The vaping industry is generally recognized as a disruptive innovation reaching the global marketplace in a very short time. In fact, the French Interprofessional Vaping Federation, estimates the number of vapers at 25 million worldwide raising concerns about the safety of vaping.
In 2015, France introduced the first voluntary standard to improve the safety of electronic cigarettes and e-liquids. Many other countries have since published standards to address growing safety concerns and to provide minimum expectations to manufacturers, as well as reassurance both to regulators and the public that product safety and quality is maintained across batches and can be reliably demonstrated with documentary evidence.
ISO, the International Organization for Standardization is an international standard-setting body composed of representatives from 165 national standards organizations. The organization has established a new ISO subcommittee, ISO/TC 126, Tobacco and tobacco products, SC 3, Vape and vapour products, and will hold its first meeting during the week of 24 October 2016 in Osaka, Japan to focus on safety and quality requirements for electronic cigarette devices and e-liquids, as well as test methods, dosage of substances, testing conditions, equipment, reference products, emissions, vaping machines, and robots, and user instructions.
ISO expects to publish the standard in 2018. Seventeen standards bodies around the world are participating on the subcommittee, including:
France (AFNOR) *Secretariat
|Korea, Republic of (KATS)
United Kingdom (BSI)
United States (ANSI)
The development of a global standard is very good news for the vaping industry, because it’s a step closer to harmonizing the inconsistencies on the international landscape, making it easier to comply with regulatory requirements around the world. All of the standards echo the same concerns expressed in emerging regulations, such as Directive 2014/40/EU, Article 20 (EU/TPD) which becomes effective on May 20, 2016.
Despite the US House Appropriations Committee vote (31-19) this month to exempt e-cigarettes and other vapor products on the market from FDA’s “deeming rule,” products that come to market 21 months after FDA's final rule will be subject to the submission requirements. Contrary to popular belief, this victory for the vaping industry doesn’t mean the products are exempt from regulation. The final rule, which is expected shortly, will restrict advertising of vapor products, limiting advertising to newspapers, magazines and other print publications read by adults.
The final rule will also prohibit internet / mail order and vending machine sales, unless the retailer can ensure that minors cannot access the products. This will require documented validation testing of the systems used to verify the age of the customer. FDA will also issue a rule on quality standards for e-liquids and additional warning labeling.
In addition to product, packaging and labeling, and reporting requirements, the EU/TPD, FDA’s proposed rule, and virtually every regulation on e-cigarettes ultimately require that a manufacturer's e-liquids products sold on the market are consistent. In other words, like the standards, regulators expect that safety and quality is maintained across batches.
Manufacturers of e-liquids will need to demonstrate that they have sufficient controls over their suppliers and their own processes in order to produce consistent products. ISO 9001 is the global benchmark for establishing a quality management system, providing the framework for producing consistent e-liquids products.
ISO 9001 certification provides the assurance to customers and regulators that the product meets not only their own specifications, but the regulatory requirements specific to the regions in which the e-liquids are marketed, consistently. ISO 9001 certification will provide a competitive advantage, as customers will begin to require ISO certification for their contract manufacturers in light of the new regulations.
These emerging regulations and standards will force e-liquids manufacturers to examine their strategic plans closely, as the barriers to entry introduce a significant increase in the cost to market. Manufacturers will become far more selective about where to distribute products, and many will not be able to handle the financial burden regulations impose on businesses.
E-liquids manufacturers should examine their approach to governance, contractual relationships with customers, and interested parties in light of government regulations, changes in the law, and how these laws affect competition. Conduct an external analysis using “PEST” (political, economic, social, technological) and SWOT (strengths, weaknesses, opportunities, threats) analyses to gain a better understanding of the context of the organization and its capabilities, and how the emerging regulations impact the business. Implement systems establishing standards for manufacturing practices, nicotine purity, lot tracking, batch records, corrective and preventive action, recalls, complaint handling and monitoring / reporting data. Then, begin conducting testing, toxicological analysis, and preparation of technical documentation to enter their products in the marketplace.