There are three ways that a tobacco company can get authorization to sell a new tobacco product in the US. The way that has attracted a lot of attention lately is through a premarket tobacco product application (PMTA); all the e-cigarettes have to go through this process. There are also two easier processes: submit a substantial equivalence (SE) application, demonstrating that the new product is so similar to a product already on the market that it does not raise new issues of public health, or request an exemption from substantial equivalence, if the new product has been modified by adding or deleting a tobacco additive or changing the quantity of an existing additive if this modification is minor and appropriate to protect the public health.
RJR secured authorization for some of its new non-menthol Newports that it is selling in California through the substantial equivalence pathway and others through the exemption from SE pathway. To argue that the new product qualifies for FDA authorization through the SE pathway, the company has to argue that it is substantially equivalent to a predicate product that was already on the market. The predicate products for RJR’s non-menthol cigarettes are Newport menthol cigarettes.
RJR has been planning this work-around for the Calif flavor ban for years
The FDA issued the substantial equivalence order letter and supporting Technical Product Lead document that sums up the scientific justification for FDA’s decision for Newport Non-Menthol Box on July 13, 2020, more than two years before they hit the market in California.
The predicate product for Newport Non-Menthol Box is Newport Menthol Box (which FDA determined was a “grandfathered product” eligible as a predicate product). (See Appendix A, page 3 of the Order letter and page 3 of the TPL)
The TPL chemistry review (page 4, TPL) concludes that the new product “has different characteristics related to product chemistry” compared to the predicate products, “but the differences do not cause the new tobacco product to raise different questions of public health.” It includes a list of six differences, four of which are redacted, but these differences do not appear to involve flavor characteristics. The TPL notes that the new tobacco product “is a non-mentholated combusted cigarette while the predicate tobacco product is a mentholated combusted cigarette” and that the new tobacco product “contains differences in the ingredients added to tobacco compared to the predicate tobacco product” (page 4, TPL). However, the TPL does not further discuss the flavor ingredients, and key words in the discussion of the differences in the ingredients are redacted (page 4, TPL). The TPL lists several differences, including that the “new tobacco product has different characteristics related to product toxicology,” but determined that these differences “do not cause the new product to raise different questions of public health” (see page 5, TPL). Differences discussed in the toxicology review (pages 5-6, TPL) include ingredient differences in the tobacco filler, some redacted additions to the side seam adhesive, a switch from non-fire safe cigarette (FSC) to fire-safe cigarette paper, and decrease in formaldehyde and increase in CO. None of these differences appears to involve the flavor characteristics.
What is key for whether RJR’s new non-menthol cigarettes violate California’s ban on the sale of flavored tobacco products is the list of “key differences in characteristics between the new and predicate tobacco product” in the TPL’s Conclusion and Recommendation section (page 7, TPL). Importantly, the fact that the new product is non-menthol and the predicate product is menthol flavored is not listed as a key difference in characteristics. Or, to put it another way, the new product (Non-Menthol Box) was considered to have the “same characteristics” as the predicate product (Newport Menthol) and therefore was deemed “substantially equivalent.”
It is possible to have a flavored product that does not include menthol
The California non-menthol cigarettes include the cooling agent WS-3. RJ Reynolds lists the ingredients of their cigarette brand varieties here. WS-3 is listed under the name “n-Ethyl-p-Menthane-3-Carboxamide” in the ingredient lists. All these varieties are exclusively marketed in California. The varieties of so-called “non-menthol” cigarettes containing WS-3 are:
- Newport non-menthol green
- Newport non-menthol green 100
- Newport EXP Mix
- Newport EXP Mix 100
- Newport EXP Max
- Newport EXP Max 100
- Camel Crisp non-menthol green
The “cooling sensation” created by WS-3 is “a feature” (characteristic) of the new tobacco products and is similar if not identical to the cooling sensation created by menthol in the predicate product.
The situation is similar for the other non-menthol brands RJR is selling in California
FDA authorized Newport Non-menthol EXP through the even more lax process, where companies can argue that the changes to the product are so trivial that they are exempt from even having to demonstrate substantial equivalence. That’s how RJR got authorization to sell Newport Non-Menthol Box and Box 100s way back in 2018.
Although the TPLs for the July 13, 2018 and the September 24, 2018 Exempt from SE marketing orders have many redactions, both of these SE Exemptions are based on Newport Menthol products as the “original products” they are compared to, for which the “Characterizing flavor” is stated to be “Menthol.” So it seems reasonable to conclude that these Newport Non-Menthol products are considered to have substantially the same characteristics as Newport Menthol cigarettes.
The subsequent SEs and Exemption from SEs all appear to trace back to these products (each is a “minor modification” of a previous product that was granted an SE order or SE Exempt order). (See page 4 of the TPLs for each.)
Significantly, page 6 of each TPL discusses that some additive (redacted) “has been used in cigarettes in order to introduce cooling, soothing, and anesthetic effects during product use. As a result, [redaction] can enhance the effort to continue smoking. These quantities of [redacted] in the original products [redacted mg/cigarette) are high enough to have an effect on use, and these quantities are similar to the levels found in cigarettes that have menthol as a characterizing flavor…”
Because of the redactions, we can’t be sure that the “new tobacco products” (i.e., the non-menthol Newports) have deleted that additive, or some other additive. Nevertheless, at the very least, this shows that FDA knew that whatever it is, it is used by tobacco companies to “introduce cooling, soothing, and anesthetic effects” and these effects “enhance the effort to continue smoking.” We know from RJR’s website (discussed above) that Newport Non-Menthol EXP has WS-3, and is allowed to be on the market because of FDA’s ill-advised decision in 2018 (signed by Matt Holman, who left FDA to work for Philip Morris) to consider this a “minor modification” to an additive that does not affect whether the product is appropriate for the protection of the public health:
RJR also received Exemptions from SE for several products, including Newport Gold Non-Menthol Box and Newport Gold Non-Menthol Box 100s in January 2020 and two other Newport Non-Menthol Gold products in May 2020.
Implications for the California AG’s enforcement of the law
Although the SE Exemption TPLs were based on so-called “minor” additions or deletions to “additives” which allowed them to be exempt from SE, for purposes of the California AG determining that these cigarettes cannot be legally sold in California, the information in the TPL demonstrates that RJR tweaked additives because they were expected to result in them affecting the flavoring characteristic of Newport Non-menthol in a way similar to menthol.
In addition, as we have discussed before, the packaging for the new products looks like menthol cigarette packaging. After all, the text of the California flavor ban says:
“(2) There is a rebuttable presumption that a tobacco product is flavored if a manufacturer … has made a statement or claim directed to consumers or the public that the tobacco product has or possesses a characterizing flavor, including, but not limited to, text, color, images or all, on the product’s labeling or packaging that are used to explicitly or implicitly communicate that the tobacco product has a characterizing flavor. “
The AG’s office has told people that enforcement is against retailers and the first line of enforcement is the local authorities. This is correct, but the AG has a responsibility to deal with these technical issues to provide everyone – local authorities, retailers, wholesalers, and, most important, RJR – an authoritative determination of whether it is legal to sell these products in California to aid local authorities in enforcement and to clearly notify businesses about their obligations. Specifically, the California Attorney General needs to write everyone notifying that these products are not legal to sell in California.
The sooner, the better.
More legal details regarding assessing substantial equivalence
We provide these technical details for people who want to get down in the weeds:
The Family Smoking Prevention and Tobacco Control Act that governs FDA decision making defines “substantial equivalence” in terms of characteristics, which it defines as the “materials, ingredients, design, composition, heating source, or other features of a tobacco product” (section 910(a)(3)(B)).
Specifically, substantially equivalent is defined: 910((a)(3)(A)
- Has the same characteristics as the predicate tobacco product; or
- Has different characteristics and the information submitted contains information, including clinical data if deemed necessary by the Secretary, that demonstrates that it is not appropriate to regulate the product under this section because the product does not raise different questions of public health.
(B) Characteristics – … the term “characteristics” means the materials, ingredients, design, composition, heating source, or other features of a tobacco product.
“Additive” is defined in section 900(1):
The Term “additive” means any substance the intended use of which results or may reasonably be expected to result, directly or indirectly, in its becoming a component or otherwise affecting the characteristic of any tobacco product (including any substances intended for use as a flavoring…”
The FDA’s 2011 Demonstrating SE Guidance on how it makes decisions provides recommendations related to characteristics. It recommends that the applicant company submit a list of ingredients that includes, but is not limited to, information about the component, subcomponent, ingredient name, common name, chemical abstract services number for individual chemical ingredients, function of the ingredient, unit of measure, level used in the new tobacco product, the predicate product, and the grandfathered product (see pages 9-10, 2011 Guidance). Since RJR presumably would have provided the flavor ingredients in this list, this suggests that FDA considered the flavor ingredients in the new product “substantially equivalent” to those in the predicate product.
It is possible that RJR reported that the new product had “different characteristics” than the predicate product, but claimed that these characteristics do not raise different questions of public health under 910(a)(3)(A)(ii). But in such a case, FDA may have requested additional data to make a SE determination, including consumer perception studies, clinical data, abuse liability data, or toxicology data (page 16-17, 2011 Guidance). It appears very unlikely that FDA requested any additional data because under the section, “Regulatory Activity Related to this Review” (page 3, TPL), FDA states that it received RJR’s SE report (SE0015804) on April 3, 2020 and issued the SE Order Letter on July 13, 2020, only three months later. Also, under “Scope of Review” (page 3, TPL), FDA states that the TPL review “captures all regulatory, compliance, and scientific review completed for this SE Report.” If FDA requested and received additional data, it would be recorded here.
FDA’s 2016 Guidance on demonstrating SE recommends that the “characterizing flavor (e.g., menthol, cherry, none)” of both the new product and the predicate product be submitted to FDA in “Product Quantity Change SE Applications” (page 10-11, Guidance; Responses to Frequently Asked Questions). Since the SE application for Newport Non-Menthol does not appear to be merely a “quantity change SE application,” it would be expected to include at least information on the “characterizing flavor.”
Lauren Lempert did most of the original research summarized here.
Stanton Glantz blog 