Congressional Law on Synthetic Nicotine Products Raises Questions for FDA

The following information is a translation from Vaporvoice: According to a new law signed on March 15, 2022 regarding synthetic nicotine products, the U.S. Congress has established a short-term deadline of 60 days for companies to submit pre-market tobacco product applications (PMTAs) and announced that if such applications are not approved within 120 days, it would be in violation of the Federal Food, Drug, and Cosmetic Act (FDCA) PMTA requirements.

As of today, it is still unclear whether the FDA will use its enforcement discretion to continue reviewing PMTA applications for synthetic nicotine products without authorization, or if it will announce that all synthetic nicotine products must be removed from the market after July 13, 2022.

Without a doubt, the FDA should use its enforcement discretion. Since the passing of this bill, the Vapor Technology Association (VTA) has had direct contact with the FDA, providing a comprehensive set of scientific and policy reasons for synthetic nicotine products, and suggesting specific ways in which the FDA can utilize its enforcement discretion to allow synthetic nicotine products to continue to be marketed during PMTA review.

However, some are suggesting that Congress authorize the removal of all unapproved products from the market this week if they do not receive FDA approval. However, a closer examination of the bill shows the opposite to be true: Congress did not require the removal of synthetic nicotine products pending PMTA from the market after July 13th.

When interpreting the law, the court will first examine the plain wording of the statute, only turning to congressional intent in cases of ambiguity. In this case, both sides support the FDA's continued discretion in enforcing the pending PMTA.

It is recommended to continue selling existing synthetic nicotine products.

There are four relevant clauses of this law. Firstly, according to clause (d) (2) (A), Congress explicitly states that all manufacturers who wish to continue selling their products must submit a PMTA before May 14, 2022.

Secondly, according to section (d)(2)(B), Congress clearly stated that companies submitting PMTA "may continue marketing" their products during the so-called "transition period" specified in the law.

Thirdly, according to Section (d)(2)(C), Congress explicitly requires that if a company fails to submit a Pre-Market Tobacco Application (PMTA) for its synthetic products before May 14, 2022, the company is "ineligible to continue marketing". Throughout these sections, Congress has made use of variations of the term "market" to clarify their guidelines on what can (or cannot) be sold and marketed.

However, in the portion (d)(3) of the regulations regarding events occurring after July 13, 2022, Congress has not made any statement regarding marketing. Instead, it states that PMTA products that have not been approved will be in violation of section 910 of the FDCA (21 USC 387g).

When asked about the issue, the court may rule that because Congress has not declared the pending applicants "ineligible to continue marketing," or that they may not market their products "after July 13th," as previously stated, Congress does not require the removal of products with pending PMTAs.

This means that synthetic nicotine products with pending PMTAs are identical to all other products with pending PMTAs. For years, the FDA has made it clear that these products are "illegal" (i.e., in violation of Section 910), but they have allowed them to remain on the market at their discretion for enforcement.

The intention of the Congress.

Even if the court deems section (d)(3) ambiguous, it would not lead to the conclusion that Congress intended to remove pending PMTA products from the market.

Firstly, if it was their intention, Congress could have banned the production of synthetic nicotine products, but they did not. Instead, Congress explicitly authorized manufacturers to release new products onto the market after the passage of this bill. Therefore, suggesting Congress remove all synthetic nicotine products from the market without PMTA approval is foolish.

Additionally, the intentions of Congress are typically conveyed through recorded statements made at committee hearings and in-person debates, rather than through press releases or media statements. However, in this case, the court may rely on this issue because the provision was quietly slipped into the Ukraine Consolidated Appropriations Act without any related hearings or in-person debates.

Thirdly, Congress is fully aware that the FDA cannot review PMTA within 180 days (as required by the FDCA). In fact, the FDA has informed the court that the review of tobacco-derived PMTA will not be completed until June 2023. Therefore, no one can suggest that the FDA has any reasonable expectation or intention to review PMTA for synthetic nicotine within 60 days.

Therefore, the only logical conclusion that can be drawn from the straightforward language and intent of Congress is that they did not require the removal of products with pending PMTAs, but rather expected the FDA to continue exercising its discretionary power to enforce its PMTA regulations after July 13th.

However, Congress has clearly stated that products that have not timely submitted PMTA have no ongoing marketing ability and authorize the FDA to take immediate action. The VTA has repeatedly conveyed to the FDA that it needs to actively remove all tobacco products that have not submitted PMTA from the market and publish a list of all products covered by synthetic nicotine PMTA, so that retailers know which products they can sell.

A thorough and comprehensive evaluation of synthetic nicotine PMTA is needed.

We live in a world that is still held captive by combustible cigarettes. While Congress has yet to prohibit their use, it has prevented the FDA from doing so. While electronic nicotine delivery systems (ENDS) offer a technological solution for delivering nicotine in a much less harmful way, synthetic nicotine is now the first technological innovation for nicotine itself.

Synthetic nicotine offers consumers a clean and pure form of nicotine without heavy metals, nitrosamines, and pesticides. Its unique properties allow consumers the opportunity to avoid tobacco plant residue.

Synthetic nicotine provides the FDA with unprecedented clarity, reproducibility, and traceability in product composition. It not only removes the dependence on tobacco for nicotine extraction in all tobacco and nicotine drug products, but also enables companies to pursue their sustainability ESG goals while taking significant steps to mitigate the negative impact of tobacco on the environment.

Our message to the FDA is both constructive and explicit: for adult smokers, the FDA must take proactive steps to create an orderly and regulated market for a variety of ideal nicotine alternatives.

Given the history of PMTA derived from tobacco, the best way for the FDA to achieve this goal is to avoid making broad and misleading statements that could lead the institution into prolonged litigation. Such legal battles will only delay progress until we establish a regulated and orderly market.

Instead, we are requesting that the FDA timely process the synthetic nicotine PMTA applications submitted by responsible companies through the scientific process and provide them with the necessary time and guidance to meet FDA requirements.

Meanwhile, we are urging the FDA to actively crack down on non-compliant companies that refuse to participate in the PMTA process, intercepting such products at the border and removing them from the market expressly mandated by Congress.

Finally, the new leadership at the FDA has a responsibility to leverage its power by embracing scientific innovation, stimulating additional financial investment, expediting authorization for pending tobacco-derived PMTAs, and ensuring that adult smokers have access to the cleanest and purest synthetic nicotine products, thereby creating a well-regulated market.

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