It was the 2009 “Family Smoking Prevention and Tobacco Control Act, that gave the Food and Drug Administration (“FDA”) more control over the U.S. tobacco products and the ability to regulate and require e-cigarette testing. As a result, the FDA had introduced regulations deeming e-cigarettes a tobacco product. The major e-cigarette issue is centered around a “grandfather” date that will determine which products can remain on the market and which products will be strictly enforced with stringent regulatory barriers. In April 2014, upcoming FDA regulations for Electronic Nicotine Delivery Systems Systems (ENDS) Testing were released that will change the e-cigarette industry and impact it negatively. The FDA is requiring e-cig manufacturers to introduce the following:
- Warning labels on vaping devices which can include about 4 warnings
- Prohibit sales to minors
- Ban free samples and ban advertising unless approved by the FDA
- Taxing e-cigarettes and vaper devices
- Prohibit vaping even in banned traditional cigarette locations
- Prohibit the flavoring of e-cigs
- Require testing on flavorings & key Ingredients
- General E-cigarette testing for product safety
There isn’t a fixed date when the FDA rules will be enforced. The FDA has given e-cigarette manufacturers two years, which brings us to 2016, to submit their applications, enabling them to sell their products under a review status. Right now, e-cigarette makers are trying hard to convince the FDA differently. The upcoming FDA regulations would affect an estimated 18,000 to 12,000 vaping stores in the U.S. as well as over 1,000 manufacturers and vaping wholesalers.
Despite the statistics stating that many people have given up real tobacco cigarettes for e-cigs and that they are safer than nicotine laden, regular cigarettes, the FDA is bent on restricting vaping and e-cigarette sales. The basis for the FDA enforced regulations is that researchers are still unsure how safe e-cigarette vaping is on the human body. Because vaping is a relatively new industry, the long-term effects are unknown and it is considered that the chemicals used in flavoring e-cigs could – sometime in the future – have dangerous side effects.
Aerosol Research and Engineering Laboratories Inc. (“ARE Labs”) has been working on developing practical solutions for a wide range of aerosol products, like e-cigarettes. ARE Labs and their expert staff, are exceptionally experienced in the fields of aerosol science, aerosol fluid dynamics, and aerobiology overall. To assist in the argument of keeping e-cigarettes and their devices on store shelves, ARE Labs can offer their expert testing and customized studies in developing and testing all e-cigarette and aerosol related products.
ARE Labs can help with specific tests to meet the new pending FDA guidelines for e-cigarette testing:
- Respirable Dose Delivery of Nicotine
- Aerosol Particle Size of other flavoring components
- In-vitro methods to determine bioavailability of delivered nicotine
- Inhalation Toxicity Studies on new Flavorings & Ingredients
- 28-Day subacute Inhalation Toxicity Studies (OECD 412)
- 90-Day subchronic Inhalation Toxicity Studies (OECD 413, 40 CFR 799.9346)
The FDA’s “deeming” rules could be implemented sometime in 2016, requiring e-cigarette manufacturers to submit to a very expensive Pre-Market Tobacco Application process, which could cost each manufacturer between $2-10 million. With these regulatory rules, 99% of the e-cigarette market could face near decimation and have to close down. However, House Bill 2058 amends the FDA’s authority over different tobacco products, which includes e-cigs.
The FDA Deeming Authority Clarification Act of 2015 (“HR 2058”), was created by Representative Tom Cole of Oklahoma. HR 2058 would help the U.S. vapor industry from being destroyed because it would amend the FDA’s grandfathering date and allow most vapor products currently on the market to remain on the market without being subject to a pre-market FDA approval application process.
ARE Labs is not a stranger to the FDA and the EPA. We are a key provider for inhalation toxicology studies for pharmaceutical, biotechnology, chemical and consumer clients. ARE Labs would be glad to help our clients meet the new and demanding requirements for e-cigarette testing by manufactures.
President ARE Labs Inc.