In an effort that Food and Drug Administration (FDA) officials say was motivated by the (Big Brother?) desire “to correct a misperception by consumers that tobacco products not regulated by FDA are safe alternatives to currently regulated tobacco products,” the FDA released proposed regulations yesterday that would regulate the rapidly growing e-cigarette market. (The regulations would also regulate cigars, pipe tobacco, nicotine gels, and hookahs.) The long-awaited proposal would subject the $2 billion industry to federal regulation for the first time. The full text of the proposed regulations are available here. A 75-day public comment period follows.
Calls for Regulation and Basis
Last September, 40 state attorneys general wrote to the FDA asking the agency to take all available measures to issue regulations on the advertising, ingredients, and sale to minors of e-cigs. There has been very little regulation of the industry since its inception– partially because the extent of the FDA’s authority to regulate e-cigarettes is not clearly defined. In 2010, the U.S. Court of Appeals for the D.C. Circuit issued an opinion in Sottera, Inc. v. Food & Drug Administration, affirming the district court’s decision that the FDA could not regulate e-cigarettes as a medical device under the Food, Drug & Cosmetic Act and finding that the FDA’s authority is limited to traditional tobacco products.. Specifically, the Tobacco Control Act authorizes the FDA to regulate “tobacco products,” giving the agency authority to impose restrictions on their sale, advertising and promotions, and establish other standards for their distribution and production. The term “tobacco product” means 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).
E-Cigarettes are Tobacco Products?
The FDA claims that e-cigarettes contain nicotine and thus derive from tobacco. However, the agency acknowledges in its proposed rules that “the health consequences of e-cigarettes are not well understood because of their relatively new entrance into the market.” Despite its questionable authority and a lack of evidence showing a need for regulation, the FDA nevertheless proposes to subject e-cigarettes to regulation similar to cigarettes and other regulated tobacco products. We expect commenters will urge the FDA to support its jurisdiction over the e-cigarette industry with a sufficient statutory basis. However laudable the FDA’s actions to protect the public may be, agencies may obviously only act pursuant to the specific statutory authority granted by Congress.
Under the proposed rules, companies offering e-cigarettes and the other products deemed tobacco products will now be required to register all their products and ingredients with the FDA, though they would not be required to adhere immediately to specific product or quality control standards. Companies would also be required to submit new and existing products to the FDA for approval. They would have two years from the time the rule goes into effect to submit an application to enable their products to continue to stay on the market or to submit a new product application.
The new regulations would require e-cigs to have health warnings on packaging, though initially the only health warning that will be required is a warning regarding the potential for addiction to nicotine. Manufacturers would be able to market new products only after a FDA review, and scientific evidence would need to be provided before any direct or indirect claim can be made of risk reduction associated with their product. Manufacturers would also be prohibited from selling their products at vending machines unless they are in adult-only venues. The proposed rules would prohibit the offering of free samples. The regulations would also require that the minimum age to buy the products be set at 18 years old.
FDA Showing Some Restraint?
Although the FDA proposal is not as broad as the regulations sought by tobacco-control advocates, FDA officials noted that further restrictions may come in the future. At this point the regulations do not seek to ban the use of flavored e-cigs or restrict online sales or advertising. However, the Federal Trade Commission (“FTC”) is closely monitoring marketing and advertisements from the industry and has the ability to take action against companies that it believes are engaging in deceptive advertising. The proposed rules note that the FDA would consult with the FTC to harmonize their requirements for health warnings.
The FDA proposal also leaves many unanswered questions regarding how new products would be regulated in the long term. Under current law, new tobacco products can be approved if they are “substantially equivalent” to a product that was sold prior to February 15, 2007. It is unclear whether any e-cigarettes were on sale prior to that date that can be used as a benchmark. An FDA official said that it would seek more information during the public comment period to determine whether the substantial equivalence test is valid for e-cigarettes.
The recommendations from the FDA that were released today will be followed by a 75-day public comment period after which the regulations will be finalized. The exact time frame for the regulations to be finalized is unclear and the final rulemaking process could alter the regulations that were proposed today. It may be more than a year before the final regulations take effect. Of course, parties are expected to challenge the FDA’s rules in court, which could further delay any new regulations.
We expect numerous, diverse parties will submit comments, including the scientific/medical community, public interest groups, and industry. The e-cigarette industry, representing a new product, would appear to have the most power to influence the outcome of the rules, because even the FDA acknowledges the product has yet to be studied in depth.