The FDA’s Regulations Aren’t Final–Yet. But Smart Vape Space Business Owners are Gearing Up For What’s to Come in Early 2016.
By Maria Verven
The FDA is coming. Make no mistake. But what it means to vape business owners is a matter of much confusion.
The industry has been collectively holding its breath since April 2014 when the FDA first proposed its “Deeming Regulation.” After they published their first draft last summer, the FDA received no shortage of comments; more than 135,000 vape business owners, vapers and advocates weighed in.
In October, the FDA submitted its final version of the regulation to the Office of Management and Budget (OMB), the executive arm of the White House charged with reviewing the proposed rules. Industry advocates like Norm Bour of VapeMentors are meeting with the OMB to discuss the impact their proposed reg could have on thousands of small business owners, potentially putting many of them out of business.
“The economic loss in this industry could be devastating,” Bour, founder and president of VapeMentors, said. “While we don’t have exact numbers, we estimate there are at least 7,500 retail shops and 8,000 e-liquid companies whose businesses would be negatively impacted if this reg passes as is,” he said.
“Companies already are gearing up to challenge the FDA in court if the Deeming Regulation is finalized,” Azim Chowdhury, partner and head of the e-cigarette/vape business practice at Keller and Heckman in Washington, D.C., said.
Chowdhury represents a number of stakeholders in the e-vapor industry, including the Right to be Smoke-Free Coalition (R2bsmokefree.org), an organization of major e-liquid companies that are challenging the law passed in Indiana that will effectively ban e-liquids beginning July 2016.
Still Categorized as a Tobacco Product
A key principle of the FDA’s approach is that they will be regulating e-cigarettes and vape products as tobacco products. Initially, the FDA sought to regulate them as drug delivery devices, but in 2010, the D.C. Circuit Court of Appeals ruled in favor of Sottera, Inc. (NJOY) and other manufacturers, agreeing with the plaintiffs that e-cigarettes are not drugs if they contain nicotine derived from tobacco and do not make any disease or “therapeutic” claims.
But, that decision also painted e-cigarettes and VTMs (vapors, tanks and mods) into the same corner as tobacco products, since most contain nicotine derived from tobacco and are not marketed as smoking cessation devices–nor should they be.
“It’s still critical to not market your products as smoking cessation devices, since that would put you in the category of an unapproved drug,” Chowdhury said.
How the FDA’s Reg Will Impact Businesses
While there’s been a lot of speculation on what’s in the final reg, and the table of contents was even leaked to a trade association, there may be some surprises in store.
“The Deeming Regulation won’t impose the types of guidelines you might think,” Chowdhury said. “It’s not going to have clean room requirements. It’s not going to outright prohibit any particular ingredients or set a maximum nicotine level in your e-liquids. It’s not even going to require the use of child-resistant packaging, ban flavors or prevent online sales. Those types of regulations and standards will come later,” he said. “The point of the Deeming Regulation is to bring all current and future tobacco products within
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FDA’s authority, and to retroactively apply the premarket authorization requirements to new products first marketed or modified after Feb. 15, 2007.”
So in theory, anything that wasn’t on the market before Feb. 15, 2007 could be effectively banned until it’s authorized for sale by the FDA, unless it’s “substantially equivalent” to a product that was sold before this grandfather date.
As of this writing, it appears that the FDA will require businesses to submit a premarket tobacco application (PMTA) for virtually every product and e-liquid they sell. Of course, the e-cigarette and VTM (vapors, tanks and mods) market has changed and improved dramatically since 2007, so this would affect nearly every business that’s kept pace with the market.
“They’re taking a one-size-fits-all approach, at least in the proposed regulation,” Chowdhury said. “They’re subjecting all vapor products containing nicotine derived from tobacco to the same requirements that currently apply to cigarettes, without making any real distinctions from those more harmful tobacco products.”
Mitch Zeller, J.D., director of the FDA’s Center for Tobacco Products said in a Nov. 10 news release: “The law is clear. The premarket tobacco application process is a viable pathway under which products can be marketed as long as the public health can be protected. As manufacturers seek to market new tobacco products, the FDA will remain committed to upholding the important public health standards under the law.”
Under the PMTA process, manufacturers must demonstrate that marketing the new tobacco product would be appropriate for the protection of the public health. The FDA will consider the risks and benefits to the population as a whole, including both users and non-users of tobacco products, and will review the product’s components, ingredients, additives and health risks as well as how the product is manufactured, packaged and labeled. Since the FDA considers all tobacco products to be potentially harmful and addictive, the PMTA review also considers if non-tobacco users could start using these products and the likelihood that existing tobacco product users could stop using them.
Vape Shops, Listen Up
Historically, the FDA has exercised relatively little regulatory control over tobacco retailers, leaving their surveillance and enforcement mostly up to state and local authorities. Vape shops that simply sell branded products and don’t modify, re-label or repackage products will not be considered a manufacturer. They’re off the hook in terms of the major requirements that apply to manufacturers, but still have to comply with retailer requirements such as ensuring they aren’t selling to minors. They will also need to make certain that the products they sell comply with label requirements such as listing all ingredients and including requisite warning language.
All tobacco products must be kept behind the counter, and sampling of e-liquid flavors will be prohibited. Consumers won’t be able to walk into a vape shop and pick up a device or try several flavors. However, sampling may possibly be allowed if the flavor samples don’t contain any nicotine.
In the future, retailers will have to make sure they only sell products authorized by the FDA through the PMTA process and their shops may be subject to FDA inspection. But, the biggest issue for vape shops is that they won’t have many products to sell if the FDA’s regulation puts most e-liquid companies out of business.
Manufacturers, Be Forewarned.
Any company making e-liquids or putting vape components together for customers will be considered a manufacturer. As defined in the Tobacco Control Act, a manufacturer is anyone who manufactures, fabricates, assembles, processes or labels a tobacco product or imports the finished tobacco product for sale or distribution in the U.S. Manufacturers will be subject to the adulteration and misbranding provision of the Tobacco Act.
“Adulterated” generally refers to quality control, and e-liquid makers will need to develop a reliable process to ensure the product is made in a safe and clean manner and does not contain poisonous or deleterious substances. “Misbranded” refers to products bearing false or mislabeled package labels or products that are advertised in a false or misleading manner.
Anyone creating or mixing and branding e-liquids will likely have to submit an ingredient list to FDA, including any flavors, compounds and additives such as PG and VG.
“Ultimately, you’re going to have to identify the sub-components of the flavors because that’s really what the FDA is concerned about when it comes to e-liquid safety,” Chowdhury said.
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He advised talking with flavor suppliers now to let them know they will need to submit their flavor formulas to the FDA or be willing to provide their proprietary formulations to customers under non-disclosure agreements (NDAs).
E-liquid manufacturers also will be required to test their e-liquids for anything the FDA considers to be a harmful or potentially harmful constituents (HPHC) when inhaled or absorbed. In 2012, the FDA published a list of 93 HPHC substances; while diacetyl is not listed, it could easily make the list when the FDA looks more closely at e-liquid ingredients. Ensuring the accuracy of e-liquid nicotine levels will also be critical.
“We’re dealing with a very dangerous substance in its concentrated form. The biggest risk for companies is if an undiluted nicotine base escaped the plant and got vaped, it could kill someone,” Dennis Moore, a former FDA investigator and president of Chemular, an all-in-one solution company for the e-liquid industry that develops FDA-style batch records, procedures and QA checking processes for e-liquid companies, said.
“Some version of the PMTA is probably going to exist, even though we’re all hoping for a lesser version than what’s been promulgated so far,” Moore said. “But no matter what FDA does and even if there’s a two-year window before you have to comply, adopting quality processes will not only give you some FDA compliance advantage, but some liability protection as well.”
Chemular uses a tiered approach with its clients, creating an overall quality manual and written processes and procedures. “We took the knowledge we gleaned from creating processes for multi-billion dollar drug firms and boiled it down to something doable for a vape shop or e-liquid operator,” Moore said. “So if someone claims they were injured by your product, you have documentation to show what you did and why it was as safe as possible when you released it.”
A Final Note
Keller and Heckman also has scientific staff with more than 20 staff scientists, toxicologists and chemists, many of whom were formerly with FDA who represent clients in preparing protocols that meet FDA standards.
“Although we’re probably some time away from seeing any specific e-liquid standards, to be smart and responsible, you’ll want to get the proper clean room facilities set up and begin the process of working with reputable laboratories and scientists to determine the levels of these substances in your products,” Chowdhury said.
He said the FDA realizes that subjecting every e-liquid and vape product developed after Feb. 15, 2007 to the PMTA process all at the same time would pretty much shut down the industry. He expects there will be a two-year grace period after the rule is made final to submit a PMTA to the FDA.
“That may sound like a long time, but two years may not be enough time for many companies to develop all the data they need to get through the PMTA process because of how high the standards will be,” he said. “Companies with clean room standards that register their facility, identify the safety of their ingredients, accurately determine the ingredients and level of nicotine in their liquids and use packaging that’s safe and doesn’t target minors will have a better chance of getting through the PMTA process.”
The original Vaping Vamp, Maria Verven is partner and chief marketing mentor of VapeMentors.com.