E-cigarette’s Adoption into the Marketplace and the Impending FDA Tobacco Product Regulations

Since their introduction into the U.S. market in 2006, e-cigarettes have been a growing trend. These battery operated devices are used as a substitute for traditional cigarettes, without many of the known health risks. Instead of burning tobacco, these refillable devices take an innovative spin on an age-old product by using a vaporized nicotine solution, called e-liquid. The e-liquid comes in several flavors and strengths of nicotine including 24 mg, 18 mg, 12 mg, 6mg, and 0mg among others. New York and some other major cities now sport modern e-cigarette lounges, complete with 90+ flavors of e-liquid for purchase.

With market revenue around $2 billion last year their popularity is undeniable. These products are predicted to grow to $3 billion of the $80 billion tobacco industry by 2015, according to Citigroup. Wells Fargo Bank in New York further expects the industry to exceed $10 billion by 2017. While currently the majority of this revenue is gained by new vapor companies, big tobacco has taken notice and is said to be looking to overtake this new market.

This market transformation is a testament to the results that can be gained through effective product innovation and next-gen thinking. However all this could come to a screeching halt depending on the regulatory actions taken by the FDA. Many individuals believe the FDA should have an active role in monitoring the safety of this new genre of cigarettes and have been requesting action from the association since the e-cigarettes first entered the market. Many are concerned about severe nicotine exposure.

In 2012 the National Poison Data System reported 438 cases of nicotine exposure from electronic cigarettes, almost half of these were children under the age of 5. As the e-liquid is highly concentrated, one refill can hold the amount of nicotine equal to that of about two packs of standard cigarettes. This level of nicotine is enough to kill a toddler if ingested.

According to the U.S. Center of Disease Control and Prevention symptoms, over exposure to nicotine can lead to:

• Nausea
• Abdominal pain
• Headache
• Dizziness
• Irregular heartbeat
• Excessive salivation
• Vomiting
• Diarrhea

Some advocates are asking the FDA to demand child-proof devices and that the products be kept behind store counters. Many parents are concerned over the rise in teens using e-cigarettes, and claim that the flavoring options and new alternative packaging forms have a greater appeal to teens then conventional cigarettes. These products are often flavored like fruits or desserts, which leads to concern for some that these items will appeal to minors and create a gateway into tobacco use at a young age.

The FDA received authority to regulate the manufacturing, labeling, distribution and marketing of all tobacco products in 2009 under the Family Smoking Prevention and Tobacco Control Act (Tobacco Act). Although electronic cigarettes are not technically a tobacco product, the nicotine in the product is derived from tobacco. Because of the nicotine’s source, the FDA can deem it necessary for regulation. The FDA stated their intent to classify e-liquids as such a substance in 2011 in a letter on its website. In order to enact any regulatory control however, the FDA must first publish a Notice of Proposed Rulemaking (NPRM) and have it approved by the White House Office of Management and Budget, a process which could take years.

In the meantime the FDA has been monitoring voluntary reports of adverse events thought to be linked to e-cigarettes and has them posted on the e-cigarette page of the FDA website. These reports include pneumonia, congestive heart failure, disorientation, seizure, hypotension, and other health issues. Although whether these symptoms are in any way linked to the e-cigarette liquid is not yet confirmed.

While an exact date of ruling is not confirmed, nor the methods of regulation, it is understood across the industry that regulatory action is eventually inevitable. Without concrete knowledge of the impending regulatory changes, e-cigarette companies are applying their best judgment to manufacturing processes in hopes to keep the momentum of this new market going. Many companies have already improved upon the initial few e-liquid formulations in hopes to have the best product on the market. This drive for competitive edge has had a duplicate benefit in that in order to achieve an optimal formula; manufacturers are attempting to ensure their raw materials’ purity and utilize consistent manufacturing practices – two aspects of the items product development that the FDA will likely scrutinize.

Analytical testing is necessary to support these types of provisions, including creating standardized methods and validation processes to confirm the products consistency over time. Some chemical laboratories offer these services and can provide innovative product development and formula revision services to help e-liquid companies compete in the market with a pure, consistent product. These analyses can also provide the information necessary to properly brand and label these products, avoiding unnecessary scrutiny.

Included in the FDA’s right to regulate tobacco products they can demand controls such as registration, product listing, ingredient listing, good manufacturing practice requirements, user fees for certain products, premarket requirements, and adulteration and misbranding provisions. These demands could require a number of review and certification procedures to be developed in order to gain compliance with these new potential changes.

Avomeen Analytical Services provides testing services on e-liquid products. Our chemists can assist with formulation development, competitor product analyses, as well as method development and validation services for e-cigarette manufacturers. We can assist manufactures at developing internal regulations to ensure that a product maintains a consistent quality level over time. Our laboratories facilities are also FDA-registered, cGMP-compliant, and DEA-licensed.

To speak to a Ph.D. chemist today regarding how Avomeen can ensure your products quality, call 800.930.5450 or email scientist@avomeen.com