17 Apr FDA Revises Ingredient Listing Guidance
Late last week, FDA published updated guidance on the ingredient listing requirements for manufacturers of pipes and pipe tobacco. Under the revised guidance, the FDA will not require ingredient listings for any product that qualifies as a “component or part” of a tobacco product (or any component or part included in a fi nished tobacco product). A list of applicable products can be found in the guidance.
In the 2016 Deeming Rule, FDA asserted that pipe tobacco pipes qualify as components or parts of tobacco products, placing a significant additional layer of regulation on the category. The policy described in the revised guidance means that, in effect, FDA will not require compliance with the listing requirements for pipes. However, pipes are still subject to the premarket pathway requirements under the rule.
Additionally, the new guidance also clarifies ingredient listing requirements for pipe tobacco manufacturers. Under the described approach, pipe tobacco manufacturers may submit a single ingredient listing (rather than multiple ingredient listings). This applies only if a pipe tobacco product is marketed under different brands/sub-brands, or in different package sizes, but has the same per weight composition of ingredients.
Essentially this means that if the specific makeup of the product does not change, manufacturers do not need to submit multiple ingredient listings for each brand name or package size of that product. Rather, a single ingredient listing providing identifying information for these variations could be submitted instead.
What does this mean for retailers?
Frankly, not much. For retailers who sell pipes and pipe tobacco, the ingredient listing requirements rest primarily with manufacturers and importers. It does however reduce the amount of information retailers need to track to ensure that they are selling compliant products. For instance, one ingredient listing submitted to the FDA could now cover a much broader base of products, and some products will not require ingredient listings at all. It also means one less compliance barrier for pipes sold at retail.
Does this impact concerns with in-store blending?
No – the guidance does not impact concerns that IPCPR and others in industry have raised with the treatment of in-store blending as “manufacturing.” Those issues remain outstanding and IPCPR continues to challenge the FDA’s expanded definition of manufacturing.
What about bulk pipe tobacco and “repackaging?”
IPCPR believes the guidance reinforces our position that if retailers are simply repackaging bulk pipe tobacco for re-sale, and they do so without changing its composition (or relabeling), they are not “manufacturing” a different product for ingredient listing purposes. In our view, the allowance under this guidance for one ingredient listing submission to cover a product in different quantities or marketed under different brand names reaffirms the association’s position.