FDA Threatens Trying New Flavors With New Guidance

Carl V. Phillips | Contributor

The FDA’s deeming of vapor products as tobacco products subjects U.S. merchants to a host of regulations that were designed for cigarettes and smokeless tobacco. The FDA has slowly been clarifying these in “guidance” documents, the latest of which is “The Prohibition of Distributing Free Samples of Tobacco Products.” While this guidance is technically about all products, it is clearly directed at vapor products (and to a lesser extent, cigars) since the rules for cigarettes and smokeless tobacco were already clear. However, this guidance just leaves vape shops waiting for the other shoe to drop.

Some FDA tobacco rules are easily transferrable to the much more complex vapor product market, such as purchaser age restrictions. Others are far more difficult for vapor product manufacturers to comply with, such as registering every product they sell. Some rules can have completely different impacts, the most extreme example being the 2007 “predicate date” that allows traditional products to stay on the market but (eventually) will subject every vapor product to a prohibitively expensive and uncertain approval products.

Bans on free samples are another such example. These bans are almost always presented as a way to prevent marketing to children. Really they are about reducing options for marketing to anyone who does not already buy the product, adult or child. The rules do not prohibit, for example, someone who is already buying a tobacco product from getting a second package free with purchase. Unlike most of tobacco control’s “think of the children!” appeals, this one does have factual legitimacy (whatever one might think of the political or ethical legitimacy). Marketers of many products know free samples are an effective way to get someone to try a product they never would have bought.

But for vape shops, offering a “free sample” includes something quite different, the chance to try a puff or two of some of the myriad flavors of e-liquid before buying a bottle. A cigarette consumer who wants to try a new brand could benefit a bit from a sample. But committing to a whole pack is not really a big deal because the differences among products are really not huge. But e-liquid flavors vary wildly, which is much of the category’s appeal, and buying a new flavor entails greater uncertainty. This is especially true for smokers who are considering switching to vaping and have no idea what flavor they might like.

Thus vape shops, vapers, and advocates have waited with trepidation to find out if FDA would ban flavor sampling. The new guidance does not actually answer the question.

[Disclaimer: Nothing in this article should be taken as legal advice. This is simply news and analysis.]

Unlike FDA guidances about application processes (e.g., for new or “substantially equivalent” tobacco products), which appear to be intended to confuse and create uncertainty, the new guidance is quite clear. This might be a sign of what some believe is the new-and-improved FDA Center for Tobacco Products, though more likely it is just because these rules have been honed by experience.

The single statement that maintains the ambiguity is, “The focus of this guidance is free samples that are not distributed in a ‘qualified adult only facility.’” The context here is that FDA allows free sample of smokeless tobacco products in venues that meet their adult-only requirements, notably including verifying all customers are at least 18 years old. There is no explicit statement that the new guidance does not apply to adult-only facilities, but that is the obvious interpretation.

If the new guidance applied to vape shops (and it does seem to apply to any shops that, for some reason, are not adult-only), it appears it would prohibit flavor sampling or perhaps allow it only as a series of small purchases. This includes zero-nicotine liquid since that is a tobacco product under current FDA rules (there is a court challenge to this interpretation of the law, but it has been unsuccessful so far).

Adult-only vape shops are left without a guidance for what rules apply to them. Technically the law and regulations, interpreted somehow, already apply. Guidance documents are merely non-binding clarifications of how the FDA will (probably) interpret existing law and regulation, not the actual rules. Those already exist. FDA has the option of just taking enforcement actions against adult-only vape shops, without first issuing another guidance, though this seems unlikely.

What will the FDA eventually do about free samples adult-only vape shops? They could just issue the same guidance without the apparent exception. They could even just declare that their “the focus of this guidance…” language never actually excluded adult-only venues from the new guidance, despite the obvious interpretation that it does. They could do this immediately if they did not really intend the obvious interpretation, or they could “realize” later that they need to issue such a “clarification.”

The good news is that the smokeless tobacco precedent makes it straightforward for them to choose to apply a similar exception to another low-risk product. The bad news is that precedent is an explicit exception to the bans on free samples (it does not apply to cigarettes). FDA would have to proactively create a similar new rule about vapor products to exempt vape shops from the blanket ban.

Further bad news is that the FDA is hostile to the marketing of all products, regardless of risk, despite being stuck with the adult-only exception for smokeless tobacco. They undoubtedly envision a vape shop or club across the street from a college campus with a sign that says, “Come on in for a free vape!” The adjacent sign that says “no one under 18 permitted” is not going to placate their feelings about this.

A sensible consumer-friendly policy would be to draw a line between flavor sampling and the out-and-out gifting of products to recruit new consumers, which is the point of concern. But tobacco regulations are seldom friendly to consumers. Moreover, the most obvious way to draw a line – between zero-nicotine and nicotine-containing e-liquids – is a threat to the FDA’s dubious position that they have jurisdiction over zero-nicotine liquids.

So despite that one sentence apparently avoiding the worst possible outcome, and despite the existing smokeless tobacco exception, vape shop flavor sampling is still under threat. The other shoe is yet to drop.

Carl V. Phillips

Contributor

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