significant costs, requirements, and regulatory arbitrage for existing businesses."
It’s unclear at this point whether or not the proposed standards will ever end up taking effect on the premium cigar industry at all, as the FDA’s regulation of handmade cigars is still under litigation. The PCA, along with Cigar Rights of America and the Cigar Association of America, are involved in a jointly-filed, ongoing lawsuit against the FDA. In July of last year, judge Amit Mehta issued his opinion on the lawsuit, siding largely in favor of the cigar groups, calling the FDA’s move to regulate premium cigars “arbitrary and capricious.” An official ruling has yet to be made.
“Depending on how Judge Mehta rules, these new regulations may not apply to unflavored handmade cigars, at least initially,” said Drew Newman of J.C. Newman Cigar Co. “Additionally, the requirements would not take effect for two years after the final rule is issued, likely late next year. Smaller cigar companies with fewer than 350 employees would have four additional years to comply.”
The FDA will hold a public hearing on April 12 to gather additional comments and insight from various stakeholders. The new proposal will be available for public comment for 180 days. There will also be a meeting between the Tobacco Products Scientific Advisory Committee (TPSAC) and the FDA on May 18, in which the agency will seek out the input from the independent panel of experts on the requirements put forth in the proposal. The public will have the opportunity to make oral presentations during this meeting.
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