FDA Announces Regulations of E - Cigarette Market

Last week the Food and Drug Administration (FDA) released a series of regulations on the e-cigarette market designed to curb sales to minors and promote public health.  The e-cigarette market, which up until now has been largely unregulated, will now be forced to transition given the new federal oversight of manufacture and sale of the products.  While proponents of the law celebrate the focus on public safety, opponents caution that e-cigarette regulations will benefit Big Tobacco by eliminating small players in the market.

FDA Regulates E-Cigarettes

In a written notice published on its official website, the FDA announced plans to regulate the growing e-cigarette market by stating, “As part of its goal to improve public health and protect future generations from the risks of tobacco use, the FDA has extended its authority to cover all products that meet the definition of a tobacco product.”  The thrust of the FDA’s regulation targets the manufacture of electronic nicotine delivery systems (ENDS), and the sale of such products to minors under the age of 18.  The regulations require e-cigarette manufacturers:

  • Register manufacturing establishments and providing product listings to the FDA;
  • Report ingredients, and harmful and potentially harmful constituents;
  • Undergo premarket review and authorization of new tobacco products by the FDA;
  • Place health warnings on product packages and advertisements; and
  • Not sell modified risk tobacco products (including those described as “light,” “low,” or “mild”) unless authorized by the FDA.

Additionally, sellers of ENDS products must take the following actions designed to limit access of e-cigarettes to youth:

  • Not sell products to persons under the age of 18 years (both in-person and online);
  • Obtain age verification by photo ID;
  • Not sell tobacco products in vending machines (unless in an adult-only facility); and
  • Not distribute free samples.

The rules go into effect on August 8th, 2016, and will allow the FDA regulative authority over e-cigarettes, pipe tobacco, hookah tobacco, cigars, and any other present or future nicotine delivery system.

Support for E – Cigarette Regulation

The FDA’s entry in to the ENDS market comes under the banner of public safety, and has been welcomed by advocates who have expressed concern about the unknown consequences of e – cigarettes and other forms of nicotine consumption which have previously fallen outside the purview of the federal government.  Use of e-cigarettes has expanded among smokers trying to quit regular cigarettes and non-smokers who prefer a safer alternative to traditional tobacco, with statistics suggesting dramatic increases in use for e-cigarettes and other non-traditional forms of tobacco, such as hookah, over the past five years, sparking concern that potentially harmful products are being used by millions of Americans who are unaware of the consequences.

To date, studies by independent groups and the FDA have not provided a complete picture on the risks of ENDS products, but in 2009 the FDA found some levels of carcinogens in a small sample of e-cigarettes, and research suggests that teens who experiment with ENDS products are more likely to try traditional cigarettes.  In 2010, a federal judge dismissed evidence against the use of e-cigarettes for the FDA’s failure to show the products harmed anyone, and the matter of how dangerous ENDS products are remains a source of debate.

Supporters of ENDS regulation argue that allowing the FDA access to manufacturing and sale of the products will provide more clear details about the consequences associated with e-cigarettes, and limit teen access to a potential gateway product which could lead to increased use of traditional cigarettes.

Opposition Criticizes Scope of FDA Regulation

On the other side of the debate, health experts and free market economists argue that ENDS products such as e-cigarettes have public health benefits as an alternative to traditional cigarette use, and the FDA’s expansive regulations will eliminate small players from the market and create more profits for Big Tobacco, which has already entered the e-cigarette game.  Proponents of e-cigarette use argue that despite potential consequences, ENDS products are safer than traditional tobacco consumption and excessive regulations could make it more difficult for smokers to transition to less dangerous substances.

The ENDS business community has expressed concern that regulations on e-cigarettes and other non-traditional forms of tobacco will make it prohibitively expensive for small players to continue operations in the market, leaving only Big Tobacco companies, who have already started manufacturing e-cigarettes, left.  With a highly regulated and uncompetitive market, the price of ENDS products could skyrocket with large tobacco companies reigning supreme as the only beneficiaries to the FDA’s newly announced activity. 

Despite concerns about the new FDA regulations, the agency is committed to putting a stop to the unregulated ENDS market by inserting itself into the manufacture and sale of e-cigarettes and other forms of non-traditional tobacco consumption.  Opponents of the action may resort to legal challenge should the regulations appear too restrictive, but for the time being the FDA intends to move forward with its aggressive regulation of ENDS products starting in August of this year.

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