Last updated on August 19th, 2015
E-Cigarette Advocates Warn FDA Regulations Can Stifle E-Cigarette Innovations and Destroy Small and New Companies
April 24th, 2014 is going to be remembered as day that will live in ecig history, but it has been both celebrated and criticized by ecig supporters.
Here’s The Best Part
The proposed legislations received some favorable feedback from the electronic cigarette industry and vapers. Many who feared extreme regulations including restrictions on the sale of eliquid flavors, ecig advertising and on-line sales were relieved that they will NOT be restricted, although sales to Americans under the age of 18 will not be permitted.
The Rest of the Story
One of the most controversial talking points within the proposal outlines the importance of scientific evidence over rhetoric when determining product safety.
Mitch Zeller, director of the FDA’s Center for Tobacco Products says the new proposed regulations are just the first step.
“For the first time, there will be a science-based, independent regulatory agency playing a vital gate-keeping function…When finalized, (the proposal) would result in significant public health benefits, including through reducing sales to youth, helping to correct consumer misperceptions, preventing misleading health claims and preventing new products from entering the market without scientific review by FDA.”
The Consumer Advocates for Smoke-Free Alternatives Association (CASAA) strongly believes the proposed regulations would create more confusion. In a recent press release Director Julie Woessner noted,
“There is no evidence that consumers are misinformed. But even if they are misinformed, there is no apparent way the proposed restrictions would change that. Indeed, we believe the proposed regulations would increase confusion.”
Is the Gate Keeper Playing Fair?
While the need for more scientific evidence (from both sides) is indicated by the Agency and bans have been avoided, these seemingly positive points detract from the fine print within the 241 page document. The FDA is demanding a strict product review process of all ecigarette products produced after 2007 that could wipe out small and new ecigarette and eliquid companies along with ecig innovation.
E-cigarette supporters, small business owners and many savvy vapers are also concerned that e-cigarettes (including ecigarette liquids and hardware) are considered to be tobacco products even though they do not contain tobacco.
Here’s the Fine Print
1- Electronic Cigarette products that were already on the market as of February 2007 will be permitted to be sold without review, although the FDA could hypothetically order them off the market. There are very few products that were produced by this early date and they had many flaws.
2. For products introduced between February 2007 and March 2011 producers must submit application for provisional review. Companies will be allowed to continue selling their products while the FDA reviews them.
3. Since March 2011, all new products must receive FDA approval before being sold.
This looks positive as it implies all e-cigarette products must prove that they are designed to be safe, but the fact is all ecig producers whose products were introduced after 2007 must submit an extremely burdensome amount of data which would entail considerable labor and costs. Small companies could be put out of business or they will be bought out by the big tobacco companies.
CASAA Predicts the Worst
The consumer advocate group believes the FDA is incapable of fairly evaluating product safety.
“They (the FDA) declare that their application process for allowing new or “substantially equivalent” products onto the market protects good products and eliminates bad ones. But there is no evidence that their process actually accomplishes this. Moreover, that process is hopelessly backlogged merely trying to regulate cigarettes and smokeless tobacco; they will be even less capable of dealing with applications about far more complicated and varying e-cigarettes. FDA actions, discussions, and statements about the approval process strongly suggest that for manufacturers to get filings approved, they will have to provide information that is next-to-impossible to produce.”
Show Me the Good News
The good news is that CASAA will fight long and hard to save the e-cigarette industry. They are preparing a detailed response that will point out the flaws in the proposed regulations. Should that fail, they plan to fight the regulations in court.
Dr. Gilbert Ross of the American Council on Science and Health (ACSH) notes that for as long as it takes the FDA to plow through and review thousands of applications (which will take 3-4 years), you’ll be able to buy your favorite e-cigarette products in stores and on-line. Smokers know e-cigarettes offer health advantages (despite the fact that the FDA won't permit ecig companies to make those claims) and ecig sales will continue to grow.
Of course, some of your favorite e-cigarette products (those manufactured by small companies) may choose to go out of business right away rather than incur the expenses of submitting product reports for FDA approval. They may be happy to be taken over by larger e-cig or tobacco companies which could compromise the quality their products.
What Can Vapers Do?
Vapers who fear the worst can buy up and stockpile their favorite vaporizors, clearomizers and eliquids before those innovative companies go out of business, but we admit that's a bit of a drastic solution. Here are a few others.
You can take action by signing a White House Petition that vetos the FDA proposed legislation demanding lengthy, expensive applications for putting new innovative e-cigarette products on the market. The petition also demands that the FDA remove classifying e-cigarettes as a “Tobacco Product” noting that they do not in fact contain tobacco. Although most ecig products contain nicotine, they should not be singled out as being different from many foods (such as tomatoes and eggplant) which also contain nicotine.
Cloud Nine will follow up as CASAA is scheduled to release their formal Call to Action detailing how the proposed regulations affect consumers along with suggested actions so that consumers can respond most effectively. In the meantime, vape on.