The Food and Drug Administration’s e-cigarette regulations, which took effect this week, immediately struck two blows against public health. As of Monday, companies that sell vaping equipment and the fluids that fill them are forbidden to share potentially lifesaving information about those products with their customers. They are also forbidden to make their products safer, more convenient, or more pleasant to use.
The FDA’s censorship and its ban on innovation will discourage smokers from switching to vaping, even though that switch would dramatically reduce the health risks they face. That effect will be compounded by the FDA’s requirement that manufacturers obtain its approval for any vaping products they want to keep on the market for longer than two years. The cost of meeting that requirement will force many companies out of business and force those that remain to shrink their offerings, dramatically reducing competition and variety.
All of this is unambiguously bad for consumers and bad for public health. Yet the FDA took none of it into account when it estimated the costs imposed by its regulations, simply assuming that good intentions would ensure good results.
Although preventing fraud is the official intent of the FDA’s speech restrictions, the agency’s rules prohibit statements that are accurate and highly relevant to consumers choosing between smoking and vaping. Nicopure, one of the companies that is challenging the FDA’s regulations in federal court, used to tell consumers that in vaping “nothing is burned,” “no smoke is released,” and “no ash” is generated. It also noted that the aerosol produced by e-cigarettes contains “no tar” and only “a fraction of the 4000 chemicals currently found in standard tobacco cigarettes.” Although all of these statements are indisputably true, they are illegal under the FDA’s reading of the Family Smoking Prevention and Tobacco Control Act.
That law gave the FDA authority over tobacco products, a category to which it has arbitrarily assigned tobacco-free e-cigarettes, even when they contain nicotine that is not derived from tobacco or no nicotine at all. The Tobacco Control Act prohibits unapproved “modified risk” claims, including any “explicit or implicit representation that [a] tobacco product or its smoke does not contain or is free of a substance or contains a reduced level of a substance, or presents a reduced exposure to a substance in tobacco smoke.” According to the FDA, that means e-cigarette companies are not allowed to advertise the main advantage of their products. Even describing an e-cigarette as “smokeless” or “smoke-free” is asking for trouble, since “the Agency will evaluate an [e-cigarette] manufacturer’s use of ‘smokeless’ or ‘smoke-free’ (and similar descriptive terms) on a case-by-case basis.”