Audacity by federal policy makers can be admirable, at least in some cases, but it can a bit more problematic in others. A case in point is the Food and Drug Administration's "deeming” of the internet to be a tobacco product.
The FDA explained that it was exercising its authority under the Family Smoking Prevention and Tobacco Control Act which gave the agency an extensive set of duties, responsibilities and authorities over "tobacco products." The law passed by Congress and signed by the President helpfully suggested to FDA that "tobacco products" are "any product made or derived from tobacco that is intended for human consumption, including any component, part, or accessory of a tobacco product (except for raw materials other than tobacco used in manufacturing a component, part, or accessory of a tobacco product)."
The FDA loved Congress' definition of tobacco products so much that it made it the basis of its establishing regulatory control over the internet and everything attached to it. In its Deeming Rule, the FDA made the regulatory determination that e-cigarettes are tobacco products and thus subject to the same regulations as any other tobacco product. There were some objections to the FDA's rule when it was proposed on the grounds that the metal tubes and batteries and buttons and bits and so forth that constitute an e-cigarette are not made of tobacco nor are they intended for human consumption. It was even noted to the agency that there are nicotine-containing e-liquids which have no tobacco in their provenance.
The FDA disagreed stating, that a "'tobacco product' includes any product made or derived from tobacco, including any component, part, or accessory of a tobacco product. An eliquid made or derived from tobacco meets this definition and, therefore, is subject to FDA's chapter IX authorities. E-liquids that do not contain nicotine or other substances derived from tobacco may still be components or parts and, therefore, subject to FDA's tobacco control authorities, if they are an assembly of materials intended or reasonably expected to be used with or for the human consumption of a tobacco product and do not meet the definition of accessory."
All manner of tobacco containing and tobacco derived products and components and parts or accessories and so forth along with vast amounts of information, some accurate, about every aspect of tobacco containing and tobacco derived products and components and parts or accessories and so forth are available over the internet. Does this mean that the FDA gets to regulate the internet as a tobacco product? The FDA asserted the extent of its authority over tobacco products in stating that "'tobacco product'. . . includes all components, parts, and accessories of tobacco products. . . ."
The FDA revealed what may be the beginning of its interpretation of its authority when it noted that the "FDA interprets components and parts of a tobacco product to include any assembly of materials intended or reasonably expected: (1) To alter or affect the tobacco product's performance, composition, constituents or characteristics; or (2) to be used with or for the human consumption of a tobacco product. Both e-cigarettes and pipes meet this definition. Thus, such products are subject to FDA's chapter IX authorities as a result of this rule.
There are already Bluetooth-enabled e-cigarettes on the market which connect the vaping device to the consumer's smartphone via the internet. Based on advertising, it appears that that the vaping apps may help alter the user's vaping experience. Thus, it appears that, because the internet's metal tubes and batteries and buttons and bits and so forth allow consumers to affect an e-cigarette's performance, these metal tubes and batteries and buttons and bits and so forth meet the FDA's definition of a tobacco product and are, at least potentially, subject to its regulatory jurisdiction.
On one hand, there is a certain sort of appeal to the notion that everything that passes over the internet should be fit for human consumption. On the other hand, unbounded regulatory authority can lead to unbounded mischief. What steps will the FDA take next in regulating the internet? If the Deeming Rule survives its various legal challenges, we'll get to find out.
Written by Bruce Levinson, SVP, Regulatory Intervention - Center for Regulatory Effectiveness