On May 16, the Republican-controlled House Appropriations Committee pushed forward its 2019 government spending bill which includes fiscal budgeting for the FDA and other federal agencies. Included in the legislative proposal is a newly revised version of the Cole-Bishop Amendment, an updated version that is mysteriously lacking its original cornerstone issue. The 2019 document essentially excludes vaping products, which means that the current 2007 predicate date will theoretically remain in place for the foreseeable future.
At least, for the vaping industry, that is.
Even more alarming is the fact that the 2019 Cole-Bishop provides specific relief from the predicate date to sectors of Big Tobacco, namely manufacturers of cigars and pipe tobacco. Meanwhile, one section specifically takes aim at batteries and e-liquid flavors used in vaping devices.
(a) Notwithstanding any other provision of law, not later than 21 months after the date of enactment of this Act, the Secretary of Health and Human Services shall issue a notice of proposed rulemaking to establish a product standard for vapor products pursuant to section 907 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 387g) to include but not be limited to—
(b) Notwithstanding any other provision of law, not later than 36 months after the date of enactment of this Act, the Secretary shall promulgate a final rule pursuant to such notice.”
Reports of kid-friendly e-liquids and exploding vaping devices circulating on mainstream and social media in recent years have likely contributed to the revisions in the 2019 Cole-Bishop Amendment. The new document is about 12-pages in length, two of which seem to provide help to the cigar and pipe tobacco industry. The other 10-pages introduce several new and unnecessary anti-vaping regulations.
The New Cole-Bishop: Biometric requirements for vaping
One of the more bizarre entries involves the requirement for the FDA to conduct a study on the potential public health benefits of biometric security protocols on vaping technology. The theory seems to be that e-cigarettes designed with FDA-required retina-scanning and/or fingerprint reading technology would reduce or eliminate underage vaping. Other key changes to the 2019 Cole-Bishop Amendment include the following.
- All vape shops and retail establishments selling vaping products must register with the Department of Health and Human Resources, the parent-agency of the FDA.
- The FDA must establish product standards for both e-liquid flavors and batteries used in vaping technology.
- Self-service purchasing of vaping products is prohibited.
- Almost all forms of vaping advertising will be restricted, with exceptions for adult-only establishments and publications.
- New labeling requirements will include such notations as “Underage Sale Prohibited” and “Keep out of reach of children.”
- Accurate nicotine concentrations must be clearly displayed on all e-liquids.
- The new version bans vaping in schools, libraries, day-care facilities, and any location as specified in the Pro-Children Act of 1994.
- Age verification will be required for remote purchases.
- The FDA will receive $50 million to establish, manage, and maintain a “Youth Vapor Product Education, Prevention, and Enforcement Program.”
- The program must be in effect within 180-days of the passage of the Cole-Bishop Amendment by both houses of congress.
- An “Enforcement Program” must also be included which will engage in consumer outreach and education regarding underage vaping and other related issues.
- Other financial grants may be awarded to schools and non-profits like the Campaign For Tobacco Free Kids - a notoriously anti-vaping group which has been very successful in spreading misinformation regarding “vaping as a gateway to teen smoking.”
- Regarding biometric technology, the FDA must research the following:
- Potential costs and public health benefits
- Potential effectiveness of biometrics in preventing underage vaping.
- Alternative technologies and solutions which may prevent underage vaping.
The original bill co-sponsored by Congressmen Tom Cole (R-OK) and Sanford Bishop (D-GA) was intended to provide significant relief to the American vaping industry by way of changing the 2007 predicate date of the FDA deeming regulations. This new version is decidedly anti-vaping in almost every way. How did we get to this point?
Vaping advocacy groups like The Smoke-Free Alternatives Trade Association (SFATA) are continuing the fight to save vaping, but vapers should be doing their part, too. The 2019 Cole-Bishop must still be approved by a full-House vote before proceeding to the Senate where additional tweaks and revisions will likely take place.
There is still time to win this battle, but vapers must act now. A mid-June vote is expected in the House for the Cole-Bishop Amendment. The time to contact your state representatives has never been more urgent!
Related Article: 5 Ways to save vaping and STOP an FDA flavor ban before it begins